- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00836433
CONNECT for Better Falls Prevention in VA Community Living Centers (CONNECT)
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 3
Contatti e Sedi
Luoghi di studio
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North Carolina
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Asheville, North Carolina, Stati Uniti, 28805
- VA Medical Center, Asheville
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Durham, North Carolina, Stati Uniti, 27705
- Durham VA Medical Center, Durham, NC
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Virginia
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Richmond, Virginia, Stati Uniti, 23249
- Hunter Holmes McGuire VA Medical Center
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Salem, Virginia, Stati Uniti, 24153
- VA Medical Center, Salem VA
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- All clinical and support staff in participating VA Community Living Centers
Exclusion Criteria:
- Inability to speak and understand English
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Ricerca sui servizi sanitari
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Comparatore attivo: 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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Sperimentale: 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.
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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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Fall-related Process Measures
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in Facility Fall Rates
Lasso di tempo: 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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Collaboratori e investigatori
Collaboratori
Investigatori
- Investigatore principale: Cathleen S. Colon-Emeric, MD, Durham VA Medical Center, Durham, NC
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
Collegamenti utili
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Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- EDU 08-417
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .