EHR Nudges: Optimizing a Clinical Decision Support System for Evidence-Based Statin Medication Prescribing to Reduce the Risk of Cardiovascular Disease
The overall objective of this proposal is to develop and optimize a CDSS, including several nudges, to increase guideline-concordant statin prescribing for CVD risk (Nudge-CVD-CDSS). Potential nudges will be developed, usability tested and refined and then evaluated in a factorial trial. The aim of this trial is to develop, based on a conceptual model of the prescribing process, a set of potential intervention components (EHR-nudges) to promote and support AHA/ACC guideline-concordant statin prescribing. A user-centered design process will be employed. EHR audit log data will be used to identify technical workflows of current provider prescribing patterns. Provider- and patient-directed default, peer comparison, and salient messaging nudges will be developed (5 total). Patient-directed nudges will encourage patients to prompt their providers to prescribe guideline-concordant statins.
연구 개요
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Nicole Redfern
- 전화번호: 646-501-2501
- 이메일: Nicole.Redfern@nyulangone.org
연구 장소
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New York
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New York, New York, 미국, 10016
- NYU Langone Health
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
Providers:
1. Medical doctor, nurse practitioner, and physician assistants practicing at any NYULH Internal or Family Medicine practice.
Patients:
- Age 40-75 years old
- Had a previous visit in the past 12 months with a provider at any NYULH Internal or Family Medicine practice.
- Had blood pressure documented in the last 12 months
- Had LDL results completed in the last 12 months
- Has either a diagnosis of cardiovascular disease, LDL > 190, or ASCVD risk score ≥ 20%
Exclusion Criteria:
Providers - N/A
Patients:
- Pregnant
- Has allergy or contraindication to statin
- Already taking a high-intensity statin
- Has diagnosis of dementia
공부 계획
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 |
|---|---|
|
실험적: Provider
Providers will be randomly assigned into 1 of 31 conditions. Each condition will have a unique combination of nudges A-E. |
A clinical decision support system (CDSS) inside of the electronic health record (EHR) to support and encourage providers to prescribe statins for at risk patients, in concordance with guidelines. EHR Nudges consist of 5 different nudges (A, B, C, D, E). |
|
간섭 없음: Control
Providers randomized to this arm will receive no EHR nudges. |
|
|
실험적: Patient
Patients will be randomly assigned into 1 of 31 conditions. Each condition will have a unique combination of nudges A-E. |
A clinical decision support system (CDSS) inside of the electronic health record (EHR) to support and encourage providers to prescribe statins for at risk patients, in concordance with guidelines. EHR Nudges consist of 5 different nudges (A, B, C, D, E). |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Percentage of patients indicated for statin therapy who were prescribed a guideline-approved statin at the correct dose during the study period
기간: Month 18
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Month 18
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Safiya Richardson, MD, MPH, NYU Langone Health
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- 23-01349
- 1R01HL171292-01 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to Nicole.Redfern@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
IPD 공유 기간
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
IPD 공유 액세스 기준
The investigator who proposed to use the data will be provided access upon reasonable request. Requests should be directed to Nicole.Redfern@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .