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Dissemination of Injury Interventions

Facilitating Dissemination of Injury Interventions: A Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00729521
Enrollment
35037
Registered
2008-08-07
Start date
2007-07-31
Completion date
2012-07-31
Last updated
2015-02-05

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

Conditions

Fall Injury

Keywords

Fall injury hospitalization, Fall injury emergency department visit, Fall injury death

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

Interventions

OTHERfacilitative system

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.

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

Sponsors

Medical College of Wisconsin
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Communities interested in participating

Exclusion criteria

* Existing facilitative system in community

Design outcomes

Primary

MeasureTime frameDescription
Emergency Department and In-patient Hospitalization for Fall Injury2007-2008; 2010-2011Rates 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.

Countries

United States

Participant flow

Recruitment details

20 interested communities were randomized to one of the three groups using a block randomization method, taking into account whether the lead agency was a health department or aging agency and whether the community had 0 or 1 or more Stepping On fall prevention program leaders already.

Participants by arm

ArmCount
Control
a control group of 10 communities and their residents over 65 years of age receiving no special resources or guidance related to fall injury prevention or the community health improvement process;
12,494
Standard Program
a Standard Program group of five communities and their residents over 65 years of age receiving modest funding to implement an evidence-based fall prevention program in their local community; Standard Program: a Standard Program group receiving modest funding to implement an evidence-based fall prevention program in their local community;
14,842
Facilitative System
a Facilitative System group of five communities and their residents over 65 years of age receiving support in addition to the resources provided the Standard Program group facilitative system: 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.
7,701
Total35,037

Baseline characteristics

CharacteristicTotalStandard ProgramControlFacilitative System
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
35037 Participants14842 Participants12494 Participants7701 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants0 Participants
Sex/Gender, Customized
Not collected
NA participantsNA participantsNA participantsNA participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
0 / 12,4940 / 14,8420 / 7,701
serious
Total, serious adverse events
0 / 12,4940 / 14,8420 / 7,701

Outcome results

Primary

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.

Time frame: 2007-2008; 2010-2011

Population: Population of residents aged 65 and older for participating communities in each study arm for 2007-2008 baseline period and 2010-2011 follow-up period.

ArmMeasureGroupValue (NUMBER)
ControlEmergency Department and In-patient Hospitalization for Fall InjuryFall Injury Rate per 100 P-Y, 2007-20085.8 Fall Injury Rate per 100 person years
ControlEmergency Department and In-patient Hospitalization for Fall InjuryFall Injury Rate per 100 P-Y 2010-20115.8 Fall Injury Rate per 100 person years
Standard ProgramEmergency Department and In-patient Hospitalization for Fall InjuryFall Injury Rate per 100 P-Y, 2007-20085.9 Fall Injury Rate per 100 person years
Standard ProgramEmergency Department and In-patient Hospitalization for Fall InjuryFall Injury Rate per 100 P-Y 2010-20115.3 Fall Injury Rate per 100 person years
Facilitative SystemEmergency Department and In-patient Hospitalization for Fall InjuryFall Injury Rate per 100 P-Y, 2007-20086.1 Fall Injury Rate per 100 person years
Facilitative SystemEmergency Department and In-patient Hospitalization for Fall InjuryFall Injury Rate per 100 P-Y 2010-20115.6 Fall Injury Rate per 100 person years
p-value: <0.0595% CI: [0.88, 0.95]Mixed Models Analysis
p-value: <0.0595% CI: [0.88, 0.94]Mixed Models Analysis

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