A multicenter trial of a shared DECision Support Intervention for Patients offered implantable Cardioverter-DEfibrillators: DECIDE-ICD rationale, design, Medicare changes, and pilot data.

Shared decision making (SDM) facilitates delivery of medical therapies that are in alignment with patients' goals and values. Medicare national coverage decision for several interventions now includes SDM mandates, but few have been evaluated in nationwide studies. Based upon a detailed needs assessment with diverse stakeholders, we developed pamphlet and video patient decision aids (PtDAs) for implantable cardioverter/defibrillator (ICD) implantation, ICD replacement, and cardiac resynchronization therapy with defibrillation to help patients contemplate, forecast, and deliberate their options. These PtDAs are the foundation of the Multicenter Trial of a Shared Decision Support Intervention for Patients Offered Implantable Cardioverter-Defibrillators (DECIDE-ICD), a multicenter, randomized trial sponsored by the National Heart, Lung, and Blood Institute aimed at understanding the effectiveness and implementation of an SDM support intervention for patients considering ICDs. Finalization of a Medicare coverage decision mandating the inclusion of SDM for new ICD implantation occurred shortly after trial initiation, raising novel practical and statistical considerations for evaluating study end points. METHODS/DESIGN: A stepped-wedge randomized controlled trial was designed, guided by the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) planning and evaluation framework using an effectiveness-implementation hybrid type II design. Six electrophysiology programs from across the United States will participate. The primary effectiveness outcome is decision quality (defined by knowledge and values-treatment concordance). Patients with heart failure who are clinically eligible for an ICD are eligible for the study. Target enrollment is 900 participants. DISCUSSION: Study findings will provide a foundation for implementing decision support interventions, including PtDAs, with patients who have chronic progressive illness and are facing decisions involving invasive, preference-sensitive therapy options.

Effects of a Personalized Web-Based Decision Aid for Surrogate Decision Makers of Patients With Prolonged Mechanical Ventilation: A Randomized Clinical Trial.

Background: Treatment decisions commonly have to be made in intensive care units (ICUs). These decisions are difficult for surrogate decision makers and often lead to decisional conflict, psychological distress, and treatments misaligned with patient preferences. Objective: To determine whether a decision aid about prolonged mechanical ventilation improved prognostic concordance between surrogate decision makers and clinicians compared with a usual care control. Design: Multicenter, parallel, randomized, clinical trial. (ClinicalTrials.gov: NCT01751061). Setting: 13 medical and surgical ICUs at 5 hospitals. Participants: Adult patients receiving prolonged mechanical ventilation and their surrogates, ICU physicians, and ICU nurses. Intervention: A Web-based decision aid provided personalized prognostic estimates, explained treatment options, and interactively clarified patient values to inform a family meeting. The control group received information according to usual care practices followed by a family meeting. Measurements: The primary outcome was improved concordance on 1-year survival estimates, measured with the clinician-surrogate concordance scale (range, 0 to 100 percentage points; higher scores indicate more discordance). Secondary and additional outcomes assessed the experiences of surrogates (psychological distress, decisional conflict, and quality of communication) and patients (length of stay and 6-month mortality). Outcomes assessors were blinded to group allocation. Results: The study enrolled 277 patients, 416 surrogates, and 427 clinicians. Concordance improvement did not differ between intervention and control groups (mean difference in score change from baseline, -1.7 percentage points [95% CI, -8.3 to 4.8 percentage points]; P = 0.60). Surrogates' postintervention estimates of patients' 1-year prognoses did not differ between intervention and control groups (median, 86.0% [interquartile range {IQR}, 50.0%] vs. 92.5% [IQR, 47.0%]; P = 0.23) and were substantially more optimistic than results of a validated prediction model (median, 56.0% [IQR, 43.0%]) and physician estimates (median, 50.0% [IQR, 55.5%]). Eighty-two intervention surrogates (43%) favored a treatment option that was more aggressive than their report of patient preferences. Although intervention surrogates had greater reduction in decisional conflict than control surrogates (mean difference in change from baseline, 0.4 points [CI, 0.0 to 0.7 points]; P = 0.041), other surrogate and patient outcomes did not differ. Limitation: Contamination among clinicians could have biased results toward the null hypothesis. Conclusion: A decision aid about prolonged mechanical ventilation did not improve prognostic concordance between clinicians and surrogates, reduce psychological distress among surrogates, or alter clinical outcomes. Decision support in acute care settings may require greater individualized attention for both the cognitive and affective challenges of decision making. Primary Funding Source: National Institutes of Health.

