Increasing Evidence-based Clinical Practices in VA

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00366028
First received: August 16, 2006
Last updated: September 18, 2014
Last verified: September 2014
Results First Received: June 6, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Factorial Assignment;   Masking: Open Label
Condition: Hand Washing
Interventions: Behavioral: Organization Model
Behavioral: Data Feedback Model

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Organizational Model

This arm is considered the intervention arm. Participants in this arm of the study will receive information regarding the organizational model and work closely with the research team throughout the project to implement various aspects of the model.

Organization Model: The organizational model contains three components: leadership support, a multidisciplinary redesign team, and management structures and processes to link the two.

Data Feedback

This arm is considered the control arm. Participants in this arm will be interviewed periodically and participate in the data feedback portion of the study but will not undergo any active intervention pertaining to the organizational model.

Data Feedback Model: This is considered the non-intervention arm. The research team will periodically interview the facilities and provide them with reported hand hygiene data.


Participant Flow:   Overall Study
    Organizational Model     Data Feedback  
STARTED     889     735  
COMPLETED     889     735  
NOT COMPLETED     0     0  



  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.
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Reporting Groups
  Description
Organizational Model

Participants in this arm of the study will receive information regarding the organizational model and work closely with the research team throughout the project to implement various aspects of the model.

Organization Model: The organizational model contains three components: leadership support, a multidisciplinary redesign team, and management structures and processes to link the two. The research team will periodically interview the facilities and provide them with reported hand hygiene data.

Data Feedback

Participants in this arm will be interviewed periodically and participate in the data feedback portion of the study but will not undergo any active intervention pertaining to the organizational model.

Data Feedback Only Model: The research team will periodically interview the facilities and provide them with reported hand hygiene data.

Total Total of all reporting groups

Baseline Measures
    Organizational Model     Data Feedback     Total  
Number of Participants  
[units: participants]
  889     735     1624  
Age [1]
[units: participants]
     
<=18 years     NA [1]   NA [1]   NA [2]
Between 18 and 65 years     NA [1]   NA [1]   NA [2]
>=65 years     NA [1]   NA [1]   NA [2]
Gender  
[units: participants]
     
Female     NA [3]   NA [3]   NA [2]
Male     NA [3]   NA [3]   NA [2]
[1] Age was not collected as it was not pertinent to the outcome of the study.
[2] Total not calculated because data are not available (NA) in one or more arms.
[3] Gender was not collected as it was not pertinent to the outcome of the study.



  Outcome Measures
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1.  Primary:   Fidelity to the Organizational Model   [ Time Frame: Fidelity was assessed at the end of the 3 year study. ]

2.  Primary:   Effect Size of Improvement in Hand Hygiene Compliance   [ Time Frame: 3 months pre and post study intervention ]


  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
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  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: Dr. Carol VanDeusen Lukas
Organization: Department of Veterans Affairs
phone: 857-364-5685
e-mail: carol.vandeusenlukas@va.gov


Publications of Results:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00366028     History of Changes
Other Study ID Numbers: IMV 04-055
Study First Received: August 16, 2006
Results First Received: June 6, 2014
Last Updated: September 18, 2014
Health Authority: United States: Federal Government