- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02991534
Cardiovascular Risk Screening and Risk Reduction in Women Vets
Facilitating Cardiovascular Risk Screening and Risk Reduction in Women Veterans (QUE 15-272)
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 is 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, we propose 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 our 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 will be conducted by an experienced multidisciplinary team. "Tailoring VA's Diabetes Prevention Program to Women Veterans' Needs" is a one-year QI project to be conducted in VA Greater Los Angeles women's health clinics. Women Veterans with prediabetes will select an in-person, peer-led or online gender-specific, evidence-based diabetes prevention program to address their risk behaviors and health conditions. "Facilitating Cardiovascular Risk Screening and Risk Reduction in Women Veterans" will increase identification of CV risk among women Veterans, enhance patient/provider communication and shared decision-making about CV risk, and provide a supportive, coordinated health coaching intervention to facilitate women Veterans' engagement and retention in appropriate health services. "Implementation of Tailored Collaborative Care for Women Veterans" will evaluate 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. Both implementation research studies will use a modified stepped wedge design and will apply the evidence-based Replicating Effective Programs (REP) implementation strategy. Mixed methods implementation evaluations will focus on investigating primary implementation outcomes of adoption, acceptability, feasibility, and reach. Multilevel stakeholder engagement will be prioritized. Program-wide organizational-, provider-, and patient-level measures and tools will be utilized to enhance synergy, productivity, and impact. As a coherent program of women's health implementation research and quality improvement, the proposed EMPOWER QUERI will constitute a major milestone in achieving BPE strategies and realizing women Veterans' engagement and, ultimately, empowerment in our VHA system.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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California
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Sepulveda, California, 미국, 91343
- VA Greater Los Angeles Healthcare System, Sepulveda, CA
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West Los Angeles, California, 미국, 90073
- VA Greater Los Angeles Healthcare System, West Los Angeles, CA
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Connecticut
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West Haven, Connecticut, 미국, 06516
- VA Connecticut Healthcare System West Haven Campus, West Haven, CT
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Texas
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San Antonio, Texas, 미국, 78229
- South Texas Health Care System, San Antonio, TX
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- For Patient Activities: Women VA patients with any cardiovascular risk factors
- For Key Stakeholder Activities: VA staff affiliated with the Women's Health Clinic
Exclusion Criteria:
- For Patient Activities: Men & Patients with cognitive impairment precluding informed consent
- For Key Stakeholder Activities: non- VA staff
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
다른: Arm 1
The investigators will use a nonrandomized stepped wedge design to evaluate the implementation in four VA Women's Practice Based Research Network (PBRN) sites.
In this nonrandomized stepped wedge design, the intervention is "turned on" when a primary care provider (PCP) uses a CV screening template which maps to the patient CV self-screener.
This design relies on sequential roll-out to participating sites over time, while using other sites as controls until they begin implementation.
The investigators will use nonrandomized stepped wedges (rather than randomized) given their suitability for studying implementation.
The design explicitly considers the timing of implementation spread and addresses the statistical issues introduced by lack of randomization in implementation starts and processes.
The investigators will analytically compensate for the design by collecting patient-, provider-, and site-level data that may be associated with timing of the adoption of each intervention.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Referrals to Health Promotion and Disease Prevention Services
기간: 6 months
|
Examples include smoking cessation, dietitian, MOVE program or other weight loss/physical activity programs, pharmacy services, facilitated groups, Health Coaching services, specialty services, and other programs.
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6 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Altarum Consumer Engagement (ACE)
기간: 6 months
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Brief measure of patient engagement in care
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6 months
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PROMIS Global Health
기간: 6 months
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Brief measure of global health
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6 months
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Patient Satisfaction
기간: 6 months
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Global rating of patient satisfaction/quality of care
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6 months
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Overall Anxiety Severity and Impairment Scale (OASIS)
기간: 6 months
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Brief measure of anxiety
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6 months
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Depression screen (PHQ-4)
기간: 6 months
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Brief measure of depression symptoms
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6 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Bevanne A Bean-Mayberry, MD MHS, VA Greater Los Angeles Healthcare System, West Los Angeles, CA
- 수석 연구원: Melissa M Farmer Coste, PhD MS, VA Greater Los Angeles Healthcare System, Sepulveda, CA
간행물 및 유용한 링크
일반 간행물
- Finley EP, Huynh AK, Farmer MM, Bean-Mayberry B, Moin T, Oishi SM, Moreau JL, Dyer KE, Lanham HJ, Leykum L, Hamilton AB. Periodic reflections: a method of guided discussions for documenting implementation phenomena. BMC Med Res Methodol. 2018 Nov 27;18(1):153. doi: 10.1186/s12874-018-0610-y.
- Hamilton AB, Farmer MM, Moin T, Finley EP, Lang AJ, Oishi SM, Huynh AK, Zuchowski J, Haskell SG, Bean-Mayberry B. Enhancing Mental and Physical Health of Women through Engagement and Retention (EMPOWER): a protocol for a program of research. Implement Sci. 2017 Nov 7;12(1):127. doi: 10.1186/s13012-017-0658-9.
유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
- 비만 [C18.654.726.500]
- 여성 [M01.975]
- 환자 참여 [N05.300.150.600.620]
- 의사, 1차 진료 [M01.526.485.810.800]
- 의사, 여성 [M01.526.485.810.820]
- 건강 행동 [F01.145.488]
- Patient Satisfaction [N05.715.360.600]
- Health Educators [M01.526.485.410]
- Cardiovascular Diseases [C14]
- Hypertension [C14.907.489]
- Hyperlipidemias [C18.452.584.500.500]
- Dyslipidemias [C18.452.584.500]
- Diabetes Mellitus [C18.452.394.750]
- Tobacco Use Disorder [C25.775.912]
- Overweight [C23.888.144.699]
추가 관련 MeSH 약관
기타 연구 ID 번호
- QUX 16-007
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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