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CONNECT for Better Falls Prevention in VA Community Living Centers (CONNECT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00836433
Recruitment Status : Completed
First Posted : February 4, 2009
Results First Posted : October 30, 2014
Last Update Posted : April 24, 2015
Sponsor:
Collaborator:
Duke University
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Health Services Research
Condition Accidental Falls
Interventions Behavioral: CONNECT educational intervention
Behavioral: FALLS educational intervention
Enrollment 689
Recruitment Details  
Pre-assignment Details  
Arm/Group Title FALLS Only CONNECT + FALLS
Hide Arm/Group Description

Traditional falls educational intervention

FALLS educational intervention: Traditional falls quality improvement education program including online modules, audit and feedback, and academic detailing sessions

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

Period Title: Overall Study
Started 361 328
Completed 349 321
Not Completed 12 7
Arm/Group Title FALLS Only CONNECT + FALLS Total
Hide Arm/Group Description

Traditional falls educational intervention

FALLS educational intervention: Traditional falls quality improvement education program including online modules, audit and feedback, and academic detailing sessions

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 of all reporting groups
Overall Number of Baseline Participants 361 328 689
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 361 participants 328 participants 689 participants
45  (6) 42  (5) 44  (5)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 361 participants 328 participants 689 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
361
 100.0%
328
 100.0%
689
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 361 participants 328 participants 689 participants
Female
307
  85.0%
285
  86.9%
592
  85.9%
Male
54
  15.0%
43
  13.1%
97
  14.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 361 participants 328 participants 689 participants
361 328 689
1.Primary Outcome
Title Fall-related Process Measures
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title FALLS CONNECT + FALLS
Hide Arm/Group Description:

Traditional falls educational intervention

FALLS educational intervention: Traditional falls quality improvement education program including online modules, audit and feedback, and academic detailing sessions

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 Number of Participants Analyzed 293 358
Mean (Standard Deviation)
Unit of Measure: proportion of indicators completed
0.40  (0.16) 0.32  (0.13)
2.Secondary Outcome
Title Change in Facility Fall Rates
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title FALLS Only CONNECT and FALLS
Hide Arm/Group Description:

Traditional falls educational intervention, including self-study modules, audit and feedback, falls team training, academic detailing, and toolkit.

FALLS educational intervention: Traditional falls quality improvement education program including online modules, audit and feedback, and academic detailing sessions

CONNECT intervention on relationship-building and communication. Includes 2 in-class session, group mapping, individual relationship mapping, coaching sessions.

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 Number of Participants Analyzed 293 358
Overall Number of Units Analyzed
Type of Units Analyzed: Facilities
4 4
Measure Type: Number
Unit of Measure: change in falls per bed per year
0.03 -0.28
Time Frame 6 months
Adverse Event Reporting Description During intervention delivery only
 
Arm/Group Title FALLS Only CONNECT + FALLS
Hide Arm/Group Description

Traditional falls educational intervention

FALLS educational intervention: Traditional falls quality improvement education program including online modules, audit and feedback, and academic detailing sessions

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

All-Cause Mortality
FALLS Only CONNECT + FALLS
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
FALLS Only CONNECT + FALLS
Affected / at Risk (%) Affected / at Risk (%)
Total   0/361 (0.00%)   0/328 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
FALLS Only CONNECT + FALLS
Affected / at Risk (%) Affected / at Risk (%)
Total   0/361 (0.00%)   0/328 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Cathleen Colon-Emeric
Organization: Durham VA GRECC
Phone: 9192860411 ext 6777
EMail: cathleen.colonemeric@va.gov
Layout table for additonal information
Responsible Party: VA Office of Research and Development ( US Department of Veterans Affairs )
ClinicalTrials.gov Identifier: NCT00836433    
Other Study ID Numbers: EDU 08-417
First Submitted: February 2, 2009
First Posted: February 4, 2009
Results First Submitted: October 9, 2014
Results First Posted: October 30, 2014
Last Update Posted: April 24, 2015