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.

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.

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.

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.

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.

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.

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.

Regional variation in colorectal cancer testing and geographic availability of care in a publicly insured population.

Despite its demonstrated effectiveness, colorectal cancer (CRC) testing is suboptimal, particularly in vulnerable populations such as those who are publicly insured. Prior studies provide an incomplete picture of the importance of the intersection of multilevel factors affecting CRC testing across heterogeneous geographic regions where vulnerable populations live. We examined CRC testing across regions of North Carolina by using population-based Medicare and Medicaid claims data from disabled individuals who turned 50 years of age during 2003-2008. We estimated multilevel models to examine predictors of CRC testing, including distance to the nearest endoscopy facility, county-level endoscopy procedural rates, and demographic and community contextual factors. Less than 50% of eligible individuals had evidence of CRC testing; men, African-Americans, Medicaid beneficiaries, and those living furthest away from endoscopy facilities had significantly lower odds of CRC testing, with significant regional variation. These results can help prioritize intervention strategies to improve CRC testing among publicly insured, disabled populations.

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.

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.

Using quality improvement techniques to increase colon cancer screening.

Screening has been shown to be effective and cost-effective in reducing the incidence of, and mortality from, colorectal cancer. Despite its demonstrated efficacy, colon cancer screening remains underused, with fewer than 60% of age-eligible adults reporting being up to date with recommended screening tests. Several factors account for the low rates of utilization, including patient, provider and system-related issues. Several interventions have been shown to be effective in overcoming these barriers, including the use of patient decision aids. Patient decision aids are tools designed to provide information to patients about screening options, help them consider the pros and cons of the alternatives, and assist them to reach a decision consistent with their values. The use of decision aids in clinical practice can increase screening rates by up to 14 percentage points. Mailing the decision aids to patients in advance of office visits appears to be a cost-effective means of implementation.

Methodology of a pilot study to improve the quality of medication use in older adults: Enhancing Quality in Psychiatry Using Pharmacists (EQUIPP).

BACKGROUND: Medication-related problems are prevalent in older adults, contributing to increased harm and health care costs and negatively impacting quality of care. Older adults with psychiatric disease are at an increased risk because of their underlying disease and types of medications prescribed. Efforts to improve the quality of medication use often focus on select medication-related problems, select diagnoses, or predefined quality indicators; however, such an approach fails to consider the potential for multiple coexisting problems within individuals. OBJECTIVE: A pilot study was conducted to test the feasibility of a medication management program designed to improve the quality of medication use in older adults with underlying psychiatric disease. This article describes the methodology of the study and details of the intervention, and presents baseline characteristics of the study population. METHODS: English-speaking psychiatry outpatients aged > or = 65 years taking > or = 2 drugs that are active in the central nervous system were enrolled into a medication management program, in which medication management was provided by a clinical pharmacist for 6 months. Patients were evaluated at baseline, 3 months, and 6 months. Data were collected on the patients' demographic characteristics, health and medications, health literacy, functional status, symptoms of depression, health services utilization, quality of medication use, adherence, and patient satisfaction with the program. RESULTS: One hundred seventy-three older adults were assessed for inclusion; 146 were not eligible, not reachable, or not interested in participating. Twenty-seven older adults were enrolled in the study, all but one of whom completed the 3- and 6-month visits. The mean (SD) age of the 27 participants was 74.7 (8.1) years; 63% were female, 74% were white, and 70% had no cognitive impairment. CONCLUSIONS: This pilot study tested the feasibility of a medication management program designed to improve the quality of medication use in older adults with underlying psychiatric disease. Findings from this study, which will be reported at a later date, will help to refine the program and subsequent testing, with the overall goal of improving the quality of medication use and health outcomes in older adults.

The effect of offering different numbers of colorectal cancer screening test options in a decision aid: a pilot randomized trial.

BACKGROUND: Decision aids can improve decision making processes, but the amount and type of information that they should attempt to communicate is controversial. We sought to compare, in a pilot randomized trial, two colorectal cancer (CRC) screening decision aids that differed in the number of screening options presented. METHODS: Adults ages 48-75 not currently up to date with screening were recruited from the community and randomized to view one of two versions of our previously tested CRC screening decision aid. The first version included five screening options: fecal occult blood test (FOBT), sigmoidoscopy, a combination of FOBT and sigmoidoscopy, colonoscopy, and barium enema. The second discussed only the two most frequently selected screening options, FOBT and colonoscopy. Main outcomes were differences in screening interest and test preferences between groups after decision aid viewing. Patient test preference was elicited first without any associated out-of-pocket costs (OPC), and then with the following costs: FOBT-$10, sigmoidoscopy-$50, barium enema-$50, and colonoscopy-$200. RESULTS: 62 adults participated: 25 viewed the 5-option decision aid, and 37 viewed the 2-option version. Mean age was 54 (range 48-72), 58% were women, 71% were White, 24% African-American; 58% had completed at least a 4-year college degree. Comparing participants that viewed the 5-option version with participants who viewed the 2-option version, there were no differences in screening interest after viewing (1.8 vs. 1.9, t-test p = 0.76). Those viewing the 2-option version were somewhat more likely to choose colonoscopy than those viewing the 5-option version when no out of pocket costs were assumed (68% vs. 46%, p = 0.11), but not when such costs were imposed (41% vs. 42%, p = 1.00). CONCLUSION: The number of screening options available does not appear to have a large effect on interest in colorectal cancer screening. The effect of offering differing numbers of options may affect test choice when out-of-pocket costs are not considered.

Surrogates' perceptions about feeding tube placement decisions.

OBJECTIVES: (1) To determine surrogates perceptions about who made the decision to place the feeding tube and who they would have preferred to have made the decision. (2) To determine surrogates' perceptions of the information they received to make this decision. METHODS: Structured interviews with 246 surrogate decision-makers. RESULTS: Fifty-five percent of surrogates felt that the decision was made primarily by the surrogate, but 75% would prefer that the decision be shared with the physician. Surrogates reported that they discussed the benefits (80%) and the risks (72%) of feeding tube placement and discussed what life would be like with the feeding tube (65%) and without the feeding tube (67%). They also reported being asked if they understood the information (85%) and their thoughts about placement (56%). Despite receiving this information, 28 to 41% reported wanting more information about these aspects. CONCLUSION: Surrogates would have preferred greater physician participation in decisions about feeding tube placement and many reported that their informational needs were not completely met. PRACTICE IMPLICATIONS: These results suggest that physicians may be justified in taking a more active role in feeding tube decisions with surrogates and that many surrogates desire more information than is required by standards of informed decision making.