Head to head randomized trial of two decision aids for prostate cancer.

BACKGROUND: While many studies have tested the impact of a decision aid (DA) compared to not receiving any DA, far fewer have tested how different types of DAs affect key outcomes such as treatment choice, patient-provider communication, or decision process/satisfaction. This study tested the impact of a complex medical oriented DA compared to a more simplistic decision aid designed to encourage shared decision making in men with clinically localized prostate cancer. METHODS: 1028 men at 4 VA hospitals were recruited after a scheduled prostate biopsy. Participants completed baseline measures and were randomized to receive either a simple or complex DA. Participants were men with clinically localized cancer (N = 285) by biopsy and who completed a baseline survey. Survey measures: baseline (biopsy); immediately prior to seeing the physician for biopsy results (pre- encounter); one week following the physician visit (post-encounter). Outcome measures included treatment preference and treatment received, knowledge, preference for shared decision making, decision making process, and patients' use and satisfaction with the DA. RESULTS: Participants who received the simple DA had greater interest in shared decision making after reading the DA (p = 0.03), found the DA more helpful (p's < 0.01) and were more likely to be considering watchful waiting (p = 0.03) compared to those receiving the complex DA at Time 2. While these differences were present before patients saw their urologists, there was no difference between groups in the treatment patients received. CONCLUSIONS: The simple DA led to increased desire for shared decision making and for less aggressive treatment. However, these differences disappeared following the physician visit, which appeared to change patients' treatment preferences. Trial registration This trial was pre-registered prior to recruitment of participants.

What is lacking in current decision aids on cancer screening?

Recent guidelines on cancer screening have provided not only more screening options but also conflicting recommendations. Thus, patients, with their clinicians' support, must decide whether to get screened, which modality to use, and how often to undergo screening. Decision aids could potentially lead to better shared decision-making regarding screening between the patient and the clinician. A total of 73 decision aids concerning screening for breast, cervical, colorectal, and prostate cancers were reviewed. The goal of this review was to assess the effectiveness of such decision aids, examine areas in need of more research, and determine how the decision aids can be currently applied in the real-world setting. Most studies used sound study designs. Significant variation existed in the setting, theoretical framework, and measured outcomes. Just over one-third of the decision aids included an explicit values clarification. Other than knowledge, little consistency was noted with regard to which patient attributes were measured as outcomes. Few studies actually measured shared decision-making. Little information was available regarding the feasibility and outcomes of integrating decision aids into practice. In this review, the implications for future research, as well as what clinicians can do now to incorporate decision aids into their practice, are discussed.

Decision aid use during post-biopsy consultations for localized prostate cancer.

BACKGROUND: Decision Aids (DAs) effectively translate medical evidence for patients but are not routinely used in clinical practice. Little is known about how DAs are used during patient-clinician encounters. OBJECTIVE: To characterize the content and communicative function of high-quality DAs during diagnostic clinic visits for prostate cancer. PARTICIPANTS: 252 men newly diagnosed with localized prostate cancer who had received a DA, 45 treating physicians at 4 US Veterans Administration urology clinics. METHODS: Qualitative analysis of transcribed audio recordings was used to inductively develop categories capturing content and function of all direct references to DAs (booklet talk). The presence or absence of any booklet talk per transcript was also calculated. RESULTS: Booklet talk occurred in 55% of transcripts. Content focused on surgical procedures (36%); treatment choice (22%); and clarifying risk classification (17%). The most common function of booklet talk was patient corroboration of physicians' explanations (42%), followed by either physician or patient acknowledgement that the patient had the booklet. Codes reflected the absence of DA use for shared decision-making. In regression analysis, predictors of booklet talk were fewer years of patient education (P = .027) and more time in the encounter (P = .027). Patient race, DA type, time reading the DA, physician informing quality and physician age did not predict booklet talk. CONCLUSIONS: Results show that good decision aids, systematically provided to patients, appeared to function not to open up deliberations about how to balance benefits and harms of competing treatments, but rather to allow patients to ask narrow technical questions about recommended treatments.

Decision aids for people facing health treatment or screening decisions.

BACKGROUND: Decision aids are interventions that support patients by making their decisions explicit, providing information about options and associated benefits/harms, and helping clarify congruence between decisions and personal values. OBJECTIVES: To assess the effects of decision aids in people facing treatment or screening decisions. SEARCH METHODS: Updated search (2012 to April 2015) in CENTRAL; MEDLINE; Embase; PsycINFO; and grey literature; includes CINAHL to September 2008. SELECTION CRITERIA: We included published randomized controlled trials comparing decision aids to usual care and/or alternative interventions. For this update, we excluded studies comparing detailed versus simple decision aids. DATA COLLECTION AND ANALYSIS: Two reviewers independently screened citations for inclusion, extracted data, and assessed risk of bias. Primary outcomes, based on the International Patient Decision Aid Standards (IPDAS), were attributes related to the choice made and the decision-making process.Secondary outcomes were behavioural, health, and health system effects.We pooled results using mean differences (MDs) and risk ratios (RRs), applying a random-effects model. We conducted a subgroup analysis of studies that used the patient decision aid to prepare for the consultation and of those that used it in the consultation. We used GRADE to assess the strength of the evidence. MAIN RESULTS: We included 105 studies involving 31,043 participants. This update added 18 studies and removed 28 previously included studies comparing detailed versus simple decision aids. During the 'Risk of bias' assessment, we rated two items (selective reporting and blinding of participants/personnel) as mostly unclear due to inadequate reporting. Twelve of 105 studies were at high risk of bias.With regard to the attributes of the choice made, decision aids increased participants' knowledge (MD 13.27/100; 95% confidence interval (CI) 11.32 to 15.23; 52 studies; N = 13,316; high-quality evidence), accuracy of risk perceptions (RR 2.10; 95% CI 1.66 to 2.66; 17 studies; N = 5096; moderate-quality evidence), and congruency between informed values and care choices (RR 2.06; 95% CI 1.46 to 2.91; 10 studies; N = 4626; low-quality evidence) compared to usual care.Regarding attributes related to the decision-making process and compared to usual care, decision aids decreased decisional conflict related to feeling uninformed (MD -9.28/100; 95% CI -12.20 to -6.36; 27 studies; N = 5707; high-quality evidence), indecision about personal values (MD -8.81/100; 95% CI -11.99 to -5.63; 23 studies; N = 5068; high-quality evidence), and the proportion of people who were passive in decision making (RR 0.68; 95% CI 0.55 to 0.83; 16 studies; N = 3180; moderate-quality evidence).Decision aids reduced the proportion of undecided participants and appeared to have a positive effect on patient-clinician communication. Moreover, those exposed to a decision aid were either equally or more satisfied with their decision, the decision-making process, and/or the preparation for decision making compared to usual care.Decision aids also reduced the number of people choosing major elective invasive surgery in favour of more conservative options (RR 0.86; 95% CI 0.75 to 1.00; 18 studies; N = 3844), but this reduction reached statistical significance only after removing the study on prophylactic mastectomy for breast cancer gene carriers (RR 0.84; 95% CI 0.73 to 0.97; 17 studies; N = 3108). Compared to usual care, decision aids reduced the number of people choosing prostate-specific antigen screening (RR 0.88; 95% CI 0.80 to 0.98; 10 studies; N = 3996) and increased those choosing to start new medications for diabetes (RR 1.65; 95% CI 1.06 to 2.56; 4 studies; N = 447). For other testing and screening choices, mostly there were no differences between decision aids and usual care.The median effect of decision aids on length of consultation was 2.6 minutes longer (24 versus 21; 7.5% increase). The costs of the decision aid group were lower in two studies and similar to usual care in four studies. People receiving decision aids do not appear to differ from those receiving usual care in terms of anxiety, general health outcomes, and condition-specific health outcomes. Studies did not report adverse events associated with the use of decision aids.In subgroup analysis, we compared results for decision aids used in preparation for the consultation versus during the consultation, finding similar improvements in pooled analysis for knowledge and accurate risk perception. For other outcomes, we could not conduct formal subgroup analyses because there were too few studies in each subgroup. AUTHORS' CONCLUSIONS: Compared to usual care across a wide variety of decision contexts, people exposed to decision aids feel more knowledgeable, better informed, and clearer about their values, and they probably have a more active role in decision making and more accurate risk perceptions. There is growing evidence that decision aids may improve values-congruent choices. There are no adverse effects on health outcomes or satisfaction. New for this updated is evidence indicating improved knowledge and accurate risk perceptions when decision aids are used either within or in preparation for the consultation. Further research is needed on the effects on adherence with the chosen option, cost-effectiveness, and use with lower literacy populations.

Patients' Survival Expectations With and Without Their Chosen Treatment for Prostate Cancer.

PURPOSE: Overtreatment of screen-detected localized prostate cancer (LPC) is an important public health concern, since the survival benefit of aggressive treatment (surgery or radiation) has not been well established. We investigated the survival expectations of patients who had LPC with and without their chosen treatment. METHODS: A population-based sample of 260 men (132 black, 128 white) 75 years old or younger with newly diagnosed LPC completed a self-administered survey. How long the patients expected to live with their chosen treatment, how long they would expect to live with no treatment, and factors associated with the difference in perceived life expectancy were assessed using multivariable analysis. RESULTS: Without any treatment, 33% of patients expected that they would live less than 5 years, 41% 5 to 10 years, 21% 10 to 20 years, and 5% more than 20 years. With their chosen treatment, 3% of patients expected to live less than 5 years, 9% 5 to 10 years, 33% 10 to 20 years, and 55% more than 20 years. Treatment chosen, age, general health perception, and perceived cancer seriousness predicted the differences in perceived life expectancy, while race and actual tumor risk did not. After adjustment for other covariates, men who choose surgery or radiation expected greater gain in survival than men who chose watchful waiting or active surveillance. CONCLUSIONS: Most patients with LPC underestimated their life expectancy without treatment and overestimated the gain in life expectancy with surgery or radiation. These unrealistic expectations may compromise patients' ability to make informed treatment decisions and may contribute to overtreatment of LPC. Primary care physicians, when included in the decision process, should focus on helping patients develop realistic expectations and choices that support their treatment goals.

Implementing shared decision making in federally qualified health centers, a quasi-experimental design study: the Office-Guidelines Applied to Practice (Office-GAP) program.

BACKGROUND: Use of Shared Decision-Making (SDM) and Decision Aids (DAs) has been encouraged but is not regularly implemented in primary care. The Office-Guidelines Applied to Practice (Office-GAP) intervention is an application of a previous model revised to address guidelines based care for low-income populations with diabetes and coronary heart disease (CHD). OBJECTIVE: To evaluate Office-GAP Program feasibility and preliminary efficacy on medication use, patient satisfaction with physician communication and confidence in decision in low-income population with diabetes and coronary heart disease (CHD) in a Federally Qualified Healthcare Center (FQHC). METHOD: Ninety-five patients participated in an Office-GAP program. A quasi-experimental design study, over 6 months with 12-month follow-up. Office-GAP program integrates health literacy, communication skills education for patients and physicians, patient/physician decision support tools and SDM into routine care. MAIN MEASURES: 1) Implementation rates of planned program elements 2) Patient satisfaction with communication and confidence in decision, and 3) Medication prescription rates. We used the GEE method for hierarchical logistic models, controlling for confounding. RESULTS: Feasibility of the Office-GAP program in the FQHC setting was established. We found significant increase in use of Aspirin/Plavix, statin and beta-blocker during follow-up compared to baseline: Aspirin OR 1.5 (95 % CI: 1.1, 2.2) at 3-months, 1.9 (1.3, 2.9) at 6-months, and 1.8 (1.2, 2.8) at 12-months. Statin OR 1.1 (1.0, 1.3) at 3-months and 1.5 (1.1, 2.2) at 12-months; beta-blocker 1.8 (1.1, 2.9) at 6-months and 12-months. Program elements were consistently used (≥ 98 % clinic attendance at training and tool used). Patient satisfaction with communication and confidence in decision increased. CONCLUSIONS: The use of Office-GAP program to teach SDM and use of DAs in real time was demonstrated to be feasible in FQHCs. It has the potential to improve satisfaction with physician communication and confidence in decisions and to improve medication use. The Office-GAP program is a brief, efficient platform for delivering patient and provider education in SDM and could serve as a model for implementing guideline based care for all chronic diseases in outpatient clinical settings. Further evaluation is needed to establish feasibility outside clinical study, reach, effectiveness and cost-effectiveness of this approach.

