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

NCT ID: NCT02275078

Last Updated: 2018-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-15
• Study Completion Date: 2017-11-29

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.

Conditions

COPD

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

COPD self-management using an action plan

Intervention Type: BEHAVIORAL

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.

Telesystem-Phone self-assessment/reporting system

Intervention Type: DEVICE

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

Nurse case manager support

Intervention Type: OTHER

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

Interventions

COPD self-management using an action plan

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.

Intervention Type: BEHAVIORAL

Telesystem-Phone self-assessment/reporting system

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

Intervention Type: DEVICE

Nurse case manager support

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

Intervention Type: OTHER

Other Intervention Names

Device:Interactive

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).

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

McGill University Health Centre/Research Institute of the McGill University Health Centre

OTHER

Sponsor Role: lead

Responsible Party

Jean Bourbeau

Director of the Respiratory Epidemiology and Clinical Research Unit, McGill University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jean Bourbeau, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

McGill University Health Centre/Research Institute of the McGill University Health Centre

Locations

Montreal Chest Institute

Montreal, Quebec, Canada

Countries

Canada

References

Farias R, Sedeno M, Beaucage D, Drouin I, Ouellet I, Joubert A, Abimaroun R, Patel M, Abou Rjeili M, Bourbeau J. Innovating the treatment of COPD exacerbations: a phone interactive telesystem to increase COPD Action Plan adherence. BMJ Open Respir Res. 2019 Apr 9;6(1):e000379. doi: 10.1136/bmjresp-2018-000379. eCollection 2019.

Reference Type: DERIVED

PMID: 31178998 (View on PubMed)

Other Identifiers

12-053-BMD

Identifier Type: -

Identifier Source: org_study_id