NCT00729521

Brief Summary

An important challenge for the field of injury prevention and control is the translation of research findings into effective community-based prevention programs and practices. The National Center for Injury Prevention and Control believes that dissemination research can overcome this challenge by providing insight into the structures and methods needed to translate injury control research into everyday practice. The proposed dissemination research study will rigorously assess whether the use of a "facilitative system" can successfully bridge the gap between injury prevention and control research and the implementation of evidence-driven, community-based programs, policies, and practices. The facilitative system links communities with academic partners to provide communities with the skills and resources needed to help facilitate the community health improvement process. The system identifies what assets are available within communities, as well as the skills and resources needed to work through the community health improvement process. The facilitative system will then provide technical assistance, best practices guides, and direct consultation in carrying out all phases of the community health improvement process. This information is designed to increase community capacity in community assessment, coalition development, accessing and interpreting local injury prevention data, searching and selecting evidence-based research, and program planning and evaluation. The study will use a randomized community trial design to evaluate fall injury occurrence and process measures of program implementation in three groups of communities:

  • a control group receiving no special resources or guidance related to fall injury prevention or the community health improvement process;
  • a "Standard Program" group receiving modest funding to implement an "evidence-based" fall prevention program in their local community;
  • a "Facilitative System" group receiving facilitative system support in addition to the resources provided the Standard Program group. We hypothesize that the Facilitative System program will be more effective at:
  • reducing fall-related injuries in the elderly;
  • building community coalitions that are goal-oriented and sustainable;
  • implementing community-based, evidence-driven fall prevention programs that are both tailored to the community needs and yet faithful to empirically-tested fall prevention research studies

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35,037

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

July 1, 2007

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 31, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 7, 2008

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

February 5, 2015

Completed
Last Updated

February 5, 2015

Status Verified

February 1, 2015

Enrollment Period

5 years

First QC Date

July 31, 2008

Results QC Date

September 15, 2014

Last Update Submit

February 3, 2015

Conditions

Keywords

Fall injury hospitalizationFall injury emergency department visitFall injury death

Outcome Measures

Primary Outcomes (1)

  • Emergency Department and In-patient Hospitalization for Fall Injury

    Rates of fall injury diagnoses per 100 person-years (P-Y) were computed for the communities in each of the study groups for a 2 year baseline period, 2007-2008, and for a 2 year follow-up period corresponding to years 2010-2011. Change in fall injury rates and their 95% confidence intervals (CI) are reported. A mixed-effects Poisson regression model was used to test the presence of an interaction effect on the fall rate between study group and time period (baseline or follow-up). The test is intended to detect a differential time effect by study group. This model, with main effects for study group and time period and an interaction term, will be referred to as the primary model. Model coefficients and incidence rate ratios (IRR) with 95% confidence intervals (CI) are reported.

    2007-2008; 2010-2011

Study Arms (3)

Control

NO INTERVENTION

a control group receiving no special resources or guidance related to fall injury prevention or the community health improvement process;

Standard Program

ACTIVE COMPARATOR

a "Standard Program" group receiving modest funding to implement an "evidence-based" fall prevention program in their local community;

Other: Standard Program

Facilitative System

EXPERIMENTAL

a "Facilitative System" group receiving facilitative system support in addition to the resources provided the Standard Program group

Other: facilitative system

Interventions

The facilitative system links communities with academic partners to provide communities with the skills and resources needed to help facilitate the community health improvement process. The system identifies what assets are available within communities, as well as the skills and resources needed to work through the community health improvement process. The facilitative system will then provide technical assistance, best practices guides, and direct consultation in carrying out all phases of the community health improvement process. This information is designed to increase community capacity in community assessment, coalition development, accessing and interpreting local injury prevention data, searching and selecting evidence-based research, and program planning and evaluation.

Facilitative System

a "Standard Program" group receiving modest funding to implement an "evidence-based" fall prevention program in their local community;

Standard Program

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Communities interested in participating

You may not qualify if:

  • Existing facilitative system in community

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Limitations and Caveats

E coding of injuries can be incomplete, but 99.7% of records with a diagnostic code in the range 800-995.89 had an E code. We may have included more than one admission for the same fall, but we excluded admissions from an acute care facility.

Results Point of Contact

Title
Peter Layde, MD, MSc
Organization
Medical College of Wisconsin

Study Officials

  • Peter M Layde, MD

    Medical College of Wisconsin

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 31, 2008

First Posted

August 7, 2008

Study Start

July 1, 2007

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

February 5, 2015

Results First Posted

February 5, 2015

Record last verified: 2015-02

Locations