Patient-physician communication about early stage prostate cancer: analysis of overall visit structure.

BACKGROUND: We know little about patient-physician communication during visits to discuss diagnosis and treatment of prostate cancer. OBJECTIVE: To examine the overall visit structure and how patients and physicians transition between communication activities during visits in which patients received new prostate cancer diagnoses. PARTICIPANTS: Forty veterans and 18 urologists at one VA medical centre. METHODS: We coded 40 transcripts to identify major communication activities during visits and used empiric discourse analysis to analyse transitions between activities. RESULTS: We identified five communication activities that occurred in the following typical sequence: 'diagnosis delivery', 'risk classification', 'options talk', 'decision talk' and 'next steps'. The first two activities were typically brief and involved minimal patient participation. Options talk was typically the longest activity; physicians explicitly announced the beginning of options talk and framed it as their professional responsibility. Some patients were unsure of the purpose of visit and/or who should make treatment decisions. CONCLUSION: Visits to deliver the diagnosis of early stage prostate cancer follow a regular sequence of communication activities. Physicians focus on discussing treatment options and devote comparatively little time and attention to discussing the new cancer diagnosis. Towards the goal of promoting patient-centred communication, physicians should consider eliciting patient reactions after diagnosis delivery and explaining the decision-making process before describing treatment options.

Patient participation in clinical encounters: a systematic review to identify self-report measures.

BACKGROUND: There is evidence suggesting that active participation of patients in their health care can improve the quality of care and decrease health-care costs. Further, patient reports of their health-care experience are increasingly used to monitor health-care quality. OBJECTIVE: This paper describes a systematic review of peer-reviewed studies to identify measures of patients' active participation in their encounters with health-care providers. METHODS: A systematic literature review was conducted for publications indexed from 1975 to 2011. Of interest were self-reported measures of patient participation that were not limited to a specific health concern. All abstracts were reviewed independently by two authors, and the full paper was considered for those meeting inclusion criteria. MAIN RESULTS: From a review of 4528 citations, ten measures were identified. The approaches to development of the measures varied considerably, as did their study samples and their psychometric quality. DISCUSSION: These measures represented three conceptual frameworks: empowerment and self-efficacy, therapeutic alliance, and consumerism/satisfaction. They provide a more comprehensive perspective of patients' experiences of their provider encounters, and a better understanding patient behaviour enhanced the quality of health-care delivery or improved health outcomes. These measures underscore the continuing challenge of defining patient participation and the multiple theoretical approaches that underlie this form of patient behaviour. CONCLUSIONS: Current interest in quality-related physician report cards gives significant weight to patients' self-reported experiences as one dimension of physician performance. It is critical to identify the specific focus and quality of measures selected for this and research purposes.

Decision aids for people facing health treatment or screening decisions.

BACKGROUND: Decision aids are intended to help people participate in decisions that involve weighing the benefits and harms of treatment options often with scientific uncertainty. OBJECTIVES: To assess the effects of decision aids for people facing treatment or screening decisions. SEARCH METHODS: For this update, we searched from 2009 to June 2012 in MEDLINE; CENTRAL; EMBASE; PsycINFO; and grey literature. Cumulatively, we have searched each database since its start date including CINAHL (to September 2008). SELECTION CRITERIA: We included published randomized controlled trials of decision aids, which are interventions designed to support patients' decision making by making explicit the decision, providing information about treatment or screening options and their associated outcomes, compared to usual care and/or alternative interventions. We excluded studies of participants making hypothetical decisions. DATA COLLECTION AND ANALYSIS: Two review authors independently screened citations for inclusion, extracted data, and assessed risk of bias. The primary outcomes, based on the International Patient Decision Aid Standards (IPDAS), were:A) 'choice made' attributes;B) 'decision-making process' attributes.Secondary outcomes were behavioral, health, and health-system effects. We pooled results using mean differences (MD) and relative risks (RR), applying a random-effects model. MAIN RESULTS: This update includes 33 new studies for a total of 115 studies involving 34,444 participants. For risk of bias, selective outcome reporting and blinding of participants and personnel were mostly rated as unclear due to inadequate reporting. Based on 7 items, 8 of 115 studies had high risk of bias for 1 or 2 items each.Of 115 included studies, 88 (76.5%) used at least one of the IPDAS effectiveness criteria: A) 'choice made' attributes criteria: knowledge scores (76 studies); accurate risk perceptions (25 studies); and informed value-based choice (20 studies); and B) 'decision-making process' attributes criteria: feeling informed (34 studies) and feeling clear about values (29 studies).A) Criteria involving 'choice made' attributes:Compared to usual care, decision aids increased knowledge (MD 13.34 out of 100; 95% confidence interval (CI) 11.17 to 15.51; n = 42). When more detailed decision aids were compared to simple decision aids, the relative improvement in knowledge was significant (MD 5.52 out of 100; 95% CI 3.90 to 7.15; n = 19). Exposure to a decision aid with expressed probabilities resulted in a higher proportion of people with accurate risk perceptions (RR 1.82; 95% CI 1.52 to 2.16; n = 19). Exposure to a decision aid with explicit values clarification resulted in a higher proportion of patients choosing an option congruent with their values (RR 1.51; 95% CI 1.17 to 1.96; n = 13).B) Criteria involving 'decision-making process' attributes:Decision aids compared to usual care interventions resulted in:a) lower decisional conflict related to feeling uninformed (MD -7.26 of 100; 95% CI -9.73 to -4.78; n = 22) and feeling unclear about personal values (MD -6.09; 95% CI -8.50 to -3.67; n = 18);b) reduced proportions of people who were passive in decision making (RR 0.66; 95% CI 0.53 to 0.81; n = 14); andc) reduced proportions of people who remained undecided post-intervention (RR 0.59; 95% CI 0.47 to 0.72; n = 18).Decision aids appeared to have a positive effect on patient-practitioner communication in all nine studies that measured this outcome. For satisfaction with the decision (n = 20), decision-making process (n = 17), and/or preparation for decision making (n = 3), those exposed to a decision aid were either more satisfied, or there was no difference between the decision aid versus comparison interventions. No studies evaluated decision-making process attributes for helping patients to recognize that a decision needs to be made, or understanding that values affect the choice.C) Secondary outcomes Exposure to decision aids compared to usual care reduced the number of people of choosing major elective invasive surgery in favour of more conservative options (RR 0.79; 95% CI 0.68 to 0.93; n = 15). Exposure to decision aids compared to usual care reduced the number of people choosing to have prostate-specific antigen screening (RR 0.87; 95% CI 0.77 to 0.98; n = 9). When detailed compared to simple decision aids were used, fewer people chose menopausal hormone therapy (RR 0.73; 95% CI 0.55 to 0.98; n = 3). For other decisions, the effect on choices was variable.The effect of decision aids on length of consultation varied from 8 minutes shorter to 23 minutes longer (median 2.55 minutes longer) with 2 studies indicating statistically-significantly longer, 1 study shorter, and 6 studies reporting no difference in consultation length. Groups of patients receiving decision aids do not appear to differ from comparison groups in terms of anxiety (n = 30), general health outcomes (n = 11), and condition-specific health outcomes (n = 11). The effects of decision aids on other outcomes (adherence to the decision, costs/resource use) were inconclusive. AUTHORS' CONCLUSIONS: There is high-quality evidence that decision aids compared to usual care improve people's knowledge regarding options, and reduce their decisional conflict related to feeling uninformed and unclear about their personal values. There is moderate-quality evidence that decision aids compared to usual care stimulate people to take a more active role in decision making, and improve accurate risk perceptions when probabilities are included in decision aids, compared to not being included. There is low-quality evidence that decision aids improve congruence between the chosen option and the patient's values.New for this updated review is further evidence indicating more informed, values-based choices, and improved patient-practitioner communication. There is a variable effect of decision aids on length of consultation. Consistent with findings from the previous review, decision aids have a variable effect on choices. They reduce the number of people choosing discretionary surgery and have no apparent adverse effects on health outcomes or satisfaction. The effects on adherence with the chosen option, cost-effectiveness, use with lower literacy populations, and level of detail needed in decision aids need further evaluation. Little is known about the degree of detail that decision aids need in order to have a positive effect on attributes of the choice made, or the decision-making process.

