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.

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.

Effect of a Patient Decision Aid on Preferences for Colorectal Cancer Screening Among Older Adults: A Secondary Analysis of a Randomized Clinical Trial.

Importance: Guidelines recommend individualized decision-making for colorectal cancer (CRC) screening among adults aged 76 to 84 years, a process that includes a consideration of health state and patient preference. Objective: To determine whether a targeted patient decision aid would align older adults' screening preference with their potential to benefit from CRC screening. Design, Setting, and Participants: This is a prespecified secondary analysis from a randomized clinical trial. Participants aged 70 to 84 years who were not up to date with screening and had an appointment within 6 weeks were purposively sampled by health state (poor, intermediate, or good) at 14 community-based primary care practices and block randomized to receive the intervention or control. Patients were recruited from March 1, 2012, to February 28, 2015, and these secondary analyses were performed from January 15 to March 1, 2022. Interventions: Patient decision aid targeted to age and sex. Main Outcomes and Measures: The primary outcome of this analysis was patient preference for CRC screening. The a priori hypothesis was that the decision aid (intervention) group would reduce the proportion preferring screening among those in poor and intermediate health compared with the control group. Results: Among the 424 participants, the mean (SD) age was 76.8 (4.2) years; 248 (58.5%) of participants were women; and 333 (78.5%) were White. The proportion preferring screening in the intervention group was less than in the control group for those in the intermediate health state (34 of 76 [44.7%] vs 40 of 73 [54.8%]; absolute difference, -10.1% [95% CI, -26.0% to 5.9%]) and in the poor health state (24 of 62 [38.7%] vs 33 of 61 [54.1%]; absolute difference, -15.4% [95% CI, -32.8% to 2.0%]). These differences were not statistically significant. The proportion of those in good health who preferred screening was similar between the intervention and control groups (44 of 74 [59.5%] for intervention vs 46 of 75 [61.3%] for control; absolute difference, -1.9% [95% CI, -17.6% to 13.8%]). Conclusions and Relevance: The findings of this secondary analysis of a clinical trial did not demonstrate statistically significant differences in patient preferences between the health groups. Additional studies that are appropriately powered are needed to determine the effect of the decision aid on the preferences of older patients for CRC screening by health state. Trial Registration: ClinicalTrials.gov Identifier: NCT01575990.

Experiences Implementing a Suite of Decision Aids for Implantable Cardioverter Defibrillators: Qualitative Insights From the DECIDE-ICD Trial.

BACKGROUND: Shared decision making (SDM) is gaining importance in cardiology, including Centers for Medicare & Medicaid Services (CMS) reimbursement policies requiring documented SDM for patients considering primary prevention implantable cardioverter defibrillators. The DECIDE-ICD Trial (Decision Support Intervention for Patients offered implantable Cardioverter-Defibrillators) assessed the implementation and effectiveness of patient decision aids (DAs) using a stepped-wedge design at 7 sites. The purpose of this subanalysis was to qualitatively describe electrophysiology clinicians' experience implementing and using the DAs. METHODS: This included semi-structured individual interviews with electrophysiology clinicians at participating sites across the US, at least 6 months following conversion into the implementation phase of the trial (from June 2020 through February 2022). The interview guide was structured according to the RE-AIM (Reach, Effectiveness, Adoption, Implementation and Maintenance [implementation evaluation model]) framework, assessing clinician experiences, which can impact implementation domains, and was qualitatively assessed using a mixed inductive/deductive method. RESULTS: We completed 22 interviews post-implementation across all 7 sites. Participants included both physicians (n=16) and other clinicians who counsel patients regarding treatment options (n=6). While perception of SDM and the DA were positive, participants highlighted reasons for uneven delivery of DAs to appropriate patients. The CMS mandate for SDM was not universally viewed as associating with patients receiving DA's, but rather (1) logistics of DA delivery, (2) perceived effectiveness in improving patient decision-making, and (3) match of DA content to current patient populations. Remaining tensions include the specific trial data used in DAs and reconciling timing of delivery with when patients are actively making decisions. CONCLUSIONS: Clinicians charged with delivering DAs to patients considering primary prevention implantable cardioverter defibrillators were generally supportive of the tenets of SDM, and of the DA tools themselves, but noted several opportunities to improve the reach and continued use of them in routine care. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique Identifier: NCT03374891.

