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CONNECT for Better Falls Prevention in VA Community Living Centers

CONNECT for Better Falls Prevention in VA Community Living Centers

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00836433
Acronym
CONNECT
Enrollment
689
Registered
2009-02-04
Start date
2010-02-28
Completion date
2012-08-31
Last updated
2015-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Accidental Falls

Keywords

staff education, complexity science, social constructivist theory

Brief 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.

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.

Interventions

BEHAVIORALCONNECT 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.

BEHAVIORALFALLS educational intervention

FALLS is a traditional falls quality improvement education program including online modules, audit and feedback, and academic detailing sessions

Sponsors

Duke University
CollaboratorOTHER
US Department of Veterans Affairs
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Inability to speak and understand English

Design outcomes

Primary

MeasureTime frameDescription
Fall-related Process Measures6 monthsThe 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

MeasureTime frameDescription
Change in Facility Fall Rates6 monthsChange in the risk-adjusted facility fall rates in the 6 months post intervention(s) compared to the 6 months before the intervention(s).

Countries

United States

Participant flow

Participants by arm

ArmCount
FALLS Only
Traditional falls educational intervention FALLS educational intervention: Traditional falls quality improvement education program including online modules, audit and feedback, and academic detailing sessions
361
CONNECT + FALLS
CONNECT intervention on relationship-building and communication CONNECT educational intervention: Training program for staff to improve communication with a more dense network of co-workers, in order to improve resident problem-solving FALLS educational intervention: Traditional falls quality improvement education program including online modules, audit and feedback, and academic detailing sessions
328
Total689

Baseline characteristics

CharacteristicFALLS OnlyCONNECT + FALLSTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
361 Participants328 Participants689 Participants
Age, Continuous45 years
STANDARD_DEVIATION 6
42 years
STANDARD_DEVIATION 5
44 years
STANDARD_DEVIATION 5
Region of Enrollment
United States
361 participants328 participants689 participants
Sex: Female, Male
Female
307 Participants285 Participants592 Participants
Sex: Female, Male
Male
54 Participants43 Participants97 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 3610 / 328
serious
Total, serious adverse events
0 / 3610 / 328

Outcome results

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.

Time frame: 6 months

Population: Note that the number of participants analyzed is not the same as the number of participants in the flow module. This is because this outcome measure is based not on the consented staff participants in the intervention, but resident charts abstracted in the pre and post intervention periods (waiver of consent obtained).

ArmMeasureValue (MEAN)Dispersion
FALLSFall-related Process Measures0.40 proportion of indicators completedStandard Deviation 0.16
CONNECT + FALLSFall-related Process Measures0.32 proportion of indicators completedStandard Deviation 0.13
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).

Time frame: 6 months

Population: This is a facility level analysis of the fall rates in the 4 facilities randomized to FALLS alone compared to the 4 receiving CONNECT + FALLS. Within these groups, medical records from 293 and 358 residents with falls were abstracted to calculate the fall rates, therefore the number of participants analyzed is not the same as the flow module.

ArmMeasureValue (NUMBER)
FALLSChange in Facility Fall Rates0.03 change in falls per bed per year
CONNECT + FALLSChange in Facility Fall Rates-0.28 change in falls per bed per year

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026