- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00366028
Increasing Evidence-based Clinical Practices in VA
Strengthening Organization to Implement Evidence-based Clinical Practice
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background:
The Veterans Health Administration (VHA) needs to develop efficient ways to broadly implement evidence based practices and foster a learning organization culture that systematically and continuously applies research to improve VA healthcare. Recognizing this need, VHA Health Services Research and Development (HSR&D) invited applications in the fall of 2003 for collaboration HSR&D investigators and Integrated Service Networks (VISNs) on a) implementing and evaluating an evidenced-based interventions or b) undergoing and evaluating an organizational or structural change to transform the VISN in to a learning organization that can efficiently implement evidence-based practices. Collaborations are intended to help improve clinical services locally within participating VISNs and provide templates for expanding successful changes nationwide.
Objectives:
Despite recognition that successful implementation of evidence-based clinical practices (EBCPs) usually depends on the on the structure and processes of the larger healthcare organization in which new clinical practices are introduced, the processes and dynamics of implementation are not well understood. The aim of this project was to deepen that understanding by testing an organizational model that we hypothesized would strengthen the ability of healthcare organizations to implement evidence-based clinical practices. The research objectives were to: - Test the hypothesis that medical centers with high fidelity to the organizational model would be more successful in improving system use of a selected EBCP; - Identify and analyze organizational factors that affect model implementation; - Test the feasibility of intervention activities to introduce and support the model.
Methods:
The three-year study used a mixed-methods pre-post comparison-group design to implement and evaluate the organizational model in medical centers in 3 VISNs in the Department of Veterans Affairs. The model posits that the implementation of evidence-based practices will be enhanced through the presence of three interacting components in the organization: 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. The target clinical practice was hand-hygiene compliance. One VISN was randomly assigned to the intervention arm that implemented the organizational model; two VISNs were assigned to a comparison arm that participated in a more limited data feedback strategy. Measures included: 1) ratings of implementation fidelity, as measured on a 0-4 scale at the site level supported by narrative evidence by research team; 2) percent compliance with national hand-hygiene guidelines for each site, as measured through structured observations by medical center staff; 3) staff ratings of team effectiveness and facility emphasis on quality, as measured through a written survey; and 4) factors affecting model implementation, as identified qualitatively through interviews and quantitatively through staff surveys
Status:
Data collection and analysis is complete. Manuscript preparation is ongoing.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02130
- VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
VA employees of VISNs 1, 10 and 23 working in participating clinical units or holding a leadership position in medical centers identified by facility leadership for participation in the study.
Exclusion Criteria:
Must have operational proficiency in English. All to be interviewed and surveyed will hold professional positions in VA, so this is not expected to be a major barrier to inclusion.
Study Plan
How is the study designed?
Design Details
- Allocation: Non-Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Organizational Model
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.
Participants in this arm of the study will be interviewed and participate in the data feedback portion of the study as well.
|
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.
|
Other: Data Feedback
Data Feedback Only: Participants in this arm will be interviewed periodically and participate in the data feedback portion of the study.
|
The research team will periodically interview the facilities and provide them with reported hand hygiene data.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fidelity to the Organizational Model
Time Frame: Fidelity was assessed at the end of the 3 year study.
|
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. |
Fidelity was assessed at the end of the 3 year study.
|
Effect Size of Improvement in Hand Hygiene Compliance
Time Frame: 3 months pre and post study intervention
|
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.
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3 months pre and post study intervention
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Collaborators and Investigators
Investigators
- Principal Investigator: Carol VanDeusen-Lukas, EdD, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- IMV 04-055
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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