Evaluating the Effectiveness of Diabetes Shared Medical Appointments (SMAs) as Implemented in Five Veterans Affairs Health Systems: a Multi-site Cluster Randomized Pragmatic Trial.

OBJECTIVE: To examine whether diabetes shared medical appointments (SMAs) implemented as part of usual clinical practice in diverse health systems are more effective than usual care in improving and sustaining A1c improvements. RESEARCH DESIGN AND METHODS: A multi-site cluster randomized pragmatic trial examining implementation in clinical practice of diabetes SMAs in five Veterans Affairs (VA) health systems was conducted from 2016 to 2020 among 1537 adults with type 2 diabetes and elevated A1cs. Eligible patients were randomly assigned to either: (1) invitation to participate in a series of SMAs totaling 8-9 h; or (2) continuation of usual care. Relative change in A1c (primary outcome) and in systolic blood pressure, insulin starts, statin starts, and anti-hypertensive medication classes (secondary outcomes) were measured as part of usual clinical care at baseline, at 6 months and at 12 months (~7 months after conclusion of the final SMA in four of five sites). We examined outcomes in three samples of SMA participants: all those scheduled for a SMA, those attending at least one SMA, and those attending at least half of SMAs. RESULTS: Baseline mean A1c was 9.0%. Participants scheduled for an SMA achieved A1c reductions 0.35% points greater than the control group between baseline and 6-months follow up (p = .001). Those who attended at least one SMA achieved reductions 0.42 % points greater (p < .001), and those who attended at least half of scheduled SMAs achieved reductions 0.53 % points greater (p < .001) than the control group. At 12-month follow-up, the three SMA analysis samples achieved reductions from baseline ranging from 0.16 % points (p = 0.12) to 0.29 % points (p = .06) greater than the control group. CONCLUSIONS: Diabetes SMAs as implemented in real-life diverse clinical practices improve glycemic control more than usual care immediately after the SMAs, but relative gains are not maintained. Our findings suggest the need for further study of whether a longer term SMA model or other follow-up strategies would sustain relative clinical improvements associated with this intervention. TRIAL REGISTRATION: ClinicalTrials.gov ID NCT02132676.

Engaging family supporters of adult patients with diabetes to improve clinical and patient-centered outcomes: study protocol for a randomized controlled trial.

BACKGROUND: Most adults with diabetes who are at high risk for complications have family or friends who are involved in their medical and self-care ("family supporters"). These family supporters are an important resource who could be leveraged to improve patients' engagement in their care and patient health outcomes. However, healthcare teams lack structured and feasible approaches to effectively engage family supporters in patient self-management support. This trial tests a strategy to strengthen the capacity of family supporters to help adults with high-risk diabetes engage in healthcare, successfully enact care plans, and lower risk of diabetes complications. METHODS/DESIGN: We will conduct a randomized trial evaluating the CO-IMPACT (Caring Others Increasing EnageMent in Patient Aligned Care Teams) intervention. Two hunded forty adults with diabetes who are at high risk for diabetes complications due to poor glycemic control or high blood pressure will be randomized, along with a family supporter (living either with the patient or remotely), to CO-IMPACT or enhanced usual primary care for 12 months. CO-IMPACT provides patient-supporter dyads: it provides one coaching session addressing supporter techniques for helping patients with behavior change motivation, action planning, and proactive communication with healthcare providers; biweekly automated phone calls to prompt dyad action on new patient health concerns; phone calls to prompt preparation for patients' primary care visits; and primary care visit summaries sent to both patient and supporter. Primary outcomes are changes in patient activation, as measured by the Patient Activation Measure-13, and change in 5-year cardiac event risk, as measured by the United Kingdom Prospective Diabetes Study cardiac risk score for people with diabetes. Secondary outcomes include patients' diabetes self-management behaviors, diabetes distress, and glycemic and blood pressure control. Measures among supporters will include use of effective support techniques, burden, and distress about patient's diabetes care. DISCUSSION: If effective in improving patient activation and diabetes management, CO-IMPACT will provide healthcare teams with evidence-based tools and techniques to engage patients' available family or friends in supporting patient self-management, even if they live remotely. The core skills addressed by CO-IMPACT can be used by patients and their supporters over time to respond to changing patient health needs and priorities. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02328326 . Registered on 31 December 2014.

