Trial to Enhance Adherence to Multiple Guidelines (ULTRA)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
rwj fam med, University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier:
NCT00201227
First received: September 16, 2005
Last updated: January 28, 2013
Last verified: August 2008

September 16, 2005
January 28, 2013
September 2002
August 2008   (final data collection date for primary outcome measure)
practice adherence to diabetes guidelines [ Time Frame: baseline, 1 year, 2 year, 3 year ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00201227 on ClinicalTrials.gov Archive Site
  • practice adherence to hypertension guideline [ Time Frame: baseline, 1 year, 2 year, 3 year ] [ Designated as safety issue: No ]
  • practice adherence to asthma guidelines [ Time Frame: baseline, 1 year, 2 year, 3 year ] [ Designated as safety issue: No ]
  • practice adherence to cholesterol screening guidelines [ Time Frame: baseline, 1 year, 2 year, 3 year ] [ Designated as safety issue: No ]
  • practice adherence to tobacco history taking guidelines [ Time Frame: baseline, 1 year, 2 year, 3 year ] [ Designated as safety issue: No ]
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Trial to Enhance Adherence to Multiple Guidelines
Using Learning Teams for Reflective Adaptation

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

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.

Interventional
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Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Health Services Research
  • Asthma
  • Cardiovascular Diseases
  • Atherosclerosis
  • Diabetes Mellitus
  • Heart Diseases
  • Hypertension
  • Lung Diseases
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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
August 2008
August 2008   (final data collection date for primary outcome measure)

No eligibility criteria

Both
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No
Contact information is only displayed when the study is recruiting subjects
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NCT00201227
278, R01HL070800, R01 HL70800
Yes
rwj fam med, University of Medicine and Dentistry New Jersey
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
Rutgers, The State University of New Jersey
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP