Innovations in Treating COPD Exacerbations: Pilot Project on Action Plans Using New Technology.

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 bronchitisdespite 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.

Official Title
-----------------
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)

Conditions
-----------------
COPD

Intervention / Treatment
-----------------
* Behavioral: COPD self-management using an action plan
* Device: Telesystem-Phone self-assessment/reporting system
* Other: Nurse case manager support


Participation Criteria
=================
Eligibility Criteria
-----------------
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).

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Interventional<br>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. | Behavioral: COPD self-management using an action plan<br>* Behavioral: Self-management education on the use of a self-administered prescription for exacerbation. Patients will be instructed to start treatment within 48 hours of experiencing an acute exacerbation of COPD and/or after starting their self-administered prescription.<br>Device: Telesystem-Phone self-assessment/reporting system<br>* Phone Self-Assessment/Reporting System. The second component of the intervention is the use of a computer-linked interactive phone assessment/reporting system that can assess respiratory status and notify the nurse case manager as needed<br>* Other names: Device:Interactive;Other: Nurse case manager support<br>* Support:Nurse Case Manager Phone Support . The nurse case manager will call patients under two conditions. The first is to provide regularly scheduled follow-up education and support.The nurse case manager will also phone patients in response to answers they have provided to the phone system. i.e Worsening COPD status<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - Patient adherence to action plan | Proportion of patients who initiate use of COPD Action Plan including starting exacerbation medications (i.e., antibiotics and/or prednisone) within 3 days. | within 3 days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory medication adherence | Patient monitoring will be done using the SmartInhaler for Advair and Ventolin on a sample of subjects. | 12 months | 
| Self-efficacy to manage exacerbations: | 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]. | 12 months | 
| Health care utilization | 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. | 12 months | 
| Phone System | 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). | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD, Action Plan, Telesystem, New technology