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Trial to Enhance Adherence to Multiple Guidelines (ULTRA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00201227
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : July 11, 2017
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey ( 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.

Condition or disease Intervention/treatment Phase
Asthma Cardiovascular Diseases Atherosclerosis Diabetes Mellitus Heart Diseases Hypertension Lung Diseases Other: practice guideline adherence Not Applicable

Detailed Description:


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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
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

Arm Intervention/treatment
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
Usual care

Primary Outcome Measures :
  1. practice adherence to diabetes guidelines [ Time Frame: baseline, 1 year, 2 year, 3 year ]

Secondary Outcome Measures :
  1. practice adherence to hypertension guideline [ Time Frame: baseline, 1 year, 2 year, 3 year ]
  2. practice adherence to asthma guidelines [ Time Frame: baseline, 1 year, 2 year, 3 year ]
  3. practice adherence to cholesterol screening guidelines [ Time Frame: baseline, 1 year, 2 year, 3 year ]
  4. practice adherence to tobacco history taking guidelines [ Time Frame: baseline, 1 year, 2 year, 3 year ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
No eligibility criteria - study subjects are medical practices, so criteria are for clinicians and staff working within these practices.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00201227

Sponsors and Collaborators
University of Medicine and Dentistry of New Jersey
National Heart, Lung, and Blood Institute (NHLBI)
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Principal Investigator: Benjamin F Crabtree Univ of Med/Dent/NJ-R W Johnson Medical School

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Responsible Party: University of Medicine and Dentistry of New Jersey Identifier: NCT00201227    
Other Study ID Numbers: 278
R01HL070800 ( U.S. NIH Grant/Contract )
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: July 11, 2017
Last Verified: October 2015
Additional relevant MeSH terms:
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Lung Diseases
Cardiovascular Diseases
Heart Diseases
Vascular Diseases
Arterial Occlusive Diseases
Respiratory Tract Diseases