CONNECT for Better Falls Prevention in VA Community Living Centers

Accidental Falls Clinical Trial

— CONNECT  

Official title:

CONNECT for Better Falls Prevention in VA Community Living Centers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00836433
• Other study ID #: EDU 08-417
• Status: Completed
• Phase: Phase 3
• First received: February 2, 2009
• Last updated: April 6, 2015
• Start date: February 2010
• Est. completion date: August 2012

Study information

• Verified date: October 2014
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

This is a randomized trial of 2 nursing home staff educational approaches to reduce falls in VA nursing home (CLC) residents. One is a traditional falls education program using web-based modules, feedback of quality indicators, and meetings with influential peers. The other is a 12 week program that trains staff to form better connections and use effective communication strategies with a diverse network of co-workers, so that problem solving about resident problems is enhanced. The study will test whether the second intervention increases the effectiveness of the traditional falls education program.

Description:

Background:

The current standard to improve resident outcomes in VA nursing homes combines educational programs and quality improvement processes. These educational programs typically focus on individual staff members' behavior and mastery of content, and use such instructional techniques as didactic modules, audit and feedback of individual performance, and academic detailing by influential peers. However, social constructivism theory and complexity science suggests that learning is a social process that occurs within the context of the relationships and interactions of the individual in their environment. Thus, traditional QI educational programs will not result in optimal changes in staff behavior unless a context is present which allows social learning to occur.

Objectives:

Based on social constructivist theory, complexity science, and prior research we have developed an educational intervention (CONNECT) that teaches staff to improve connections within and between disciplines, improve information flow, and seek out cognitive diversity in problem-solving about resident issues. The objectives of this study are to: (a) determine whether CONNECT improves staff interaction measures, fall-related process measures, and fall rates when combined with standard training on fall risk factor reduction, and (b) use the insights gained about social constructivist learning in CLCs to develop other educational interventions that address multi-factorial geriatric syndromes and system issues such as patient safety in VA nursing homes.

Methods:

To achieve these objectives we are conducting a randomized, controlled, single-blind study in which nursing homes receive either CONNECT plus a falls QI educational intervention (FALLS) or FALLS alone. Four VA CLCs in VISN-6 will participate, with an estimated n=144 participating staff members, and n=340 unique individuals with falls. The CONNECT intervention will be delivered over 3 months, and includes interactive in-class learning sessions, unit-based mentoring, and relationship mapping, all focused on helping staff build networks and relationships for problem-solving. The FALLS intervention will be delivered over 3 months either alone or after the CONNECT intervention. It includes web-based modules, audit and feedback, and academic detailing, all focused on individual fall reduction behaviors. Measurement is performed prior to intervention (all measures), at the conclusion of intervention (staff interaction measures, work environment measures, and social constructivist learning focus groups), and 6 months after the intervention (fall-related process and outcome measures). Analysis will use mixed models to account for the complex nesting of patients and staff within facilities.

Status:

Funding will begin on August 1, 2009 with anticipated intervention start time of January, 2010.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 689
• Est. completion date: August 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All clinical and support staff in participating VA Community Living Centers

Exclusion Criteria:

• Inability to speak and understand English

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Accidental Falls

Intervention

Behavioral:
• CONNECT educational intervention
The CONNECT educational intervention is a training program for staff to improve communication with a more dense network of co-workers, in order to improve resident problem-solving. Includes in class sessions, group and individual mapping exercises, self-monitoring of interactions, and individual staff coaching.
• FALLS educational intervention
FALLS is a traditional falls quality improvement education program including online modules, audit and feedback, and academic detailing sessions

Locations

Country	Name	City	State
United States	VA Medical Center, Asheville	Asheville	North Carolina
United States	Durham VA Medical Center, Durham, NC	Durham	North Carolina
United States	Hunter Holmes McGuire VA Medical Center	Richmond	Virginia
United States	VA Medical Center, Salem VA	Salem	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	Duke University

Country where clinical trial is conducted

United States, 

References & Publications (2)

Anderson RA, Corazzini K, Porter K, Daily K, McDaniel RR Jr, Colón-Emeric C. CONNECT for quality: protocol of a cluster randomized controlled trial to improve fall prevention in nursing homes. Implement Sci. 2012 Feb 29;7:11. doi: 10.1186/1748-5908-7-11. — View Citation

Colón-Emeric CS, Lyles KW, Su G, Pieper CF, Magaziner JS, Adachi JD, Bucci-Rechtweg CM, Haentjens P, Boonen S; HORIZON Recurrent Fracture Trial. Clinical risk factors for recurrent fracture after hip fracture: a prospective study. Calcif Tissue Int. 2011 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fall-related Process Measures	The proportion of applicable fall quality indicators documented for residents with falls during the study period. Quality indicators are specific fall risk assessment or prevention activities including orthostatic blood pressure assessment, vision assessment, environmental modification (bedroom, bathroom), footwear change, physical or occupational therapy referral, psychoactive medication reduction.	6 months	No
Secondary	Change in Facility Fall Rates	Change in the risk-adjusted facility fall rates in the 6 months post intervention(s) compared to the 6 months before the intervention(s).	6 months	Yes

External Links

•   Pubmed reference link
•   Pubmed reference link