Outcomes of Nursing Management Practice in Nursing Homes (NMP)
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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 |
- Fall related process measures [ Time Frame: baseline; 3 and 6 months post intervention ] [ Designated as safety issue: Yes ]
- 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:
|
|
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:
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| Contact: Ruth A Anderson, RN, PhD | 919-668-4599 | ruth.anderson@duke.edu |
| 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 | |
| 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