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

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ClinicalTrials.gov Identifier: NCT00636675
Recruitment Status : Completed
First Posted : March 14, 2008
Results First Posted : December 11, 2018
Last Update Posted : December 11, 2018
Sponsor:
Collaborators:
The Carolinas Center for Medical Excellence
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Duke University

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Accidental Falls Behavioral: Falls QI Behavioral: Connect Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1726 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Outcomes of Nursing Management Practice in Nursing Homes
Study Start Date : September 2009
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Falls Nursing Homes

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Fall Related Process Measures [ Time Frame: 6 months post intervention ]
    Mean of the total number of fall risk reduction indicators (steps staff have taken to reduce fall risk) that were documented in residents with high fall risk. These included orthostatic blood pressure measurement/intervention; sensory impairment evaluation/intervention; footwear; exercise/assistive device intervention; toileting schedule; environmental modification; psychoactive medication reduction; and vitamin D supplements. Note that this measure is NOT related to staff but rather residents in the nursing home, therefore the numbers are different from participant flow. The residents were not considered enrolled participants in the study.


Secondary Outcome Measures :
  1. Fall Rates [ Time Frame: 6 months post intervention ]
    Numerator: number of falls occurring in a 6 month period, denominator: number of bed days for resident. Rate adjusted for baseline rate and casemix. Note that this measure is NOT related to staff but rather residents in the nursing home. The residents were not considered enrolled participants in the study.

  2. Change in Weighted Average of Staff Interaction Scales [ Time Frame: baseline to post intervention, an average of 6 months ]
    This is a summary measure of 7 staff surveys using the weighted average on a 1-5 Likert scale with 5 indicating the highest (best) quality. Scales include Communication Openness, Accuracy, and Timeliness; Participation in Decision Making, Local Interaction Strategies, Safety Climate, and Staff Perceptions of Quality. Number presented is the change from baseline attributable to the intervention. Higher numbers represent a greater change attributable to the intervention.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00636675


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

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00636675     History of Changes
Other Study ID Numbers: Pro00018745
5R01NR003178 ( U.S. NIH Grant/Contract )
2R56NR003178-09 ( U.S. NIH Grant/Contract )
First Posted: March 14, 2008    Key Record Dates
Results First Posted: December 11, 2018
Last Update Posted: December 11, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Duke University:
Accidental falls