- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02433496
Physician Coaching to Reduce Opioid-related Harms
연구 개요
상세 설명
This project addresses the urgent need to promote the adoption of evidence-based practices in healthcare by pilot-testing an innovative implementation strategy. The implementation strategy aims primarily to reduce variation in opioid prescribing practices for chronic pain in primary care settings.
The standard approach to improving medical practice involves groups of clinical experts reviewing the literature to produce clinical guidelines based on scientific evidence, and disseminating those guidelines by publishing them in medical journals. A clinical guideline has been developed for opioid prescribing for chronic non-cancer pain using this type of approach. The implementation strategy for promoting uptake of the guideline in primary care settings tested in this study consists of three innovations: (1) a process for translating clinical guidelines into a checklist-based implementation guide for clinicians, (2) a physician peer coaching model, and (3) implementation support using tools from systems engineering. This project teams the experts who developed the guideline for opioid prescribing with experts in implementation science and primary care to translate the guideline into an actionable, checklist-based implementation guide. If the implementation strategy is effective in this pilot test, it will be used in a larger cluster-randomized trial to test it against other approaches to evidence-based practice adoption.The long-term goal of this research is to improve the adoption of evidence-based practices in primary care by producing a generalizable model of change.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Wisconsin
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Madison, Wisconsin, 미국, 53705
- University of Wisconsin - Madison
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
At each of the 4 coaching intervention sites, we aim to recruit between 3-7 clinical care providers with prescribing authority (e.g., primary care physicians, mid-level practitioners, etc.) to participate in interviews and focus groups. All clinic staff (e.g., medical assistants, office staff) are welcome to participate in coaching site visits and follow up correspondence, but only staff with prescribing authority will be considered research participants.
Exclusion Criteria:
- Residents will be excluded.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
---|---|
Physician coaching
This group includes 4 intervention primary care clinics that are part of the University of Wisconsin's Department of Family Medicine.
These clinics will receive an organizational coaching intervention that includes in-person site visits and phone/email communication.
Each participating clinic will designate one primary care physician to act as a clinic lead in working with the coach to coordinate an initial site visit (during project month 13, July 2015), a follow-up site visit (month 15, October, 2015), and communicating with the coach throughout the 6-month follow-up period via phone and email.
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The coach will present the latest research on the benefits and risks of long-term opioid use. The presentation will be followed by a brainstorming exercise where the coach joins the clinic team in experiencing clinical practices from the perspective of a patient with chronic pain. The coach will help the clinic team flowchart clinical workflows and determine the best course for implementing aspects of a checklist-based implementation guide developed to support adoption of the guidelines for opioid prescribing. The coach will help the team implement ideas using Plan-Do-Study-Act change cycles. The coach will maintain monthly email and phone contact with the clinic lead and clinic team after the initial site visit to monitor implementation progress and offer advice. |
Control Group
This group includes 4 control primary care clinics that will not receive any intervention.
A de-identified dataset will be created to examine differences in outcome variables between intervention and control clinics.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Overall Rate of Opioid Prescribing
기간: Up to 3 years
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The proportion of patients with a chronic pain diagnosis receiving daily opioids.
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Up to 3 years
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Rate of Opioid / Benzodiazepine Co-prescribing
기간: Up to 3 years
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Proportion of patients with a chronic pain diagnosis receiving daily opioids and benzodiazepines concurrently.
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Up to 3 years
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Urine Drug Screening Rate
기간: Up to 3 years
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Proportion of opioid patients completing urine drug screens prior to and during the study intervention
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Up to 3 years
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Mental Health Screening Rate
기간: Up to 3 years
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Proportion of opioid patients screened for mental health/substance use problems
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Up to 3 years
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Use of Pain Management Agreements
기간: Up to 3 years
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Proportion of opioid patients signing pain management agreements
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Up to 3 years
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High-dose Patients
기간: Up to 3 years
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Proportion of opioid prescriptions above 120 mg daily morphine equivalent
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Up to 3 years
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Provider Drop-out Rate
기간: 3 months
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Number and percentage of providers who drop out of study at 3 months
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3 months
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Participating Patient Demographics
기간: Up to 3 years
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Characteristics of participating patients vs. general patient population (race, gender, ethnicity)
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Up to 3 years
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Participating Clinic Characteristics
기간: Up to 12 months
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Characteristics of participating clinics vs. non-participating clinics (number of patients, number of providers, overall opioid prescribing rate)
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Up to 12 months
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Participating Staff Characteristics
기간: Up to 12 months
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Characteristics of participating staff (profession)
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Up to 12 months
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Intervention Fidelity
기간: Up to 12 months
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Total hours of coaching delivered/received among all clinics that received physician coaching.
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Up to 12 months
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Intervention Cost
기간: Up to 12 months
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Total cost of coaching intervention among all clinics that received physician coaching.
At clinic level.
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Up to 12 months
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Proportion With MEDD >120 mg
기간: Up to 12 months
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The proportion of patients who have consistent opioid Rx above a morphine equivalent daily dose about 120 mg.
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Up to 12 months
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Average Morphine Equivalent Daily Dose (MEDD)
기간: Up to 12 months
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The average MEDD in milligrams for patients with consistent opioid Rx.
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Up to 12 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Andrew R Quanbeck, PhD, Center for Health Enhancement Systems Studies
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
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 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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