- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02515578
Southwest Health Extension Partnership to Enhance Research Dissemination
2021년 1월 22일 업데이트: University of Colorado, Denver
Heart disease and strokes cause one in three deaths reported each year in the United States.
Primary care practices need to implement new research findings that help decrease patients' risk for heart disease and stroke.
This project will help to build primary care practice capacity for quality improvement and change management in small and medium size primary care practices in Colorado and New Mexico.
This project will also help practices implement patient-centered outcomes research findings.
연구 개요
상태
완전한
정황
상세 설명
Cardiovascular disease (CVD) causes one in three deaths reported each year in the United States.
Strategies derived from patient-centered outcomes research (PCOR) that address CVD risk factors can greatly reduce the burden of CVD.
Primary care practices must transform to deliver a higher level of PCOR evidence-based prevention to decrease cardiovascular risk.
PCOR interventions that emphasize patient-centered care including self-management support, team-based care, improved information systems, and active quality improvement have been shown to be effective.
Practices often require assistance integrating new programs into clinical operations.
Practice facilitation has been shown to enhance implementation of new programs for patients with chronic disease in primary care.
Other methods of practice support, including academic detailing, collaborative learning sessions, and health information technology assistance, have also been shown to be effective, by themselves and in combination with practice facilitation.
Patient involvement may also aid practice transformation.
Increasingly, practices are actively including patients as part of the change process through the creation of patient advisory councils and including patients in practice quality improvement teams.
Another method of patient involvement to inform implementation of evidence-based care is the Boot Camp Translation process, in which patients collaborate with primary care clinicians, staff members, and community members to translate best practices into culturally and community relevant implementation at the local level.
However, while these efforts have had considerable success, no study has looked at the incremental value of adding patient engagement strategies to the more standard approaches to practice transformation listed above.
This project would implement the Southwest Health Extension Program to Enhance Research Dissemination (SHEPERD) as a cooperative program to build primary care practice capacity for quality improvement, change management, and implementation of PCOR findings in small and medium size primary care practices in Colorado and New Mexico, with an initial focus on cardiovascular care.
It also would conduct a cluster randomized trial with an external matched cohort control group to examine the Reach, Effectiveness, Adoption, Implementation, and Maintenance of two approaches to practice transformation to implement PCOR interventions for reducing cardiovascular risks in primary care practices, comparing the impact of 1) a standard practice transformation support intervention (including practice facilitation, practice assessment with feedback, HIT assistance, academic detailing, and collaborative learning sessions) to 2) an approach that adds patient engagement activities (including patient advisory councils and boot camp translation) as part of the practice transformation support.
This project will provide critical information regarding the added value of patient engagement in practice transformation efforts and will also result in a network of practices across the region with increased capacity for practice transformation and implementation of PCOR findings.
연구 유형
중재적
등록 (실제)
5508
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Colorado
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Denver, Colorado, 미국
- University of Colorado, Denver
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Must be staff or clinicians (including physicians, nurse practitioners, and physician assistants) in an enrolled primary care practice
- Primary care practices must be family medicine or general internal medicine practices with a maximum of ten lead clinicians
- Primary care practices must be either independent or, if part of a larger organization, demonstrate on careful screening that they do not receive significant quality improvement support from the larger organization
Exclusion Criteria:
- Primary care practices with more than 10 lead clinicians
- Non-independent primary care practices that receive significant quality improvement support from their system or organization
- Clinicians and staff who do not speak or read English
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: Standard practice transformation support
Primary care practices will receive a cardiovascular care toolkit, practice facilitation, practice assessment with feedback, health information technology assistance, academic detailing, and periodic collaborative learning sessions
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실험적: Enhanced practice transformation support
Primary care practices will receive practice facilitation, practice assessment with feedback, health information technology assistance, academic detailing, and periodic collaborative learning sessions PLUS patient advisory council support and a modified cardiovascular care toolkit based on combined practice and patient input regarding the local context.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change of documentation of aspirin therapy in patients with ischemic vascular disease.
기간: Baseline, 3, 6, 9, 12, and 15 months from baseline
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The percent of patients aged 18 years and older with Ischemic Vascular Disease (IVD) with documented use of aspirin or other antithrombotic.
This is a practice-level indicator of documentation of care processes for cardiovascular disease.
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Baseline, 3, 6, 9, 12, and 15 months from baseline
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Change of documentation of blood pressure in patients with a diagnosis of hypertension.
기간: Baseline, 3, 6, 9, 12, and 15 months from baseline
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The percent of patients aged 18 - 85 who had a diagnosis of hypertension (HTN) and whose blood pressure (BP) was adequately controlled (<140/90) during the measurement year.
This is a practice-level indicator of documentation of care processes for cardiovascular disease.
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Baseline, 3, 6, 9, 12, and 15 months from baseline
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Change of documentation of blood pressure in patients with adequately controlled blood pressure.
기간: Baseline, 3, 6, 9, 12, and 15 months from baseline
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The percent of patients aged 18 - 85 who had a diagnosis of hypertension (HTN) and whose blood pressure (BP) was adequately controlled (age 18-59 and/or people with diabetes or chronic kidney disease <140/90; age 60-85 <150/90) during the measurement year.
This is a practice-level indicator of documentation of care processes for cardiovascular disease.
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Baseline, 3, 6, 9, 12, and 15 months from baseline
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Change of documentation of fasting LDL in patients with a fasting LDL at or below the LDL goal.
기간: Baseline, 3, 6, 9, 12, and 15 months from baseline
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The percent of patients aged 20 - 79 who had a fasting LDL test performed and whose risk-stratified fasting LDL is at or below the recommended LDL goal.
This is a practice-level indicator of documentation of care processes for cardiovascular disease.
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Baseline, 3, 6, 9, 12, and 15 months from baseline
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Change of documentation of patients who had a fasting LDL test performed and prescribed a statin based on risk.
기간: Baseline, 3, 6, 9, 12, and 15 months from baseline
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The percent of patients aged 20 - 79 who had a fasting LDL test performed and who are prescribed a recommended dose of statin based on risk status if indicated.
This is a practice-level indicator of documentation of care processes for cardiovascular disease.
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Baseline, 3, 6, 9, 12, and 15 months from baseline
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Change of documentation of patients screened about tobacco use.
기간: Baseline, 3, 6, 9, 12, and 15 months from baseline
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The percent of patients aged 18 years or older screened about tobacco use one or more times within 24 months AND who received cessation counseling intervention if identified as a tobacco user.
This is a practice-level indicator of documentation of care processes for cardiovascular disease.
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Baseline, 3, 6, 9, 12, and 15 months from baseline
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change of the documentation in primary care practice's.
기간: Baseline, 9 and 15 months from baseline
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This primary care practice capacity to implement PCOR findings and improve quality and implementation of the planned comprehensive approach.
The measure is based on practice-level scores of change process capacity, adaptive reserve, clinician experience and implementation of patient-centered medical home components.
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Baseline, 9 and 15 months from baseline
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: W. Perry Dickinson, MD, University of Colorado, Denver
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- Fernald DH, Mullen R, Hall T, Bienstock A, Kirchner S, Knierim K, de la Cerda D, Callan D, Rhyne RL, Dickinson LM, Dickinson WP. Exemplary Practices in Cardiovascular Care: Results on Clinical Quality Measures from the EvidenceNOW Southwest Cooperative. J Gen Intern Med. 2020 Nov;35(11):3197-3204. doi: 10.1007/s11606-020-06094-5. Epub 2020 Aug 17.
- English AF, Dickinson LM, Zittleman L, Nease DE Jr, Herrick A, Westfall JM, Simpson MJ, Fernald DH, Rhyne RL, Dickinson WP. A Community Engagement Method to Design Patient Engagement Materials for Cardiovascular Health. Ann Fam Med. 2018 Apr;16(Suppl 1):S58-S64. doi: 10.1370/afm.2173.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2015년 10월 1일
기본 완료 (실제)
2018년 7월 31일
연구 완료 (실제)
2018년 7월 31일
연구 등록 날짜
최초 제출
2015년 7월 15일
QC 기준을 충족하는 최초 제출
2015년 7월 31일
처음 게시됨 (추정)
2015년 8월 5일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2021년 1월 25일
QC 기준을 충족하는 마지막 업데이트 제출
2021년 1월 22일
마지막으로 확인됨
2021년 1월 1일
추가 정보
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. .