Assessing Residents' Veteran-Centered Care Skills in the Clinical Setting.

BACKGROUND: Despite their placement in Veterans Health Administration centers nationwide, residents' training and assessment in veteran-centered care is variable and often insufficient. OBJECTIVE: We assessed residents' ability to recognize and address mental health issues that affect US military veterans. METHODS: Two unannounced standardized patient (SP) cases were used to assess internal medicine residents' veteran-centered care skills from September 2014 to March 2016. Residents were assessed on 7 domains: military history taking, communication skills, assessment skills, mental health screening, triage, and professionalism, using a 36-item checklist. After each encounter, residents completed a questionnaire to assess their ability to recognize knowledge deficits. Residents' mean scores were compared across training levels, between the 2 cases, and by SP gender. We conducted analysis of variance (ANOVA) tests to analyze mean performance differences across training levels and descriptive statistics to analyze self-assessment questionnaire results. RESULTS: Ninety-eight residents from 2 internal medicine programs completed the encounter and 53 completed the self-assessment questionnaire. Residents performed best on professionalism (0.92 ± 0.20, percentage of the maximal score) and triage (0.87 ± 0.17), and they scored lowest on posttraumatic stress disorder (0.52 ± 0.30) and military sexual trauma (0.33 ± 0.39). Few residents reported that they sought out training to enhance their knowledge and skills in the provision of services and support to military and veteran groups beyond their core curriculum. CONCLUSIONS: This study suggests that additional education and assessment in veteran-centered care may be needed, particularly in the areas of posttraumatic stress disorder and military sexual trauma.

Designing for Clinical Change: Creating an Intervention to Implement New Statin Guidelines in a Primary Care Clinic.

BACKGROUND: Recent clinical practice guidelines from major national organizations, including a joint United States Department of Veterans Affairs (VA) and Department of Defense (DoD) committee, have substantially changed recommendations for the use of the cholesterol-lowering statin medications after years of relative stability. Because statin medications are among the most commonly prescribed treatments in the United States, any change in their use may have significant implications for patients and providers alike. Prior research has shown that effective implementation interventions should be both user centered and specifically chosen to address identified barriers. OBJECTIVE: The objectives of this study were to identify potential determinants of provider uptake of the new statin guidelines and to use that information to tailor a coordinated and streamlined local quality improvement intervention focused on prescribing appropriate statins. METHODS: We employed user-centered design principles to guide the development and testing of a multicomponent guideline implementation intervention to improve statin prescribing. This paper describes the intervention development process whereby semistructured qualitative interviews with providers were conducted to (1) illuminate the knowledge, attitudes, and behaviors of providers and (2) elicit feedback on intervention prototypes developed to align with and support the use of the VA/DoD guidelines. Our aim was to use this information to design a local quality improvement intervention focused on statin prescribing that was tailored to the needs of primary care providers at our facility. Cabana's Clinical Practice Guidelines Framework for Improvement and Nielsen's Usability Heuristics were used to guide the analysis of data obtained in the intervention development process. RESULTS: Semistructured qualitative interviews were conducted with 15 primary care Patient Aligned Care Team professionals (13 physicians and 2 clinical pharmacists) at a single VA medical center. Findings highlight that providers were generally comfortable with the paradigm shift to risk-based guidelines but less clear on the need for the VA/DoD guidelines in specific. Providers preferred a clinical decision support tool that helped them calculate patient risk and guide their care without limiting autonomy. They were less comfortable with risk communication and performance measurement systems that do not account for shared decision making. When possible, we incorporated their recommendations into the intervention. CONCLUSIONS: By combining qualitative methods and user-centered design principles, we could inform the design of a multicomponent guideline implementation intervention to better address the needs and preferences of providers, including clear and direct language, logical decision prompts with an option to dismiss a clinical decision support tool, and logical ordering of feedback information. Additionally, this process allowed us to identify future design considerations for quality improvement interventions.

