NCT00836433

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
689

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Feb 2010

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 4, 2009

Completed
12 months until next milestone

Study Start

First participant enrolled

February 1, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

October 30, 2014

Completed
Last Updated

April 24, 2015

Status Verified

October 1, 2014

Enrollment Period

1.7 years

First QC Date

February 2, 2009

Results QC Date

October 9, 2014

Last Update Submit

April 6, 2015

Conditions

Keywords

staff educationcomplexity sciencesocial constructivist theory

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 months

Secondary Outcomes (1)

  • Change in Facility Fall Rates

    6 months

Study Arms (2)

FALLS only

ACTIVE COMPARATOR

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

Behavioral: FALLS educational intervention

CONNECT and FALLS

EXPERIMENTAL

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 interventionBehavioral: FALLS educational intervention

Interventions

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.

CONNECT and FALLS

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

CONNECT and FALLSFALLS only

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Inability to speak and understand English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

VA Medical Center, Asheville

Asheville, North Carolina, 28805, United States

Location

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705, United States

Location

Hunter Holmes McGuire VA Medical Center

Richmond, Virginia, 23249, United States

Location

VA Medical Center, Salem VA

Salem, Virginia, 24153, United States

Location

Related Publications (2)

  • Colon-Emeric CS, Lyles KW, Su G, Pieper CF, Magaziner JS, Adachi JD, Bucci-Rechtweg CM, Haentjens P, Boonen S; HORIZON Recurrent Fracture Trial. Clinical risk factors for recurrent fracture after hip fracture: a prospective study. Calcif Tissue Int. 2011 May;88(5):425-31. doi: 10.1007/s00223-011-9474-4. Epub 2011 Feb 18.

  • Anderson RA, Corazzini K, Porter K, Daily K, McDaniel RR Jr, Colon-Emeric C. CONNECT for quality: protocol of a cluster randomized controlled trial to improve fall prevention in nursing homes. Implement Sci. 2012 Feb 29;7:11. doi: 10.1186/1748-5908-7-11.

Related Links

Results Point of Contact

Title
Dr. Cathleen Colon-Emeric
Organization
Durham VA GRECC

Study Officials

  • Cathleen S. Colon-Emeric, MD

    Durham VA Medical Center, Durham, NC

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2009

First Posted

February 4, 2009

Study Start

February 1, 2010

Primary Completion

October 1, 2011

Study Completion

August 1, 2012

Last Updated

April 24, 2015

Results First Posted

October 30, 2014

Record last verified: 2014-10

Locations