Development and validation of a 5-year mortality prediction model using regularized regression and Medicare data.

PURPOSE: De-implementation of low-value services among patients with limited life expectancy is challenging. Robust mortality prediction models using routinely collected health care data can enhance health care stakeholders' ability to identify populations with limited life expectancy. We developed and validated a claims-based prediction model for 5-year mortality using regularized regression methods. METHODS: Medicare beneficiaries age 66 or older with an office visit and at least 12 months of pre-visit continuous Medicare A/B enrollment were identified in 2008. Five-year mortality was assessed through 2013. Secondary outcomes included 30-, 90-, and 180-day and 1-year mortality. Claims-based predictors, including comorbidities and indicators of disability, frailty, and functional impairment, were selected using regularized logistic regression, applying the least absolute shrinkage and selection operator (LASSO) in a random 80% training sample. Model performance was assessed and compared with the Gagne comorbidity score in the 20% validation sample. RESULTS: Overall, 183 204 (24%) individuals died. In addition to demographics, 161 indicators of comorbidity and function were included in the final model. In the validation sample, the c-statistic was 0.825 (0.823-0.828). Median-predicted probability of 5-year mortality was 14%; almost 4% of the cohort had a predicted probability greater than 80%. Compared with the Gagne score, the LASSO model led to improved 5-year mortality classification (net reclassification index = 9.9%; integrated discrimination index = 5.2%). CONCLUSIONS: Our claims-based model predicting 5-year mortality showed excellent discrimination and calibration, similar to the Gagne score model, but resulted in improved mortality classification. Regularized regression is a feasible approach for developing prediction tools that could enhance health care research and evaluation of care quality.

Implementation and Evaluation of a Novel Colorectal Cancer Decision Aid Using a Centralized Delivery Strategy.

BACKGROUND: Colorectal cancer (CRC) is the second leading cause of cancer-related deaths in the United States; however, CRC screening reduces both incidence and mortality rates. Patient decision aids (DAs) are an evidence-based strategy to support patients making health-related decisions. CRC screening DAs can be unsuccessful due to provider preferences for colonoscopy and lack of effective DA implementation strategies within clinical settings. METHODS: A hybrid implementation-effectiveness study was conducted testing the feasibility of using an existing centralized preventive health screening outreach infrastructure to implement a novel CRC DA across a health care system. Participants included primary care patients at one of three study clinics. Implementation was assessed by determining whether patients remembered receiving the DA and were aware of CRC screening options. Effectiveness was measured by comparing overall screening rates between the control and intervention groups. RESULTS: Using a centralized delivery system was a feasible and efficient method for implementing DAs to a large academic health system. More than 90% of the intervention group remembered receiving the DA, and 80% found it helpful in their decision-making process. The DA was successful in improving CRC screening knowledge; however, overall CRC screening rates significantly decreased between the control and intervention periods (50.8% vs. 39.2%, respectively; p = 0.03). CONCLUSION: Centralized delivery is a feasible method for DA implementation. Although DAs increase knowledge, the true effectiveness of CRC DAs in clinical settings is unknown, as a result of the number in screening tests, diversity in DA format, and the variability in dissemination and implementation practices.

Design of a randomized clinical trial of a colorectal cancer screening decision aid to promote appropriate screening in community-dwelling older adults.

BACKGROUND: Appropriate colorectal cancer screening in older adults should be aligned with the likelihood of net benefit. In general, patient decision aids improve knowledge and values clarity, but in older adults, they may also help patients identify their individual likelihood of benefit and foster individualized decision-making. We report on the design of a randomized clinical trial to understand the effects of a patient decision aid on appropriate colorectal cancer screening. This report includes a description of the baseline characteristics of participants. METHODS: English-speaking primary care patients aged 70-84 years who were not currently up to date with screening were recruited into a randomized clinical trial comparing a tailored colorectal cancer screening decision aid with an attention control. The intervention group received a decision aid that included a values clarification exercise and individualized decision-making worksheet, while the control group received an educational pamphlet on safe driving behaviors. The primary outcome was appropriate screening at 6 months based on chart review. We used a composite measure to define appropriate screening as screening for participants in good health, a discussion about screening for patients in intermediate health, and no screening for patients in poor health. Health state was objectively determined using patients' Charlson Comorbidity Index score and age. RESULTS: A total of 14 practices in central North Carolina participated as part of a practice-based research network. In total, 424 patients were recruited to participate and completed a baseline visit. Overall, 79% of participants were White and 58% female, with a mean age of 76.8 years. Patient characteristics between groups were similar by age, gender, race, education, insurance coverage, or work status. Overall, 70% had some college education or more, 57% were married, and virtually all had Medicare insurance (90%). The three primary medical conditions among the cohort were a history of diabetes, pneumonia, and cancer (28%, 26%, and 21%, respectively). CONCLUSION: We designed a randomized clinical trial to test a novel use of a patient decision aid to promote appropriate colorectal cancer screening and have recruited a diverse study population that seems similar between the intervention and control groups. The study should be able to determine the ability of a patient decision aid to increase individualized and appropriate colorectal cancer screening.

