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Increasing Evidence-based Clinical Practices in VA

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ClinicalTrials.gov Identifier: NCT00366028
Recruitment Status : Completed
First Posted : August 18, 2006
Results First Posted : September 26, 2014
Last Update Posted : April 28, 2015
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Factorial Assignment;   Masking: None (Open Label)
Condition Hand Washing
Interventions Behavioral: Organization Model
Behavioral: Data Feedback Model
Enrollment 1624
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Organizational Model Data Feedback
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 889 735
Completed 889 735
Not Completed 0 0
Arm/Group Title Organizational Model Data Feedback Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 889 735 1624
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 889 participants 735 participants 1624 participants
<=18 years NA [2]  NA [2]  NA [3] 
Between 18 and 65 years NA [2]  NA [2]  NA [3] 
>=65 years NA [2]  NA [2]  NA [3] 
[1]
Measure Description: Age was not collected as it was not pertinent to the outcome of the study.
[2]
Age was not collected as it was not pertinent to the outcome of the study.
[3]
Total not calculated because data are not available (NA) in one or more arms.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 889 participants 735 participants 1624 participants
Female NA [1]  NA [1]  NA [2] 
Male NA [1]  NA [1]  NA [2] 
[1]
Gender 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.
1.Primary Outcome
Title Fidelity to the Organizational Model
Hide Description

Final fidelity to the Organizational Model was assessed by averaging scores for each component of the model. Scores ranged from 0 (no evidence of that factor present) to 4 (factor fully present and used as intended). The 3 main components of the model included 1) active leadership commitment to quality, 2) robust clinical process redesign to incorporate evidence-based practices into routine operations, and 3) use of management structures and processes to support and align redesign. Scores for each component of the model were measured by the study team using structured rating instruments based on data collected during interviews.

Sites with an overall fidelity score above 3.0 were considered to have high fidelity to the organizational model.

Time Frame Fidelity was assessed at the end of the 3 year study.
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Hide Analysis Population Description
This outcome measure was only assessed at the site (facility) level.
Arm/Group Title Organizational Model Data Feedback
Hide Arm/Group Description:

Participants in this arm of the study received information regarding the organizational model and worked 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 Intervention Arm included 889 individual participants across 7 study sites (medical centers).

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

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

The Control Arm included 735 individual participants across 9 study sites (medical centers) in total. Only 5 of the study sites are included in the reporting of outcome data due to incomplete data at 4 of the study sites.

Overall Number of Participants Analyzed 889 735
Overall Number of Units Analyzed
Type of Units Analyzed: Facilities
7 5
Measure Type: Number
Unit of Measure: units on a scale
Site A 3.95 NA [1] 
Site B 3.38 NA [1] 
Site C 3.23 NA [1] 
Site D 3.17 NA [1] 
Site E 2.15 NA [1] 
Site F 1.98 NA [1] 
Site G 1.42 NA [1] 
Site H NA [2]  2.30
Site I NA [2]  1.62
Site J NA [2]  1.52
Site K NA [2]  1.40
Site L NA [2]  1.30
[1]
This site is not in the Organizational Model Arm.
[2]
This site is not in the Data Feedback Arm.
2.Primary Outcome
Title Effect Size of Improvement in Hand Hygiene Compliance
Hide Description The effect size of improvement in hand-hygiene compliance was calculated by comparing the baseline three-month periods to the last three-month periods of the study. To evaluate the statistical significance of changes in proportion adherence over time, we ran a weighted least squares regression model with time (i.e. month) as the independent variable and adherence proportion as the dependent variable. The sample size in each data collection period was used as the weight. Our interest is in the statistical significance of the coefficient associated with time. To evaluate the practical significance of the change pre and post intervention, we examined the effect size associated with the change in proportion adherence in the first 3-month period of data collection and the last 3-month period. Effect size was calculated as 2*arcsin(sqr(p2)) - 2*arcsin(sqr(p1)). Using Cohen's criteria, an effect size of .2 is interpreted as small, .5 as medium and .8 as large.
Time Frame 3 months pre and post study intervention
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Hide Analysis Population Description
This outcome measure was only assessed at the site (facility) level.
Arm/Group Title Organizational Model Data Feedback
Hide Arm/Group Description:

Participants in this arm of the study received information regarding the organizational model and worked 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 Intervention Arm included 7 study sites (medical centers). Of the 7 sites there were 4 with high fidelity to the Organizational Model and 3 with low fidelity to the Organizational Model.

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

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

The Control Arm included 9 study sites (medical centers) in total. Only 5 of the study sites are included in analysis of this outcome measure due to incomplete hand hygiene data at 4 of the study sites. Of the 5 study sites included, there were 2 sites with high fidelity to the Organization Model and 3 sites with low fidelity to the Organizational model, even though the model was not specifically introduced to the control arm.

Overall Number of Participants Analyzed 7 5
Overall Number of Units Analyzed
Type of Units Analyzed: Facilities
7 5
Measure Type: Number
Unit of Measure: effect size
Site A 0.67 NA [1] 
Site B 0.48 NA [1] 
Site C 0.92 NA [1] 
Site D 0.52 NA [1] 
Site E 0.14 NA [1] 
Site F 0.14 NA [1] 
Site G -0.22 NA [1] 
Site H NA [2]  0.77
Site I NA [2]  0.61
Site J NA [2]  -0.26
Site K NA [2]  0.05
Site L NA [2]  0.24
[1]
This site was not in the Organizational Model Arm.
[2]
This site was not in the Data Feedback Arm.
Time Frame [Not Specified]
Adverse Event Reporting Description No adverse events were collected.
 
Arm/Group Title Organizational Model Data Feedback
Hide Arm/Group Description

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

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.

All-Cause Mortality
Organizational Model Data Feedback
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Organizational Model Data Feedback
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Organizational Model Data Feedback
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
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
Responsible Party: VA Office of Research and Development ( US Department of Veterans Affairs )
ClinicalTrials.gov Identifier: NCT00366028     History of Changes
Other Study ID Numbers: IMV 04-055
First Submitted: August 16, 2006
First Posted: August 18, 2006
Results First Submitted: June 6, 2014
Results First Posted: September 26, 2014
Last Update Posted: April 28, 2015