Trial to Enhance Adherence to Multiple Guidelines

Not Applicable

Completed

• Conditions: Cardiovascular Diseases; Diabetes Mellitus; Hypertension; Lung Diseases; Asthma; Atherosclerosis; Heart Diseases
• Interventions: Other: practice guideline adherence

• Registration Number: NCT00201227
• Lead Sponsor: University of Medicine and Dentistry of New Jersey

Brief Summary

To evaluate whether the innovative multimethod assessment process/participatory quality improvement (MAP/PQI) intervention increases adherence to multiple cardiorespiratory guidelines in primary care practice.

Detailed Description

BACKGROUND:

Because of its ongoing access to the majority of the U.S. population, the primary care setting has great potential for preventing and managing cardiorespiratory illness. However, due to their broad focus and competing demands, primary care practices often fail to translate evidence-based guidelines into practice. Based on more than 10 years of practice-based observational and intervention research, the investigators have developed a multimethod assessment process (MAP) for understanding the unique barriers, opportunities and complexity of diverse primary care practice settings. MAP has been used to inform a practice-individualized intervention that resulted in sustained increases of evidence-based guidelines for clinical preventive service delivery. They integrated a participatory quality improvement (PQI) process that involves patients, office staff, and physicians with MAP (MAP/PQI) to enhance and promote ongoing practice-specific quality improvement.

The study is in response to a Request for Applications on "Trials Assessing Innovative Strategies to Improve Clinical Practice Through Guidelines in Heart, Lung and Blood Diseases".

DESIGN NARRATIVE:

This study will evaluate whether the innovative MAP/PQI intervention increases adherence to multiple cardiorespiratory guidelines in primary care practice. A group randomized clinical trial of 60 primary care practices representing diverse patient populations and payment systems will be conducted. After a 2-year follow-up, the control group will cross-over to a refined delayed intervention. MAP at each practice will identify features that foster and/or impede adherence to screening and treatment guidelines for multiple cardiorespiratory diseases among the competing demands of practices. PQI will then engage clinicians, staff, and patients in implementing tailored improvements that target the whole practice and simultaneously focus on changes that affect multiple guidelines. Rates of adherence to multiple guidelines will be compared for intervention and control practices. A comparative case study process analysis will identify features associated with success. The major outcome is adherence to a select group of guidelines addressing: hypertension (chronic disease,) asthma (cyclic disease), diabetes (chronic with multiple co-morbidities), smoking (simple screening) and cholesterol (complicated). The conceptual framework is well developed by the authors with significant prior work in this area. These insights will be incorporated into a refined intervention for the control group (delayed intervention), and evaluated in a pre/post design. Tailoring MAP/PQI to unique practice characteristics is likely to result in sustained increases in adherence to cardiorespiratory guidelines. The intervention will be translatable into ongoing implementations of evidence-based guidelines in the primary care setting where the majority of Americans receive their medical care.

Study Timeline

• Study Start: 2002-09
• Study First Submitted: 2005-09-16
• Study First Submitted QC: 2005-09-16
• Study First Posted: 2005-09-20
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Status Verified: 2015-10
• Last Update Submitted: 2017-07-07
• Last Update Posted: 2017-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Practice Change	practice guideline adherence	Enhancement of primary care practice performance and practice guideline adherence

Primary Outcome Measures

Name	Time	Method
practice adherence to diabetes guidelines	baseline, 1 year, 2 year, 3 year

Secondary Outcome Measures

Name	Time	Method
practice adherence to hypertension guideline	baseline, 1 year, 2 year, 3 year
practice adherence to asthma guidelines	baseline, 1 year, 2 year, 3 year
practice adherence to cholesterol screening guidelines	baseline, 1 year, 2 year, 3 year
practice adherence to tobacco history taking guidelines	baseline, 1 year, 2 year, 3 year