Using Multimedia Digital Health to Enable and Engage Pediatric Inpatients and Their Parents
2016년 5월 12일 업데이트: University of California, San Francisco
Using Multimedia Digital Health to Enable and Engage Pediatric Inpatients and Their Parents: A Pilot Study
This project leverages digital health technology to support patient engagement and shared decision-making between families, patients, and providers.
The investigators will start by finalizing the educational module and adding randomization for the trial (Aim 1).
The investigators will then complete iterative user testing in the live system through measurement of educational module views and usability feedback interviews with 20 end users (Aim 2).
The investigators will then conduct a randomized controlled trial to test the impact of the educational module on existing measures of patient engagement (Aim 3).
The hypothesis is that parents who receive the educational module will have higher scores on shared decision-making, patient activation and overall patient experience.
연구 개요
상태
완전한
개입 / 치료
상세 설명
Hospitals are not consistently patient centered, contributing to worse outcomes and a sense of loss of control.
Prior interventions that promote patient-centered care focused on provider and hospital factors vs. engaging patients directly.
No project to date has capitalized on digital health technology to engage families in shared decision-making and patient engagement.
The goal of the proposed randomized controlled trial is to test the impact of an evidence-based educational module delivered using an interactive patient-facing IT platform, on measures of patient engagement and shared decision-making.
The platform was developed for the UCSF Benioff Children's Hospital by OneView, Inc. and includes an educational module that promotes shared decision-making through orientation to the hospital and evidence-based teaching on engaging with providers.
This study will provide pilot data for a large-scale trial measuring the impact of the system on patient engagement.
The investigators will start by finalizing the educational module and adding randomization for the trial (Aim 1).
The investigators will then complete iterative user testing in the live system through measurement of educational module views and usability feedback interviews with 20 end users (Aim 2).
The investigators will then conduct a randomized controlled trial to test the impact of the educational module on existing measures of patient engagement (Aim 3).
Our hypothesis is that parents who receive the educational module will have higher scores on shared decision-making, patient activation and overall patient experience.
The eligible study population is all pediatric and newborn inpatients and their caregivers from June 2015 - August 2015.
The investigators anticipate needing a sample size of 100, 50 in each arm.
This pilot will generate key information on the platform's feasibility and acceptability and initial data on effect sizes to power future large-scale grants.
연구 유형
중재적
등록 (실제)
58
단계
- 해당 없음
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
95년 이하 (어린이, 성인, 고령자)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
Inclusion Criteria:
- An admitted patient (up to age 22) or caregiver (up to 95) of an admitted patient at Benioff Children's Hospital in the acute care units, the pediatric hematology-oncology units, or the transitional care units, admitted to the hospital within the past 72 hours.
Exclusion Criteria:
- Was already admitted and discharged during the study period.
- Not an English speaker.
- Not having a parent or legal guardian present or available by phone to give consent for those <18 years of age.
- Patient is in foster care.
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: 단일 그룹 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Treatment
Empower educational module: After the patient activation measure/s are collected, for parents or patients assigned to the intervention arm, they will be given an opportunity to launch the EMPOWER video and interactive powerpoint.
They will be able to pause on reviewing the educational material and come back to it, as with other assigned education, and they will be able to review it again if they would like.
Discharge surveys will be assigned 24 hours prior to the estimated discharge time in Apex.
Oneview will display notifications that the surveys have been assigned.
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Evidence-based video module delivering content of the Right Question intervention from Deen et al. (2011)
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간섭 없음: Control
Standard care: Those who opt to participate in the study will be randomly assigned to receive standard features of the media center (control group), or standard features plus the educational module intervention.
They will complete online (1) a baseline patient activation survey (for patients old enough to complete and for caregivers) at the start of their participation, and (2) an end-of-study survey pre-discharge or at the end of the study period.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Change in activation as measured with the Parent Patient Activation Measure (PPAM)
기간: Measured at enrollment, and at hospital discharge--duration of hospital stay is an average of 3 days. Calculated as change in PPAM scores.
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Measured at enrollment, and at hospital discharge--duration of hospital stay is an average of 3 days. Calculated as change in PPAM scores.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Quality of Shared Decision-Making measured using the CollaboRATE 3-item scale
기간: Measured at discharge, an average of 3 days after study enrollment
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Measured at discharge, an average of 3 days after study enrollment
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Quality of Shared Decision-Making measured using M-PICS scores
기간: Measured at discharge, an average of 3 days after study enrollment
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Measured at discharge, an average of 3 days after study enrollment
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Length of Stay obtained from the Epic electronic health record
기간: Measured at discharge, an average of 3 days after study enrollment
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Measured at discharge, an average of 3 days after study enrollment
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30-day readmission obtained from the Epic electronic health record
기간: Measured 30 days after discharge. Discharge occurs an average of 3 days after study enrollment
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This is a binary measure assessing whether the patient was readmitted to the hospital (Benioff Children' Hospital) within 30 days after discharge date.
