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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Duke University
Sponsor:
Collaborator:
The Carolinas Center for Medical Excellence
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00636675
First received: March 9, 2008
Last updated: July 14, 2014
Last verified: January 2014
  Purpose

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 RO1 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.


Condition Intervention
Accidental Falls
Behavioral: Falls QI
Behavioral: Connect

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Outcomes of Nursing Management Practice in Nursing Homes

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Fall related process measures [ Time Frame: baseline; 3 and 6 months post intervention ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Fall rates [ Time Frame: baseline; 3 and 6 months post intervention ] [ Designated as safety issue: Yes ]
  • Staff interaction measures [ Time Frame: baseline; 3 and 6 months post intervention ] [ Designated as safety issue: No ]
  • Probability of Recurrent Falls [ Time Frame: baseline; 3 and 6 months post intervention ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1136
Study Start Date: September 2009
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fall QI
Falls QI includes quality improvement training about falls to be implement by indigenous nursing home staff with support of study personnel.
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.
Experimental: Connect & Falls QI
Connect is delivered, followed by Falls. Behavioral intervention to improve staff interaction for better care planning and execution. Connect will be delivered, followed by the Falls quality improvement intervention.
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.

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  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00636675

Contacts
Contact: Ruth A Anderson, RN, PhD 919-668-4599 ruth.anderson@duke.edu

Locations
United States, North Carolina
Duke University School of Nursing Recruiting
Durham, North Carolina, United States, 27710
Principal Investigator: Ruth A Anderson, RN, PhD         
Principal Investigator: Cathleen S Colon-Emeric, MD, MHSc         
Sponsors and Collaborators
Duke University
The Carolinas Center for Medical Excellence
Investigators
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
  More Information

Publications:

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00636675     History of Changes
Other Study ID Numbers: Pro00018745, 5R01NR003178, 2R56NR003178 - 09
Study First Received: March 9, 2008
Last Updated: July 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Accidental falls

ClinicalTrials.gov processed this record on October 02, 2014