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Trial to Enhance Adherence to Multiple Guidelines (ULTRA)

Primary Purpose

Asthma, Cardiovascular Diseases, Atherosclerosis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
practice guideline adherence
Sponsored by
University of Medicine and Dentistry of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Asthma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

No eligibility criteria - study subjects are medical practices, so criteria are for clinicians and staff working within these practices.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Practice Change

    Control

    Arm Description

    Enhancement of primary care practice performance and practice guideline adherence

    Usual care

    Outcomes

    Primary Outcome Measures

    practice adherence to diabetes guidelines

    Secondary Outcome Measures

    practice adherence to hypertension guideline
    practice adherence to asthma guidelines
    practice adherence to cholesterol screening guidelines
    practice adherence to tobacco history taking guidelines

    Full Information

    First Posted
    September 16, 2005
    Last Updated
    July 7, 2017
    Sponsor
    University of Medicine and Dentistry of New Jersey
    Collaborators
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00201227
    Brief Title
    Trial to Enhance Adherence to Multiple Guidelines
    Acronym
    ULTRA
    Official Title
    Using Learning Teams for Reflective Adaptation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2002 (undefined)
    Primary Completion Date
    August 2008 (Actual)
    Study Completion Date
    August 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Medicine and Dentistry of New Jersey
    Collaborators
    National Heart, Lung, and Blood Institute (NHLBI)

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Asthma, Cardiovascular Diseases, Atherosclerosis, Diabetes Mellitus, Heart Diseases, Hypertension, Lung Diseases

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Practice Change
    Arm Type
    Experimental
    Arm Description
    Enhancement of primary care practice performance and practice guideline adherence
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Usual care
    Intervention Type
    Other
    Intervention Name(s)
    practice guideline adherence
    Intervention Description
    Project facilitator assist primary care practice clinicians and staff work in effective quality improvement teams through the use of facilitated collaborative meetings.
    Primary Outcome Measure Information:
    Title
    practice adherence to diabetes guidelines
    Time Frame
    baseline, 1 year, 2 year, 3 year
    Secondary Outcome Measure Information:
    Title
    practice adherence to hypertension guideline
    Time Frame
    baseline, 1 year, 2 year, 3 year
    Title
    practice adherence to asthma guidelines
    Time Frame
    baseline, 1 year, 2 year, 3 year
    Title
    practice adherence to cholesterol screening guidelines
    Time Frame
    baseline, 1 year, 2 year, 3 year
    Title
    practice adherence to tobacco history taking guidelines
    Time Frame
    baseline, 1 year, 2 year, 3 year

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    No eligibility criteria - study subjects are medical practices, so criteria are for clinicians and staff working within these practices.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Benjamin F Crabtree
    Organizational Affiliation
    Univ of Med/Dent/NJ-R W Johnson Medical School
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    16156191
    Citation
    Stroebel CK, McDaniel RR Jr, Crabtree BF, Miller WL, Nutting PA, Stange KC. How complexity science can inform a reflective process for improvement in primary care practices. Jt Comm J Qual Patient Saf. 2005 Aug;31(8):438-46. doi: 10.1016/s1553-7250(05)31057-9.
    Results Reference
    background
    PubMed Identifier
    16046562
    Citation
    Crosson JC, Stroebel C, Scott JG, Stello B, Crabtree BF. Implementing an electronic medical record in a family medicine practice: communication, decision making, and conflict. Ann Fam Med. 2005 Jul-Aug;3(4):307-11. doi: 10.1370/afm.326.
    Results Reference
    background
    PubMed Identifier
    15190858
    Citation
    Cohen D, McDaniel RR Jr, Crabtree BF, Ruhe MC, Weyer SM, Tallia A, Miller WL, Goodwin MA, Nutting P, Solberg LI, Zyzanski SJ, Jaen CR, Gilchrist V, Stange KC. A practice change model for quality improvement in primary care practice. J Healthc Manag. 2004 May-Jun;49(3):155-68; discussion 169-70.
    Results Reference
    background
    PubMed Identifier
    18195310
    Citation
    Ohman-Strickland PA, Orzano AJ, Hudson SV, Solberg LI, DiCiccio-Bloom B, O'Malley D, Tallia AF, Balasubramanian BA, Crabtree BF. Quality of diabetes care in family medicine practices: influence of nurse-practitioners and physician's assistants. Ann Fam Med. 2008 Jan-Feb;6(1):14-22. doi: 10.1370/afm.758.
    Results Reference
    background
    PubMed Identifier
    17211824
    Citation
    Strickland PA, Crabtree BF. Modelling effectiveness of internally heterogeneous organizations in the presence of survey non-response: an application to the ULTRA study. Stat Med. 2007 Apr 15;26(8):1702-11. doi: 10.1002/sim.2794.
    Results Reference
    background
    PubMed Identifier
    16799365
    Citation
    Hudson SV, Harris-Haywood S, Stange KC, Orzano AJ, Crabtree BF. Recruiting minority primary care practices into practice-based research. Med Care. 2006 Jul;44(7):696-700. doi: 10.1097/01.mlr.0000215818.38729.81.
    Results Reference
    background
    PubMed Identifier
    17548848
    Citation
    Crosson JC, Ohman-Strickland PA, Hahn KA, DiCicco-Bloom B, Shaw E, Orzano AJ, Crabtree BF. Electronic medical records and diabetes quality of care: results from a sample of family medicine practices. Ann Fam Med. 2007 May-Jun;5(3):209-15. doi: 10.1370/afm.696.
    Results Reference
    background
    PubMed Identifier
    18031947
    Citation
    Hudson SV, Ohman-Strickland P, Cunningham R, Ferrante JM, Hahn K, Crabtree BF. The effects of teamwork and system support on colorectal cancer screening in primary care practices. Cancer Detect Prev. 2007;31(5):417-23. doi: 10.1016/j.cdp.2007.08.004. Epub 2007 Nov 26.
    Results Reference
    background
    PubMed Identifier
    17489913
    Citation
    Ohman-Strickland PA, John Orzano A, Nutting PA, Perry Dickinson W, Scott-Cawiezell J, Hahn K, Gibel M, Crabtree BF. Measuring organizational attributes of primary care practices: development of a new instrument. Health Serv Res. 2007 Jun;42(3 Pt 1):1257-73. doi: 10.1111/j.1475-6773.2006.00644.x.
    Results Reference
    background
    PubMed Identifier
    17125419
    Citation
    Hahn KA, Strickland PA, Hamilton JL, Scott JG, Nazareth TA, Crabtree BF. Hyperlipidemia guideline adherence and association with patient gender. J Womens Health (Larchmt). 2006 Nov;15(9):1009-13. doi: 10.1089/jwh.2006.15.1009.
    Results Reference
    background
    PubMed Identifier
    17067753
    Citation
    Ferrante JM, Ohman-Strickland P, Hudson SV, Hahn KA, Scott JG, Crabtree BF. Colorectal cancer screening among obese versus non-obese patients in primary care practices. Cancer Detect Prev. 2006;30(5):459-65. doi: 10.1016/j.cdp.2006.09.003. Epub 2006 Oct 25.
    Results Reference
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