Is quality improvement sustainable? Findings of the American College of Cardiology's Guidelines Applied in Practice.

OBJECTIVE: (i) To examine the sustainability of an in-hospital quality improvement (QI) intervention, the American College of Cardiology's Guideline Applied to Practice (GAP) in acute myocardial infarction (AMI). (ii) To determine the predictors of physician adherence to AMI guidelines-recommended medication prescribing. DESIGN: Prospective observational study. SETTING: Five mid-Michigan community hospitals. PARTICIPANTS: 516 AMI patients admitted consecutively 1 year after the GAP intervention. These patients were compared with 499 post-GAP patients. MAIN OUTCOME MEASURES: The main outcome was adherence to medication use guidelines. Predictors of medication use were determined using multivariable logistic regression analysis. RESULTS: 1 year after GAP implementation, adherence to most medications remained high. We found a significant increase in beta-blocker (BB) use in-hospital (87.9 vs. 72.1%, P < 0.001) whereas cholesterol assessment within 24 h (79.5 vs. 83.6%, P > 0.225) did not change significantly. However, discharge aspirin (83 vs. 90%, P < 0.018) and BB prescriptions (84 vs. 92%, P < 0.016) dropped to preintervention rates. Discharge angiotensin-converting enzyme inhibitor and treatment of patients with low-density lipoprotein of ≥ 100 were unchanged. Predictors of receiving appropriate medications were male gender (for aspirin and BBs) and treatment with percutaneous coronary intervention compared with coronary artery bypass graft. Notably, prescription rates for discharge medications differed significantly by hospital. CONCLUSIONS: Early benefits of the Mid-Michigan GAP intervention on guideline use were only partially sustained at 1 year. Differences in guideline adherence by treatment modality and hospital demonstrate challenges for follow-up phases of GAP. Additional strategies to improve sustainability of QI efforts are urgently needed.

Refining a brief decision aid in stable CAD: cognitive interviews.

BACKGROUND: We describe the results of cognitive interviews to refine the "Making Choices©" Decision Aid (DA) for shared decision-making (SDM) about stress testing in patients with stable coronary artery disease (CAD). METHODS: We conducted a systematic development process to design a DA consistent with International Patient Decision Aid Standards (IPDAS) focused on Alpha testing criteria. Cognitive interviews were conducted with ten stable CAD patients using the "think aloud" interview technique to assess the clarity, usefulness, and design of each page of the DA. RESULTS: Participants identified three main messages: 1) patients have multiple options based on stress tests and they should be discussed with a physician, 2) take care of yourself, 3) the stress test is the gold standard for determining the severity of your heart disease. Revisions corrected the inaccurate assumption of item number three. CONCLUSIONS: Cognitive interviews proved critical for engaging patients in the development process and highlighted the necessity of clear message development and use of design principles that make decision materials easy to read and easy to use. Cognitive interviews appear to contribute critical information from the patient perspective to the overall systematic development process for designing decision aids.

Addressing health literacy in patient decision aids.

