Allison Soprovich

Controlled trial of a collaborative primary care team model for patients with diabetes and depression: Rationale and design for a comprehensive evaluation

BackgroundWhen depression accompanies diabetes, it complicates treatment, portends worse outcomes and increases health care costs. A collaborative care case-management model, previously tested in an urban managed care organization in the US, achieved significant reduction of depressive symptoms, improved diabetes disease control and patient-reported outcomes, and saved money. While impressive, these findings need to be replicated and extended to other healthcare settings. Our objective is to comprehensively evaluate a collaborative care model for comorbid depression and type 2 diabetes within a Canadian primary care setting.Methods/designWe initiated the TeamCare model in four Primary Care Networks in Northern Alberta. The intervention involves a nurse care manager guiding patient-centered care with family physicians and consultant physician specialists to monitor progress and develop tailored care plans. Patients eligible for the intervention will be identified using the Patient Health Questionnaire-9 as a screen for depressive symptoms. Care managers will then guide patients through three phases: 1) improving depressive symptoms, 2) improving blood glucose, blood pressure and cholesterol, and 3) improving lifestyle behaviors. We will employ the RE-AIM framework for a comprehensive and mixed-methods approach to our evaluation. Effectiveness will be assessed using a controlled “on-off” trial design, whereby eligible patients would be alternately enrolled in the TeamCare intervention or usual care on a monthly basis. All patients will be assessed at baseline, 6 and 12 months. Our primary analyses will be based on changes in two outcomes: depressive symptoms, and a multivariable, scaled marginal model for the combined outcome of global disease control (i.e., A1c, systolic blood pressure, LDL cholesterol). Our planned enrolment of 168 patients will provide greater than 80% power to observe clinically important improvements in all measured outcomes. Direct costing of all intervention components and measurement of all health care utilization using linked administrative databases will be used to determine the cost-effectiveness of the intervention relative to usual care.DiscussionOur comprehensive evaluation will generate evidence to reliability, effectiveness and sustainability of this collaborative care model for patients with chronic diseases and depression.Trials registrationClintrials.gov Identifier: NCT01328639

Collaborative Care Versus Screening and Follow-up for Patients With Diabetes and Depressive Symptoms: Results of a Primary-Care Based Comparative Effectiveness Trial

OBJECTIVE Depressive symptoms are common and, when coexisting with diabetes, worsen outcomes and increase health care costs. We evaluated a nurse case-manager–based collaborative primary care team model to improve depressive symptoms in diabetic patients. RESEARCH DESIGN AND METHODS We conducted a controlled implementation trial in four nonmetropolitan primary care networks. Eligible patients had type 2 diabetes and screened positive for depressive symptoms, based on a Patient Health Questionnaire (PHQ) score of ≥10. Patients were allocated using an “on-off” monthly time series. Intervention consisted of case-managers working 1:1 with patients to deliver individualized care. The main outcome was improvement in PHQ scores at 12 months. A concurrent cohort of 71 comparable patients was used as nonscreened usual care control subjects. RESULTS Of 1,924 patients screened, 476 (25%) had a PHQ score >10. Of these, 95 were allocated to intervention and 62 to active control. There were no baseline differences between groups: mean age was 57.8 years, 55% were women, and the mean PHQ score was 14.5 (SD 3.7). Intervention patients had greater 12-month improvements in PHQ (7.3 [SD 5.6]) compared with active-control subjects (5.2 [SD 5.7], P = 0.015). Recovery of depressive symptoms (i.e., PHQ reduced by 50%) was greater among intervention patients (61% vs. 44%, P = 0.03). Compared with trial patients, nonscreened control subjects had significantly less improvement at 12 months in the PHQ score (3.2 [SD 4.9]) and lower rates of recovery (24%, P < 0.05 for both). CONCLUSIONS In patients with type 2 diabetes who screened positive for depressive symptoms, collaborative care improved depressive symptoms, but physician notification and follow-up was also a clinically effective initial strategy compared with usual care.

Applying the RE-AIM framework to the Alberta's Caring for Diabetes Project: a protocol for a comprehensive evaluation of primary care quality improvement interventions

Introduction Diabetes represents a major public health and health system burden. As part of the Albertas Caring for Diabetes (ABCD) Project, two quality-improvement interventions are being piloted in four Primary Care Networks in Alberta. Gaps between health research, policy and practice have been documented and the need to evaluate the impact of public health interventions in real-world settings to inform decision-making and clinical practice is paramount. In this article, we describe the application of the RE-AIM framework to evaluate the interventions beyond effectiveness. Methods and analysis Two quality-improvement interventions were implemented, based on previously proven effective models of care and are directed at improving the physical and mental health of patients with type-2 diabetes. Our goal is to adapt and apply the RE-AIM framework, using a mixed-methods approach, to understand the impact of the interventions to inform policy and clinical decision-making. We present the proposed measures, data sources and data management and analysis strategies used to evaluate the interventions by RE-AIM dimension. Ethics and dissemination Ethics approval for the ABCD Project has been granted from the Health Research Ethics Board (HREB #PRO00012663) at the University of Alberta. The RE-AIM framework will be used to structure our dissemination activities by dimension. Results It will be presented at relevant conferences and prepared for publication in peer-reviewed journals. Various products, such as presentations, briefing reports and webinars, will be developed to inform key stakeholders of the findings. Presentation of findings by RE-AIM dimension will facilitate discussion regarding the public health impact of the two interventions within the primary care context of Alberta and lessons learned to be used in programme planning and care delivery for patients with type-2 diabetes. It will also promote the application of evaluation models to better assess the impact of community-based primary healthcare interventions through our dissemination activities.

Healthy eating and active living for diabetes in primary care networks (HEALD-PCN): rationale, design, and evaluation of a pragmatic controlled trial for adults with type 2 diabetes

BackgroundWhile strong and consistent evidence supports the role of lifestyle modification in the prevention and management of type 2 diabetes (T2DM), the best strategies for program implementation to support lifestyle modification within primary care remain to be determined. The objective of the study is to evaluate the implementation of an evidence-based self- management program for patients with T2DM within a newly established primary care network (PCN) environment.MethodUsing a non-randomized design, participants (total N = 110 per group) will be consecutively allocated in bi-monthly blocks to either a 6-month self-management program lead by an Exercise Specialist or to usual care. Our primary outcome is self-reported physical activity and pedometer steps.DiscussionThe present study will assess whether a diabetes self-management program lead by an Exercise Specialist provided within a newly emerging model of primary care and linked to available community-based resources, can lead to positive changes in self-management behaviours for adults with T2DM. Ultimately, our work will serve as a platform upon which an emerging model of primary care can incorporate effective and efficient chronic disease management practices that are sustainable through partnerships with local community partners.Clinical Trials RegistrationClinicalTrials.gov identifier: NCT00991380

The Alberta's Caring for Diabetes (ABCD) Study: Rationale, Design and Baseline Characteristics of a Prospective Cohort of Adults with Type 2 Diabetes

OBJECTIVE To better understand the factors that affect care and outcomes in patients with type 2 diabetes, we developed the prospective Albertas Caring for Diabetes (ABCD) cohort to collect, monitor and analyze data concerning several sociodemographic, behavioural, psychosocial, clinical and physiological factors that might influence diabetes care and outcomes. METHODS We recruited 2040 individuals with type 2 diabetes through primary care networks, diabetes clinics and public advertisements. Data are being collected through self-administered surveys, including standardized measures of health status and self-care behaviours, and will eventually be linked to laboratory and administrative healthcare data and other novel databases. RESULTS The average age of respondents was 64.4 years (SD=10.7); 45% were female, and 91% were white, with average duration of diabetes of 12 years (SD=10.0). The majority (76%) were physically inactive, and 10% were smokers. Most (88%) reported 2 or more chronic conditions in addition to diabetes, and 18% screened positively for depressive symptoms. The majority (92%) consented to future linkage with administrative data. Based on the literature and comparison with other surveys, the cohort appeared to fairly represent the general Alberta population with diabetes. CONCLUSIONS The ABCD cohort will serve as the basis for explorations of the multidimensional and dynamic nature of diabetes care and complications. These data will contribute to broader scientific literature and will also help to identify local benchmarks and targets for intervention strategies, helping to guide policies and resource allocation related to the care and management of patients with type 2 diabetes in Alberta, Canada.

Increase in Daily Steps After an Exercise Specialist Led Lifestyle Intervention for Adults With Type 2 Diabetes In Primary Care: A Controlled Implementation Trial

OBJECTIVE To determine the effectiveness of an exercise specialist led lifestyle program for adults with type 2 diabetes in primary care. METHODS Eligible participants from 4 primary care networks in Alberta, Canada were assigned to either a lifestyle program or a control group. The program targeted increased daily walking through individualized daily pedometer step goals for the first 3 months and brisk walking speed, along with substitution of low-relative to high-glycemic index foods over the next 3 months. The outcomes were daily steps, diet, and clinical markers, and were compared using random effects models. RESULTS 198 participants were enrolled (102 in the intervention and 96 in the control). For all participants, (51% were women), mean age 59.5 (SD 8.3) years, A1c 6.8% (SD 1.1), BMI 33.6 kg/m(2) (SD 6.5), systolic BP 125.6 mmHg (SD 16.2), glycemic index 51.7 (4.6), daily steps 5879 (SD 3130). Daily steps increased for the intervention compared with the control at 3-months (1292 [SD 2698] vs. 418 [SD 2458] and 6-months (1481 [SD 2631] vs. 336 [SD 2712]; adjusted P = .002). No significant differences were observed for diet or clinical outcomes. CONCLUSIONS A 6-month lifestyle program delivered in primary care by an exercise specialist can be effective for increasing daily walking among adults with recently diagnosed type 2 diabetes. This short-term increase in daily steps requires longer follow-up to estimate the potential impact on health outcomes.

