Trial to Enhance Adherence to Multiple Guidelines (ULTRA)

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Asthma; Cardiovascular Diseases; Atherosclerosis; Diabetes Mellitus; Heart Diseases; Hypertension; Lung Diseases	Other: practice guideline adherence	Not Applicable

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	60 participants
Allocation:	Randomized
Intervention Model:	Factorial Assignment
Masking:	None (Open Label)
Primary Purpose:	Health Services Research
Official Title:	Using Learning Teams for Reflective Adaptation
Study Start Date :	September 2002
Actual Primary Completion Date :	August 2008
Actual Study Completion Date :	August 2008

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Practice Change; Enhancement of primary care practice performance and practice guideline adherence	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.
No Intervention: Control; Usual care

Outcome Measures

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Primary Outcome Measures :

1. practice adherence to diabetes guidelines [ Time Frame: baseline, 1 year, 2 year, 3 year ]

Secondary Outcome Measures :

1. practice adherence to hypertension guideline [ Time Frame: baseline, 1 year, 2 year, 3 year ]
2. practice adherence to asthma guidelines [ Time Frame: baseline, 1 year, 2 year, 3 year ]
3. practice adherence to cholesterol screening guidelines [ Time Frame: baseline, 1 year, 2 year, 3 year ]
4. practice adherence to tobacco history taking guidelines [ Time Frame: baseline, 1 year, 2 year, 3 year ]

Eligibility Criteria

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Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Sponsors and Collaborators

University of Medicine and Dentistry of New Jersey

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Principal Investigator:	Benjamin F Crabtree	Univ of Med/Dent/NJ-R W Johnson Medical School

More Information

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Publications:

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.

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.

Cohen D, McDaniel RR Jr, Crabtree BF, Ruhe MC, Weyer SM, Tallia A, Miller WL, Goodwin MA, Nutting P, Solberg LI, Zyzanski SJ, Jaén 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.

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.

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.

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.

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.

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. Epub 2007 Nov 26.

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.

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.

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. Epub 2006 Oct 25.

Responsible Party:	University of Medicine and Dentistry of New Jersey
ClinicalTrials.gov Identifier:	NCT00201227 History of Changes
Other Study ID Numbers:	278; R01HL070800 ( U.S. NIH Grant/Contract )
First Posted:	September 20, 2005
Last Update Posted:	July 11, 2017
Last Verified:	October 2015

Additional relevant MeSH terms:

Diabetes Mellitus; Cardiovascular Diseases; Heart Diseases; Atherosclerosis; Lung Diseases; Glucose Metabolism Disorders	Metabolic Diseases; Endocrine System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Respiratory Tract Diseases