Fall InjuryNCT00729521
Dissemination of Injury Interventions
A study testing facilitative system and Standard Program in people with Fall Injury, run by Medical College of Wisconsin at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Fall Injury
- What is being tested?
- facilitative system and Standard Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35,037 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Jul 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Communities interested in participating
Who cannot join
- Existing facilitative system in community
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
Official title: Facilitating Dissemination of Injury Interventions: A Randomized Controlled Trial
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.
Read more
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
- Conditions
- Fall Injury
- Being tested
- facilitative system, Standard Program
- Keywords
- Fall injury hospitalization, Fall injury emergency department visit, Fall injury death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
facilitative systemOther
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.
Standard ProgramOther
a "Standard Program" group receiving modest funding to implement an "evidence-based" fall prevention program in their local community;
| Study group | Role | What they receive |
|---|---|---|
| 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; Receives: Other: Standard Program |
| Facilitative System | Experimental | a "Facilitative System" group receiving facilitative system support in addition to the resources provided the Standard Program group Receives: Other: facilitative system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2007-2008; 2010-2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2008 (estimated)
- Study startJul 2007
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Fall InjuryStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 35,037 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Layde, Medical College of Wisconsin
- Investigators
- Peter M Layde, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00729521
- Sponsor's protocol ID
- PRO00007160
- Status last verified
- Feb 2015
- First submitted
- 31 Jul 2008
- Last updated
- 5 Feb 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facilitating Dissemination of Injury Interventions: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00729521
- Acronym / sponsor ID
- PRO00007160
- Conditions
- Fall Injury
- Keywords
- Fall injury hospitalization, Fall injury emergency department visit, Fall injury death
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35,037 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 7 Aug 2008 (estimated)
- Results
- Posted 5 Feb 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Standard Programa "Standard Program" group receiving modest funding to implement an "evidence-based" fall prevention program in their local community; |
| Facilitative System | Experimental | Other: facilitative systema "Facilitative System" group receiving facilitative system support in addition to the resources provided the Standard Program group |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Communities interested in participating
Key exclusion criteria (1 listed)
- Existing facilitative system in community
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| facilitative systemThe 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. | Other | Facilitative System |
| Standard Programa "Standard Program" group receiving modest funding to implement an "evidence-based" fall prevention program in their local community; | Other | Standard Program |
Primary outcome
Emergency Department and In-patient Hospitalization for Fall Injury
Time frame: 2007-2008; 2010-2011
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter M Layde, MD principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing facilitative system and Standard Program in people with Fall Injury, run by Medical College of Wisconsin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emergency Department and In-patient Hospitalization for Fall Injury (time frame: 2007-2008; 2010-2011). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2015.