NCT00366028

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,624

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 18, 2006

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
5.7 years until next milestone

Results Posted

Study results publicly available

September 26, 2014

Completed
Last Updated

April 28, 2015

Status Verified

May 1, 2014

Enrollment Period

2.6 years

First QC Date

August 16, 2006

Results QC Date

June 6, 2014

Last Update Submit

April 6, 2015

Conditions

Keywords

Organization InnovationDiffusion of InnovationEvidence-based MedicineInfection Control

Outcome Measures

Primary Outcomes (2)

  • Fidelity to the Organizational Model

    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

    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.

    3 months pre and post study intervention

Study Arms (2)

Organizational Model

OTHER

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.

Behavioral: Organization ModelBehavioral: Data Feedback Model

Data Feedback

OTHER

Data Feedback Only: Participants in this arm will be interviewed periodically and participate in the data feedback portion of the study.

Behavioral: Data Feedback Model

Interventions

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

Organizational Model

The research team will periodically interview the facilities and provide them with reported hand hygiene data.

Data FeedbackOrganizational Model

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Boston, Massachusetts, 02130, United States

Location

Related Publications (1)

  • 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.

Results Point of Contact

Title
Dr. Carol VanDeusen Lukas
Organization
Department of Veterans Affairs

Study Officials

  • Carol VanDeusen-Lukas, EdD

    VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
FACTORIAL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2006

First Posted

August 18, 2006

Study Start

January 1, 2006

Primary Completion

August 1, 2008

Study Completion

January 1, 2009

Last Updated

April 28, 2015

Results First Posted

September 26, 2014

Record last verified: 2014-05

Locations