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Trial to Enhance Adherence to Multiple Guidelines (ULTRA)

This study has been completed.
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 ) Identifier:
First received: September 16, 2005
Last updated: October 27, 2015
Last verified: October 2015
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 Intervention
Cardiovascular Diseases
Diabetes Mellitus
Heart Diseases
Lung Diseases
Other: practice guideline adherence

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Using Learning Teams for Reflective Adaptation

Further study details as provided by Rutgers, The State University of New Jersey:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 60
Study Start Date: September 2002
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.


Ages Eligible for Study:   Child, Adult, Senior
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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00201227

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


Responsible Party: University of Medicine and Dentistry of New Jersey Identifier: NCT00201227     History of Changes
Other Study ID Numbers: 278
R01HL070800 ( US NIH Grant/Contract Award Number )
Study First Received: September 16, 2005
Last Updated: October 27, 2015

Additional relevant MeSH terms:
Diabetes Mellitus
Cardiovascular Diseases
Heart Diseases
Lung Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Respiratory Tract Diseases processed this record on May 25, 2017