Developing a patient and family research advisory panel to include people with significant disease, multimorbidity and advanced age.

Background: People who have experienced illness due to significant disease, multimorbidity and/or advanced age are high utilizers of the health care system. Yet this population has had little formal opportunity to participate in guiding the health care research agenda, and few mechanisms exist for researchers to engage this population in an efficient way. Objective: We describe the process of developing a standing patient and family advisory panel to incorporate this population's voice into research in the USA. Methods: The panel was created at the University of Colorado. Preliminary panel development consisted of a needs assessment, information gathering and participant recruitment. We collected feedback from researchers who consulted with the panel and from panel members in order to better understand the experience from the patient and family member perspective. Results: The patient and family research advisory panel consists of eight advisors who have experience with significant disease, multimorbidity and/or advanced age, two physicians and a program manager. The panel meets every other month for 2 hours with the main purpose of advising diverse researchers on health care studies. Conclusion: People with significant disease, multimorbidity and/or advanced age represent a growing demographic in the USA, and their engagement in research is essential as the model of health care delivery moves from volume to value.

Underuse of surveillance colonoscopy in patients at increased risk of colorectal cancer.

OBJECTIVES: Colorectal cancer incidence and mortality have declined over the past two decades, and much of this improvement is attributed to increased use of screening. Approximately 25% of patients who undergo screening colonoscopy have premalignant adenomas that require removal and follow-up colonoscopy. However, there are few studies of the use of surveillance colonoscopy in increased risk patients with previous adenomas. METHODS: We conducted a cross-sectional study to examine factors associated with underuse of surveillance colonoscopy among patients who are at increased risk for colorectal cancer. The study population consisted of patients with previously identified adenomatous polyps and who were due for follow-up colonoscopy. Patients were categorized as attenders (n=100) or non-attenders (n=104) on the basis of completion of follow-up colonoscopy. Telephone surveys assessed the use of surveillance colonoscopy across domains of predisposing patient characteristics, enabling factors, and patient need. Mutlivariable logistic regression was used to identify factors associated with screening completion. RESULTS: Perceived barriers, perceived benefits, social deprivation, and cancer worry were associated with attendance at colonoscopy. Higher benefits (odds ratio (OR) 2.37, 95% confidence interval (CI) 1.04-5.41) and cancer worry (OR 1.73, 95% CI 1.07-2.79) increased the odds of attendance at follow-up colonoscopy, whereas greater barriers (OR 0.49, 95% CI 0.28-0.88) and high social deprivation (≥2; OR 0.09, 95% CI 0.01-0.76) were associated with lower odds. CONCLUSIONS: Our results suggest that multilevel factors contribute to the use of surveillance colonoscopy in higher risk populations, many of which are amenable to intervention. Interventions, such as patient navigation, may help facilitate appropriate use of surveillance colonoscopy.

A Randomized Controlled Effectiveness Trial for PSA Screening Decision Support Interventions in Two Primary Care Settings.

