Innovations in Treating COPD Exacerbations: Pilot Project on Action Plans Using New Technology.
- Conditions
- COPD
- Interventions
- Behavioral: COPD self-management using an action planDevice: Telesystem-Phone self-assessment/reporting systemOther: Nurse case manager support
- Registration Number
- NCT02275078
- Lead Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- 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)
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Interventional Nurse case manager support 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. Interventional COPD self-management using an action plan 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. Interventional Telesystem-Phone self-assessment/reporting system 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.
- Primary Outcome Measures
Name Time Method - Patient adherence to action plan 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 Outcome Measures
Name Time Method Respiratory medication adherence 12 months Patient monitoring will be done using the SmartInhaler for Advair and Ventolin on a sample of subjects.
Self-efficacy to manage exacerbations: 12 months Self-efficacy will be measured using a scale from 0-10 asking patients to rate their level of confidence, 0= not confident at all, 10=very confident, based on the "Understanding COPD questionnaire" \[Wilson 2007; O'Neill 2012\] and the principles of self-efficacy scale design, according to the construct proposed by Bandura.Level of confidence will be rated with respect to: taking medications as prescribed; items that are behavior-specific related to recognition and appropriate management of exacerbation including ability to identify signs of deterioration and need to initiate the prescribed action plan. CAT- The COPD Assessment Test (CAT) is a simple and quick questionnaire to give a reliable measure of health status in COPD which will complement existing approaches and will assess impact of COPD and exacerbation on the health of individual patients \[Jones P 2009; Jones PW 2009\].
Health care utilization 12 months The Exacerbation Questionnaire provides detailed information about contacts with health care providers for both respiratory and non-respiratory problems including unplanned physician visits, Emergency Department, use and hospitalizations since the previous call. Program resources: Practice staff who assist with patient identification and chart review will be paid for their time on an hourly basis. Nurse case managers will keep records of all contact with patients (content, time spent); information on interaction between the nurse case manager and other providers (physicians, pharmacists, etc.) including type of call, who is making the call, duration and reason will be recorded.
Phone System 12 months We will closely monitor use (according to symptom changes from the daily diary), record all feedback related to utilization (patients' responses using keypad vs. question verified when case manager call back the patient) and algorithm with corresponding status (Well, Worse, Alarm).
Trial Locations
- Locations (1)
Montreal Chest Institute
🇨🇦Montreal, Quebec, Canada