Dissemination of Injury Interventions

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Peter Layde, Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT00729521
First received: July 31, 2008
Last updated: February 3, 2015
Last verified: February 2015
Results First Received: September 15, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Prevention
Condition: Fall Injury
Interventions: Other: facilitative system
Other: Standard Program

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Control a control group receiving no special resources or guidance related to fall injury prevention or the community health improvement process;
Standard Program

a "Standard Program" group 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;

Facilitative System

a "Facilitative System" group receiving facilitative system 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.


Participant Flow:   Overall Study
    Control     Standard Program     Facilitative System  
STARTED     12494 [1]   14842 [2]   7701 [3]
COMPLETED     12494 [4]   14842 [4]   7701 [4]
NOT COMPLETED     0     0     0  
[1] 10 communities in Control with average annual population of 12,494 residents over 65 years old.
[2] Five communities with average annual population of 14,842 residents over 65 years old.
[3] 5 communities in Facilitative System with average annual pop. of 7,701 residents over 65 years.
[4] Average annual population over 65 years old.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Average annual population over residents over 65 years of age.

Reporting Groups
  Description
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;
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;

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.

Total Total of all reporting groups

Baseline Measures
    Control     Standard Program     Facilitative System     Total  
Number of Participants  
[units: participants]
  12494     14842     7701     35037  
Age [1]
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     0     0     0     0  
>=65 years     12494     14842     7701     35037  
Gender, Customized  
[units: participants]
       
Not collected     NA [3]   NA [3]   NA [3]   NA [2]
[1] Adults age 65 years.
[2] Total not calculated because data are not available (NA) in one or more arms.
[3] Study looked at all older adults over age 65 years and not specifically at male and females



  Outcome Measures

1.  Primary:   Emergency Department and In-patient Hospitalization for Fall Injury   [ Time Frame: 2007-2008; 2010-2011 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Peter Layde, MD, MSc
Organization: Medical College of Wisconsin
phone: 414-955-8113
e-mail: playde@mcw.edu


No publications provided


Responsible Party: Peter Layde, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT00729521     History of Changes
Other Study ID Numbers: PRO00007160
Study First Received: July 31, 2008
Results First Received: September 15, 2014
Last Updated: February 3, 2015
Health Authority: United States: Institutional Review Board