BACKGROUND: Decision support interventions (DESIs) provide a mechanism to translate comparative effectiveness research results into clinical care so that patients are able to make informed decisions. Patient decision support interventions for prostate-specific antigen (PSA) have been shown to promote informed decision making and reduce PSA testing in efficacy trials, but their impact in real world settings is not clear. OBJECTIVE: We performed an effectiveness trial of PSA decision support interventions in primary care. DESIGN: A randomized controlled trial of three distribution strategies was compared to a control. PARTICIPANTS: Participants included 2,550 men eligible for PSA testing (76.6 % of the eligible population) and 2001 survey respondents (60.1 % survey response rate). INTERVENTIONS: The intervention groups were: 1) mailed the DESI in DVD format, 2) offered a shared medical appointment (SMA) to view the DESI with other men and discuss, and 3) both options. MAIN MEASURES: We measured PSA testing identified via electronic medical record at 12 months and DESI use by self-report 4 months after the intervention mailing. KEY RESULTS: We found no differences in PSA testing across the three distribution strategies over a year-long follow-up period: 21 %, 24 %, 22 % in the DESI, SMA, and combined group respectively, compared to 21 % in the control group (p = 0.51). Self-reported DESI use was low across all strategies at 4 months: 16 % in the mailed DESI group, 6 % in the SMA group, and 15 % in the combined group (p = < 0.0001). CONCLUSIONS: Mailing PSA decision support interventions or inviting men to shared medical appointments unrelated to a primary care office visit do not appear to promote informed decision making, or change PSA testing behavior.

Comparing 3 values clarification methods for colorectal cancer screening decision-making: a randomized trial in the US and Australia.

PURPOSE: To compare the effects of three methods of values clarification (VCM): balance sheet; rating and ranking; and a discrete choice experiment (DCE) on decision-making about colorectal cancer (CRC) screening among adults in the US and Australia. METHODS: Using online panels managed by a survey research organization in the US and Australia, we recruited adults ages 50-75 at average risk for CRC for an online survey. Those eligible were randomized to one of the three VCM tasks. CRC screening options were described in terms of five key attributes: reduction in risk of CRC incidence and mortality; nature of the screening test; screening frequency; complications from screening; and chance of requiring a colonoscopy (as initial or follow-up testing). Main outcomes included self-reported most important attribute and unlabeled screening test preference by VCM and by country, assessed after the VCM. RESULTS: A total of 920 participants were enrolled; 51 % were Australian; mean age was 59.0; 87.0 % were white; 34.2 % had a 4-year college degree; 42.8 % had household incomes less than $45,000 USD per year; 44.9 % were up to date with CRC screening. Most important attribute differed across VCM groups: the rating and ranking group was more likely to choose risk reduction as most important attribute (69.8 %) than the balance sheet group (54.7 %) or DCE (49.3 %), p < 0.0001; most important attribute did not vary by country (p = 0.236). The fecal occult blood test (FOBT)-like test was the most frequently preferred test overall (55.9 %). Unlabeled test choice did not differ meaningfully by VCM. Australians were more likely to prefer the FOBT (AU 66.2 % vs. US 45.1 %, OR 2.4, 95 % CI 1.8, 3.1). Few participants favored no screening (US: 9.2 %, AU: 6.2 %). CONCLUSIONS: Screening test attribute importance varied by VCM, but not by country. FOBT was more commonly preferred by Australians than by Americans, but test preferences were heterogeneous in both countries.

Enhancing Quality in Psychiatry with Psychiatrists (EQUIPP)--results from a pilot study.

OBJECTIVES: To pilot a pharmacist-led, patient centered medication management program. DESIGN: Prospective, single arm trial. SETTING: Academic geriatric psychiatry outpatient clinic. PARTICIPANTS: Outpatients at least 65 years old, proxy available if demented, and on two or more psychiatric medications. INTERVENTION: A clinical pharmacist completed a baseline medication review and made evidence-based recommendations that were implemented by the pharmacist after discussion with the physician. The pharmacist made a minimum of monthly contact for 6 months to review medications and related issues. MEASUREMENTS: The primary outcome was the change in number of medication related problems over time (3 and 6 months) as defined by a predetermined classification system. RESULTS: The mean age of the 27 patients was 75 years, 10 of whom required a proxy to participate. On average, patients had nine chronic conditions and were taking 14 medications. The mean number (SD; range) of medication related problems at baseline was 4.1 (2.2; 0-8) and at 3 and 6 months were 3.6 (2.4, 0-9) and 3.4 (2.1; 0-8), respectively. Most follow-up problems were new (80% and 89% at 3 and 6 months, respectively). CONCLUSION: Using a pharmacist to deliver a medication management program was feasible and addressed existing problems. New problems, however, developed over a short interval (3-6 months), suggesting that ongoing intervention is required.

Using a discrete choice experiment to inform the design of programs to promote colon cancer screening for vulnerable populations in North Carolina.

