Primary Care Management/Action Plans for Advanced Chronic Diseases

Heart Failure Clinical Trial

Official title:

Primary Care Management/Action Plans for Advanced Chronic Diseases (The RoadMAP Project)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00202150
• Other study ID #: G03-02765
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 13, 2005
• Last updated: March 10, 2015
• Start date: September 2004
• Est. completion date: September 2006

Study information

• Verified date: March 2015
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: September 2006
• Est. primary completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Disease
• Chronic Obstructive Lung Disease
• Heart Failure
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Behavioral:
• Application of a management action plan

Locations

Country	Name	City	State
Canada	Centre for Studies in Primary Care	Kingston	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Queen's University	Ontario Ministry of Health and Long Term Care

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Degree of adherence to the clinical practice guidelines.
Secondary	Patient satisfaction
Secondary	General health related quality of life
Secondary	Therapeutic Self Care
Secondary	Number of referrals to community-based services
Secondary	Number of emergency room visits annually
Secondary	Number of hospitalizations annually