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临床试验/NCT02379078
NCT02379078已完成不适用

Impact of an Interprofessional Shared Decision-making and Goal-setting Decision Aid for Patients With Diabetes - A Pilot Cluster Randomized Controlled Trial

Unity Health Toronto0 个研究点目标入组 225 人开始时间: 2016年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
225
主要终点
Decisional Conflict in Patients With Diabetes

研究概览

简要总结

Diabetes care is complicated for people with diabetes as well as for health care providers: they have to watch their diet, exercise, take medications, checking blood sugars and blood pressure, get tests and see multiple doctors. On top of that, many with diabetes have other health problems, such as high blood pressure or arthritis, that make care even more complicated. Guidelines for improving the care of people with diabetes try to help by summarizing the best practices for care, but because diabetes care is so complicated, it is hard for them to be put into practice. One solution to this is a tool that can help people with diabetes set health care goals that are important to them, and participate actively in decisions about their own health care, together with health care providers. This tool would have an information booklet for patients with facts that can help them make a decision, a worksheet to help spell out what their goals are and how they want to get there, and a cheat-sheet for health care providers that gives them tips on how to do this. The purpose of this project is to find out if a tool like this would be helpful, how to make it more helpful and usable, and what the best way would be to make sure that people use it.

An interprofessional (IP) shared decision-making (SDM) and goal-setting tool kit, including a 1-page provider enabler, a point-of-care worksheet and a patient workbook, can be implemented successfully in clinical practice and will reduce decisional conflict and diabetes distress and improve chronic care delivery and quality of life in patients with type 1 or type 2 diabetes and 2 other comorbid chronic diseases. The investigators hypothesize that patients in the intervention arm of the study will have reduced decisional conflict and diabetes distress, and improved decision-making satisfaction, chronic care delivery and quality of life.

详细描述

Significance:

Diabetes is prevalent and results in major morbidity. Care of the patient with diabetes is complex and often occurs in the context of other chronic illness; this multimorbidity negatively impacts morbidity and mortality. The Canadian Diabetes Association (CDA) Clinical Practice Guidelines (CPG) are a rigorously developed knowledge tool that comprehensively address all aspects of diabetes care, conforming to AGREE II standards for guideline development. However, guideline adherence in the patient with multimorbidity is challenging both for the provider and the patient, who are overwhelmed by numerous, often conflicting recommendations. An individualized approach to the multimorbid diabetic patient using shared decision-making (SDM) and goal setting may overcome challenges to guideline adherence; however these strategies have not been taken up extensively in clinical practice. Barriers to uptake can be overcome by incorporating SDM into the context of interprofessional care: in diabetes care, role expansion, active participation by more than one discipline and adding additional team members have been demonstrated to improve clinical outcomes. While SDM and decision aids have typically focused on one issue, the precedent and potential exists for their use in the translation of the CDA CPG into practice through the prioritization of complex guideline recommendations. Given the growing prevalence of diabetes and multimorbidity in Canada, effectively bridging the knowledge to practice gap in this area has the potential to significantly improve patient-important outcomes, health care delivery and system sustainability.

Objectives:

  1. To enhance the implementation of a complex guidelines document (CDA 2013 CPG) by assisting in prioritizing care for patients with diabetes and multiple other comorbidities through the use of a diabetes-focused SDM intervention;
  2. To systematically develop, test and pilot a SDM and goal-setting intervention following the United Kingdom Medical Research Council and Knowledge to Action Frameworks;
  3. To build a team consisting of members of the research community, patients, health care providers, CDA, and Local Health Integration Networks of the Ministry of Health and Long-Term Care, in order to increase the relevance of research conducted and enable dissemination of these research results into practice.

Hypothesis An interprofessional SDM and goal-setting tool kit, including a 1-page provider enabler, a point-of-care worksheet and a patient workbook, can be implemented successfully in clinical practice and will reduce decisional conflict and diabetes distress and improve chronic care delivery and quality of life in patients with type 1 or type 2 diabetes and 2 other comorbid chronic diseases.

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
Single (Outcomes Assessor)

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

  • •diagnosis of Type 1 or Type 2 diabetes and
  • •have 2 or more other chronic comorbidities

排除标准

  • •do not speak English
  • •have documented cognitive deficits
  • •unable to give informed consent
  • •have limited life expectancy (<1 year)
  • •not available for follow-up
  • •seen primarily by a resident physician
  • •are pregnant or considering conception

研究组 & 干预措施

Shared decision-making aid

Experimental

At study start (step 1: provider-directed intervention phase): Online shared decision-making aid, 1-page provider enabler, provider training video made available to health care providers

At 6 months (step 2: provider- and patient-directed phase): Online shared decision-making aid, 1-page patient enabler, patient training video also made available to patients (in addition to health care providers)

干预措施: Shared decision-making aid (Other)

Generic hard-copy diabetes resources

Placebo Comparator

At study start (step 1: Provider-directed intervention phase): A hard copy of the executive summary of the CDA CPG and postcard outlining online resources made available to health care providers

At 6 months (step 2: provider- and patient-directed phase): A CDA patient education pamphlet regarding diabetes self-management also made available to patients

In addition, provider- and patient-directed guideline dissemination tools (not incorporating SDM) will also be publicly accessible from the CDA website.

干预措施: Generic hard copy diabetes resources (Other)

Generic hard-copy diabetes resources

Placebo Comparator

At study start (step 1: Provider-directed intervention phase): A hard copy of the executive summary of the CDA CPG and postcard outlining online resources made available to health care providers

At 6 months (step 2: provider- and patient-directed phase): A CDA patient education pamphlet regarding diabetes self-management also made available to patients

In addition, provider- and patient-directed guideline dissemination tools (not incorporating SDM) will also be publicly accessible from the CDA website.

干预措施: Generic online diabetes resources (Other)

结局指标

主要结局

Decisional Conflict in Patients With Diabetes

时间窗: This outcome is measured at 0, 6 and 12 months.

Decisional conflict was chosen to allow us to assess the impact of our decision aid on the quality of the decision-making process, an important first measure of the effectiveness of a decision aid and the shared decision making process. This outcome is assessed by the Decisional Conflict Scale (DCS), a well-validated, patient-completed measure. DCS consists of 16 items, with 5 subscales (informed, values clarity, support, uncertainty, and effective decision) and an overall summary score. IT is scored on a 5-item Likert scale ranging from '0- strongly agree' to '4- strongly disagree'. It's minimum total score is 0 and it's maximum total score is 100. The higher the score, the worse the outcome. The lower the score, the better the outcome.

次要结局

  • Health-related Quality of Life in Patients With Diabetes(This outcome is measured at 0, 6 and 12 months.)
  • Patient With Diabetes' Assessment of Their Chronic Illness Care(This outcome is measured at 0, 6 and 12 months.)
  • Diabetes Distress in Patients With Diabetes(This outcome is measured at 0, 6 and 12 months.)
  • Intention to Engage in Shared Decision-making in Health Care Providers(This outcome is measured at 0, 6 and 12 months.)

研究者

申办方类型
Other
责任方
Sponsor

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