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Measured 30 days after discharge. Discharge occurs an average of 3 days after study enrollment
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Study Recruitment Rate
기간: Baseline
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Number of patients with at least one person agreeing to participate (either a family member or a child) / Number of eligible patients who were assigned the study introduction materials in the hospital electronic educational center
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Baseline
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Study Retention
기간: Measured at discharge, an average of 3 days after study enrollment
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Number of participants who complete the survey capturing the second patient activation measure prior to hospital discharge / Number of participants who completed the first Patient Activation Measure
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Measured at discharge, an average of 3 days after study enrollment
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Engagement with the Educational Module
기간: Duration of the hospital stay, an average of 3 days
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Number of participants viewing the EMPOWER educational module (intervention) at least once / Number of patients assigned the module.
Data from the OneView system
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Duration of the hospital stay, an average of 3 days
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Repeated Engagement with the Education Module
기간: Duration of the hospital stay, an average of 3 days
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Number of views of the educational module for participants who viewed it at least once
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Duration of the hospital stay, an average of 3 days
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Naomi S. Bardach, MD, MAS, University of California, San Francisco
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
- Barr PJ, Thompson R, Walsh T, Grande SW, Ozanne EM, Elwyn G. The psychometric properties of CollaboRATE: a fast and frugal patient-reported measure of the shared decision-making process. J Med Internet Res. 2014 Jan 3;16(1):e2. doi: 10.2196/jmir.3085. Erratum In: J Med Internet Res. 2015;17(2):e32. J Med Internet Res. 2015;17(2):e32.
- Hibbard JH, Mahoney ER, Stockard J, Tusler M. Development and testing of a short form of the patient activation measure. Health Serv Res. 2005 Dec;40(6 Pt 1):1918-30. doi: 10.1111/j.1475-6773.2005.00438.x.
- Hibbard JH, Stockard J, Mahoney ER, Tusler M. Development of the Patient Activation Measure (PAM): conceptualizing and measuring activation in patients and consumers. Health Serv Res. 2004 Aug;39(4 Pt 1):1005-26. doi: 10.1111/j.1475-6773.2004.00269.x.
- Alegria M, Polo A, Gao S, Santana L, Rothstein D, Jimenez A, Hunter ML, Mendieta F, Oddo V, Normand SL. Evaluation of a patient activation and empowerment intervention in mental health care. Med Care. 2008 Mar;46(3):247-56. doi: 10.1097/MLR.0b013e318158af52.
- Pennarola BW, Rodday AM, Mayer DK, Ratichek SJ, Davies SM, Syrjala KL, Patel S, Bingen K, Kupst MJ, Schwartz L, Guinan EC, Hibbard JH, Parsons SK; HSCT-CHESS Study. Factors associated with parental activation in pediatric hematopoietic stem cell transplant. Med Care Res Rev. 2012 Apr;69(2):194-214. doi: 10.1177/1077558711431460. Epub 2011 Dec 26.
- Deen D, Lu WH, Rothstein D, Santana L, Gold MR. Asking questions: the effect of a brief intervention in community health centers on patient activation. Patient Educ Couns. 2011 Aug;84(2):257-60. doi: 10.1016/j.pec.2010.07.026. Epub 2010 Aug 25.
- Smith MY, Winkel G, Egert J, Diaz-Wionczek M, DuHamel KN. Patient-physician communication in the context of persistent pain: validation of a modified version of the patients' Perceived Involvement in Care Scale. J Pain Symptom Manage. 2006 Jul;32(1):71-81. doi: 10.1016/j.jpainsymman.2006.01.007.
- Alegria M, Sribney W, Perez D, Laderman M, Keefe K. The role of patient activation on patient-provider communication and quality of care for US and foreign born Latino patients. J Gen Intern Med. 2009 Nov;24 Suppl 3(Suppl 3):534-41. doi: 10.1007/s11606-009-1074-x.
- Bardach NS, Lam R, Jasik CB. Assessment of automated clinical trial recruitment and enrolment using patient-facing technology. BMJ Health Care Inform. 2021 Jan;28(1):e100076. doi: 10.1136/bmjhci-2019-100076.
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
2015년 8월 1일
기본 완료 (실제)
2016년 1월 1일
연구 완료 (실제)
2016년 3월 1일
연구 등록 날짜
최초 제출
2015년 6월 26일
QC 기준을 충족하는 최초 제출
2015년 7월 6일
처음 게시됨 (추정)
2015년 7월 7일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2016년 5월 16일
QC 기준을 충족하는 마지막 업데이트 제출
2016년 5월 12일
마지막으로 확인됨
2016년 5월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 15-16151
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
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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