A Program to TRANSform InTerprofessional Clinical Practices to Improve Cardiovascular Prevention in Primary Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 759
- 试验地点
- 2
- 主要终点
- Quality of the cardiovascular preventive care
研究概览
简要总结
The TRANSIT program is a program to TRANSform InTerprofessional clinical practices to improve cardiovascular prevention in primary care. It addresses priorities in primary care relevant to the Chronic Care Model (Wagner 2001): self-management support, delivery-system design, and management of clinical information.
The program includes :
- a case manager to coordinate and provide care and follow up;
- clinical protocols and tools to support interprofessional and systematic follow up;
- training for clinicians;
- patient's personalized cardiovascular health booklet;
- tools to promote group sessions for patient education on cholesterol, hypertension, and diabetes.
The general OBJECTIVE of this trial is to evaluate and compare two STRATEGIES for implementing the TRANSIT program in Family Medicine Groups (FMGs):
- facilitation, and
- passive diffusion.
Passive diffusion is the usual strategy where clinicians implement an intervention program by themselves. Facilitation is a strategy whereby a facilitator provides support to a team of clinicians to help them introduce the changes required to implement the program into practice.
The hypothesis is that facilitation will be more efficacious to implement the program than passive diffusion:
- it will enhance the provision of cardiovascular preventive care;
- it will enhance interprofessional collaboration;
- it will enable more efficaciously the implementation of new clinical processes;
- it will improve patient clinical outcomes;
- it will cost more in the short term, but will have positive economic impact in the long term;
- there will be less "undesired effects" of all types related to implementation.
To test the hypothesis, we assess the efficacy of the implementation strategies to enhance interprofessional collaboration and better support patients in the management of their conditions. Impact on provision of care, interprofessional collaboration, clinical processes, and patient clinical outcomes (values, therapeutic targets, and lifestyle habits) will be evaluated. Moreover, the implementation cost related to each strategy will be estimated.
We complement the trial with qualitative methods to document the perceptions of clinicians, facilitators, patients and members of the family regarding the TRANSIT program, the implementation strategies and the observed changes in the clinical practices and outcomes.
详细描述
STUDY DESIGN:
Pragmatic cluster randomized clinical trial
SETTING:
Nine Family Medicine Groups (FMGs) take part in the study. FMGs are primary care clinics delivering family medicine services. They include physicians and nurses, and collaborate with other health professionals.
Eligible FMGs meet the following criteria:
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •patient is registered in a Family Medicine Group;
- •10-year Framingham risk score (FRS) moderate (11-19%) to high (≥ 20%);
- •at least one of the following condition uncontrolled:
- •Diabetes: HbA1C > 7% OR fasting blood glucose > 7 mmol/L OR 2-hour postprandial blood glucose > 10 mmol/L (OR > 8 mmol/L if HbA1C target is not acheived)(Canadian Diabetes Association Clinical Practice Guidelines Expert Committee, Canadian Journal of Diabetes, 2008)
- •Dyslipidemia: C-LDL ≥ 2 mmol/L in moderate to high risk patients OR less than 50% reduction of C-LDL compared to initial value OR Apo-B ≥ 0,8 g/L (Genest, McPherson et al. 2009)
- •Hypertension: blood pressure ≥ 140/90 ou ≥ 130/80 in diabetic patients or with chronic kidney disease (TFG < 60mL/min/1,73m2; (Cloutier & Poirier 2011)
- •Patient with at least two chronic disease or chronic health problem other than type II diabetes, dyslipidemia, hypertension, or cardiovascular disease (e.g. : angina, previous history of myocard infarct, stroke, and intermittent claudication).
排除标准
- •Patient followed for a cardiovascular disease in a specialized clinic in secondary care (ex.: cardiology, endocrinology etc).
结局指标
主要结局
Quality of the cardiovascular preventive care
时间窗: Baseline and 12 months after randomization
Mean change in the composite score of the quality of the cardiovascular preventive care
次要结局
- c-LDL(Baseline and 12 months after randomization)
- Achieved therapeutic targets(Baseline and 12 months after randomization)
- Glycosylated hemoglobine (HgA1c)(Baseline and 12 months after randomization)
- Lifestyle habits(Baseline and 12 months after randomization)
- Organisational outcomes(Baseline and 12 months after randomization)
- Blood pressure(Baseline and 12 months after randomization)
- Use of public programs(Baseline and 12 months after randomization)
研究者
Lyne Lalonde
Professor (professeur agrégé)
Fonds de la Recherche en Santé du Québec