Contextualizing the Effectiveness of a Collaborative Care Model for Primary Care Patients with Diabetes and Depression (Teamcare): A Qualitative Assessment Using RE-AIM

OBJECTIVE We evaluated the implementation of an efficacious collaborative care model for patients with diabetes and depression in a controlled trial in 4 community-based primary care networks (PCNs) in Alberta, Canada. Similar to previous randomized trials, the nurse care manager-led TeamCare intervention demonstrated statistically significant improvements in depressive symptoms compared with usual care. We contextualized TeamCares effectiveness by describing implementation fidelity at the organizational and patient levels. METHODS We used the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework to evaluate TeamCare. Qualitative methods used to collect data regarding the RE-AIM dimensions of Implementation and Effectiveness included interviews with PCN staff and specialists (n=36), research team reflections (n=4) and systematic documentation. We used content analysis, and Nvivo 10 for data management. RESULTS TeamCare was implemented as intended but with suboptimal fidelity. Deviations from the model included limited degrees of collaborative care practised within the PCNs, including varying physician participation, limited comfort in practising collaborative care and discontinuity of care managers. Despite suboptimal fidelity, respondents identified several implementation facilitators at the organizational level: training, ongoing implementation support, professional and personal qualities of the care manager and pre-existing relationships. Without knowledge of the effectiveness of the intervention in our controlled trial, respondents anticipated improved patient outcomes due to the main intervention components, including active patient follow up, specialist consultation and treat-to-target principles. CONCLUSIONS Despite suboptimal implementation in Albertas primary care context, TeamCare resulted in improved outcomes similar to those demonstrated in previous randomized trials. A stronger culture of collaborative care would likely have yielded greater implementation fidelity and possibly better outcomes.

Challenges in Identifying Patients with Type 2 Diabetes for Quality-Improvement Interventions in Primary Care Settings and the Importance of Valid Disease Registries

OBJECTIVE Patient registries are considered an important foundation of chronic disease management, and diabetes patient registries are associated with better processes and outcomes of care. The purpose of this article is to describe the development and use of registries in the Albertas Caring for Diabetes (ABCD) project to identify and reach target populations for quality-improvement interventions in the primary care setting. METHODS We applied the reach, effectiveness, adoption, implementation and maintenance (RE-AIM) framework and expanded the definition of reach beyond the individual (i.e. patient) level to include the ability to identify target populations at an organizational level. To characterize reach and the implementation of registries, semistructured interviews were conducted with key informants, and a usual-care checklist was compiled for each participating Primary Care Network (PCN). Content analysis was used to analyze qualitative data. RESULTS Using registries to identify and recruit participants for the ABCD interventions proved challenging. The quality of the registries depended on whether physicians granted PCN access to patient lists, the strategies used in development, the reliability of diagnostic information and the data elements collected. In addition, once a diabetes registry was developed, there was limited ability to update it. CONCLUSIONS Proactive management of chronic diseases like diabetes requires the ability to reach targeted patients at the population level. We observed several challenges to the development and application of patient registries. Given the importance of valid registries, strong collaborations and novel strategies that involve policy-makers, PCNs and providers are needed to help find solutions to improve registry quality and resolve maintenance issues.

How much will we pay to increase steps per day? Examining the cost-effectiveness of a pedometer-based lifestyle program in primary care.

We previously demonstrated the Healthy Eating and Active Living for Diabetes (HEALD) intervention was effective for increasing daily steps. Here, we consider the cost-effectiveness of the HEALD intervention implemented in primary care. HEALD was a pedometer-based program for adults with type-2 diabetes in Alberta, Canada completed between January 2010 and September 2012. The main outcome was the change in pedometer-determined steps/day compared to usual care. We estimated total costs per participant for HEALD, and total costs of health care utilization through linkage with administrative health databases. An incremental cost–effectiveness ratio (ICER) was estimated with regression models for differences in costs and effects between study groups. The HEALD intervention cost

A qualitative study examining healthcare managers and providers’ perspectives on participating in primary care implementation research

340 per participant over the 6-month follow-up. The difference in total costs (intervention plus health care utilization) was