- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00202150
Primary Care Management/Action Plans for Advanced Chronic Diseases
Primary Care Management/Action Plans for Advanced Chronic Diseases (The RoadMAP Project)
Patients living with advanced chronic diseases (ACD), such as congestive heart failure (CHF) and chronic obstructive lung disease (COPD) present substantial care and economic challenges for the health care system due to frequent emergency room visits and acute care hospitalizations. Morbidity and mortality is high in these complex populations, and patient quality of life is often compromised.
Care of patients with ACD occurs across health care sectors, by providers in the acute, primary and community settings. Despite recent efforts to enhance the care of patients with ACD, through multidisciplinary disease management programs, variations and gaps exist along the continuum of care. The available evidence suggests that there are opportunities to optimize the primary care of patients with ACD. We are proposing to build upon the current evidence and guidelines for disease management programs, our existing specialized resources, our existing primary care practices, and develop and test a model of care that is primary care based, sensitive to the unique demands and characteristics of different primary practices. Our goal is to design linkages and care strategies of relevance and importance to the primary care providers who care for patients with advanced COPD and CHF.
This demonstration project is a randomized controlled clinical trial of the RoadMAP program (intervention) delivered by a Primary Care Nurse Specialist (PCNS) compared to usual care (control group). The primary outcomes will be degree of adherence to clinical practice guidelines. Secondary outcomes will be patient satisfaction, quality of life, use of community-based services, number of emergency room visits, and number of hospitalizations.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The available evidence suggests that there are opportunities to optimize the primary care of patients with ACD. We are proposing to build upon the current evidence and guidelines for disease management programs, our existing specialized resources, our existing primary care practices, and develop and test a model of care that is primary care based, sensitive to the unique demands and characteristics of different primary practices. Our goal is to design linkage and care strategies of relevance and importance to the primary care providers who care for patients with advanced COPD and CHF.
The study is a randomized controlled clinical trial of the RoadMAP program (intervention) delivered by a PCNS compared to usual care (control group). The primary outcome will be degree of adherence to clinical practice guidelines. Secondary outcomes will be patient satisfaction, quality of life, use of community-based services, number of emergency room visits, and number of hospitalizations. The purpose of the RoadMAP program is to improve the care of people with advanced stage COPD and CHF. Specifically, activities will be aimed at improving patients' self care ability, facilitating access to the most appropriate services, ensuring medical treatment according to consensus guidelines and promoting consistency of health care communication. Adherence to guidelines is a process that involves activities by the patient, PCNS, and the Primary Care Physician. The PCNS would follow-up the patient again at approximately one month after initial contact and then every 3 months, to assess and monitor adherence to the proposed MAP by the patient, the physician, and the nurse. Patients will have the option of returning to the physician office or to be monitored by phone. An office visit will be recommended if there is a perceived need for medical assessment and intervention. The family physician would continue to see the patient as required in order to carry out the medical portion of the MAP and to deal with other primary care problems as needed. Additionally, the PCNS would be available to work with nurses and other health professionals in each primary care practice in the provision of care to the ACD patients.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
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Ontario
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Kingston, Ontario, Canada, K7L 5E9
- Centre for Studies in Primary Care
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- diagnosis of Chronic Heart Failure
- diagnosis of Chronic Obstructive Pulmonary Disease
Exclusion Criteria:
- living in a nursing home
- inability to give informed consent
- involved in other studies of CHF or COPD
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Degree of adherence to the clinical practice guidelines.
|
Secondary Outcome Measures
Outcome Measure |
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Patient satisfaction
|
General health related quality of life
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Therapeutic Self Care
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Number of referrals to community-based services
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Number of emergency room visits annually
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Number of hospitalizations annually
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Marshall Godwin, MD MSc, Centre for Studies in Primary Care
- Principal Investigator: Joan Tranmer, RN PhD, Queen's University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- G03-02765
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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