Pilot Study Evaluating the Feasibility and Potential Benefits of a Novel Approach of COPD Self-management That Includes a Phone Assessment/Reporting System (Tele-system)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- - Patient adherence to action plan
Study Overview
Brief Summary
The purpose of this project is to conduct a pilot study evaluating the feasibility and potential benefits of a phone assessment/reporting system (tele-system) in addition to a written action plan and nurse case manager support to improve patients' adherence to COPD treatment in those at risk for exacerbations.
Primary objective: explore the potential benefits with respect to patient's adherence, i.e., prompt use of the antibiotic and/or prednisone in the event of an exacerbation, increased adherence to maintenance medication; to increase patient's self-efficacy" in self-managing their disease; and to use more efficiently program resources, i.e., the case-manager.
Secondary objectives:
To assess the proportion of patients who effectively self manage exacerbations by using their COPD Action Plan
To assess self management of COPD patients with respect to the increased adherence to regular respiratory medication, (SmartInhaler electronic monitoring);
To assess increased self-efficacy in COPD patients identifying and managing exacerbations (baseline vs after 12 months);
To assess symptoms recovery, health status improvement, and prevention of ER visits and hospital admissions for COPD exacerbations.
To assess the efficiency in using program resources,
To evaluate the feasibility of this treatment approach and to provide pilot data (needed for a larger multi-centre clinical trial;
To evaluate the feasibility and need of assessment during and after exacerbation onset, health-related quality of life and physical activity;
To evaluate the safety of this approach; this is in terms of the delay in starting prednisone and an unfavourable outcome (ER visits and/or hospitalization).
Detailed Description
BACKGROUND: Chronic Obstructive Pulmonary Disease (COPD) is the 4th leading cause of death in Canada and the only chronic disease where mortality rates continue to climb. Acute exacerbations are common.Unfortunately, exacerbations are often viewed as trivial events or "simple bronchitis"despite being linked with accelerated lung function decline, poor health, hospital admissions and premature death.Conversely, prompt treatment reduces recovery time,improves health status, and decrease hospital admissions.In most patients, exacerbations are managed either in primary care walk-in clinics or emergency departments (ED), resulting in suboptimal management and high utilization costs.Furthermore, less severe exacerbations (~60%) remain unreported and untreated, although these likely have a significant negative impact on health. In Canada, quality indicators suggest that chronic disease management remains suboptimal, especially in COPD.
RATIONALE: In COPD clinics, the investigators group and others have shown that patients who learn how to self-monitor and manage acute exacerbations by following a COPD Action Plan have better health outcomes and lower rates of health care utilization (unplanned office visits, ED use, and hospital admissions). Key elements of effective self-management programs include a written Action Plan, standing orders for exacerbation medications (antibiotics/prednisone), and self-management skills training combined with access to nurse case manager support. However, these programs are time and resource intensive and hence very challenging to implement across practices, especially in those that are not specialized. Recent advances in patient-provider communication technology, such as interactive phone systems, show promise in helping inform and motivate patients with asthma, diabetes and hypertension to effectively self monitor symptoms and better self-manage their diseases.Communication technology offers new opportunities to develop chronic disease self-management programs that can be easily implemented and less likely to place additional burden on busy practices.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients will be adults with COPD at high risk for exacerbations
- •Post bronchodilator spirometry FEV1 <80% pred. and FEV1/FVC <0.70
- •Aged ≥ 40 yrs
- •Smoking ≥ 10 pack-years
- •1 or more exacerbations requiring antibiotic or prednisone in the last year. (This is the population with the highest chance of having another exacerbation
- •Combination therapy LABA-ICS (Advair) with or without an anticholinergic (Spiriva or Atrovent) and a rescue SABA (Ventolin)
Exclusion Criteria
- •Combination therapy LABA-ICS other than Advair
- •Home oxygen for 18-24 hours/day
- •Chronic CO2 retention
- •Previous NIMV/MV
- •Cognitive impairment
- •Does not speak English or French fluently
- •Severe co-morbidities such as bronchiectasis with recurrent infections, severe left congestive heart failure
- •Survival <6 months
- •Any significant medical condition other than COPD that may also result in dyspnea (e.g. unstable angina, BMI > 40).
Arms & Interventions
Interventional
The program consists of 3 components: 1) COPD self-management using an Action Plan; 2) Telesystem-Phone self-assessment/reporting system; and 3) Nurse case manager support.
Intervention: COPD self-management using an action plan (Behavioral)
Interventional
The program consists of 3 components: 1) COPD self-management using an Action Plan; 2) Telesystem-Phone self-assessment/reporting system; and 3) Nurse case manager support.
Intervention: Telesystem-Phone self-assessment/reporting system (Device)
Interventional
The program consists of 3 components: 1) COPD self-management using an Action Plan; 2) Telesystem-Phone self-assessment/reporting system; and 3) Nurse case manager support.
Intervention: Nurse case manager support (Other)
Outcomes
Primary Outcomes
- Patient adherence to action plan
Time Frame: within 3 days.
Proportion of patients who initiate use of COPD Action Plan including starting exacerbation medications (i.e., antibiotics and/or prednisone) within 3 days.
Secondary Outcomes
- Respiratory medication adherence(12 months)
- Self-efficacy to manage exacerbations:(12 months)
- Health care utilization(12 months)
- Phone System(12 months)
Investigators
Jean Bourbeau
Director of the Respiratory Epidemiology and Clinical Research Unit, McGill University
McGill University Health Centre/Research Institute of the McGill University Health Centre