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临床试验/NCT01945918
NCT01945918已完成不适用

Comparing Strategies for Translating Self-management Support Into Primary Care

University of Colorado, Denver2 个研究点 分布在 1 个国家目标入组 901 人开始时间: 2013年10月最近更新:
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
901
试验地点
2
主要终点
Change in LDL from baseline to 18 months

研究概览

简要总结

This project will test different ways of helping primary care practices to do a better job of self-management support (SMS) for their patients with diabetes.

详细描述

The specific aims of the proposed study are:

  • Primary Specific Aims
  1. To conduct a cluster randomized trial to examine the reach, effectiveness, adoption, implementation and maintenance (RE-AIM) of Connection to Health (CTH) for patients with type 2 diabetes in primary care practice settings. Primary effectiveness outcomes will include hemoglobin A1c, Body Mass Index (BMI), blood pressure and Low Desity Lipprotein (LDL) cholesterol.
  2. To determine the incremental benefit, using the RE-AIM framework, of brief targeted practice coaching on the implementation of CTH in diverse primary care practices.
  • Secondary Specific Aims
  1. To identify key practice characteristics (e.g., practice size, organization, setting, and level of experience with practice redesign efforts) that impact CTH RE-AIM. These results will inform dissemination of the CTH intervention.
  2. To determine the relative costs associated with implementing CTH and practice coaching to further inform dissemination efforts.

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
21 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 21 years old or over
  • Type 2 Diabetes Mellitus diagnosed for a minimum of 12 months
  • Able to read in English or Spanish
  • Plan to remain in the practice during the study period

排除标准

  • Developmentally disabled
  • Decisionally challenged
  • Pregnant women

研究组 & 干预措施

Self-management support education

Active Comparator

Project staff will meet onsite with practice clinicians for a two-hour session to discuss what self-management support (SMS) is, why it is important, how primary care plays a role in this process, how others have approached it, and how it can be time and cost efficient for them to engage in SMS as part of standard diabetes care. Practices will have access to a website displaying general and local SMS resources. Discussion of the implementation of these resources into the practice will be facilitated. Two additional academic detailing visits will be made to check on progress on SMS adoption, provide additional information as needed, and answer questions. No input will be provided regarding how unique practice characteristics might be utilized for more effective implementation of SMS, and CTH will not be introduced.

干预措施: Self-management support education (Behavioral)

Connection to Health Interactive Behavior Change Technology

Active Comparator

Connection to Health (CTH) Arm: The number and length of staff visits to these practices will be the same as for the SMS Education Arm, but the content of the visits will center on the implementation and use of the CTH program as a way to implement SMS. Clinicians and selected staff members will be given hands-on experience using the system and will be provided with scenarios that will highlight the effective use of CTH as a tool for diabetes SMS. The practices will then implement CTH, using protocols selected from several suggested by the research team. Additional technical assistance with implementing CTH will also be provided as needed.

干预措施: Connection to Health Interactive Behavior Change Technology (Behavioral)

Connection to Health plus Coaching

Experimental

Connection to Health plus Coaching (CTH+C) Arm: This arm adds practice coaching as described above to CTH. The active coaching phase focuses on meetings of the practice improvement team, scheduled every other week for approximately 40 minutes each. The improvement team will consist of 6 - 10 diverse representatives of the practice (e.g., front office, medical assistants, physicians). The coach will assist the team in developing a CTH adoption plan and then help them break it down into small bites for rapid cycle change using the Plan-Do-Study-Act quality improvement (QI) model. Active coaching will last for 3 months, followed by monthly calls by the coach to review data regarding the practice's use of CTH and brief "booster" coaching to deal with problems.

干预措施: Connection to Health Interactive Behavior Change Technology (Behavioral)

Connection to Health plus Coaching

Experimental

Connection to Health plus Coaching (CTH+C) Arm: This arm adds practice coaching as described above to CTH. The active coaching phase focuses on meetings of the practice improvement team, scheduled every other week for approximately 40 minutes each. The improvement team will consist of 6 - 10 diverse representatives of the practice (e.g., front office, medical assistants, physicians). The coach will assist the team in developing a CTH adoption plan and then help them break it down into small bites for rapid cycle change using the Plan-Do-Study-Act quality improvement (QI) model. Active coaching will last for 3 months, followed by monthly calls by the coach to review data regarding the practice's use of CTH and brief "booster" coaching to deal with problems.

干预措施: Connection to Health plus Coaching (CTH+C) (Behavioral)

结局指标

主要结局

Change in LDL from baseline to 18 months

时间窗: 18 months from baseline

Low-density lipoprotein (LDL) cholesterol will be measured at baseline and 18 months from baseline (in mg/dL; e.g., 160 mg/dL).

Change in HbA1c from baseline to 18 months

时间窗: 18 months from baseline

Glycosylated hemoglobin (HbA1c) will be measured at baseline and 18 months from baseline.

Change in body mass index (BMI) from baseline to 18 months

时间窗: 18 months from baseline

Body mass index (BMI) will be measured at baseline and 18 months from baseline (weight (kg) / \[height (m)\]2; e.g., 24.96)

Change in systolic and diastolic blood pressure from baseline to 18 months

时间窗: 18 months from baseline

Systolic and diastolic blood pressure will be measured at baseline and 18 months from baseline (in mmHg; e.g., 140/90 mmHg)

次要结局

  • Evidence of documented self-management support for patients through medical record review(18 months from baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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