- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00836433
CONNECT for Better Falls Prevention in VA Community Living Centers (CONNECT)
연구 개요
상세 설명
Background:
The current standard to improve resident outcomes in VA nursing homes combines educational programs and quality improvement processes. These educational programs typically focus on individual staff members' behavior and mastery of content, and use such instructional techniques as didactic modules, audit and feedback of individual performance, and academic detailing by influential peers. However, social constructivism theory and complexity science suggests that learning is a social process that occurs within the context of the relationships and interactions of the individual in their environment. Thus, traditional QI educational programs will not result in optimal changes in staff behavior unless a context is present which allows social learning to occur.
Objectives:
Based on social constructivist theory, complexity science, and prior research we have developed an educational intervention (CONNECT) that teaches staff to improve connections within and between disciplines, improve information flow, and seek out cognitive diversity in problem-solving about resident issues. The objectives of this study are to: (a) determine whether CONNECT improves staff interaction measures, fall-related process measures, and fall rates when combined with standard training on fall risk factor reduction, and (b) use the insights gained about social constructivist learning in CLCs to develop other educational interventions that address multi-factorial geriatric syndromes and system issues such as patient safety in VA nursing homes.
Methods:
To achieve these objectives we are conducting a randomized, controlled, single-blind study in which nursing homes receive either CONNECT plus a falls QI educational intervention (FALLS) or FALLS alone. Four VA CLCs in VISN-6 will participate, with an estimated n=144 participating staff members, and n=340 unique individuals with falls. The CONNECT intervention will be delivered over 3 months, and includes interactive in-class learning sessions, unit-based mentoring, and relationship mapping, all focused on helping staff build networks and relationships for problem-solving. The FALLS intervention will be delivered over 3 months either alone or after the CONNECT intervention. It includes web-based modules, audit and feedback, and academic detailing, all focused on individual fall reduction behaviors. Measurement is performed prior to intervention (all measures), at the conclusion of intervention (staff interaction measures, work environment measures, and social constructivist learning focus groups), and 6 months after the intervention (fall-related process and outcome measures). Analysis will use mixed models to account for the complex nesting of patients and staff within facilities.
Status:
Funding will begin on August 1, 2009 with anticipated intervention start time of January, 2010.
연구 유형
등록 (실제)
단계
- 3단계
연락처 및 위치
연구 장소
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North Carolina
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Asheville, North Carolina, 미국, 28805
- VA Medical Center, Asheville
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Durham, North Carolina, 미국, 27705
- Durham VA Medical Center, Durham, NC
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Virginia
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Richmond, Virginia, 미국, 23249
- Hunter Holmes McGuire VA Medical Center
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Salem, Virginia, 미국, 24153
- VA Medical Center, Salem VA
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- All clinical and support staff in participating VA Community Living Centers
Exclusion Criteria:
- Inability to speak and understand English
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 |
---|---|
활성 비교기: FALLS only
Traditional falls educational intervention, including self-study modules, audit and feedback, falls team training, academic detailing, and toolkit.
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FALLS is a traditional falls quality improvement education program including online modules, audit and feedback, and academic detailing sessions
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실험적: CONNECT and FALLS
CONNECT educational intervention is designed to improve relationship-building and communication.
The intervention includes 2 in-class session, group mapping exercise, individual relationship mapping exercises, Self-monitoring of interactions, individual staff coaching sessions.
FALLS is a traditional falls educational intervention, including self-study modules, audit and feedback, falls team training, academic detailing, and toolkit.
|
FALLS is a traditional falls quality improvement education program including online modules, audit and feedback, and academic detailing sessions
The CONNECT educational intervention is a training program for staff to improve communication with a more dense network of co-workers, in order to improve resident problem-solving.
Includes in class sessions, group and individual mapping exercises, self-monitoring of interactions, and individual staff coaching.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Fall-related Process Measures
기간: 6 months
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The proportion of applicable fall quality indicators documented for residents with falls during the study period.
Quality indicators are specific fall risk assessment or prevention activities including orthostatic blood pressure assessment, vision assessment, environmental modification (bedroom, bathroom), footwear change, physical or occupational therapy referral, psychoactive medication reduction.
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6 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Change in Facility Fall Rates
기간: 6 months
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Change in the risk-adjusted facility fall rates in the 6 months post intervention(s) compared to the 6 months before the intervention(s).
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6 months
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공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: Cathleen S. Colon-Emeric, MD, Durham VA Medical Center, Durham, NC
간행물 및 유용한 링크
일반 간행물
- Anderson RA, Corazzini K, Porter K, Daily K, McDaniel RR Jr, Colon-Emeric C. CONNECT for quality: protocol of a cluster randomized controlled trial to improve fall prevention in nursing homes. Implement Sci. 2012 Feb 29;7:11. doi: 10.1186/1748-5908-7-11.
- Colon-Emeric CS, Lyles KW, Su G, Pieper CF, Magaziner JS, Adachi JD, Bucci-Rechtweg CM, Haentjens P, Boonen S; HORIZON Recurrent Fracture Trial. Clinical risk factors for recurrent fracture after hip fracture: a prospective study. Calcif Tissue Int. 2011 May;88(5):425-31. doi: 10.1007/s00223-011-9474-4. Epub 2011 Feb 18.
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
기타 연구 ID 번호
- EDU 08-417
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. .
우연한 폭포에 대한 임상 시험
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LMU Klinikum모병중증 근무력증 | 근긴장성 이영양증 | 봉입체 근염 | 안면견갑상완 근이영양증 | Falls Efficacy Scale International | 모스 가을 규모독일
FALLS educational intervention에 대한 임상 시험
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Portland VA Medical CenterOregon Health and Science University완전한
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VA Office of Research and Development모집하지 않고 적극적으로
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Washington University School of MedicineSt. Jude Children's Research Hospital완전한
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Kanuni Sultan Suleyman Training and Research Hospital완전한
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University of MichiganNational Institute on Drug Abuse (NIDA)모병
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The University of Hong KongResearch Grants Council, Hong Kong모집하지 않고 적극적으로