BACKGROUND: Effective use of a patient decision aid (PtDA) can be affected by the user's health literacy and the PtDA's characteristics. Systematic reviews of the relevant literature can guide PtDA developers to attend to the health literacy needs of patients. The reviews reported here aimed to assess: METHODS: We reviewed literature for evidence relevant to these two aims. When high-quality systematic reviews existed, we summarized their evidence. When reviews were unavailable, we conducted our own systematic reviews. RESULTS: Aim 1: In an existing systematic review of PtDA trials, lower health literacy was associated with lower patient health knowledge (14 of 16 eligible studies). Fourteen studies reported practical design strategies to improve knowledge for lower health literacy patients. In our own systematic review, no studies reported on values clarity per se, but in 2 lower health literacy was related to higher decisional uncertainty and regret. Lower health literacy was associated with less desire for involvement in 3 studies, less question-asking in 2, and less patient-centered communication in 4 studies; its effects on other measures of patient involvement were mixed. Only one study assessed the effects of a health literacy intervention on outcomes; it showed that using video to improve the salience of health states reduced decisional uncertainty. Aim 2: In our review of 97 trials, only 3 PtDAs overtly addressed the needs of lower health literacy users. In 90% of trials, user health literacy and readability of the PtDA were not reported. However, increases in knowledge and informed choice were reported in those studies in which health literacy needs were addressed. CONCLUSION: Lower health literacy affects key decision-making outcomes, but few existing PtDAs have addressed the needs of lower health literacy users. The specific effects of PtDAs designed to mitigate the influence of low health literacy are unknown. More attention to the needs of patients with lower health literacy is indicated, to ensure that PtDAs are appropriate for lower as well as higher health literacy patients.

Nurse-led group visits support shared decision making in stable coronary artery disease.

OBJECTIVE: The aim of this study was to develop and evaluate a nurse-led educational group visit (GV) as part of a multifaceted intervention, shared decision making (SDM) guidance reminders in practice, to prompt SDM in primary care about angiography in stable coronary artery disease. METHODS: A process evaluation designed to test the feasibility of a nurse-led educational GV was conducted. The evaluation used retrospective pre-post surveys. RESULTS: Nurse-led GV was well received and logistically feasible. Patients gained knowledge of options and confidence in doing SDM with providers. However, recruitment at the point of the educational GV was below the threshold of 12 patients per group that would support sustaining this approach in fee-for-service clinical practice. CONCLUSIONS: Nurse-led GV can produce gains in knowledge and confidence required for patients to participate in SDM. However, the constraints of time and personnel required to bring groups of patients together require new approaches. Future development will focus on adapting the content of the GV for SDM as an electronic teaching module associated with integrated personal health records.

Interventions for providers to promote a patient-centred approach in clinical consultations.

BACKGROUND: Communication problems in health care may arise as a result of healthcare providers focusing on diseases and their management, rather than people, their lives and their health problems. Patient-centred approaches to care delivery in the patient encounter are increasingly advocated by consumers and clinicians and incorporated into training for healthcare providers. However, the impact of these interventions directly on clinical encounters and indirectly on patient satisfaction, healthcare behaviour and health status has not been adequately evaluated. OBJECTIVES: To assess the effects of interventions for healthcare providers that aim to promote patient-centred care (PCC) approaches in clinical consultations. SEARCH METHODS: For this update, we searched: MEDLINE (OvidSP), EMBASE (OvidSP), PsycINFO (OvidSP), and CINAHL (EbscoHOST) from January 2000 to June 2010. The earlier version of this review searched MEDLINE (1966 to December 1999), EMBASE (1985 to December 1999), PsycLIT (1987 to December 1999), CINAHL (1982 to December 1999) and HEALTH STAR (1975 to December 1999). We searched the bibliographies of studies assessed for inclusion and contacted study authors to identify other relevant studies. Any study authors who were contacted for further information on their studies were also asked if they were aware of any other published or ongoing studies that would meet our inclusion criteria. SELECTION CRITERIA: In the original review, study designs included randomized controlled trials, controlled clinical trials, controlled before and after studies, and interrupted time series studies of interventions for healthcare providers that promote patient-centred care in clinical consultations. In the present update, we were able to limit the studies to randomized controlled trials, thus limiting the likelihood of sampling error. This is especially important because the providers who volunteer for studies of PCC methods are likely to be different from the general population of providers. Patient-centred care was defined as a philosophy of care that encourages: (a) shared control of the consultation, decisions about interventions or management of the health problems with the patient, and/or (b) a focus in the consultation on the patient as a whole person who has individual preferences situated within social contexts (in contrast to a focus in the consultation on a body part or disease). Within our definition, shared treatment decision-making was a sufficient indicator of PCC. The participants were healthcare providers, including those in training. DATA COLLECTION AND ANALYSIS: We classified interventions by whether they focused only on training providers or on training providers and patients, with and without condition-specific educational materials. We grouped outcome data from the studies to evaluate both direct effects on patient encounters (consultation process variables) and effects on patient outcomes (satisfaction, healthcare behaviour change, health status). We pooled results of RCTs using standardized mean difference (SMD) and relative risks (RR) applying a fixed-effect model. MAIN RESULTS: Forty-three randomized trials met the inclusion criteria, of which 29 are new in this update. In most of the studies, training interventions were directed at primary care physicians (general practitioners, internists, paediatricians or family doctors) or nurses practising in community or hospital outpatient settings. Some studies trained specialists. Patients were predominantly adults with general medical problems, though two studies included children with asthma. Descriptive and pooled analyses showed generally positive effects on consultation processes on a range of measures relating to clarifying patients' concerns and beliefs; communicating about treatment options; levels of empathy; and patients' perception of providers' attentiveness to them and their concerns as well as their diseases. A new finding for this update is that short-term training (less than 10 hours) is as successful as longer training.The analyses showed mixed results on satisfaction, behaviour and health status. Studies using complex interventions that focused on providers and patients with condition-specific materials generally showed benefit in health behaviour and satisfaction, as well as consultation processes, with mixed effects on health status. Pooled analysis of the fewer than half of included studies with adequate data suggests moderate beneficial effects from interventions on the consultation process; and mixed effects on behaviour and patient satisfaction, with small positive effects on health status. Risk of bias varied across studies. Studies that focused only on provider behaviour frequently did not collect data on patient outcomes, limiting the conclusions that can be drawn about the relative effect of intervention focus on providers compared with providers and patients. AUTHORS' CONCLUSIONS: Interventions to promote patient-centred care within clinical consultations are effective across studies in transferring patient-centred skills to providers. However the effects on patient satisfaction, health behaviour and health status are mixed. There is some indication that complex interventions directed at providers and patients that include condition-specific educational materials have beneficial effects on health behaviour and health status, outcomes not assessed in studies reviewed previously. The latter conclusion is tentative at this time and requires more data. The heterogeneity of outcomes, and the use of single item consultation and health behaviour measures limit the strength of the conclusions.

Do self-report and medical record comorbidity data predict longitudinal functional capacity and quality of life health outcomes similarly?

BACKGROUND: The search for a reliable, valid and cost-effective comorbidity risk adjustment method for outcomes research continues to be a challenge. The most widely used tool, the Charlson Comorbidity Index (CCI) is limited due to frequent missing data in medical records and administrative data. Patient self-report data has the potential to be more complete but has not been widely used. The purpose of this study was to evaluate the performance of the Self-Administered Comorbidity Questionnaire (SCQ) to predict functional capacity, quality of life (QOL) health outcomes compared to CCI medical records data. METHOD: An SCQ-score was generated from patient interview, and the CCI score was generated by medical record review for 525 patients hospitalized for Acute Coronary Syndrome (ACS) at baseline, three months and eight months post-discharge. Linear regression models assessed the extent to which there were differences in the ability of comorbidity measures to predict functional capacity (Activity Status Index [ASI] scores) and quality of life (EuroQOL 5D [EQ5D] scores). RESULTS: The CCI (R2 = 0.245; p = 0.132) did not predict quality of life scores while the SCQ self-report method (R2 = 0.265; p < 0.0005) predicted the EQ5D scores. However, the CCI was almost as good as the SCQ for predicting the ASI scores at three and six months and performed slightly better in predicting ASI at eight-month follow up (R2 = 0.370; p < 0.0005 vs. R2 = 0.358; p < 0.0005) respectively. Only age, gender, family income and Center for Epidemiologic Studies-Depression (CESD) scores showed significant association with both measures in predicting QOL and functional capacity. CONCLUSIONS: Although our model R-squares were fairly low, these results show that the self-report SCQ index is a good alternative method to predict QOL health outcomes when compared to a CCI medical record score. Both measures predicted physical functioning similarly. This suggests that patient self-reported comorbidity data can be used for predicting physical functional capacity and QOL and can serve as a reliable risk adjustment measure. Self-report comorbidity data may provide a cost-effective alternative method for risk adjustment in clinical research, health policy and organizational improvement analyses. TRIAL REGISTRATION: Clinical Trials.gov NCT00416026.

Type 2 diabetes patient activation and mHealth interventions decreased cardiovascular disease risk.

OBJECTIVES: Cardiovascular disease (CVD) deaths in patients with type 2 diabetes (T2D) are 2 to 4 times higher than among those without T2D. Our objective was to determine whether a patient activation program (Office-Guidelines Applied to Practice [Office-GAP]) plus a mobile health (mHealth) intervention compared with mHealth alone improved medication use and decreased 10-year atherosclerotic CVD (ASCVD) risk score in patients with T2D. STUDY DESIGN: Quasi-experimental design; Office-GAP plus mHealth vs mHealth only. METHODS: The Office-GAP intervention included (1) a patient activation group visit, (2) provider training, and (3) a decision support checklist used in real time during the encounter. The mHealth intervention included daily text messages for 15 weeks. Patients with T2D (hemoglobin A1c ≥ 8%) attending internal medicine residency clinics were randomly assigned to either the combined Office-GAP + mHealth group (Green) or mHealth-only group (White). After group visits, patients followed up with providers at 2 and 4 months. A generalized estimating equation regression model was used to compare change in medication use and ASCVD risk scores between the 2 arms at 0, 2, and 4 months. RESULTS: Fifty-one patients with diabetes (26 in Green team and 25 in White team) completed the study. The 10-year ASCVD risk score decreased in both groups (Green: -3.23; P = .06; White: -3.98; P = .01). Medication use increased from baseline to 4-month follow-up (statin: odds ratio [OR], 2.20; 95% CI, 1.32-3.67; aspirin: OR, 3.21, 95% CI, 1.44-7.17; angiotensin-converting enzyme inhibitor/angiotensin receptor blocker: OR, 2.67, 95% CI, 1.09-6.56). There was no significant difference in impact of the combined intervention (Office-GAP + mHealth) compared with mHealth alone. CONCLUSIONS: Both Office-GAP + mHealth and mHealth alone increased the use of evidence-based medications and decreased 10-year ASCVD risk scores for patients with T2D in 4 months.

Improving diabetic patients' adherence to treatment and prevention of cardiovascular disease (Office Guidelines Applied to Practice-IMPACT Study)-a cluster randomized controlled effectiveness trial.

BACKGROUND: Despite nationwide improvements in cardiovascular disease (CVD) mortality and morbidity, CVD deaths in adults with type 2 diabetes (T2DM) are 2-4 times higher than among those without T2DM. A key contributor to these poor health outcomes is medication non-adherence. Twenty-one to 42% of T2DM patients do not take blood sugar, blood pressure (BP), or statin medications as prescribed. Interventions that foster and reinforce patient-centered communication show promise in improving health outcomes. However, they have not been widely implemented, in part due to a lack of compelling evidence for their effectiveness in real-life primary care settings. METHODS: This pragmatic cluster-randomized trial randomizes 17 teams in 12 Federally Qualified Healthcare Centers (FQHCs) to two experimental groups: intervention (group 1): Office-Gap + Texting vs. control (group 2): Texting only. Office-GAP (Office-Guidelines Applied to Practice) is a patient activation intervention to improve communication and patient-provider partnerships through brief patient and provider training in shared decision-making (SDM) and use of a guideline-based checklist. The texting intervention (Way2Health) is a cell phone messaging service that informs and encourages patients to adhere to goals, adhere to medication use and improve communication. After recruitment, patients in groups 1 and 2 will both attend (1) one scheduled group visit, (90-120 min) conducted by trained research assistants, and (2) follow-up visits with their providers after group visit at 0-1, 3, 6, 9, and 12 months. Data will be collected over 12-month intervention period. Our primary outcome is medication adherence measured using eCAP electronic monitoring and self-report. Secondary outcomes are (a) diabetes-specific 5-year CVD risk as measured with the UK Prospective Diabetes Study (UKPDS) Engine score, (b) provider engagement as measured by the CollaboRATE Shared-Decision Making measure, and (c) patient activation measures (PAM). DISCUSSION: This study will provide a rigorous pragmatic evaluation of the effectiveness of combined mHealth, and patient activation interventions compared to mHealth alone, targeting patients and healthcare providers in safety net health centers, in improving medication adherence and decreasing CVD risk. Given that 20-50% of adults with chronic illness demonstrate medication non-adherence, increasing adherence is essential to improve CVD outcomes as well as healthcare cost savings. TRIAL REGISTRATION: The ClinicalTrials.gov registration number is NCT04874116.

