跳至主要内容
临床试验/NCT02950961
NCT02950961已完成不适用

Implementation of Tailored Collaborative Care For Women Veterans (CCWV) (QUE 15-272)

VA Office of Research and Development6 个研究点 分布在 1 个国家目标入组 153 人开始时间: 2017年6月30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
153
试验地点
6
主要终点
WHO Disability Assessment Schedule (WHODAS) Out Of Role Days Items

研究概览

简要总结

Implementation of Tailored Collaborative Care for Women Veterans (CCWV) was designed to enhance primary care-mental health integration for women Veterans by tailoring services to women Veterans' and providers' needs and providing an evidence-based intervention, Coordinated Anxiety Learning and Management, to address anxiety and depression in a patient-centered approach. CCWV was implemented in two of the Women's Health Practice-Based Research Network sites, with careful attention to local tailoring and adaptation to enhance the fit of the care model in varied local contexts.

详细描述

Background: Women Veterans are the fastest growing segment of Veterans Health Administration (VHA) users. This dramatic growth has created challenges for VHA. Gender disparities persist in cardiovascular (CV) and diabetes risk factor control, and rates of depression, anxiety, and mental health comorbidity are disproportionately high among women Veterans. Furthermore, a high rate of women Veterans' attrition from VA care, along with organizational barriers to care, substantiate that organizational changes are needed in order to engage and retain women Veteran VHA users in evidence-based, patient-centered care.

Objectives: The Enhancing Mental and Physical health of Women through Engagement and Retention (EMPOWER) QUERI addresses VHA Blueprint for Excellence Strategy 6, by advancing "personalized, proactive, patient-centered" care models, and Transformational Strategy 7.2.g by implementation of innovative care models in women Veterans' health care." The EMPOWER QUERI Program was designed to improve women Veterans' engagement and retention in evidence-based care for three high priority health conditions, i.e., prediabetes, cardiovascular, and mental health. To achieve this impact goal, the investigators proposed a cohesive portfolio of projects with the following aims: (1) To use an evidence-based implementation strategy that emphasizes local tailoring of care models, multilevel stakeholder engagement, and systematic evaluation of complex implementation processes in order to enrich organizational capacity for innovations in women Veterans' VHA health care; (2) To implement personalized, proactive, patient-centered innovations in VHA women's health that are acceptable, feasible, satisfactory, relevant, and effective for both providers and patients, thereby encouraging women Veterans' engagement and retention and sustainability of the innovations; and, (3) To generate implementation "playbooks" for the investigators' partners that are scalable and serve as guidance for future implementation of a broader array of evidence-based women's health programs and policy.

Methods: Three projects were conducted by an experienced multidisciplinary team. This trial pertains to "Implementation of Tailored Collaborative Care for Women Veterans," which evaluated implementation of an evidence-based collaborative care model tailored to enhance provider- and system-level capabilities to address women Veterans' anxiety and depression treatment needs, thereby improving organizational primary care-mental health integration (PC-MHI) effectiveness and women Veterans' engagement and retention in PC-MHI. This implementation research study used mixed methods implementation evaluation to investigate primary implementation outcomes of adoption, acceptability, feasibility, and reach. Multilevel stakeholder engagement was prioritized. Program-wide organizational-, provider-, and patient-level data was utilized to enhance synergy, productivity, and impact. Several implementation outcomes were assessed using qualitative methods and will be reported elsewhere (e.g. final report, manuscripts).These include Adoption of Care Model, Acceptability of Care Model, Feasibility of Care Model, and Satisfaction With Care Model.

As a coherent program of women's health implementation research and quality improvement, the EMPOWER QUERI constituted a major milestone in achieving Blueprint for Excellence (BPE) strategies and realizing women Veterans' engagement and, ultimately, empowerment in the VHA system.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Arm 1: Mixed Methods Implementation Evaluation

Other

The investigators used mixed methods to evaluate the implementation in two VA Women's Practice Based Research Network (PBRN) sites, describing services and patterns of care utilized by patients prior to seeing a care manager, and then 30, 60, 180, and 365 days post initiation of care with the care manager. Investigators also evaluated facilitators and barriers to implementation of this collaborative care model.

干预措施: Collaborative Care for Women Veterans (Behavioral)

结局指标

主要结局

WHO Disability Assessment Schedule (WHODAS) Out Of Role Days Items

时间窗: 6 months

brief measure of impact of disability on role functioning: WHO Disability Assessment Schedule (WHODAS) Out Of Role Days items

Health Literacy (Chew et al. 2004)

时间窗: 6 months

brief measure of health literacy: (Chew et al. 2004)

Change in Referrals

时间窗: baseline, 18 months (implementation phase)

Using the nonrandomized stepped wedge design, we will compare referrals to PC-MHI at baseline at each site, and compare to referrals throughout the 18-month implementation phase.

Patient-Reported Outcomes Measurement Information System (PROMIS)

时间窗: 6 months

brief measure of global health: Patient-Reported Outcomes Measurement Information System (PROMIS)

Overall Anxiety Severity and Impairment Scale (OASIS)

时间窗: 6 months

brief measure of anxiety: Overall Anxiety Severity and Impairment Scale (OASIS)

Change in Utilization of Services (180 Days)

时间窗: 180 days

Change in utilization of services 180 days prior to 180 days post initiation of care with the care manager.

Change in Utilization of Services (365 Days)

时间窗: 365 days

Change in utilization of services comparing utilization 365 days prior to 365 days post initiation of care with the care manager.

Change in Utilization of Services (30 Days)

时间窗: 30 days

Change in utilization of services comparing utilization 30 days prior to 30 days post initiation of care with the care manager.

Patient Health Questionnaire for Depression and Anxiety (PHQ-4)

时间窗: 6 months

brief measure of depression: Patient Health Questionnaire for Depression and Anxiety (PHQ-4)

Change in Utilization of Services (60 Days)

时间窗: 60 days

Change in utilization of services comparing utilization 60 days prior to 60 days post initiation of care with the care manager.

Global Rating of Satisfaction/Quality of Care

时间窗: 6 months

brief measure of satisfaction and quality that we have used in several surveys of women Veteran VA patients

Altarum Consumer Engagement

时间窗: 6 months

brief measure of patient engagement in care

次要结局

未报告次要终点

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (6)

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