BACKGROUND: Screening for colorectal cancer (CRC) is suboptimal, particularly for vulnerable populations. Effective intervention programs are needed to increase screening rates. We used a discrete choice experiment (DCE) to learn about how vulnerable individuals in North Carolina value different aspects of CRC screening programs. METHODS: We enrolled English-speaking adults ages 50-75 at average risk of CRC from rural North Carolina communities with low rates of CRC screening, targeting those with public or no insurance and low incomes. Participants received basic information about CRC screening and potential program features, then completed a 16 task DCE and survey questions that examined preferences for four attributes of screening programs: testing options available; travel time required; money paid for screening or rewards for completing screening; and the portion of the cost of follow-up care paid out of pocket. We used Hierarchical Bayesian methods to calculate individual-level utilities for the 4 attributes' levels and individual-level attribute importance scores. For each individual, the attribute with the highest importance score was considered the most important attribute. Individual utilities were then aggregated to produce mean utilities for each attribute. We also compared DCE-based results with those from direct questions in a post-DCE survey. RESULTS: We enrolled 150 adults. Mean age was 57.8 (range 50-74); 55% were women; 76% White and 19% African-American; 87% annual household income under $30,000; and 51% were uninsured. Individuals preferred shorter travel; rewards or small copayments compared with large copayments; programs that included stool testing as an option; and greater coverage of follow-up costs. Follow-up cost coverage was most frequently found to be the most important attribute from the DCE (47%); followed by test reward/copayment (33%). From the survey, proportion of follow-up costs paid was most frequently cited as most important (42% of participants), followed by testing options (32%). There was moderate agreement (45%) in attribute importance between the DCE and the single question in the post-DCE survey. CONCLUSIONS: Screening test copayments and follow-up care coverage costs are important program characteristics in this vulnerable, rural population.

Physician decision making for colorectal cancer screening in the elderly.

BACKGROUND: Although individualized decision making is recommended to appropriately screen for colorectal cancer (CRC) in older adults, it is unclear whether physicians solicit input from older patients before making a recommendation for or against CRC screening. OBJECTIVE: The purpose of this study was to examine whether physicians elect to engage older patients in individualized decision making for CRC screening. DESIGN AND PARTICIPANTS: We surveyed a random sample of 650 US primary care physicians by mail. Physicians responded to questions about three clinical vignettes involving 80-year-old female patients in good, fair, and poor health. We examined whether physicians reported that they would initiate a discussion with the patients about CRC screening and whether they would make a recommendation about screening or seek patient input first. RESULTS: A total of 276 eligible physicians responded (52 % corrected response rate). Whether physicians indicated they would initiate a discussion about CRC screening varied by vignette: 91 % of physicians indicated they would do so for the patient in good health and 66 % and 44 % for the patients in fair and poor health, respectively (p<0.0001). The proportion of physicians that would seek patient input for their screening recommendation also varied by vignette (45 % for good, 49 % for fair, and 26 % for poor). CONCLUSION: We found that physicians often individualize their CRC screening recommendations for older women by electing to engage patients in discussions and seeking their input before making a CRC recommendation. Physicians were more likely to elect to engage the patients represented by the good and fair health vignette, where the potential benefits likely outweigh the potential harms, than the patient in poor health, where the potential harms likely outweigh the potential benefits.

A comparison of US and Australian men's values and preferences for PSA screening.

BACKGROUND: Patient preferences derived from an assessment of values can help inform the design of screening programs, but how best to do so, and whether such preferences differ cross-nationally, has not been well-examined. The objective of this study was to compare the values and preferences of Australian and US men for PSA (prostate specific antigen) screening. METHODS: We used an internet based survey of men aged 50-75 with no personal or family history of prostate cancer recruited from on-line panels of a survey research organization in the US and Australia. Participants viewed information on prostate cancer and prostate cancer screening with PSA testing then completed a values clarification task that included information on 4 key attributes: chance of 1) being diagnosed with prostate cancer, 2) dying from prostate cancer, 3) requiring a biopsy as a result of screening, and 4) developing impotence or incontinence as a result of screening. The outcome measures were self reported most important attribute, unlabelled screening test choice, and labelled screening intent, assessed on post-task questionnaires. RESULTS: We enrolled 911 participants (US:456; AU:455), mean age was 59.7; 88.0% were white; 36.4% had completed at least a Bachelors' degree; 42.0% reported a PSA test in the past 12 months. Australian men were more likely to be white and to have had recent screening. For both US and Australian men, the most important attribute was the chance of dying from prostate cancer. Unlabelled post-task preference for the PSA screening-like option was greater for Australian (39.1%) compared to US (26.3%) participants (adjusted OR 1.68 (1.28-2.22)). Labelled intent for screening was high for both countries: US:73.7%, AUS:78.0% (p = 0.308). CONCLUSIONS: There was high intent for PSA screening in both US and Australian men; fewer men in each country chose the PSA-like option on the unlabelled question. Australian men were somewhat more likely to prefer PSA screening. Men in both countries did not view the increased risk of diagnosis as a negative aspect, suggesting more work needs to be done on communicating the concept of overdiagnosis to men facing a PSA screening decision. TRIAL REGISTRATION: This trial was registered at ClinicalTrials.gov (NCT01558583).

