- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02839382
The Northwest Coalition for Primary Care Practice Support (H2N)
2019년 9월 12일 업데이트: Kaiser Permanente
The purpose of this project is to build capacity for quality improvement (QI) in small primary care practices across Washington, Oregon and Idaho by improving risk factors for heart attacks such as blood pressure, cholesterol and smoking.
The Northwest Coalition for Primary Care Practice Support will assist practices by providing them with a QI coach, creating group learning opportunities, and conducting educational outreach activities.
An innovative study design will be used to determine what levels and types of support are most helpful and effective.
연구 개요
상세 설명
The Northwest Coalition for Primary Care Practice Support will provide a comprehensive and robust external practice support infrastructure for small and medium primary care practices across Washington (WA), Oregon (OR) and Idaho (ID) to build their internal quality improvement (QI) capacity and improve performance on the heart health indicators of aspirin use, blood pressure and cholesterol control and smoking cessation (ABCS indicators) by disseminating and supporting the implementation of relevant Patient Centered Outcomes Research findings.
This coalition of partners has a remarkable track record of collaboration and improving primary care practice: the MacColl Center for Health Care Innovation and the Center for Community Health Evaluation at Group Health Research Institute; Qualis Health, the Health IT Regional Extension Center (REC) and designated Quality Improvement Organization (QIO) for WA and ID; and the Oregon Rural Practice-based Research Network (ORPRN), along with state-level partners who are membership organizations for clinicians in small practice settings.
Recruitment will leverage existing small practice relationships between Qualis Health as the health information technology (IT) REC for WA and ID and ORPRN's existing network of small practices with a goal of enrolling 320 small practices out of an estimated 1,479 with stage 1 meaningful use of their electronic health record across the three states.
In addition to providing health IT support for the Physician Quality Reporting System (PQRS) to measure the ABCS indicators in all practices, our comprehensive approach to building QI capacity and improving the ABCS measures consists of: 1) practice facilitation as a unifying strategy, 2) academic detailing/outreach to support implementation of PCOR findings, and 3) shared learning collaboratives.
We will employ an innovative study and evaluation design by providing two levels of support for each of the latter three practice support components.
By randomly assigning practices to one of eight possible combinations of practice support, we will "…develop new evidence about the contribution of various components of the comprehensive approach and the effect of the intensity of the approach on outcomes."
Our rigorous mixed-method evaluation is based on the RE-AIM framework and will employ multi-level models and interrupted time series regression.
Data will be collected from a control group of practices to examine secular trends.
Our Specific Aims are to: 1) Identify, recruit and conduct baseline assessments in 320 small to medium size primary care practices across the geographically contiguous region of WA, OR and ID; 2) Provide comprehensive external practice support to build QI capacity within these practices; 3) Disseminate and support the adoption of PCOR findings relevant to the ABCS quality measures; 4) Conduct a rigorous evaluation of the effectiveness of providing external practice support to implement PCOR findings and improve ABCS measures; and 5) Assess the sustainability of changes made in QI capacity and ABCS improvements and develop a model of dissemination and primary care practice support infrastructure.
연구 유형
중재적
등록 (실제)
209
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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Washington
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Seattle, Washington, 미국, 98101
- GroupHealthCoop
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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
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Primary care practice with 10 or fewer providers and an Electronic Health Record (EHR) that meets Stage 1 meaningful use criteria
Exclusion Criteria:
- No EHR
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: 요인 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: Coaching
External facilitation by a practice coach for 15 months
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An external facilitator or coach is assigned 15-20 primary care clinics and will make face-to-face site visits and monthly phone calls for 15 months to support building QI capacity in each assigned practcie
다른 이름들:
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활성 비교기: Educational Outreach
Academic detailing phone calls to support implementation of a cardiovascular risk calculator/estimator in each clinic
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An external facilitator or coach is assigned 15-20 primary care clinics and will make face-to-face site visits and monthly phone calls for 15 months to support building QI capacity in each assigned practcie
다른 이름들:
Practices randomized to this arm of the study will receive an educational outreach phone call by an academic expert on implementation strategies for use of a cardiovascular risk calculator within their daily work flow and clinic setting
다른 이름들:
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활성 비교기: Site Visit
Site visits made by practices to 'exemplar" practices to learn innovative approaches to quality improvement
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An external facilitator or coach is assigned 15-20 primary care clinics and will make face-to-face site visits and monthly phone calls for 15 months to support building QI capacity in each assigned practcie
다른 이름들:
Practices randomized to this arm of the study will be given an opportunity to make a site visit to an "exemplar" practice to learn about innovative approaches to conducting quality improvement activities.
