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Outcomes of Nursing Management Practice in Nursing Homes (NMP)
This study is not yet open for participant recruitment.
Verified by Duke University, March 2008
First Received: March 9, 2008   No Changes Posted
Sponsors and Collaborators: Duke University
The Carolinas Center for Medical Excellence
Information provided by: Duke University
ClinicalTrials.gov Identifier: NCT00636675
  Purpose

Previous work shows that low connection, information flow, and cognitive diversity among nursing home (NH) staff explains poor quality of care delivered for complex problems such as falls. Our pilot work shows that our "CONNECT" intervention fosters staff in learning to improve the density and quality of their interactions. CONNECT is a multi-component intervention based on our previous case study research that encourages staff to engage in network-building and use simple strategies to enhance information flow, connection among staff, and cognitive diversity. We hypothesize that high 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+FALLS or FALLS alone. We estimate that 560 residents and 576 staff members will participate. Specific aims are (1) Aim 1: 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 outcome measures in NH residents; (2) Aim 2: Compare the impact of CONNECT+FALLS to FALLS alone on fall-related process measures in NH residents, and determine whether these mediate the impact on fall-related outcome measures. (3) Aim 3: 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.

Measurements of staff interaction and residents' fall-related outcomes are taken at baseline, post intervention, 3 and 6 months. Fall rates and proportion of recurrent fallers is the primary study outcome. Exploratory measures include fall-related process 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.

To promote the health of the frail NH population, interventions must be useable in actual practice. CONNECT the potential to improve care in NHs for many complex medical and psycho-social problems among frail older adults.


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

MedlinePlus related topics: Nursing Homes
U.S. FDA Resources
Study Type: Interventional
Study Design: Health Services Research, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title: Outcomes of Nursing Management Practice in Nursing Homes

Further study details as provided by Duke University:

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

Secondary Outcome Measures:
  • Fall-related process measures [ 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: December 2008
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
FALL intervention alone
Behavioral: FALLS
Quality improvement training about falls to be implement by indigenous nursing home staff with support of study personnel.
2: Experimental
CONNECT is delivered followed by FALLS
Behavioral: CONNECT and FALLS
Behavioral intervention to improve staff interaction for better care planning and execution. CONNECT will be delivered, followed by the FALL quality improvement intervention

  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
Durham, North Carolina, United States, 27710
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

No publications provided

Responsible Party: Duke University School of Nursing ( Ruth A. Anderson )
Study ID Numbers: 5R01NR003178, 5R01NR003178
Study First Received: March 9, 2008
Last Updated: March 9, 2008
ClinicalTrials.gov Identifier: NCT00636675     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Accidental falls

ClinicalTrials.gov processed this record on May 07, 2009