CONNECT for Better Falls Prevention in VA Community Living Centers

This study has been completed.
Sponsor:
Collaborator:
Duke University
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00836433
First received: February 2, 2009
Last updated: October 23, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Accidental Falls
Behavioral: CONNECT educational intervention
Behavioral: FALLS educational intervention
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: CONNECT for Better Falls Prevention in VA Community Living Centers

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Fall-related Process Measures [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Change in Facility Fall Rates [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Change in the risk-adjusted facility fall rates in the 6 months post intervention(s) compared to the 6 months before the intervention(s).


Enrollment: 689
Study Start Date: February 2010
Study Completion Date: August 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: FALLS only
Traditional falls educational intervention, including self-study modules, audit and feedback, falls team training, academic detailing, and toolkit.
Behavioral: FALLS educational intervention
FALLS is a traditional falls quality improvement education program including online modules, audit and feedback, and academic detailing sessions
Experimental: CONNECT and FALLS
CONNECT educational intervention is designed to improve relationship-building and communication. The intervention includes 2 in-class session, group mapping exercise, individual relationship mapping exercises, Self-monitoring of interactions, individual staff coaching sessions. FALLS is a traditional falls educational intervention, including self-study modules, audit and feedback, falls team training, academic detailing, and toolkit.
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.
Behavioral: FALLS educational intervention
FALLS is a traditional falls quality improvement education program including online modules, audit and feedback, and academic detailing sessions

Detailed 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Inability to speak and understand English
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00836433

Locations
United States, North Carolina
VA Medical Center, Asheville
Asheville, North Carolina, United States, 28805
VA Medical Center, Durham
Durham, North Carolina, United States, 27705
United States, Virginia
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, United States, 23249
VA Medical Center, Salem VA
Salem, Virginia, United States, 24153
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Cathleen S. Colon-Emeric, MD VA Medical Center, Durham
  More Information

Additional Information:
Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00836433     History of Changes
Other Study ID Numbers: EDU 08-417
Study First Received: February 2, 2009
Results First Received: October 9, 2014
Last Updated: October 23, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
staff education
complexity science
social constructivist theory

ClinicalTrials.gov processed this record on October 29, 2014