Clinical trial NCT00366028: Increasing Evidence-based Clinical Practices in VA
Official title: Strengthening Organization to Implement Evidence-based Clinical Practice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hand Washing
Keywords: Organization Innovation
Diffusion of Innovation
Evidence-based Medicine
Infection Control
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2006-08-18
Enrollment: 1624
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Fidelity to the Organizational Model
timeFrame: Fidelity was assessed at the end of the 3 year study.
measure: Effect Size of Improvement in Hand Hygiene Compliance
timeFrame: 3 months pre and post study intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
state: Massachusetts
Study officials:
affiliation: VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
name: Carol VanDeusen-Lukas, EdD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.