Outcomes of Nursing Management Practice in Nursing Homes (NMP)

This study is currently recruiting participants.
Verified February 2012 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: November 9, 2012
Last verified: February 2012
  Purpose

Although clinical trials have identified interventions that reduce adverse outcomes such as falls in nursing home (NH) residents, attempts to translate those interventions into practice using current standard of care quality improvement (QI) techniques have not been successful. Using a complexity science framework, our previous RO1 has shown that low connection, information flow, and cognitive diversity among NH staff explains much of the poor quality of care delivered for complex problems such as falls. Our pilot work 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 learn to improve the density and quality of their interactions. We hypothesize that higher 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 and a standard falls QI program (CONNECT + FALLS) or FALLS alone. We estimate that 560 residents and 576 staff members will participate. Specific aims are (1) Aim 1 (primary): 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 process measures in nursing home residents; (2) Aim 2 (exploratory): Compare the impact of CONNECT+FALLS to FALLS alone on fall-related outcome measures in nursing home residents, and determine whether these are mediated by the change in fall-related process measures; (3) Aim 3 (exploratory): 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. Cross-sectional, repeated measures of staff interaction are taken prior to first intervention, at 3 months and at 6 months. Longitudinal resident fall-related process and outcomes are measured for the 6 months prior to the FALLS intervention, and the 6 months after the FALLS intervention is completed. Fall-related process measures are the primary outcome. Exploratory outcome measures include fall-related outcome 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 and staff turnover rates.


Condition Intervention
Accidental Falls
Behavioral: FALLS
Behavioral: CONNECT and FALLS

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: 1
Quality improvement training about falls to be implement by indigenous nursing home staff with support of study personnel.
Behavioral: FALLS

The FALLS intervention is based on the Falls Management Program developed by the AHRQ and Emory University. It is familiar to nursing homes, uses minimal researcher time, is adaptable, and simulates real word quality improvement practices. The FALLS intervention is delivered over 3 months. Components include:

  1. In-House Falls Coordinator who is trained on alls aspects of content and falls processes.
  2. Case based modules (online and paper versions) covering fall prevention and tailored for various team members' roles.
  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: 2
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 FALL quality improvement intervention.
Behavioral: CONNECT and FALLS

CONNECT, delivered over 12 weeks, helps nursing home staff learn ways to facilitate 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 using storytelling and role playing.
  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. Self-monitoring reinforces and sustains newly acquired behaviors and provides an indicator of behavioral change.
  3. Mentoring is provided by the researcher to facilitate authentic learning which occurs when learners directly and independently apply concepts. In-house staff volunteers and are facilitated to assume a mentoring role.

  Show Detailed Description

  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
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:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00636675     History of Changes
Other Study ID Numbers: Pro00018745 /2R56NR003178 - 09, 5R01NR003178
Study First Received: March 9, 2008
Last Updated: November 9, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Accidental falls

ClinicalTrials.gov processed this record on May 16, 2013