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

About this trial
This is an interventional health services research trial for Asthma
Eligibility Criteria
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
NCT ID
NCT00201227
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)
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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Trial to Enhance Adherence to Multiple Guidelines
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