Reach, usage, and effectiveness of a Medicaid patient navigator intervention to increase colorectal cancer screening, Cape Fear, North Carolina, 2011.

INTRODUCTION: Screening for colorectal cancer can reduce incidence and death, but screening is underused, especially among vulnerable groups such as Medicaid patients. Effective interventions are needed to increase screening frequency. Our study consisted of a controlled trial of an intervention designed to improve colorectal cancer screening among Medicaid patients in North Carolina. METHODS: The intervention included a mailed screening reminder letter and decision aid followed by telephone support from an offsite, Medicaid-based, patient navigator. The study included 12 clinical practices, 6 as intervention practices and 6 as matched controls. Eligible patients were aged 50 years or older, covered by Medicaid, and identified from Medicaid claims data as not current with colorectal cancer screening recommendations. We reviewed Medicaid claims data at 6 months and conducted multivariate logistic regression to compare participant screening in intervention practices with participants in control practices. We controlled for sociodemographic characteristics. RESULTS: Most of the sample was black (53.1%) and female (57.2%); the average age was 56.5 years. On the basis of Medicaid claims, 9.2% of intervention participants (n = 22/240) had had a colorectal cancer screening at the 6-month review, compared with 7.5% of control patients (n = 13/174). The adjusted odds ratio when controlling for age, comorbidities, race, sex, and continuous Medicaid eligibility was 1.44 (95% confidence interval, 0.68-3.06). The patient navigator reached 44 participants (27.6%). CONCLUSION: The intervention had limited reach and little effect after 6 months on the number of participants screened. Higher-intensity interventions, such as use of practice-based navigators, may be needed to reach and improve screening rates in vulnerable populations.

"Many miles to go ": a systematic review of the implementation of patient decision support interventions into routine clinical practice.

BACKGROUND: Two decades of research has established the positive effect of using patient-targeted decision support interventions: patients gain knowledge, greater understanding of probabilities and increased confidence in decisions. Yet, despite their efficacy, the effectiveness of these decision support interventions in routine practice has yet to be established; widespread adoption has not occurred. The aim of this review was to search for and analyze the findings of published peer-reviewed studies that investigated the success levels of strategies or methods where attempts were made to implement patient-targeted decision support interventions into routine clinical settings. METHODS: An electronic search strategy was devised and adapted for the following databases: ASSIA, CINAHL, Embase, HMIC, Medline, Medline-in-process, OpenSIGLE, PsycINFO, Scopus, Social Services Abstracts, and the Web of Science. In addition, we used snowballing techniques. Studies were included after dual independent assessment. RESULTS: After assessment, 5322 abstracts yielded 51 articles for consideration. After examining full-texts, 17 studies were included and subjected to data extraction. The approach used in all studies was one where clinicians and their staff used a referral model, asking eligible patients to use decision support. The results point to significant challenges to the implementation of patient decision support using this model, including indifference on the part of health care professionals. This indifference stemmed from a reported lack of confidence in the content of decision support interventions and concern about disruption to established workflows, ultimately contributing to organizational inertia regarding their adoption. CONCLUSIONS: It seems too early to make firm recommendations about how best to implement patient decision support into routine practice because approaches that use a 'referral model' consistently report difficulties. We sense that the underlying issues that militate against the use of patient decision support and, more generally, limit the adoption of shared decision making, are under-investigated and under-specified. Future reports from implementation studies could be improved by following guidelines, for example the SQUIRE proposals, and by adopting methods that would be able to go beyond the 'barriers' and 'facilitators' approach to understand more about the nature of professional and organizational resistance to these tools. The lack of incentives that reward the use of these interventions needs to be considered as a significant impediment.

