N/A
N=1,726
CONNECT for Quality: A Study to Reduce Falls in Nursing Homes
Accidental Falls
Bottom Line
View on ClinicalTrials.gov: NCT00636675 ↗Enrolled (actual)
1,726
Serious AEs
0.0%
Results posted
Dec 2018
Primary outcome: Primary: Fall Related Process Measures — 3.3; 3.2 number of fall risk reduction indicators
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Falls QI (Behavioral); Connect (Behavioral)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Jan 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fall Related Process Measures |
3.3; 3.2 | — |
| SECONDARY Fall Rates |
4.06; 4.06 | — |
| SECONDARY Change in Weighted Average of Staff Interaction Scales |
NA; .03 | — |
Summary
Clinical trials have identified interventions that reduce adverse outcomes such as falls in nursing home (NH) residents but attempts to translate these into practice quality improvement (QI) techniques have not been successful. Using a complexity science framework, our previous study showed that low connection, information flow, and cognitive diversity among NH staff explains quality of care for complex problems such as falls. Our pilot of "Connect," a multi-component intervention that encourages staff to engage in network-building and use simple strategies to make new connections with others, enhance information flow, and use cognitive diversity, suggests that staff can improve the density and quality of their interactions. This 5-year study uses a prospective, cluster-randomized, outcome assessment blinded design, with NHs (n=16) randomized to either Connect and a falls QI program (Connect + Falls) or QI alone (Falls). About 800 residents and 576 staff will participate. Specific aims are to, in nursing homes: 1) Compare the impact of the Connect intervention plus a falls reduction QI intervention (Connect+Falls) to a falls reduction QI intervention (Falls) on fall risk reduction indicators (orthostatic blood pressure, sensory impairment, footwear appropriateness, gait; assistive device; toileting needs, environment, and psychotropic medication); 2) Compare the impact of Connect+Falls to Falls alone on fall rates and injurious falls, and determine whether these are mediated by the change in fall risk reduction indicators; 3) Compare the impact of Connect+Falls to Falls alone on complexity science measures (communication, participation in decision making, local interactions, safety climate, staff perceptions of quality) and determine whether these mediate the impact on fall risk reduction indicators and fall rates and injurious falls. Cross-sectional observations of complexity science measures are taken at baseline, at 3 months, at 6 months, and at 9 months. Resident fall risk reduction indicators, fall rates, and injurious falls are measured for the 6 months prior to the first intervention and the 6 months after the final intervention is completed. Analysis will use a 3-level mixed model to account for the complex nesting of patients and staff within nursing homes, and to control for covariates associated with fall risk, including baseline facility fall rates and staff turnover rates.
Eligibility Criteria
Inclusion Criteria
- Eligible residents will be long-term care residents at least 65 years of age who have resided in the NH at least 6 months and are likely to survive at least 6 months. Residents must be potentially at risk for falls, which we define as ambulatory or transfer-independent as recorded on the Minimum Data Set.
Exclusion Criteria
- None.
Data sourced from ClinicalTrials.gov (NCT00636675). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.