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Primary Care Management/Action Plans for Advanced Chronic Diseases
This study has been completed.
First Received: September 13, 2005   Last Updated: May 17, 2007   History of Changes
Sponsors and Collaborators: Queen's University
Ontario Ministry of Health and Long Term Care
Information provided by: Queen's University
ClinicalTrials.gov Identifier: NCT00202150
  Purpose

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.


Condition Intervention Phase
Heart Failure
Chronic Obstructive Lung Disease
Behavioral: Application of a management action plan
Phase II
Phase III

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease) Coping with Chronic Illness Heart Failure
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: Primary Care Management/Action Plans for Advanced Chronic Diseases (The RoadMAP Project)

Further study details as provided by Queen's University:

Primary Outcome Measures:
  • Degree of adherence to the clinical practice guidelines.

Secondary Outcome Measures:
  • Patient satisfaction
  • General health related quality of life
  • Therapeutic Self Care
  • Number of referrals to community-based services
  • Number of emergency room visits annually
  • Number of hospitalizations annually

Enrollment: 139
Study Start Date: September 2004
Study Completion Date: September 2006
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.

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00202150

Locations
Canada, Ontario
Centre for Studies in Primary Care
Kingston, Ontario, Canada, K7L 5E9
Sponsors and Collaborators
Queen's University
Ontario Ministry of Health and Long Term Care
Investigators
Principal Investigator: Marshall Godwin, MD MSc Centre for Studies in Primary Care
Principal Investigator: Joan Tranmer, RN PhD Kingston General Hospital
  More Information

No publications provided

Study ID Numbers: G03-02765
Study First Received: September 13, 2005
Last Updated: May 17, 2007
ClinicalTrials.gov Identifier: NCT00202150     History of Changes
Health Authority: Canada: Health Canada

Keywords provided by Queen's University:
Advanced chronic diseases
Heart failure
Chronic obstructive lung disease
primary care
Chronic Care

Study placed in the following topic categories:
Heart Failure
Lung Diseases, Obstructive
Heart Diseases
Respiratory Tract Diseases
Lung Diseases
Chronic Disease
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:
Disease Attributes
Lung Diseases, Obstructive
Heart Failure
Heart Diseases
Pathologic Processes
Respiratory Tract Diseases
Lung Diseases
Cardiovascular Diseases
Chronic Disease
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on May 07, 2009