Trial Outcomes & Findings for Increasing Evidence-based Clinical Practices in VA (NCT NCT00366028)

Last Updated: 2015-04-28

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

1624 participants

Primary outcome timeframe

Fidelity was assessed at the end of the 3 year study.

Results posted on

2015-04-28

Participant Flow

Participant milestones

Participant milestones
Measure	Organizational Model This arm is considered the intervention arm. 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.	Data Feedback This arm is considered the control arm. 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 Model: This is considered the non-intervention arm. The research team will periodically interview the facilities and provide them with reported hand hygiene data.
Overall Study STARTED	889	735
Overall Study COMPLETED	889	735
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Increasing Evidence-based Clinical Practices in VA

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Organizational Model n=889 Participants 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.	Data Feedback n=735 Participants 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.	Total n=1624 Participants Total of all reporting groups
Age, Categorical <=18 years	NA Participants n=5 Participants	NA Participants n=7 Participants	NA Participants n=5 Participants
Age, Categorical Between 18 and 65 years	NA Participants n=5 Participants	NA Participants n=7 Participants	NA Participants n=5 Participants
Age, Categorical >=65 years	NA Participants n=5 Participants	NA Participants n=7 Participants	NA Participants n=5 Participants
Sex: Female, Male Female	NA Participants n=5 Participants	NA Participants n=7 Participants	NA Participants n=5 Participants
Sex: Female, Male Male	NA Participants n=5 Participants	NA Participants n=7 Participants	NA Participants n=5 Participants

PRIMARY outcome

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

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

Outcome measures

Outcome measures
Measure	Organizational Model n=7 Facilities Participants in this arm of the study received information regarding the organizational model and worked 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 Intervention Arm included 889 individual participants across 7 study sites (medical centers).	Data Feedback n=5 Facilities Participants in this arm were interviewed periodically and participated in the data feedback portion of the study but did not undergo any active intervention pertaining to the organizational model. Data Feedback Model: This is considered the non-intervention arm. The research team periodically interviewed the facilities and provided them with reported hand hygiene data. The Control Arm included 735 individual participants across 9 study sites (medical centers) in total. Only 5 of the study sites are included in the reporting of outcome data due to incomplete data at 4 of the study sites.
Fidelity to the Organizational Model Site G	1.42 units on a scale	NA units on a scale This site is not in the Organizational Model Arm.
Fidelity to the Organizational Model Site K	NA units on a scale This site is not in the Data Feedback Arm.	1.40 units on a scale
Fidelity to the Organizational Model Site A	3.95 units on a scale	NA units on a scale This site is not in the Organizational Model Arm.
Fidelity to the Organizational Model Site B	3.38 units on a scale	NA units on a scale This site is not in the Organizational Model Arm.
Fidelity to the Organizational Model Site C	3.23 units on a scale	NA units on a scale This site is not in the Organizational Model Arm.
Fidelity to the Organizational Model Site D	3.17 units on a scale	NA units on a scale This site is not in the Organizational Model Arm.
Fidelity to the Organizational Model Site E	2.15 units on a scale	NA units on a scale This site is not in the Organizational Model Arm.
Fidelity to the Organizational Model Site F	1.98 units on a scale	NA units on a scale This site is not in the Organizational Model Arm.
Fidelity to the Organizational Model Site H	NA units on a scale This site is not in the Data Feedback Arm.	2.30 units on a scale
Fidelity to the Organizational Model Site I	NA units on a scale This site is not in the Data Feedback Arm.	1.62 units on a scale
Fidelity to the Organizational Model Site J	NA units on a scale This site is not in the Data Feedback Arm.	1.52 units on a scale
Fidelity to the Organizational Model Site L	NA units on a scale This site is not in the Data Feedback Arm.	1.30 units on a scale

PRIMARY outcome

Timeframe: 3 months pre and post study intervention

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

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.

Outcome measures

Outcome measures
Measure	Organizational Model n=7 Facilities Participants in this arm of the study received information regarding the organizational model and worked 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 Intervention Arm included 889 individual participants across 7 study sites (medical centers).	Data Feedback n=5 Facilities Participants in this arm were interviewed periodically and participated in the data feedback portion of the study but did not undergo any active intervention pertaining to the organizational model. Data Feedback Model: This is considered the non-intervention arm. The research team periodically interviewed the facilities and provided them with reported hand hygiene data. The Control Arm included 735 individual participants across 9 study sites (medical centers) in total. Only 5 of the study sites are included in the reporting of outcome data due to incomplete data at 4 of the study sites.
Effect Size of Improvement in Hand Hygiene Compliance Site A	0.67 effect size	NA effect size This site was not in the Organizational Model Arm.
Effect Size of Improvement in Hand Hygiene Compliance Site B	0.48 effect size	NA effect size This site was not in the Organizational Model Arm.
Effect Size of Improvement in Hand Hygiene Compliance Site C	0.92 effect size	NA effect size This site was not in the Organizational Model Arm.
Effect Size of Improvement in Hand Hygiene Compliance Site D	0.52 effect size	NA effect size This site was not in the Organizational Model Arm.
Effect Size of Improvement in Hand Hygiene Compliance Site E	0.14 effect size	NA effect size This site was not in the Organizational Model Arm.
Effect Size of Improvement in Hand Hygiene Compliance Site F	0.14 effect size	NA effect size This site was not in the Organizational Model Arm.
Effect Size of Improvement in Hand Hygiene Compliance Site G	-0.22 effect size	NA effect size This site was not in the Organizational Model Arm.
Effect Size of Improvement in Hand Hygiene Compliance Site H	NA effect size This site was not in the Data Feedback Arm.	0.77 effect size
Effect Size of Improvement in Hand Hygiene Compliance Site I	NA effect size This site was not in the Data Feedback Arm.	0.61 effect size
Effect Size of Improvement in Hand Hygiene Compliance Site J	NA effect size This site was not in the Data Feedback Arm.	-0.26 effect size
Effect Size of Improvement in Hand Hygiene Compliance Site K	NA effect size This site was not in the Data Feedback Arm.	0.05 effect size
Effect Size of Improvement in Hand Hygiene Compliance Site L	NA effect size This site was not in the Data Feedback Arm.	0.24 effect size

Adverse Events

Organizational Model

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Data Feedback

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Carol VanDeusen Lukas

Department of Veterans Affairs

Phone: 857-364-5685

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place