Decision aids for people facing health treatment or screening decisions.

BACKGROUND: Decision aids prepare people to participate in decisions that involve weighing benefits, harms, and scientific uncertainty. OBJECTIVES: To evaluate the effectiveness of decision aids for people facing treatment or screening decisions. SEARCH STRATEGY: For this update, we searched from January 2006 to December 2009 in MEDLINE (Ovid); Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, issue 4 2009); CINAHL (Ovid) (to September 2008 only); EMBASE (Ovid); PsycINFO (Ovid); and grey literature. Cumulatively, we have searched each database since its start date. SELECTION CRITERIA: We included published randomised controlled trials (RCTs) of decision aids, which are interventions designed to support patients' decision making by providing information about treatment or screening options and their associated outcomes, compared to usual care and/or alternative interventions. We excluded studies in which participants were not making an active treatment or screening decision. DATA COLLECTION AND ANALYSIS: Two review authors independently screened abstracts for inclusion, extracted data, and assessed potential risk of bias. The primary outcomes, based on the International Patient Decision Aid Standards, were:A) decision attributes;B) decision making process attributes.Secondary outcomes were behavioral, health, and health system effects. We pooled results of RCTs using mean differences (MD) and relative risks (RR), applying a random effects model. MAIN RESULTS: Of 34,316 unique citations, 86 studies involving 20,209 participants met the eligibility criteria and were included. Thirty-one of these studies are new in this update. Twenty-nine trials are ongoing. There was variability in potential risk of bias across studies. The two criteria that were most problematic were lack of blinding and the potential for selective outcome reporting, given that most of the earlier trials were not registered.Of 86 included studies, 63 (73%) used at least one measure that mapped onto an IPDAS effectiveness criterion: A) criteria involving decision attributes: knowledge scores (51 studies); accurate risk perceptions (16 studies); and informed value-based choice (12 studies); and B) criteria involving decision process attributes: feeling informed (30 studies) and feeling clear about values (18 studies).A) Criteria involving decision attributes:Decision aids performed better than usual care interventions by increasing knowledge (MD 13.77 out of 100; 95% confidence interval (CI) 11.40 to 16.15; n = 26). When more detailed decision aids were compared to simpler decision aids, the relative improvement in knowledge was significant (MD 4.97 out of 100; 95% CI 3.22 to 6.72; n = 15). Exposure to a decision aid with expressed probabilities resulted in a higher proportion of people with accurate risk perceptions (RR 1.74; 95% CI 1.46 to 2.08; n = 14). The effect was stronger when probabilities were expressed in numbers (RR 1.93; 95% CI 1.58 to 2.37; n = 11) rather than words (RR 1.27; 95% CI 1.09 to 1.48; n = 3). Exposure to a decision aid with explicit values clarification compared to those without explicit values clarification resulted in a higher proportion of patients achieving decisions that were informed and consistent with their values (RR 1.25; 95% CI 1.03 to 1.52; n = 8).B) Criteria involving decision process attributes:Decision aids compared to usual care interventions resulted in: a) lower decisional conflict related to feeling uninformed (MD -6.43 of 100; 95% CI -9.16 to -3.70; n = 17); b) lower decisional conflict related to feeling unclear about personal values (MD -4.81; 95% CI -7.23 to -2.40; n = 14); c) reduced the proportions of people who were passive in decision making (RR 0.61; 95% CI 0.49 to 0.77; n = 11); and d) reduced proportions of people who remained undecided post-intervention (RR 0.57; 95% CI 0.44 to 0.74; n = 9). Decision aids appear to have a positive effect on patient-practitioner communication in the four studies that measured this outcome. For satisfaction with the decision (n = 12) and/or the decision making process (n = 12), those exposed to a decision aid were either more satisfied or there was no difference between the decision aid versus comparison interventions. There were no studies evaluating the decision process attributes relating to helping patients to recognize that a decision needs to be made or understand that values affect the choice.C) Secondary outcomesExposure to decision aids compared to usual care continued to demonstrate reduced choice of: major elective invasive surgery in favour of conservative options (RR 0.80; 95% CI 0.64 to 1.00; n = 11). Exposure to decision aids compared to usual care also resulted in reduced choice of PSA screening (RR 0.85; 95% CI 0.74 to 0.98; n = 7). When detailed compared to simple decision aids were used, there was reduced choice of menopausal hormones (RR 0.73; 95% CI 0.55 to 0.98; n = 3). For other decisions, the effect on choices was variable. The effect of decision aids on length of consultation varied from -8 minutes to +23 minutes (median 2.5 minutes). Decision aids do not appear to be different from comparisons in terms of anxiety (n = 20), and general health outcomes (n = 7), and condition specific health outcomes (n = 9). The effects of decision aids on other outcomes (adherence to the decision, costs/resource use) were inconclusive. AUTHORS' CONCLUSIONS: New for this updated review is evidence that: decision aids with explicit values clarification exercises improve informed values-based choices; decision aids appear to have a positive effect on patient-practitioner communication; and decision aids have a variable effect on length of consultation.Consistent with findings from the previous review, which had included studies up to 2006: decision aids increase people's involvement, and improve knowledge and realistic perception of outcomes; however, the size of the effect varies across studies. Decision aids have a variable effect on choices. They reduce the choice of discretionary surgery and have no apparent adverse effects on health outcomes or satisfaction. The effects on adherence with the chosen option, patient-practitioner communication, cost-effectiveness, and use with developing and/or lower literacy populations need further evaluation. Little is known about the degree of detail that decision aids need in order to have positive effects on attributes of the decision or decision-making process.

