Skip to content

Increasing Evidence-based Clinical Practices in VA

Strengthening Organization to Implement Evidence-based Clinical Practice

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00366028
Enrollment
1624
Registered
2006-08-18
Start date
2006-01-31
Completion date
2009-01-31
Last updated
2015-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hand Washing

Keywords

Organization Innovation, Diffusion of Innovation, Evidence-based Medicine, Infection Control

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.

Interventions

BEHAVIORALOrganization Model

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

BEHAVIORALData Feedback Model

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

Sponsors

US Department of Veterans Affairs
Lead SponsorFED

Study design

Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Fidelity to the Organizational ModelFidelity 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.
Effect Size of Improvement in Hand Hygiene Compliance3 months pre and post study interventionThe 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
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. 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.
889
Data Feedback
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.
735
Total1,624

Baseline characteristics

CharacteristicOrganizational ModelData FeedbackTotal
Age, Categorical
<=18 years
NA ParticipantsNA ParticipantsNA Participants
Age, Categorical
>=65 years
NA ParticipantsNA ParticipantsNA Participants
Age, Categorical
Between 18 and 65 years
NA ParticipantsNA ParticipantsNA Participants
Sex: Female, Male
Female
NA ParticipantsNA ParticipantsNA Participants
Sex: Female, Male
Male
NA ParticipantsNA ParticipantsNA Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

Primary

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.

Time frame: 3 months pre and post study intervention

Population: This outcome measure was only assessed at the site (facility) level.

ArmMeasureGroupValue (NUMBER)
Organizational ModelEffect Size of Improvement in Hand Hygiene ComplianceSite G-0.22 effect size
Organizational ModelEffect Size of Improvement in Hand Hygiene ComplianceSite B0.48 effect size
Organizational ModelEffect Size of Improvement in Hand Hygiene ComplianceSite C0.92 effect size
Organizational ModelEffect Size of Improvement in Hand Hygiene ComplianceSite JNA effect size
Organizational ModelEffect Size of Improvement in Hand Hygiene ComplianceSite LNA effect size
Organizational ModelEffect Size of Improvement in Hand Hygiene ComplianceSite D0.52 effect size
Organizational ModelEffect Size of Improvement in Hand Hygiene ComplianceSite HNA effect size
Organizational ModelEffect Size of Improvement in Hand Hygiene ComplianceSite INA effect size
Organizational ModelEffect Size of Improvement in Hand Hygiene ComplianceSite KNA effect size
Organizational ModelEffect Size of Improvement in Hand Hygiene ComplianceSite E0.14 effect size
Organizational ModelEffect Size of Improvement in Hand Hygiene ComplianceSite F0.14 effect size
Organizational ModelEffect Size of Improvement in Hand Hygiene ComplianceSite A0.67 effect size
Data FeedbackEffect Size of Improvement in Hand Hygiene ComplianceSite K0.05 effect size
Data FeedbackEffect Size of Improvement in Hand Hygiene ComplianceSite ANA effect size
Data FeedbackEffect Size of Improvement in Hand Hygiene ComplianceSite H0.77 effect size
Data FeedbackEffect Size of Improvement in Hand Hygiene ComplianceSite BNA effect size
Data FeedbackEffect Size of Improvement in Hand Hygiene ComplianceSite FNA effect size
Data FeedbackEffect Size of Improvement in Hand Hygiene ComplianceSite CNA effect size
Data FeedbackEffect Size of Improvement in Hand Hygiene ComplianceSite I0.61 effect size
Data FeedbackEffect Size of Improvement in Hand Hygiene ComplianceSite J-0.26 effect size
Data FeedbackEffect Size of Improvement in Hand Hygiene ComplianceSite L0.24 effect size
Data FeedbackEffect Size of Improvement in Hand Hygiene ComplianceSite ENA effect size
Data FeedbackEffect Size of Improvement in Hand Hygiene ComplianceSite DNA effect size
Data FeedbackEffect Size of Improvement in Hand Hygiene ComplianceSite GNA effect size
Primary

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.

Time frame: Fidelity was assessed at the end of the 3 year study.

Population: This outcome measure was only assessed at the site (facility) level.

ArmMeasureGroupValue (NUMBER)
Organizational ModelFidelity to the Organizational ModelSite B3.38 units on a scale
Organizational ModelFidelity to the Organizational ModelSite C3.23 units on a scale
Organizational ModelFidelity to the Organizational ModelSite E2.15 units on a scale
Organizational ModelFidelity to the Organizational ModelSite F1.98 units on a scale
Organizational ModelFidelity to the Organizational ModelSite G1.42 units on a scale
Organizational ModelFidelity to the Organizational ModelSite HNA units on a scale
Organizational ModelFidelity to the Organizational ModelSite INA units on a scale
Organizational ModelFidelity to the Organizational ModelSite JNA units on a scale
Organizational ModelFidelity to the Organizational ModelSite LNA units on a scale
Organizational ModelFidelity to the Organizational ModelSite D3.17 units on a scale
Organizational ModelFidelity to the Organizational ModelSite KNA units on a scale
Organizational ModelFidelity to the Organizational ModelSite A3.95 units on a scale
Data FeedbackFidelity to the Organizational ModelSite BNA units on a scale
Data FeedbackFidelity to the Organizational ModelSite I1.62 units on a scale
Data FeedbackFidelity to the Organizational ModelSite CNA units on a scale
Data FeedbackFidelity to the Organizational ModelSite DNA units on a scale
Data FeedbackFidelity to the Organizational ModelSite ANA units on a scale
Data FeedbackFidelity to the Organizational ModelSite ENA units on a scale
Data FeedbackFidelity to the Organizational ModelSite J1.52 units on a scale
Data FeedbackFidelity to the Organizational ModelSite FNA units on a scale
Data FeedbackFidelity to the Organizational ModelSite K1.40 units on a scale
Data FeedbackFidelity to the Organizational ModelSite GNA units on a scale
Data FeedbackFidelity to the Organizational ModelSite L1.30 units on a scale
Data FeedbackFidelity to the Organizational ModelSite H2.30 units on a scale

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026