TeamCare PCN: Collaborative Care for Patients With Diabetes and Depression in Primary Care Networks
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 157
- 试验地点
- 4
- 主要终点
- Change in Patient Health Questionnaire-9 items (PHQ-9) score
研究概览
简要总结
Background & Objective: Type 2 diabetes is a complex disease characterized by multiple comorbidities. Depression is one of the most common comorbidities in individuals with diabetes with prevalence rates reaching 30%. Depression complicates diabetes treatment, portends worse outcomes and increases health care costs. One novel approach to managing diabetes with co-morbid depression is a collaborative primary care model involving a multidisciplinary health care team guiding patient-centered care. This model has been tested in the US and showed a significant reduction of depressive symptoms, improved diabetes care and patient-reported outcomes, and saved money. Our aim is to evaluate the implementation of this collaborative care model for type 2 diabetes and comorbid depression within the non-metro Primary Care Network (PCN) setting in Canada.
Intervention: The intervention involves three phases: (1) improving depressive symptoms, (2) improving blood sugar, blood pressure and cholesterol, and (3) improving lifestyle behaviours. The intervention is administered by a CM in collaboration with family physicians, psychiatrists, and internists.
Hypotheses: The TeamCare-PCN intervention will reduce depressive symptoms, achieve targets for cardio-metabolic measures and improve lifestyle behaviours. Furthermore, the investigators anticipate this intervention will be acceptable and implemented in a cost-effective manner in the PCN environment.
Methods: The investigators will employ a mixed-methods approach to our evaluation, using a controlled "on-off" trial design. Our primary analysis will be based on a multivariable scaled marginal model for the combined outcome of depressive symptoms and medical care. Secondary analyses will assess changes in lifestyle behaviours and patient-reported outcomes.
Significance: Our work will serve as a platform upon which an emerging model of primary care can incorporate an effective and cost-effective depression intervention into the management of individuals with type 2 diabetes, and as a framework for implementing and evaluating similar interventions in individuals with other chronic conditions.
详细描述
I. Brief Overview The over-arching objectives of this study are to implement and evaluate an evidence-based intervention called TeamCare-PCN for individuals with type-2 diabetes and comorbid depression within primary care networks (PCNs). TeamCare-PCN is based on a proven efficacious and cost-saving collaborative primary care model (Katon et al., 2010) which involves a Care Manager (CM) providing active patient management under the supervision of a family physician and consulting psychiatrists and internists. The goal of the intervention is to achieve remission of depression, reach targets for cardio-metabolic measures, and improve lifestyle behaviours.
II. Hypothesis The investigators hypothesize that the TeamCare-PCN intervention will reduce depressive symptoms, achieve targets for cardio-metabolic measures and improve lifestyle behaviours.
III. Setting, Participants, and Sample Size TeamCare-PCN will be conducted in collaboration with 4 PCNs in non-metro Alberta: St. Albert Sturgeon PCN, Leduc/Beaumont/ Devon PCN, Camrose PCN, and Heartland PCN.
We estimate that a minimum total sample size of 120, with 60 in each arm, would provide power of 0.80 to detest a mean difference of 5 points in the PHQ-9, assuming a repeated measures correlation of 0.6, and 2-tailed alpha of 0.05. This sample size also provides more than 80% power (two sided alpha = 0.05) to detect any between-group absolute difference in proportions of 15% or more (e.g., 45% of usual care patients achieve depression remission vs 60% of intervention patients) (Katon et al., 2010). Anticipating a 40% attrition rate, we planned to recruit 168 patients in total across our 4 PCN sites.
IV. Participant Recruitment and Allocation Recruiting participants into TeamCare-PCN involves four steps. i) A screening survey accompanied with an endorsement letter from the PCN and a general information letter. Included in the screen is the PHQ-9.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have family physician-identified type 2 diabetes
- •18 years of age or older
- •Score >=10 on the PHQ-9
- •Speak English and have adequate hearing to complete phone interviews
- •Be willing and able to provide written informed consent to participate
排除标准
- •Severe and/or terminal physical illness
- •Serious and/or severe mental or psychiatric illness
- •Pregnant or breastfeeding
- •Live in long term care facility
- •Already participating in other clinical trials
结局指标
主要结局
Change in Patient Health Questionnaire-9 items (PHQ-9) score
时间窗: Baseline, 3-month, 6-month, 9-month, 12-month
A remission of depression symptoms is indicated with a PHQ-9 score \<10 for a period of three consecutive months.
次要结局
- Change in HbA1c level(baseline, 6-month, 12-month)
- Change in total cholesterol level(baseline, 6-month, 12-month)
- Change in Systolic blood pressure measurement(baseline, 6-month, 12-month)
- Change in self-reported Health Related Quality of Life(Baseline, 6-month, 12-month)
- Change in Diabetes-specific stress(Baseline, 6-month, 12-month)
- Change in Health behaviours(Baseline, 6-month, 12-month)
- Change in Self-care management activities(Baseline, 6-month, 12-month)
- Change in Satisfaction with care(Baseline, 12-month)
研究者
Dr. Jeffrey Johnson
Professor
The Alliance for Canadian Health Outcomes Research in Diabetes