Fall Injury Clinical Trial
Official title:
Facilitating Dissemination of Injury Interventions: A Randomized Controlled Trial
Verified date | February 2015 |
Source | Medical College of Wisconsin |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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
Status | Completed |
Enrollment | 35037 |
Est. completion date | July 2012 |
Est. primary completion date | July 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 65 Years and older |
Eligibility |
Inclusion Criteria: - Communities interested in participating Exclusion Criteria: - Existing facilitative system in community |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | Medical College of Wisconsin | Milwaukee | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
Medical College of Wisconsin |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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. | 2007-2008; 2010-2011 | No |
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