Trial to Enhance Adherence to Multiple Guidelines (ULTRA)
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|ClinicalTrials.gov Identifier: NCT00201227|
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : July 11, 2017
|Condition or disease||Intervention/treatment||Phase|
|Asthma Cardiovascular Diseases Atherosclerosis Diabetes Mellitus Heart Diseases Hypertension Lung Diseases||Other: practice guideline adherence||Not Applicable|
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".
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Using Learning Teams for Reflective Adaptation|
|Study Start Date :||September 2002|
|Actual Primary Completion Date :||August 2008|
|Actual Study Completion Date :||August 2008|
Experimental: Practice Change
Enhancement of primary care practice performance and practice guideline adherence
Other: practice guideline adherence
Project facilitator assist primary care practice clinicians and staff work in effective quality improvement teams through the use of facilitated collaborative meetings.
No Intervention: Control
- practice adherence to diabetes guidelines [ Time Frame: baseline, 1 year, 2 year, 3 year ]
- practice adherence to hypertension guideline [ Time Frame: baseline, 1 year, 2 year, 3 year ]
- practice adherence to asthma guidelines [ Time Frame: baseline, 1 year, 2 year, 3 year ]
- practice adherence to cholesterol screening guidelines [ Time Frame: baseline, 1 year, 2 year, 3 year ]
- practice adherence to tobacco history taking guidelines [ Time Frame: baseline, 1 year, 2 year, 3 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00201227
|Principal Investigator:||Benjamin F Crabtree||Univ of Med/Dent/NJ-R W Johnson Medical School|