Improving Tobacco Cessation Rates Using Inline Clinical Decision Support.

BACKGROUND: Tobacco use is a significant cause of morbidity and mortality in the United States. Even brief advice from a clinician can significantly influence cessation rates among tobacco users, but clinicians often miss opportunities to provide this simple intervention. OBJECTIVES: The intent of this quality improvement project was to increase tobacco cessation among tobacco users by nudging clinicians using a clinical decision support (CDS) tool. METHODS: We developed a CDS tool using principles of user-centered design and the CDS Five Rights to dynamically insert actionable information about current tobacco users into the Assessment and Plan section of clinicians' notes. We conducted a retrospective analysis of patients at four primary care practices in the Denver Metro area evaluating the impact of the CDS tool on time to tobacco cessation. A multivariable Cox proportional-hazards model was used in this determination. Kaplan-Meier curves were used to estimate tobacco cessation probabilities at 90, 180, and 365 days. RESULTS: We analyzed 5,644 patients with a median age of 45 years, most of whom lived in an urban location (99.5%) and the majority of whom were males (60%). The median follow-up time for patients was 16 months. After adjustment for age, gender, practice site, and patient location (rural, urban), the intervention group had significantly greater risk of tobacco cessation compared to those in the control group (hazard ratio: 1.22, 95% confidence interval: 1.08-1.36; p = 0.001). CONCLUSION: This study suggests a CDS intervention which respects the CDS Five Rights and incorporates user-centered design can affect tobacco use rates. Future work should expand the target population of this CDS tool and continue a user-centered, iterative design process.

Primary Care Provider Knowledge and Practice in Risk Assessment for Early Age Onset Colorectal Cancer: Opportunities for Improvement.

Colorectal cancer (CRC) incidence and mortality are rising in individuals under age 50, termed early age onset (EAO) CRC. Lower endoscopy is recommended for all patients with unexplained iron deficiency anemia (IDA) or hematochezia to assess the EAO-CRC. For those without symptoms, professional societies recommend decreasing the age to start screening from 50 to 45. Primary care provider (PCP) knowledge and practices around EAO-CRC risk assessment and screening are unknown. We conducted a survey study in May, 2020 of multi-specialty PCPs from three large medical systems to assess PCP knowledge, risk stratification practices and barriers/facilitators they face to offer CRC screening in patients < 50. We conducted univariate analysis to assess factors associated with knowledge and diagnostic practices. Response rate was 27.7% (196/708). Although 77.6% of respondents were aware that EAO-CRC incidence is increasing, only 42.9% knew that EAO-CRC mortality is also increasing. Of note, 91.8% recommend starting average risk screening at age 50. For 40- to 49-year-old patients present with unexplained IDA or hematochezia, 71.9% and 50.5% of respondents, respectively, recommend a diagnostic colonoscopy. Trainees were less likely to be aware of rising EAO-CRC mortality (odds ratio, 0.42; 95% CI, 0.21 to 0.82) and non-internal medicine providers were less likely to recommend CRC screening in those with a first-degree relative with CRC (odds ratio, 0.82; 95% CI, 0.72 to 0.93). Ongoing education efforts will be required to improve recognition and management of high-risk symptoms, particularly among non-internists and trainees.

Validation of a 5-Year Mortality Prediction Model among U.S. Medicare Beneficiaries.

BACKGROUND/OBJECTIVES: A claims-based model predicting 5-year mortality (Lund-Lewis) was developed in a 2008 cohort of North Carolina (NC) Medicare beneficiaries and included indicators of comorbid conditions, frailty, disability, and functional impairment. The objective of this study was to validate the Lund-Lewis model externally within a nationwide sample of Medicare beneficiaries. DESIGN: Retrospective validation study. SETTING: U.S. Medicare population. PARTICIPANTS: From a random sample of Medicare beneficiaries, we created four annual cohorts from 2008 to 2011 of individuals aged 66 and older with an office visit in that year. The annual cohorts ranged from 1.13 to 1.18 million beneficiaries. MEASUREMENTS: The outcome was 5-year all-cause mortality. We assessed clinical indicators in the 12 months before the qualifying office visit and estimated predicted 5-year mortality for each beneficiary in the nationwide sample by applying estimates derived in the original NC cohort. Model performance was assessed by quantifying discrimination, calibration, and reclassification metrics compared with a model fit on a comorbidity score. RESULTS: Across the annual cohorts, 5-year mortality ranged from 24.4% to 25.5%. The model had strong discrimination (C-statistics ranged across cohorts from .823 to .826). Reclassification measures showed improvement over a comorbidity score model for beneficiaries who died but reduced performance among beneficiaries who survived. The calibration slope ranged from .83 to .86; the model generally predicted a higher risk than observed. CONCLUSION: The Lund-Lewis model showed strong and consistent discrimination in a national U.S. Medicare sample, although calibration indicated slight overfitting. Future work should investigate methods for improving model calibration and evaluating performance within specific disease settings.

