AsthmaULTRANCT00201227
Trial to Enhance Adherence to Multiple Guidelines
A study testing practice guideline adherence in people with Asthma and Cardiovascular Diseases, run by University of Medicine and Dentistry of New Jersey.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Asthma, Cardiovascular Diseases, Atherosclerosis
- What is being tested?
- practice guideline adherence
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Sep 2002to Aug 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria - study subjects are medical practices, so criteria are for clinicians and staff working within these practices.
About this study
Official title: Using Learning Teams for Reflective Adaptation
To evaluate whether the innovative multimethod assessment process/participatory quality improvement (MAP/PQI) intervention increases adherence to multiple cardiorespiratory guidelines in primary care practice.
Read the 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.
- Conditions
- Asthma, Cardiovascular Diseases, Atherosclerosis, Diabetes Mellitus, Heart Diseases, Hypertension
- Being tested
- practice guideline adherence
- Medical subject headings
- Asthma, Cardiovascular Diseases, Atherosclerosis, Diabetes Mellitus, Heart Diseases, Hypertension, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
practice guideline adherenceOther
Project facilitator assist primary care practice clinicians and staff work in effective quality improvement teams through the use of facilitated collaborative meetings.
| Study group | Role | What they receive |
|---|---|---|
| Practice Change | Experimental | Enhancement of primary care practice performance and practice guideline adherence Receives: Other: practice guideline adherence |
| Control | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
practice adherence to diabetes guidelines
Measured: baseline, 1 year, 2 year, 3 year
Secondary outcomes (4)
practice adherence to hypertension guideline
Measured: baseline, 1 year, 2 year, 3 year
practice adherence to asthma guidelines
Measured: baseline, 1 year, 2 year, 3 year
practice adherence to cholesterol screening guidelines
Measured: baseline, 1 year, 2 year, 3 year
practice adherence to tobacco history taking guidelines
Measured: baseline, 1 year, 2 year, 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startSep 2002
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Medicine and Dentistry of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Benjamin F Crabtree, Principal investigator, Univ of Med/Dent/NJ-R W Johnson Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00201227
- Sponsor's protocol ID
- 278
- Other IDs
- R01HL070800
- Acronym
- ULTRA
- Status last verified
- Oct 2015
- First submitted
- 16 Sep 2005
- Last updated
- 11 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
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. doi: 10.1016/s1553-7250(05)31057-9.
PubMed 16156191Crosson 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.
PubMed 16046562Cohen 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.
PubMed 15190858Ohman-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.
PubMed 18195310Strickland 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.
PubMed 17211824Hudson 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.
PubMed 16799365Crosson 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.
PubMed 17548848Hudson 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.
PubMed 18031947Ohman-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.
PubMed 17489913Hahn 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.
PubMed 17125419Ferrante 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.
PubMed 17067753
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Learning Teams for Reflective Adaptation
- ClinicalTrials.gov ID
- NCT00201227
- Acronym / sponsor ID
- ULTRA / 278
- Conditions
- Asthma, Cardiovascular Diseases, Atherosclerosis, Diabetes Mellitus, Heart Diseases, Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Medicine and Dentistry of New JerseyUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Sep 2002
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Practice Change | Experimental | Other: practice guideline adherenceEnhancement of primary care practice performance and practice guideline adherence |
| Control | No intervention | –Usual care |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| practice guideline adherenceProject facilitator assist primary care practice clinicians and staff work in effective quality improvement teams through the use of facilitated collaborative meetings. | Other | Practice Change |
Primary outcome
practice adherence to diabetes guidelines
Time frame: baseline, 1 year, 2 year, 3 year
4 secondary outcomes
practice adherence to hypertension guideline
Time frame: baseline, 1 year, 2 year, 3 year
practice adherence to asthma guidelines
Time frame: baseline, 1 year, 2 year, 3 year
practice adherence to cholesterol screening guidelines
Time frame: baseline, 1 year, 2 year, 3 year
practice adherence to tobacco history taking guidelines
Time frame: baseline, 1 year, 2 year, 3 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2017.
- Background: PubMed 16156191Stroebel 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.
- Background: PubMed 16046562Crosson 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.
- Background: PubMed 15190858Cohen 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.
- Background: PubMed 18195310Ohman-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.
- Background: PubMed 17211824Strickland 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.
- Background: PubMed 16799365Hudson 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.
- Background: PubMed 17548848Crosson 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.
- Background: PubMed 18031947Hudson 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.
- Background: PubMed 17489913Ohman-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.
- Background: PubMed 17125419Hahn 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.
- Background: PubMed 17067753Ferrante 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin F Crabtree principal investigator
Univ of Med/Dent/NJ-R W Johnson Medical School
Questions about this trial
What is this clinical trial studying?
A study testing practice guideline adherence in people with Asthma and Cardiovascular Diseases, run by University of Medicine and Dentistry of New Jersey.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
practice adherence to diabetes guidelines (time frame: baseline, 1 year, 2 year, 3 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00201227, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2017; AzTrials last refreshed its copy on 28 Oct 2026.