CONNECT for Quality: A Study to Reduce Falls in Nursing Homes

NCT00636675 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1726

Last updated 2018-12-11

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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.

Conditions

  • Accidental Falls

Interventions

BEHAVIORAL

Falls QI

Falls uses the Falls Management Program (AHRQ); it is familiar to nursing homes, uses minimal researcher time, is adaptable, and simulates real word quality improvement practices. Falls is delivered over 3 months. Components include: 1. In-House Falls Coordinator training on content and falls processes. 2. Case-based modules about fall prevention and tailored for various team members. 3. Academic Detailing in which researcher consults with staff regarding challenging residents with falls. 4. Audit and Feedback. Discussions about comparison of nursing home's current practice on fall-related process and outcome measures, and how it compares with the median and the 90th percentile of peer NHs. 5. Toolbox: Handbook of useful measures and worksheets.

BEHAVIORAL

Connect

Connect, delivered over 12 weeks, helps nursing home staff learn interactions that increase exchange of new information, number and quality of connections among staff, and improve problem-solving about patient care. Protocols: 1. In-class learning sessions introduce interaction strategies. 2. Relationship map protocols assist staff to examine existing interaction patterns and agree on goals for improvement. Individuals develop their own relationship maps and use them to practice new horizontal and vertical connections and self-monitoring their own interactions. 3. Researcher facilitates authentic learning which occurs when learners directly and independently apply concepts. In-house staff volunteers and are facilitated to assume a mentoring role.

Sponsors & Collaborators

  • The Carolinas Center for Medical Excellence

    collaborator OTHER
  • National Institute of Nursing Research (NINR)

    collaborator NIH
  • Duke University

    lead OTHER

Principal Investigators

  • Ruth A Anderson, RN, PhD · Duke University School of Nursing

  • Cathleen S Colon-Emeric, MD, MHSc · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2016-01-31
Completion
2016-01-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00636675 on ClinicalTrials.gov