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.

Achieving 70% Hypertension Control: How Hard Can It Be?

BACKGROUND: Although decades of research support hypertension treatment, studies guiding the successful implementation of programs to control blood pressure (BP) in real-world primary care settings are sparse. METHODS: In this study a multicomponent intervention was implemented, with the following goals: (1) achieve 70% control of hypertension within 18 months, (2) use the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework to evaluate the implementation of the program, and (3) assess additional actions that could have been undertaken to achieve control among those who remained uncontrolled. RESULTS: Of 786 patients, 597 achieved BP control (75.9%; improvement of 20.9 percentage points). For RE-AIM outcomes, (1) staff performed outreach for all uncontrolled patients, with 75.3% making follow-up appointments, and 61.3% attending at least one appointment; (2) the proportion of faculty with at least 70% control increased from 26.7% to 87.5%, indicating significant physician adoption; (3) implementation outcomes were mixed, with four of six medical assistant BP training sessions completed, outreach calls performed in 16 of 18 months, but only 24 patients referred to the patient counseling and medication management program. For maintenance, 70% control was maintained for a 7-month observation period. The research team determined that 16.8% of those uncontrolled could have had additional actions taken to achieve control. CONCLUSION: The goal of 70% control was achieved, improving control by 20.9 percentage points over 18 months. The RE-AIM framework evaluation demonstrated successful implementation and likely contributed to achievement of the target. The chart review findings revealed that a minority of patients could have additional interventions provided by the primary care practice.

Effect of a Mammography Screening Decision Aid for Women 75 Years and Older: A Cluster Randomized Clinical Trial.

Importance: Guidelines recommend that women 75 years and older be informed of the benefits and harms of mammography before screening. Objective: To test the effects of receipt of a paper-based mammography screening decision aid (DA) for women 75 years and older on their screening decisions. Design, Setting, and Participants: A cluster randomized clinical trial with clinician as the unit of randomization. All analyses were completed on an intent-to-treat basis. The setting was 11 primary care practices in Massachusetts or North Carolina. Of 1247 eligible women reached, 546 aged 75 to 89 years without breast cancer or dementia who had a mammogram within 24 months but not within 6 months and saw 1 of 137 clinicians (herein referred to as PCPs) from November 3, 2014, to January 26, 2017, participated. A research assistant (RA) administered a previsit questionnaire on each participant's health, breast cancer risk factors, sociodemographic characteristics, and screening intentions. After the visit, the RA administered a postvisit questionnaire on screening intentions and knowledge. Interventions: Receipt of the DA (DA arm) or a home safety (HS) pamphlet (control arm) before a PCP visit. Main Outcomes and Measures: Participants were followed up for 18 months for receipt of mammography screening (primary outcome). To examine the effects of the DA, marginal logistic regression models were fit using generalized estimating equations to allow for clustering by PCP. Adjusted probabilities and risk differences were estimated to account for clustering by PCP. Results: Of 546 women in the study, 283 (51.8%) received the DA. Patients in each arm were well matched; their mean (SD) age was 79.8 (3.7) years, 428 (78.4%) were non-Hispanic white, 321 (of 543 [59.1%]) had completed college, and 192 (35.2%) had less than a 10-year life expectancy. After 18 months, 9.1% (95% CI, 1.2%-16.9%) fewer women in the DA arm than in the control arm had undergone mammography screening (51.3% vs 60.4%; adjusted risk ratio, 0.84; 95% CI, 0.75-0.95; P = .006). Women in the DA arm were more likely than those in the control arm to rate their screening intentions lower from previsit to postvisit (69 of 283 [adjusted %, 24.5%] vs 47 of 263 [adjusted %, 15.3%]), to be more knowledgeable about the benefits and harms of screening (86 [adjusted %, 25.5%] vs 32 [adjusted %, 11.7%]), and to have a documented discussion about mammography with their PCP (146 [adjusted %, 47.4%] vs 111 [adjusted %, 38.9%]). Almost all women in the DA arm (94.9%) would recommend the DA. Conclusions and Relevance: Providing women 75 years and older with a mammography screening DA before a PCP visit helps them make more informed screening decisions and leads to fewer women choosing to be screened, suggesting that the DA may help reduce overscreening. Trial Registration: ClinicalTrials.gov Identifier: NCT02198690.

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.

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.

Individualized Colorectal Cancer Screening Discussions Between Older Adults and Their Primary Care Providers: A Cross-Sectional Study.

Introduction. Discussions of colorectal cancer (CRC) screening with older adults should be individualized to maximize appropriate screening. Our aim was to describe CRC screening discussions and explore their associations with patient characteristics and screening intentions. Methods. Cross-sectional survey of 422 primary care patients aged ≥70 years and eligible for CRC screening, including open-ended questions about CRC screening discussions. Primary outcomes were the frequency with which CRC screening discussions occurred, who had those discussions, and the domains that emerged from thematic analysis of participants' brief reports of their discussions. We also examined the associations between 1) patient characteristics and whether a screening discussion occurred and 2) the domains discussed and what screening decisions were made. Results. Of 422 participants, 209 reported having discussions and 201 responded to open-ended questions about CRC discussions. In a regression analysis, several factors were associated with increased odds of having a discussion: participants' preference to pursue screening (odds ratio [OR] 2.3, 95% confidence interval [CI] 1.3, 3.9), good health (OR 2.9, 95% CI 1.7, 4.8), and receipt of the decision aid (OR 2.1, 95% CI 1.4, 3.2). Our thematic analysis identified five domains related to discussion content and three related to discussion process. The CRC screening-related information domain was the most commonly discussed content domain, and the timing/frequency domain was associated with increased odds of intent to pursue screening. Decision-making role, the most commonly discussed process domain, was associated with increased odds of the intent to forgo CRC screening. Conclusions and Relevance. CRC screening discussions varied by type of participant and content. Future work is needed to determine if interventions focused on specific domains alters the appropriateness of participants' colorectal cancer screening intentions.

Developing a Quality Measurement Strategy in an Academic Primary Care Setting: An Environmental Scan.

PURPOSE: The purpose of this project was to: (1) develop a strategy for primary care quality measurement using an environmental scan and interviews to identify best practices and candidate measures; (2) present recommendations to facilitate successful measurement. METHODS: Following stakeholder interviews and review of existing measures, we created a three-tiered recommendation system for selecting and implementing measures. We also developed a framework for reviewing and prioritizing measures and prepared a detailed project report. RESULTS: Interviews provided a broader perspective on measuring quality, including implementing measures, measuring value, and identifying measurement gaps. Our recommendations fall into three tiers: Tier 1 measures can be implemented quickly and include clinical processes and outcomes for preventive care and disease states. Tier 2 measures require modifications to electronic health record, workflows, and/or staff preparation. Tier 3 (Strategic Vision) addresses topics that should be incorporated in the future to ensure high-quality primary care (adherence, patient activation, patient experience, teamness, staff satisfaction, and value), and infrastructure development to support ongoing quality measurement. CONCLUSIONS: Implementing a quality measurement strategy is challenging and labor-intensive but is necessary to improve healthcare quality. Our work demonstrates the effort and investment required to progress quality measurement and offers recommendations for successfully undertaking this type of endeavor.

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.

A Decision Aid to Promote Appropriate Colorectal Cancer Screening among Older Adults: A Randomized Controlled Trial.