Performance of Medometer visual tool for measuring medication adherence and comparison with other measures.

OBJECTIVES: To measure adherence in older adults with the use of a novel visual scale screening tool and to compare this adherence measurement with other adherence measures. DESIGN: Noncontrolled prospective intervention trial. SETTING: Geriatric psychiatry clinic in North Carolina between February 2008 and July 2009. PARTICIPANTS: 27 geriatric psychiatry clinic patients were identified as meeting eligibility criteria, and 26 of these participants completed the baseline and 3- and 6-month visits. INTERVENTION: Pharmacist-provided medication management program. MAIN OUTCOME MEASURES: A novel visual scale, the Medometer, assessed patient adherence to individual medications and aggregate medication regimen. The Medometer was compared with pharmacist subjective adherence assessment and the four-item Morisky scale. RESULTS: Aggregate regimen adherence based on the Morisky scale was 44%, 50%, and 38% at baseline, 3 months, and 6 months, respectively. Similarly it was 48%, 50%, and 46%, respectively, for the aggregate Medometer measurement. Measured individually by drug, average adherence at baseline, 3 months, and 6 months was 44%, 50%, and 35%, respectively, with the Medometer and 74%, 65%, and 50%, respectively, for the pharmacist's subjective assessment. Less stringent definitions for categorizing adherence identified a higher proportion of patients as adherent, with similar trends across measures. Individual medication and aggregate regimen adherence estimates provided face validity for the Medometer, with moderate agreement with other measures. CONCLUSION: The Medometer is a visual scale that can assess individual medication and overall medication regimen adherence. It performed well in this pilot study, but additional research is needed to assess the reliability and validity of this tool in larger, diverse populations and to test the effectiveness of this tool in guiding pharmacists' efforts to improve medication outcomes.

Assessing and Understanding Reactance, Self-Exemption, Disbelief, Source Derogation and Information Conflict in Reaction to Overdiagnosis in Mammography Screening: Scale Development and Preliminary Validation.

PURPOSE: Overdiagnosis is a concept central to making informed breast cancer screening decisions, and yet some people may react to overdiagnosis with doubt and skepticism. The present research assessed 4 related reactions to overdiagnosis: reactance, self-exemption, disbelief, and source derogation (REDS). The degree to which the concept of overdiagnosis conflicts with participants' prior beliefs and health messages (information conflict) was also assessed as a potential antecedent of REDS. We developed a scale to assess these reactions, evaluated how those reactions are related, and identified their potential implications for screening decision making. METHODS: Female participants aged 39 to 49 years read information about overdiagnosis in mammography screening and completed survey questions assessing their reactions to that information. We used a multidimensional theoretical framework to assess dimensionality and overall domain-specific internal consistency of the REDS and Information Conflict questions. Exploratory and confirmatory factor analyses were performed using data randomly split into a training set and test set. Correlations between REDS, screening intentions, and other outcomes were evaluated. RESULTS: Five-hundred twenty-five participants completed an online survey. Exploratory and confirmatory factor analyses identified that Reactance, Self Exemption, Disbelief, Source Derogation, and Information Conflict represent unique constructs. A reduced 20-item scale was created by selecting 4 items per construct, which showed good model fit. Reactance, Disbelief, and Source Derogation were associated with lower intent to use information about overdiagnosis in decision making and the belief that informing people about overdiagnosis is unimportant. CONCLUSIONS: REDS and Information Conflict are distinct but correlated constructs that are common reactions to overdiagnosis. Some of these reactions may have negative implications for making informed screening decisions. HIGHLIGHTS: Overdiagnosis is a concept central to making informed breast cancer screening decisions, and yet when provided information about overdiagnosis, some people are skeptical.This research developed a measure that assessed different ways in which people might express skepticism about overdiagnosis (reactance, self-exemption, disbelief, source derogation) and also the perception that overdiagnosis conflicts with prior knowledge and health messages (information conflict).These different reactions are distinct but correlated and are common reactions when people learn about overdiagnosis.Reactance, disbelief, and source derogation are associated with lower intent to use information about overdiagnosis in decision making as well as the belief that informing people about overdiagnosis is unimportant.

Personalized Multilevel Intervention for Improving Appropriate Use of Colorectal Cancer Screening in Older Adults: A Cluster Randomized Clinical Trial.