Racial differences in veterans' response to a standard vs. patient-centered decision aid for prostate cancer: Implications for decision making in African American and White men.

OBJECTIVE: To determine whether racial differences exist in patient preferences for prostate cancer treatment after being informed about options using a patient-centered vs. a standard decision aid (DA). METHODS: This article reports secondary analyses of a large study of men diagnosed with early stage prostate cancer. Men were recruited from 4 VA Health Systems and randomized to receive a patient-centered or standard DA about prostate cancer treatment options. Data were collected at 1) baseline, 2) after reading the DA but prior to diagnosis, and 3) after receiving a cancer diagnosis and meeting with a urologist. RESULTS: White patients who received the patient-centered DA written at a 7th grade reading level were more likely to prefer active surveillance and less likely to prefer radiation compared to those who received the standard DA written at >9th grade reading level. African American patients' treatment preferences did not differ as a function of DA. CONCLUSIONS: When informed about prostate cancer treatment options through a patient-centered DA, White patients changed their treatment preferences but African American patients did not. PRACTICE IMPLICATIONS: As DAs are increasingly being used in clinical practice, more research is needed regarding the efficacy, relevance, and receptivity of DAs for African Americans.

Decision aids for people facing health treatment or screening decisions.

BACKGROUND: Decision aids prepare people to participate in 'close call' decisions that involve weighing benefits, harms, and scientific uncertainty. OBJECTIVES: To conduct a systematic review of randomised controlled trials (RCTs) evaluating the efficacy of decision aids for people facing difficult treatment or screening decisions. SEARCH STRATEGY: We searched MEDLINE (Ovid) (1966 to July 2006); Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library; 2006, Issue 2); CINAHL (Ovid) (1982 to July 2006); EMBASE (Ovid) (1980 to July 2006); and PsycINFO (Ovid) (1806 to July 2006). We contacted researchers active in the field up to December 2006. There were no language restrictions. SELECTION CRITERIA: We included published RCTs of interventions designed to aid patients' decision making by providing information about treatment or screening options and their associated outcomes, compared to no intervention, usual care, and alternate interventions. We excluded studies in which participants were not making an active treatment or screening decision, or if the study's intervention was not available to determine that it met the minimum criteria to qualify as a patient decision aid. DATA COLLECTION AND ANALYSIS: Two review authors independently screened abstracts for inclusion, and extracted data from included studies using standardized forms. The primary outcomes focused on the effectiveness criteria of the International Patient Decision Aid Standards (IPDAS) Collaboration: attributes of the decision and attributes of the decision process. We considered other behavioural, health, and health system effects as secondary outcomes. We pooled results of RCTs using mean differences (MD) and relative risks (RR) using a random effects model. MAIN RESULTS: This update added 25 new RCTs, bringing the total to 55. Thirty-eight (69%) used at least one measure that mapped onto an IPDAS effectiveness criterion: decision attributes: knowledge scores (27 trials); accurate risk perceptions (11 trials); and value congruence with chosen option (4 trials); and decision process attributes: feeling informed (15 trials) and feeling clear about values (13 trials).This review confirmed the following findings from the previous (2003) review. Decision aids performed better than usual care interventions in terms of: a) greater knowledge (MD 15.2 out of 100; 95% CI 11.7 to 18.7); b) lower decisional conflict related to feeling uninformed (MD -8.3 of 100; 95% CI -11.9 to -4.8); c) lower decisional conflict related to feeling unclear about personal values (MD -6.4; 95% CI -10.0 to -2.7); d) reduced the proportion of people who were passive in decision making (RR 0.6; 95% CI 0.5 to 0.8); and e) reduced proportion of people who remained undecided post-intervention (RR 0.5; 95% CI 0.3 to 0.8). When simpler decision aids were compared to more detailed decision aids, the relative improvement was significant in knowledge (MD 4.6 out of 100; 95% CI 3.0 to 6.2) and there was some evidence of greater agreement between values and choice.In this review, we were able to explore the use of probabilities in decision aids. Exposure to a decision aid with probabilities resulted in a higher proportion of people with accurate risk perceptions (RR 1.6; 95% CI 1.4 to 1.9). The effect was stronger when probabilities were measured quantitatively (RR 1.8; 95% CI 1.4 to 2.3) versus qualitatively (RR 1.3; 95% CI 1.1 to 1.5).As in the previous review, exposure to decision aids continued to demonstrate reduced rates of: elective invasive surgery in favour of conservative options, decision aid versus usual care (RR 0.8; 95% CI 0.6 to 0.9); and use of menopausal hormones, detailed versus simple aid (RR 0.7; 95% CI 0.6 to 1.0). There is now evidence that exposure to decision aids results in reduced PSA screening, decision aid versus usual care (RR 0.8; 95% CI 0.7 to 1.0) . For other decisions, the effect on decisions remains variable.As in the previous review, decision aids are no better than comparisons in affecting satisfaction with decision making, anxiety, and health outcomes. The effects of decision aids on other outcomes (patient-practitioner communication, consultation length, continuance, resource use) were inconclusive.There were no trials evaluating the IPDAS decision process criteria relating to helping patients to recognize a decision needs to be made, understand that values affect the decision, or discuss values with the practitioner. AUTHORS' CONCLUSIONS: Patient decision aids increase people's involvement and are more likely to lead to informed values-based decisions; however, the size of the effect varies across studies. Decision aids have a variable effect on decisions. They reduce the use of discretionary surgery without apparent adverse effects on health outcomes or satisfaction. The degree of detail patient decision aids require for positive effects on decision quality should be explored. The effects on continuance with chosen option, patient-practitioner communication, consultation length, and cost-effectiveness need further evaluation.