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Sponsors and Collaborators: |
Duke University The Carolinas Center for Medical Excellence |
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Information provided by: | Duke University |
ClinicalTrials.gov Identifier: | NCT00636675 |
Previous work shows that low connection, information flow, and cognitive diversity among nursing home (NH) staff explains poor quality of care delivered for complex problems such as falls. Our pilot work shows that our "CONNECT" intervention fosters staff in learning to improve the density and quality of their interactions. CONNECT is a multi-component intervention based on our previous case study research that encourages staff to engage in network-building and use simple strategies to enhance information flow, connection among staff, and cognitive diversity. We hypothesize that high levels of connection, information flow and cognitive diversity are necessary before any QI intervention for a complex geriatric problem, such as falls, can be successful.
This 5-year study will use a prospective, cluster-randomized, outcome assessment blinded design, with NHs (n=16) randomized to either CONNECT+FALLS or FALLS alone. We estimate that 560 residents and 576 staff members will participate. Specific aims are (1) Aim 1: Compare the impact of the CONNECT intervention plus a falls reduction QI intervention (CONNECT+FALLS) to the falls reduction QI intervention alone (FALLS), on fall-related outcome measures in NH residents; (2) Aim 2: Compare the impact of CONNECT+FALLS to FALLS alone on fall-related process measures in NH residents, and determine whether these mediate the impact on fall-related outcome measures. (3) Aim 3: Compare the impact of CONNECT+FALLS to FALLS alone on staff interaction measures, as reported by NH staff, and determine whether these mediate the impact on fall-related process measures and fall-related outcome measures.
Measurements of staff interaction and residents' fall-related outcomes are taken at baseline, post intervention, 3 and 6 months. Fall rates and proportion of recurrent fallers is the primary study outcome. Exploratory measures include fall-related process measures and staff interaction measures (communication; participation, group-to-group interaction, psychological safety, and safety culture). Analysis will use a 3-level mixed model to account for the complex nesting of patients and staff within homes, and control for covariates associated with fall risk, including baseline facility fall rates.
To promote the health of the frail NH population, interventions must be useable in actual practice. CONNECT the potential to improve care in NHs for many complex medical and psycho-social problems among frail older adults.
Condition | Intervention |
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Accidental Falls |
Behavioral: FALLS Behavioral: CONNECT and FALLS |
Study Type: | Interventional |
Study Design: | Health Services Research, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | Outcomes of Nursing Management Practice in Nursing Homes |
Estimated Enrollment: | 1136 |
Study Start Date: | December 2008 |
Estimated Study Completion Date: | December 2013 |
Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
FALL intervention alone
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Behavioral: FALLS
Quality improvement training about falls to be implement by indigenous nursing home staff with support of study personnel.
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2: Experimental
CONNECT is delivered followed by FALLS
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Behavioral: CONNECT and FALLS
Behavioral intervention to improve staff interaction for better care planning and execution. CONNECT will be delivered, followed by the FALL quality improvement intervention
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Ages Eligible for Study: | 65 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Ruth A Anderson, RN, PhD | 919-668-4599 | ruth.anderson@duke.edu |
United States, North Carolina | |
Duke University School of Nursing | |
Durham, North Carolina, United States, 27710 |
Principal Investigator: | Ruth A Anderson, RN, PhD | Duke University School of Nursing |
Principal Investigator: | Cathleen S Colon-Emeric, MD, MHSc | Duke University School of Medicine |
Responsible Party: | Duke University School of Nursing ( Ruth A. Anderson ) |
Study ID Numbers: | 5R01NR003178, 5R01NR003178 |
Study First Received: | March 9, 2008 |
Last Updated: | March 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00636675 History of Changes |
Health Authority: | United States: Institutional Review Board |
Accidental falls |