- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01784575
Increasing Use of Publicly Reported Pediatric Quality Data (IDEAS)
IDEAS for a Healthy Baby: Reducing Disparities in Consumer Use of Publicly Reported Quality Data
연구 개요
상세 설명
Efforts to increase transparency regarding health care quality and safety are partially guided by the belief that making performance information publicly available will enable patients to make more informed choices. Although the amount of information reported on websites and through other channels has increased dramatically, use by consumers remains limited and largely restricted to white, college educated and middle aged consumers. There are many barriers that prevent patients from making effective use of current public reporting websites, including failure to recognize that quality may vary between providers, lack of awareness of publicly reported data, limited internet access, and low health literacy and numeracy. Innovative approaches are therefore needed to overcome barriers to using these data, particularly in vulnerable populations, to ensure a health care system in which every consumer can benefit from public reporting. Patient navigators have helped patients take greater advantage of the complex health care delivery environment, and use of patient navigators may be an effective approach to engage consumers and to help them to interpret the information presented in public reports.
The scientific aims of the study are: 1) to test the efficacy of an office-based patient navigator to assist low income pregnant women in using publicly reported data to select a pediatric care provider; 2) to assess the efficacy of the intervention in subgroups defined by parity, race/ethnicity, and health literacy; 3) to evaluate the importance of publicly reported information about quality compared to other factors when selecting a pediatric provider; and 4) to assess the intervention's impact on self-management of health care. English speaking women ages 16-45 attending the prenatal clinic at a large urban medical center will be recruited, enrolled, consented and randomized to the navigator intervention or an informational pamphlet control between 24-34 weeks of gestation. Women randomized to the intervention arm will receive two 20 minute sessions with a trained patient navigator who will guide women in navigating and interpreting information about the quality of care provided at local pediatric practices on the Massachusetts Health Quality Partners web site. A survey designed for the purpose of this study will be administered at baseline and post-intervention. Health literacy, numeracy and level of activation for self-management of health care will also be assessed as potential mediators of intervention effectiveness. The primary study outcome will be the average performance on quality measures for the practices selected in the intervention and control groups. Secondary outcomes will include analyses of efficacy among groups of women defined by parity and an assessment of the relative importance of factors considered when choosing a pediatric care provider. Successful completion of the study aims will yield important new knowledge about the value of guided web-site navigation as a strategy to reduce disparities in the use of publicly reported information.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Massachusetts
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Springfield, Massachusetts, 미국, 01199
- Baystate Medical Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- 20-34 weeks of pregnancy
- comfortable speaking English
- ages 16-50
Exclusion Criteria:
- age 15 or younger
- age 51 or greater
- not comfortable speaking or understanding English
- less than 20 or greater than 34 weeks of pregnancy
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Patient Navigator Intervention
The Patient Navigator Intervention arm will have two 20 minute interactive sessions with a patient navigator in which they will learn about quality measures and view scores on the Massachusetts Health Quality Partner's website.
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The Patient Navigator Intervention will include 2 - 20 minute sessions with a patient navigator in which women are shown publicly available health care quality data about local pediatric practices on a non-profit quality collaborative's web site.
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활성 비교기: Control
The control arm will receive an information pamphlet about health care quality.
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The Patient Navigator Intervention will include 2 - 20 minute sessions with a patient navigator in which women are shown publicly available health care quality data about local pediatric practices on a non-profit quality collaborative's web site.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Quality score of pediatric practices chosen by participants
기간: 6-20 weeks
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Each pediatric practice will be given a composite clinical quality and patient experience score based upon scores reported on the Massachusetts Health Quality Partners "Quality Insights" reports.
The mean scores of practices chosen by women in the intervention compared to the control arm will assessed.
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6-20 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Factors important to pregnant women when choosing a pediatric practice
기간: 6-20 weeks
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The study survey will assess relative importance of a range of factors that might be important to women when selecting a pediatric practice.
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6-20 weeks
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Patient activation
기간: 6-20 weeks
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We will be assessing changes in patients engagement in self-management of their and their child's health care using Patient Activation Measures.
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6-20 weeks
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공동 작업자 및 조사자
수사관
- 수석 연구원: Sarah L Goff, MD, Baystate Medical Center
간행물 및 유용한 링크
일반 간행물
- Goff SL, Mazor KM, Guhn-Knight H, Budway YY, Murphy L, White KO, Lagu T, Pekow PS, Priya A, Lindenauer PK. Factors That Matter to Low-Income and Racial/Ethnic Minority Mothers When Choosing a Pediatric Practice: a Mixed Methods Analysis. J Racial Ethn Health Disparities. 2017 Dec;4(6):1051-1060. doi: 10.1007/s40615-016-0309-x. Epub 2017 Mar 8.
- Goff SL, Mazor KM, Pekow PS, White KO, Priya A, Lagu T, Guhn-Knight H, Murphy L, Youssef Budway Y, Lindenauer PK. Patient Navigators and Parent Use of Quality Data: A Randomized Trial. Pediatrics. 2016 Oct;138(4):e20161140. doi: 10.1542/peds.2016-1140. Epub 2016 Sep 6.
- Goff SL, Youssef Y, Pekow PS, White KO, Guhn-Knight H, Lagu T, Mazor KM, Lindenauer PK. Successful Strategies for Practice-Based Recruitment of Racial and Ethnic Minority Pregnant Women in a Randomized Controlled Trial: the IDEAS for a Healthy Baby Study. J Racial Ethn Health Disparities. 2016 Dec;3(4):731-737. doi: 10.1007/s40615-015-0192-x. Epub 2016 Apr 11.
- Goff SL, Pekow PS, White KO, Lagu T, Mazor KM, Lindenauer PK. IDEAS for a healthy baby--reducing disparities in use of publicly reported quality data: study protocol for a randomized controlled trial. Trials. 2013 Aug 7;14:244. doi: 10.1186/1745-6215-14-244.
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 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- 1R21HS021864-01 (미국 AHRQ 보조금/계약)
- R21HS021864-01 (미국 AHRQ 보조금/계약)
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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