A Phase 3 interventional study of CONNECT educational intervention and FALLS educational intervention in Accidental Falls, sponsored by US Department of Veterans Affairs. Completed at 4 sites in United States. Per ClinicalTrials.gov, last updated 2015-04-24.
Sponsored by US Department of Veterans Affairs · Phase 3, Interventional, and Health services research
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.
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.
US Department of Veterans Affairs is the lead sponsor of 675 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Traditional falls educational intervention, including self-study modules, audit and feedback, falls team training, academic detailing, and toolkit.
Behavioral: FALLS educational intervention
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 · Behavioral: FALLS 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 is a traditional falls quality improvement education program including online modules, audit and feedback, and academic detailing sessions
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.
Time frame: 6 months
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).
Time frame: 6 months
| Milestone | FALLS Only | CONNECT + FALLS |
|---|---|---|
| Started | 361 | 328 |
| Completed | 349 | 321 |
| Not completed | 12 | 7 |
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.
| proportion of indicators completed | FALLS | CONNECT + FALLS |
|---|---|---|
| Fall-related Process Measures | 0.40 ± 0.16 | 0.32 ± 0.13 |
Change in the risk-adjusted facility fall rates in the 6 months post intervention(s) compared to the 6 months before the intervention(s).
| change in falls per bed per year | FALLS Only | CONNECT and FALLS |
|---|---|---|
| Change in Facility Fall Rates | 0.03 | -0.28 |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| FALLS Only | — | 0/361 (0%) | 0/361 (0%) |
| CONNECT + FALLS | — | 0/328 (0%) | 0/328 (0%) |
| Age, Continuous(years) | FALLS Only | CONNECT + FALLS | Total |
|---|---|---|---|
| Mean | 45 ± 6 | 42 ± 5 | 44 ± 5 |
| Age, Categorical(Participants) | FALLS Only | CONNECT + FALLS | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 361 | 328 | 689 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | FALLS Only | CONNECT + FALLS | Total |
|---|---|---|---|
| Female | 307 | 285 | 592 |
| Male | 54 | 43 | 97 |
| Region of Enrollment(participants) | FALLS Only | CONNECT + FALLS | Total |
|---|---|---|---|
| United States | 361 | 328 | 689 |
This study is completed, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.
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