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
  Purpose

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
Asthma
Cardiovascular Diseases
Atherosclerosis
Diabetes Mellitus
Heart Diseases
Hypertension
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

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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)
Intervention Details:
    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.
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

No eligibility criteria

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00201227

Sponsors and Collaborators
University of Medicine and Dentistry of New Jersey
Investigators
Principal Investigator: Benjamin F Crabtree Univ of Med/Dent/NJ-R W Johnson Medical School
  More Information

Publications:

Responsible Party: rwj fam med, Professor, University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier: NCT00201227     History of Changes
Other Study ID Numbers: 278, R01HL070800, R01 HL70800
Study First Received: September 16, 2005
Last Updated: January 28, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Asthma
Atherosclerosis
Arteriosclerosis
Cardiovascular Diseases
Diabetes Mellitus
Heart Diseases
Hypertension
Lung Diseases
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 27, 2014