Trial Outcomes & Findings for CONNECT for Better Falls Prevention in VA Community Living Centers (NCT NCT00836433)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

689 participants

Primary outcome timeframe

6 months

Results posted on

2015-04-24

Participant Flow

Participant milestones

Participant milestones
Measure	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	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
Overall Study STARTED	361	328
Overall Study COMPLETED	349	321
Overall Study NOT COMPLETED	12	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

CONNECT for Better Falls Prevention in VA Community Living Centers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FALLS Only n=361 Participants Traditional falls educational intervention FALLS educational intervention: Traditional falls quality improvement education program including online modules, audit and feedback, and academic detailing sessions	CONNECT + FALLS n=328 Participants 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	Total n=689 Participants Total of all reporting groups
Age, Continuous	45 years STANDARD_DEVIATION 6 • n=93 Participants	42 years STANDARD_DEVIATION 5 • n=4 Participants	44 years STANDARD_DEVIATION 5 • n=27 Participants
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	361 Participants n=93 Participants	328 Participants n=4 Participants	689 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Sex: Female, Male Female	307 Participants n=93 Participants	285 Participants n=4 Participants	592 Participants n=27 Participants
Sex: Female, Male Male	54 Participants n=93 Participants	43 Participants n=4 Participants	97 Participants n=27 Participants
Region of Enrollment United States	361 participants n=93 Participants	328 participants n=4 Participants	689 participants n=27 Participants

PRIMARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure	FALLS n=293 Participants Traditional falls educational intervention FALLS educational intervention: Traditional falls quality improvement education program including online modules, audit and feedback, and academic detailing sessions	CONNECT + FALLS n=358 Participants 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
Fall-related Process Measures	0.40 proportion of indicators completed Standard Deviation 0.16	0.32 proportion of indicators completed Standard Deviation 0.13

SECONDARY outcome

Timeframe: 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.

Change in the risk-adjusted facility fall rates in the 6 months post intervention(s) compared to the 6 months before the intervention(s).

Outcome measures

Outcome measures
Measure	FALLS n=4 facilities Traditional falls educational intervention FALLS educational intervention: Traditional falls quality improvement education program including online modules, audit and feedback, and academic detailing sessions	CONNECT + FALLS n=4 facilities 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
Change in Facility Fall Rates	0.03 change in falls per bed per year	-0.28 change in falls per bed per year

Adverse Events

FALLS Only

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

CONNECT + FALLS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Cathleen Colon-Emeric

Durham VA GRECC

Phone: 9192860411

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place