다른 이름들:
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활성 비교기: Educational Outreach and Site Visit
In this arm of the study, practices will be offered both educational outreach and an opportunity for a site visit
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An external facilitator or coach is assigned 15-20 primary care clinics and will make face-to-face site visits and monthly phone calls for 15 months to support building QI capacity in each assigned practcie
다른 이름들:
Practices randomized to this arm of the study will receive an educational outreach phone call by an academic expert on implementation strategies for use of a cardiovascular risk calculator within their daily work flow and clinic setting
다른 이름들:
Practices randomized to this arm of the study will be given an opportunity to make a site visit to an "exemplar" practice to learn about innovative approaches to conducting quality improvement activities.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Appropriate use of Aspirin
기간: Every 3 months with 12 month look-back
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National Quality Forum (NQF) 0068 Ischemic Vascular Disease (IVD): Use of Aspirin or another Antithrombotic
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Every 3 months with 12 month look-back
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Hypertension
기간: Every 3 months with 12 month look-back
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NQF 0018 Controlling hypertension
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Every 3 months with 12 month look-back
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Smoking
기간: Every 3 months with 12 month look-back
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NQF 0027 Smoking and Tobacco Use Cessation, Medical Assistance
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Every 3 months with 12 month look-back
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change Process Capacity
기간: Baseline, 15 months, 21 months
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The change process capacity questionnaire
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Baseline, 15 months, 21 months
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Quality Improvement Capacity Assessment
기간: Baseline and 12 months
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Practice-level consensus agreement on QI capacity
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Baseline and 12 months
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Michael L Parchman, MD, Kaiser Permanente
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
- Parchman ML, Fagnan LJ, Dorr DA, Evans P, Cook AJ, Penfold RB, Hsu C, Cheadle A, Baldwin LM, Tuzzio L. Study protocol for "Healthy Hearts Northwest": a 2 x 2 randomized factorial trial to build quality improvement capacity in primary care. Implement Sci. 2016 Oct 13;11(1):138. doi: 10.1186/s13012-016-0502-7.
- Fagnan LJ, Walunas TL, Parchman ML, Dickinson CL, Murphy KM, Howell R, Jackson KL, Madden MB, Ciesla JR, Mazurek KD, Kho AN, Solberg LI. Engaging Primary Care Practices in Studies of Improvement: Did You Budget Enough for Practice Recruitment? Ann Fam Med. 2018 Apr;16(Suppl 1):S72-S79. doi: 10.1370/afm.2199.
- Baldwin LM, Fischer MA, Powell J, Holden E, Tuzzio L, Fagnan LJ, Hummel J, Parchman ML. Virtual Educational Outreach Intervention in Primary Care Based on the Principles of Academic Detailing. J Contin Educ Health Prof. 2018 Fall;38(4):269-275. doi: 10.1097/CEH.0000000000000224. No abstract available.
- Tuzzio L, O'Meara ES, Holden E, Parchman ML, Ralston JD, Powell JA, Baldwin LM. Barriers to Implementing Cardiovascular Risk Calculation in Primary Care: Alignment With the Consolidated Framework for Implementation Research. Am J Prev Med. 2021 Feb;60(2):250-257. doi: 10.1016/j.amepre.2020.07.027. Epub 2020 Dec 3.
- Parchman ML, Anderson ML, Penfold RB, Kuo E, Dorr DA. The Ability of Practices to Report Clinical Quality Measures: More Evidence of the Size Paradox? J Am Board Fam Med. 2020 Jul-Aug;33(4):620-625. doi: 10.3122/jabfm.2020.04.190369.
- Parchman ML, Anderson ML, Coleman K, Michaels LA, Schuttner L, Conway C, Hsu C, Fagnan LJ. Assessing quality improvement capacity in primary care practices. BMC Fam Pract. 2019 Jul 25;20(1):103. doi: 10.1186/s12875-019-1000-1.
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 5월 1일
기본 완료 (실제)
2018년 5월 1일
연구 완료 (실제)
2018년 5월 1일
연구 등록 날짜
최초 제출
2016년 7월 18일
QC 기준을 충족하는 최초 제출
2016년 7월 18일
처음 게시됨 (추정)
2016년 7월 21일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 9월 16일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 9월 12일
마지막으로 확인됨
2019년 9월 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. .
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