Trial to Enhance Adherence to Multiple Guidelines (ULTRA)
| Tracking Information | |||||
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| First Received Date ICMJE | September 16, 2005 | ||||
| Last Updated Date | January 28, 2013 | ||||
| Start Date ICMJE | September 2002 | ||||
| Primary Completion Date | August 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
practice adherence to diabetes guidelines [ Time Frame: baseline, 1 year, 2 year, 3 year ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00201227 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Trial to Enhance Adherence to Multiple Guidelines | ||||
| Official Title ICMJE | Using Learning Teams for Reflective Adaptation | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Health Services Research |
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| Condition ICMJE |
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| Intervention ICMJE | 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. |
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| Study Arm (s) | Not Provided | ||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 60 | ||||
| Completion Date | August 2008 | ||||
| Primary Completion Date | August 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | No eligibility criteria |
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00201227 | ||||
| Other Study ID Numbers ICMJE | 278, R01HL070800, R01 HL70800 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | rwj fam med, University of Medicine and Dentistry New Jersey | ||||
| Study Sponsor ICMJE | University of Medicine and Dentistry New Jersey | ||||
| Collaborators ICMJE | National Heart, Lung, and Blood Institute (NHLBI) | ||||
| Investigators ICMJE |
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| Information Provided By | University of Medicine and Dentistry New Jersey | ||||
| Verification Date | August 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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