The Shared Health Appointments and Reciprocal Enhanced Support (SHARES) study: study protocol for a randomized trial.

BACKGROUND: Diabetes shared medical appointments (SMAs) and reciprocal peer support programs have been found in efficacy trials to help adults with diabetes improve their self-management and achieve short-term gains in clinical and patient-centered outcomes. In order to translate this evidence to system-level interventions, there is a need for large-scale, pragmatic trials that examine the effectiveness, implementation, and costs of SMAs and reciprocal peer support across diverse settings. METHODS: The Shared Health Appointments and Reciprocal Enhanced Support (SHARES) study is a multisite, cluster randomized trial that is evaluating the effectiveness and implementation of SMAs with and without an additional reciprocal Peer-to-Peer (P2P) support program, when compared to usual care. The P2P program comprises periodic peer support group sessions and telephone contact between SMA participant pairs to promote more effective diabetes self-management. We will examine outcomes across three different treatment groups: (1) SMAs, (2) SMAs plus P2P, and (3) usual care. We will collect and analyze data over a 2.5-year implementation period at five geographically diverse Veterans Affairs (VA) health systems. The primary outcome is the relative change in hemoglobin A1c over time. Secondary outcomes are changes in systolic blood pressure, antihypertensive medication use, statin use, and insulin initiation over the study period. The unit of analysis is the individual, adjusted by the individual's SMA group (the cluster). We will use mixed methods to rigorously evaluate processes and costs of implementing these programs in each of the clinic settings. DISCUSSION: We hypothesize that patients will experience improved outcomes immediately following participation in SMAs and that augmenting SMAs with reciprocal peer support will help to maintain these gains over time. The results of this study will be among the first to examine the effects of diabetes SMAs alone and in conjunction with P2P in a range of real-life clinical settings. In addition, the study will provide important information on contextual factors associated with successful program implementation. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT02132676 . Registered on 21 August 2013.

"It goes beyond good camaraderie": A qualitative study of the process of becoming an interprofessional healthcare "teamlet".

Within the US, the patient-centred medical home has become a predominant model in the delivery of primary care. This model requires a shift from the physician-centric model to an interprofessional team-based approach. Thus, healthcare staff are being reorganized into teams, resulting in having to work and relate to one another in new ways. In 2010, the Veterans Health Administration implemented the patient aligned care team (PACT) model, its version of the patient-centred medical home. The transition to the PACT model involved restructuring primary care staff into "teamlets", consisting of a registered nurse, licensed practical nurse, and administrative clerk for each full-time-equivalent primary care provider. This qualitative study used observation and semi-structured interviews to understand the factors that affect teamlet functioning as they implement this new model of care and how teams are interacting to address those factors. Findings suggest that role understanding includes understanding how each teamlet member's tasks are performed in the daily operations of the clinic. In addition, willingness to perform tasks that benefit the teamlet and acceptance of delegation from all teamlet members were found to be important for teamlet functioning and cohesion. In order for healthcare teams to provide patient-centred care, it is important to provide guidance and support about what these new relationships and roles will entail. The building of team relationships is not a static process; ways of working together build over time and, therefore, should be seen as a continuous cycle of quality improvement.

Measuring patient-centered medical home access and continuity in clinics with part-time clinicians.

OBJECTIVES: Common patient-centered medical home (PCMH) performance measures value access to a single primary care provider (PCP), which may have unintended consequences for clinics that rely on part-time PCPs and team-based care. STUDY DESIGN AND METHODS: Retrospective analysis of 110,454 primary care visits from 2 Veterans Health Administration clinics from 2010 to 2012. Multi-level models examined associations between PCP availability in clinic, and performance on access and continuity measures. Patient experiences with access and continuity were compared using 2012 patient survey data (N = 2881). RESULTS: Patients of PCPs with fewer half-day clinic sessions per week were significantly less likely to get a requested same-day appointment with their usual PCP (predicted probability 17% for PCPs with 2 sessions/week, 20% for 5 sessions/week, and 26% for 10 sessions/week). Among requests that did not result in a same-day appointment with the usual PCP, there were no significant differences in same-day access to a different PCP, or access within 2 to 7 days with patients' usual PCP. Overall, patients had >92% continuity with their usual PCP at the hospital-based site regardless of PCP sessions/week. Patients of full-time PCPs reported timely appointments for urgent needs more often than patients of part-time PCPs (82% vs 71%; P < .01), but reported similar experiences with routine access and continuity. CONCLUSIONS: Part-time PCP performance appeared worse when using measures focused on same-day access to patients' usual PCP. However, clinic-level same-day access, same-week access to the usual PCP, and overall continuity were similar for patients of part-time and full-time PCPs. Measures of in-person access to a usual PCP do not capture alternate access approaches encouraged by PCMH, and often used by part-time providers, such as team-based or non-face-to-face care.

Improving chronic illness care for veterans within the framework of the Patient-Centered Medical Home: experiences from the Ann Arbor Patient-Aligned Care Team Laboratory.

While key components of the Patient-Centered Medical Home (PCMH) have been described, improved patient outcomes and efficiencies have yet to be conclusively demonstrated. We describe the rationale, conceptual framework, and progress to date as part of the VA Ann Arbor Patient-Aligned Care Team (PACT) Demonstration Laboratory, a clinical care-research partnership designed to implement and evaluate PCMH programs. Evidence and experience underlying this initiative is presented. Key components of this innovation are: (a) a population-based registry; (b) a navigator system that matches veterans to programs; and (c) a menu of self-management support programs designed to improve between-visit support and leverage the assistance of patient-peers and informal caregivers. This approach integrates PCMH principles with novel implementation tools allowing patients, caregivers, and clinicians to improve disease management and self-care. Making changes within a complex organization and integrating programmatic and research goals represent unique opportunities and challenges for evidence-based healthcare improvements in the VA.

Study protocol: the Adherence and Intensification of Medications (AIM) study--a cluster randomized controlled effectiveness study.

BACKGROUND: Many patients with diabetes have poor blood pressure (BP) control. Pharmacological therapy is the cornerstone of effective BP treatment, yet there are high rates both of poor medication adherence and failure to intensify medications. Successful medication management requires an effective partnership between providers who initiate and increase doses of effective medications and patients who adhere to the regimen. METHODS: In this cluster-randomized controlled effectiveness study, primary care teams within sites were randomized to a program led by a clinical pharmacist trained in motivational interviewing-based behavioral counseling approaches and authorized to make BP medication changes or to usual care. This study involved the collection of data during a 14-month intervention period in three Department of Veterans Affairs facilities and two Kaiser Permanente Northern California facilities. The clinical pharmacist was supported by clinical information systems that enabled proactive identification of, and outreach to, eligible patients identified on the basis of poor BP control and either medication refill gaps or lack of recent medication intensification. The primary outcome is the relative change in systolic blood pressure (SBP) measurements over time. Secondary outcomes are changes in Hemoglobin A1c, low-density lipoprotein cholesterol (LDL), medication adherence determined from pharmacy refill data, and medication intensification rates. DISCUSSION: Integration of the three intervention elements--proactive identification, adherence counseling and medication intensification--is essential to achieve optimal levels of control for high-risk patients. Testing the effectiveness of this intervention at the team level allows us to study the program as it would typically be implemented within a clinic setting, including how it integrates with other elements of care. TRIAL REGISTRATION: The ClinicalTrials.gov registration number is NCT00495794.