BACKGROUND: Concerns have been raised about both over- and underutilization of colorectal cancer (CRC) screening in older patients and the need to align screening behavior with likelihood of net benefit. OBJECTIVE: The purpose of this study was to test a novel use of a patient decision aid (PtDA) to promote appropriate CRC screening in older adults. METHODS: A total of 424 patients ages 70 to 84 y who were not up to date with CRC screening participated in a double-blinded randomized controlled trial of a PtDA targeted to older adults making decisions about whether to undergo CRC screening from March 2012 to February 2015. INTERVENTION: Patients were randomized to a targeted PtDA or an attention control. The PtDA was designed to facilitate individualized decision making-helping patients understand the potential risks, benefits, and uncertainties of CRC screening given advanced age, health state, preferences, and values. OUTCOMES: Two composite outcomes, appropriate CRC screening behavior 6 mo after the index visit and appropriate screening intent immediately after the visit, were defined as completed screening or intent for patients in good health, discussion about screening with their provider for patients in intermediate health, and no screening or intent for patients in poor health. Health state was determined by age and Charlson Comorbidity Index. RESULTS: Four hundred twelve (97%) and 421 (99%) patients were analyzed for the primary and secondary outcomes, respectively. Appropriate screening behavior at 6 mo was higher in the intervention group (55% v. 45%, P = 0.023) as was appropriate screening intent following the provider visit (61% v. 47%, P = 0.003). LIMITATIONS: The study took place in a single geographic region. The appropriate CRC screening classification system used in this study has not been formally validated. CONCLUSIONS: A PtDA for older adults promoted appropriate CRC screening behavior and intent. TRIAL REGISTRATION: Clinicaltrials.gov, registration number NCT01575990. https://clinicaltrials.gov/ct2/show/NCT01575990?term=epic-d&rank=1.

Exploring factors that might influence primary-care provider discussion of and recommendation for prostate and colon cancer screening.

BACKGROUND: Primary-care providers may contribute to the use of low-value cancer screening. OBJECTIVE: We sought to examine circumstances under which primary-care providers would discuss and recommend two types of cancer screening services across a spectrum of net benefit and other factors known to influence screening. PATIENTS AND METHODS: This was a cross sectional survey of 126 primary-care providers in 24 primary-care clinics in the US. Participants completed surveys with two hypothetical screening scenarios for prostate or colorectal cancer (CRC). Patients in the scenarios varied by age and screening-request status. For each scenario, providers indicated whether they would discuss and recommend screening. Providers also reported on their screening attitudes and the influence of other factors known to affect screening (short patient visits, worry about lawsuits, clinical reminders/performance measures, and screening guidelines). We examined associations between providers' attitudes and their screening recommendations for hypothetical 90-year-olds (the lowest-value screening). RESULTS: Providers reported they would discuss cancer screening more often than they would recommend it (P<0.001). More providers would discuss and recommend screening for CRC than prostate cancer (P<0.001), for younger than older patients (P<0.001), and when the patient requested it than when not (P<0.001). For a 90-year-old patient, every point increase in cancer-specific screening attitude increased the likelihood of a screening recommendation (30% for prostate cancer and 30% for CRC). DISCUSSION: While most providers' reported practice patterns aligned with net benefit, some providers would discuss and recommend low-value cancer screening, particularly when faced with a patient request. CONCLUSION: More work appears to be needed to help providers to discuss and recommend screening that aligns with value.

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.

Implementation of a pharmacist-managed clinic for patients with chronic nonmalignant pain.

PURPOSE: A pharmacist-managed chronic pain clinic (PMCPC) in a primary care setting is described. SUMMARY: As primary care providers (PCPs) may be unprepared or lack time to manage high-risk patients receiving opioids for chronic nonmalignant pain, alternative models of care are needed. The University of Colorado PMCPC is integrated into an internal medicine outpatient clinic. The PMCPC is staffed by 1 clinical pharmacist, with pharmacy students and residents also performing clinic duties. The pharmacy team reviews health records to determine eligibility for PMCPC services and documents referral requests in the electronic health record (EHR); on PCP acceptance of a referral, the pharmacy team assumes primary responsibility for the patient's pain management under a collaborative practice agreement. Using a collaborative drug therapy management (CDTM) protocol, the pharmacy team conducts patient assessments, including an assessment for signs of aberrant drug-taking behaviors; provides initial and ongoing counseling and education; and makes recommendations to the PCP for opioid dosage adjustments and regimen additions and discontinuations. Experience at the clinic to date indicates that the PMCPC model is feasible and accepted by PCPs and patients. CONCLUSION: A PMCPC based in a primary care setting was established to improve the care of patients with chronic nonmalignant pain who are prescribed opioid therapy for a period of 3 months or longer. Clinic patients are referred to the clinic through the EHR and managed by a pharmacist under a CDTM protocol.