Importance: Despite guideline recommendations, clinicians do not systematically use prior screening or health history to guide colorectal cancer (CRC) screening decisions in older adults. Objective: To evaluate the effect of a personalized multilevel intervention on screening orders in older adults due for average-risk CRC screening. Design, Setting, and Participants: Interventional 2-group parallel unmasked cluster randomized clinical trial conducted from November 2015 to February 2019 at 2 US Department of Veterans Affairs (VA) facilities: 1 academic VA medical center and 1 of its connected outpatient clinics. Randomization at the primary care physician/clinician (PCP) level, stratified by study site and clinical full-time equivalency. Participants were 431 average-risk, screen-due US veterans aged 70 to 75 years attending a primary care visit. Data analysis was performed from August 2018 to August 2023. Intervention: The intervention group received a multilevel intervention including a decision-aid booklet with detailed information on screening benefits and harms, personalized for each participant based on age, sex, prior screening, and comorbidity. The control group received a multilevel intervention including a screening informational booklet. All participants received PCP education and system-level modifications to support personalized screening. Main Outcomes and Measures: The primary outcome was whether screening was ordered within 2 weeks of clinic visit. Secondary outcomes were concordance between screening orders and screening benefit and screening utilization within 6 months. Results: A total of 436 patients were consented, and 431 were analyzed across 67 PCPs. Patients had a mean (SD) age of 71.5 (1.7) years; 424 were male (98.4%); 374 were White (86.8%); 89 were college graduates (21.5%); and 351 (81.4%) had undergone prior screening. A total of 258 (59.9%) were randomized to intervention, and 173 (40.1%) to control. Screening orders were placed for 162 of 258 intervention patients (62.8%) vs 114 of 173 control patients (65.9%) (adjusted difference, -4.0 percentage points [pp]; 95% CI, -15.4 to 7.4 pp). In a prespecified interaction analysis, the proportion receiving orders was lower in the intervention group than in the control group for those in the lowest benefit quartile (59.4% vs 71.1%). In contrast, the proportion receiving orders was higher in the intervention group than in the control group for those in the highest benefit quartile (67.6% vs 52.2%) (interaction P = .049). Fewer intervention patients (106 of 256 [41.4%]) utilized screening overall at 6 months than controls (96 of 173 [55.9%]) (adjusted difference, -13.4 pp; 95% CI, -25.3 to -1.6 pp). Conclusions and Relevance: In this cluster randomized clinical trial, patients who were presented with personalized information about screening benefits and harms in the context of a multilevel intervention were more likely to receive screening orders concordant with benefit and were less likely to utilize screening. Trial Registration: ClinicalTrials.gov Identifier: NCT02027545.

Development and pilot testing of a decision aid for surrogates of patients with prolonged mechanical ventilation.

OBJECTIVE: Shared decision making is inadequate in intensive care units. Decision aids can improve decision making quality, though their role in an intensive care units setting is unclear. We aimed to develop and pilot test a decision aid for shared decision makers of patients undergoing prolonged mechanical ventilation. SETTING: Intensive care units at three medical centers. SUBJECTS: Fifty-three surrogate decision makers and 58 physicians. DESIGN AND INTERVENTIONS: We developed the decision aid using defined methodological guidelines. After an iterative revision process, formative cognitive testing was performed among surrogate-physician dyads. Next, we compared the decision aid to usual care control in a prospective, before/after design study. MEASUREMENTS AND MAIN RESULTS: Primary outcomes were physician-surrogate discordance for expected patient survival, comprehension of relevant medical information, and the quality of communication. Compared to control, the intervention group had lower surrogate-physician discordance (7 [10] vs. 43 [21]), greater comprehension (11.4 [0.7] vs. 6.1 [3.7]), and improved quality of communication (8.7 [1.3] vs. 8.4 [1.3]) (all p<.05) post-intervention. Hospital costs were lower in the intervention group ($110,609 vs. $178,618; p=.044); mortality did not differ by group (38% vs. 50%, p=.95). Ninety-four percent of the surrogates and 100% of the physicians reported that the decision aid was useful in decision making. CONCLUSION: We developed a prolonged mechanical ventilation decision aid that is feasible, acceptable, and associated with both improved decision-making quality and less resource utilization. Further evaluation using a randomized controlled trial design is required to evaluate the decision aid's effect on long-term patient and surrogate outcomes.