Empowering Veterans to Actively Communicate and Engage in Shared Decision Making in Medical Visits, A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 512
- 试验地点
- 6
- 主要终点
- Change from pre-visit diabetes distress score at 1 week post visit
研究概览
简要总结
Type 2 diabetes is a significant condition in VA affecting 20% of VA patients. Adherence to medication regimens and lifestyle factors is important to achieve care goals for these patients. Patients who use active participatory communication behaviors with their providers have better adherence to treatment and better biomedical outcomes, yet many patients are not prepared to engage in active communication with their providers. Existing coaching interventions have not been adopted in practice because of the cost of trained personnel. The investigators have shown the efficacy of a low-cost video that did not require trained personnel. This proposal proposes to test implementation strategies to deliver that video in VA primary care clinics and to test the effectiveness of the video to improve outcomes in a Hybrid Type 2 effectiveness-implementation trial using a cluster randomized stepped wedge design at six sites. This proposal will test feasibility of implementing the video and if successful will generate the evidence to justify widespread dissemination of the video.
详细描述
Background: Type 2 diabetes mellitus (T2D) affects almost one in five VA patients overall and almost one in four VA patients who are racial and ethnic minorities. Adherence to medication regimens and lifestyle factors (such as diet and exercise) is important to improve outcomes in T2D. Adherence to these factors and subsequent achievement of outcomes is related, at least in part, to effective communication in medical encounters. Empowering and activating patients to use more effective communication behaviors with their providers leads to better adherence to treatment and better biomedical outcomes. However, interventions to improve communication have not been adopted in practice largely due to the cost of trained personnel to deliver the training. Thus, there is a gap in effective interventions that can improve communication related outcomes. In a recent VA HSR&D funded trial the investigators showed efficacy of the Speak Up! video. Veterans watching the video had significantly higher self-efficacy to communicate and lower hemoglobin A1c at follow-up.
Significance: Type 2 diabetes (T2D) is common, expensive, and chronic. Estimates put the prevalence of T2D at almost 20 percent. The proposed study is highly significant because the condition under study, T2D, is highly prevalent and has negative impacts for Veterans with the symptoms and sequelae of T2D. The objective to activate patients' communication to achieve goals of care and to improve outcomes of T2D is responsive to VA priorities to improve customer service, primary care practice, and care of complex chronic diseases.
Innovation: The proposal to engage patients in communication in medical visits is innovative because addressing patients' communication as contrasted with providers' communication is unique in the VA. It is also innovative because activating patients facilitates patient-centered care and shared decision making which are key goals in the VA/DOD guideline for the management of T2D and contributes to VA's commitment to the Whole Health model. Also, the intervention could be a paradigm for encouraging patients with other conditions to use active participatory communication. Specifically, the design and communication content of Speak Up! Could serve as a model for the development of activation interventions for Veterans with other conditions.
Specific Aims: The proposed Hybrid Type 2 study has two specific aims:
Aim 1. Implementation aim - In partnership with key clinical staff develop a strategy to deliver the Speak Up! video in VA outpatient primary care clinics using a facilitated Plan Do Study Act (PDSA) process.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Health Services Research
- 盲法
- None
盲法说明
No masking
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
- •Dx of T2D
- •Hemoglobin A1c ("A1c") 7 or greater
- •Adults, age 18 or older
- •Visit at a participating site
- •Receives care from primary care provider more than once a year at VA
排除标准
- •Lives in skilled nursing facility
- •Dementia (abnormal SBT)63
- •Creatinine >3 (or eGFR<30), recent MI or admission for HF
- •Terminal medical condition
- •Drug- (e.g., steroid) induced diabetes.
- •Blind or deaf (e.g., unable to view/hear video
结局指标
主要结局
Change from pre-visit diabetes distress score at 1 week post visit
时间窗: Collected at pre-visit and 1 week post-visit
Diabetes Distress is a 17-item scale that measures the emotional burden of diabetes on four subscales: emotional burden, physician-related distress, regimen-related distress, and diabetes-related interpersonal distress subscale. The Diabetes Distress scale is internally consistent and is well correlated with measures of depression, meal planning, exercise, and cholesterol levels. The scale ranges from 17 to 102. Higher scores indicate higher distress.
Change from pre-visit communication self-efficacy score at 1 week post visit
时间窗: Collected at pre-visit and 1 week post-visit
Communication Self-Efficacy (pre and post visit) is the degree to which a patient feels able to interact with his/her provider in order to provide information about problems, obtain desired information about diagnosis, treatment and prognosis, and participate in formulating a plan. The Perceived Efficacy in Physician-Patient Interactions scale (PEPPI) is a valid and reliable measure of patients' perceived self-efficacy in interacting with physicians (alpha 0.83). The short form of the PEPPI (PEPPI-5) has 5-items. Score on the PEPPI-5 ranges from 5-25. Higher scores reflect a better perceived self-efficacy in interacting with physicians.
Change from baseline HgbA1c at 3 months post-visit
时间窗: Collected at baseline and 3 months post-visit
HgbA1c is regarded as the standard laboratory measurement (blood test) for assessing the control of diabetes over approximately three months preceding the test. HgbA1c is usually checked several times a year in patients with poorly controlled diabetes.
次要结局
- Change from baseline trust in provider score at 1 week post visit(Collected at baseline and 1 week post-visit)
- Change from pre-visit patient engagement score at 1 week post visit(Collected at pre-visit and 1 week post-visit)
- Change from pre-visit medication adherence at 1 week post visit(Collected at pre-visit and 1 week post-visit)
- Change from pre-visit self-care score at 1 week post visit(Collected at pre-visit and 1 week post-visit)
- Shared decision making(Collected 1 week post visit)
- Communication Ratings(Collected 1 week post visit)
- Patient Centered Care(Collected 1 week post visit)
- Change from pre-visit medication adherence at 3 months post visit(Collected at pre-visit and 3 months post visit)
- Change from baseline functional status score at 1 week post visit(Collected at baseline and 1 week post visit)
- Change from pre-visit self-management score at 1 week post visit(Collected at pre-visit and 1 week post visit)
- Promis(Change from baseline promis score at 1 week post visit)