Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

August 16, 2006
September 18, 2014
January 2006
August 2008   (final data collection date for primary outcome measure)
  • Fidelity to the Organizational Model [ Time Frame: Fidelity was assessed at the end of the 3 year study. ] [ Designated as safety issue: No ]

    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.

  • Effect Size of Improvement in Hand Hygiene Compliance [ Time Frame: 3 months pre and post study intervention ] [ Designated as safety issue: No ]
    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.
To create and test organizations that facilitate the use of evidence-based clinical practice and to test the effectiveness of a proposed organizational model in comparison with a more limited data feedback strategy and improving hand hygiene compliance.
Complete list of historical versions of study NCT00366028 on ClinicalTrials.gov Archive Site
Not Provided
To identify and analyze organizational factors that affect implementation of the organizational model and to test the feasibility of intervention activities to introduce and support the model.
Not Provided
Not Provided
 
Increasing Evidence-based Clinical Practices in VA
Strengthening Organization to Implement Evidence-based Clinical Practice

Evidence-based clinical practices (EBCPs) are often not widely adopted, despite extensive efforts to influence individual practitioners to use them. The aim of the project is to work with Veterans Integrated Service Networks (VISN) 1, 10, and 23 and their medical centers to create and test organizations that facilitate the use of EBCPs. The research objectives are to: Test the effectiveness of the proposed organizational model in comparison with a more limited data-feedback strategy 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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Hand Washing
  • Behavioral: Organization Model
    The organizational model contains three components: leadership support, a multidisciplinary redesign team, and management structures and processes to link the two.
  • Behavioral: Data Feedback Model
    The research team will periodically interview the facilities and provide them with reported hand hygiene data.
  • 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.
    Interventions:
    • Behavioral: Organization Model
    • Behavioral: Data Feedback Model
  • Data Feedback
    Data Feedback Only: Participants in this arm will be interviewed periodically and participate in the data feedback portion of the study.
    Intervention: Behavioral: Data Feedback Model
VanDeusen Lukas C, Engle RL, Holmes SK, Parker VA, Petzel RA, Nealon Seibert M, Shwartz M, Sullivan JL. Strengthening organizations to implement evidence-based clinical practices. Health Care Manage Rev. 2010 Jul-Sep;35(3):235-45. doi: 10.1097/HMR.0b013e3181dde6a5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1624
January 2009
August 2008   (final data collection date for primary outcome measure)

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.

Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00366028
IMV 04-055
No
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Carol VanDeusen-Lukas, EdD VA New England Health Care System
Department of Veterans Affairs
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP