- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02665429
A Quality Improvement Project to Investigate Individual Provider Variation in Opioid Prescribing From the Emergency Department
연구 개요
상태
상세 설명
Opioid misuse is a known public safety threat and public health problem, both nationwide and in the Commonwealth of Massachusetts. As a part of these efforts, Emergency Department (ED) outpatient prescriptions have been identified as a potential area for improvement. The Massachusetts Hospital Association (MHA), in conjunction with other stakeholders, developed a set of recommendations to address opioid management and prescribing within the ED setting.
This study is timed to coincide with the rollout by UMassMemorial Health Care of a system-wide opioid prescribing practice guideline/policy which mirrors the Massachusetts Hospital Association's guideline. This rollout provides a unique opportunity for a natural experiment related to provider prescribing practices.
This is a quality improvement project with two primary objectives:
- Improve understanding of physician practice patterns related to emergency department (ED) opioid prescribing
- Evaluate the effectiveness of providing individual clinician profile data in influencing behavior change among ED providers, as it relates to their opioid prescribing patterns
There are two corresponding specific aims:
- Quantitatively describe the current state of opioid prescribing by ED clinicians at four UMass Memorial EDs (using prescriptions generated within the ED electronic health information system between February 2014 and the study implementation date). Descriptive statistics being considered for feasibility of study include:
- Number of opioid prescriptions per hundred patients seen
- Percentage of total prescriptions written that are opioids
- Mean or median quantity of pills dispensed per opioid prescription
- Number of prescriptions for long-acting opioid formulations
- Evaluate the effect on prescribing practices of providing individual clinicians with their profile data to illustrate their personal opioid prescribing patterns, relative to the de-identified distribution for all other clinicians in the ED group
This project is timed to coincide with the separately planned implementation of a system-wide opioid prescribing guideline. The guideline implementation is an independent event, but we feel that it presents a unique opportunity for a simultaneous experimental intervention to assess whether providing clinicians with their individual data alters their prescribing practices beyond any effect achieved simply by being subject to the new guideline. Data collected from the electronic medical record and clinician self-reported data about their perceptions of their prescribing practices will be used to evaluate both the effect of the guideline implementation (i.e. comparison of prescribing patterns for all clinicians before and after guideline implementation) and the combined effect of guideline implementation plus individual profile intervention (i.e. comparisons across intervention versus control groups).
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Massachusetts
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Clinton, Massachusetts, 미국
- UMass Clinton Hospital
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Marlborough, Massachusetts, 미국
- UMass Memorial Marlborough Hospital
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Worcester, Massachusetts, 미국
- UMass Memorial Medical Center
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Provider who practices Emergency Medicine in one or more of four UMass-affiliated EDs (UMassMemorial Medical Center, Marlborough Hospital, and Clinton Hospital), including attending physicians, resident physicians, and advanced practice providers (PAs and NPs).
- Have placed at least one electronic prescription for a medication of interest (namely opioids) in the PulseCheck electronic medical record system during the 12 months prior to the implementation of the opioid guidelines
- Be actively practicing in a UMass-affiliated ED at time of implementation of the guidelines
Exclusion Criteria:
- None
공부 계획
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 |
|---|---|
|
간섭 없음: Control
Providers who are subject only to the routine implementation of clinical practice guidelines without additional experimental intervention
|
|
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실험적: Intervention
Providers who are subject to routine clinical practice guideline implementation AND receive provider's own individual prescribing data profile intervention ("Individual prescribing data profile and self-assessment")
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Prior to receiving his or her individual data profile, each provider in the intervention group will be asked to identify his or her self-assessment of his or her own opioid prescribing practices.
Immediately after providing self-perception data, providers will be provided with their true profile data with a visual display of where they fall within the distribution of their peers.
All peer data are de-identified.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Change in number of opioid prescriptions per hundred patients seen
기간: Pre-intervention baseline compared to 1, 2, 3, 6, 9, 12 months post-intervention
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Pre-intervention baseline compared to 1, 2, 3, 6, 9, 12 months post-intervention
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
Change in percentage of total prescriptions written that are opioids
기간: Pre-intervention baseline compared to 1, 2, 3, 6, 9, 12 months post-intervention
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Pre-intervention baseline compared to 1, 2, 3, 6, 9, 12 months post-intervention
|
|
Change in median quantity of pills dispensed per opioid prescription
기간: Pre-intervention baseline compared to 1, 2, 3, 6, 9, 12 months post-intervention
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Pre-intervention baseline compared to 1, 2, 3, 6, 9, 12 months post-intervention
|
|
Change in number of prescriptions for long-acting opioid formulations
기간: Pre-intervention baseline compared to 1, 2, 3, 6, 9, 12 months post-intervention
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Pre-intervention baseline compared to 1, 2, 3, 6, 9, 12 months post-intervention
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Self-assessment of decile for number of opioid prescriptions per hundred patients seen
기간: Once, at time of enrollment
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The provider's self-assessment of their decile of number of opioid prescriptions per hundred patients seen, compared to their peers
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Once, at time of enrollment
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Self-assessment of decile for percentage of total prescriptions written that are opioids
기간: Once, at time of enrollment
|
The provider's self-assessment of their decile of their percentage of total prescriptions written that are opioids, compared to their peers
|
Once, at time of enrollment
|
|
Self-assessment of decile for median quantity of pills dispensed per opioid prescription
기간: Once, at time of enrollment
|
The provider's self-assessment of their decile of their median quantity of pills dispensed per opioid prescription, compared to their peers
|
Once, at time of enrollment
|
|
Self-assessment of decile for number of prescriptions for long-acting opioid formulations
기간: Once, at time of enrollment
|
The provider's self-assessment of their decile of their number of prescriptions for long-acting opioid formulations, compared to their peers
|
Once, at time of enrollment
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Sean Michael, MD, UMass Memorial Health Care
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 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. .
건강 관리 제공에 대한 임상 시험
-
University of North Carolina, Chapel HillNational Institute on Drug Abuse (NIDA); National Institute of Mental Health (NIMH)완전한