NCT01648621

Program of Integrated Care for Patients With Chronic Obstructive Pulmonary Disease and Multiple Comorbidities

Program of Integrated Care for Patients With Chronic Obstructive Pulmonary Disease and Multiple Comorbidities: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 470 (actual)
• Sponsor: Michael Garron Hospital · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

Many patients with chronic obstructive pulmonary disease (COPD) also have other diseases referred to as comorbidities. Often these patients require health care by a variety of health care professionals from services linked to hospitals and in the community. Unfortunately, sometimes it may be difficult for these patients to receive appropriate care in a timely manner resulting in a trip to the emergency department. As well, patients may benefit from education that enables them to recognize early signs indicating they are getting sicker and to self-manage their disease. Our study will examine a strategy that includes a case manager who will make weekly phone contact with COPD patients with comorbidity that present either to the emergency department or are admitted to hospital. Weekly contact will focus on teaching patients to recognize worsening symptoms and self-management strategies. The case manager will work with patients, caregivers, community health care providers and hospital specialists to promote communication and optimize care delivery. The investigators will examine the impact of our intervention on the need for emergency department visits and hospital admission. The investigators will also examine the impact on patients' health related quality of life, number of COPD exacerbations, and disease progression.

Conditions

• Chronic Obstructive Pulmonary Disease
• Multiple Comorbidity

Interventions

Type	Name	Description
BEHAVIORAL	40 minute standardized education session	40 minute standardized education session based on the Living Well with COPD Patient's Education Tool on study enrolment to assess and improve understanding of disease and ability to monitor symptoms and recognize exacerbation
BEHAVIORAL	Individualized action plan	Individualized action plan using the Living Well with COPD template with patient individualized modification to address management strategies for exacerbation of comorbidity developed during the initial 40 minute session with case manager.
BEHAVIORAL	Individualized care plan	Individualized care plan for management of COPD and comorbidities developed by the case manager in consultation with family physician and specialists.
BEHAVIORAL	Standardized reinforcement/motivational interviewing and action plan teach-back sessions	Standardized reinforcement/motivational interviewing and action plan teach-back sessions based on Living Well with COPD modules as well as assessment of symptoms, progress and problems, and problem solving by phone weekly for 12 weeks, then monthly for 9 months (21 sessions) (telephone script; NOTE: case managers will make up to 3 attempts to contact participants during each week of the 12 weeks of weekly phone calls before determining inability to contact the participant for that week.
BEHAVIORAL	Tele-home monitoring	Tele-home monitoring of SpO2, weight, dyspnea, sputum quantity and characteristics, and general well-being for maximum of 6 months. Inclusion criteria for tele-home monitoring: a. compatible phone line b. patient consent c. patient or caregiver demonstrated ability to use monitoring equipment d. patient unable to attend outpatient/community appointments for assessment and monitoring because of environmental barriers to access (e.g. physician's office only accessible by stairs) e. severe dyspnea on activities of daily living (Medical Research Council Questionnaire for Assessing Severity of Breathlessness \[MRC\] Class 4 \& 5 or modified MRC \[mMRC\] 3 \& 4) f. frequent ED visits (\> 2) in last 12 months 5\. 12 weeks of clinical stability with no ED visits.
BEHAVIORAL	Coordinated and improved communication	Coordinated and improved communication between the patient, family caregivers, family physicians, specialists, and Community Care Access Centres (CCACs) facilitated by the case manager. This will include phone contact by case manager to family physicians and CCAC case manager if applicable after initial enrollment, education session and development of action plan, then monthly to report general status as well as after subsequent ED presentations/hospital admissions
BEHAVIORAL	Priority access	Priority access to ambulatory clinics (Respirology and other specialties as required including Psychiatry) facilitated through the case manager.
BEHAVIORAL	Dictated patient summary	Dictated patient summary sent by specialists (e.g. respirologists) to family physicians following each respiratory centre visit (every 12 weeks)
BEHAVIORAL	in-hospital rehabilitation/self-management program	Referral to an 8 week in-hospital rehabilitation and self-management education program for patients that are: 1. have had a recent exacerbation, but are now clinically stable; 2. symptomatic COPD including reduced activity levels and increased dyspnea despite pharmacological treatment; 3. have stabilized comorbidity (no evidence of active ischemic, musculoskeletal, psychiatric or other systemic disease); and 4. have sufficient motivation to participate.
BEHAVIORAL	Smoking cessation	Referral to a smoking cessation program (as applicable)
BEHAVIORAL	Action plan Respirologist	Individualized action plan developed with treating respirologist at the discretion of the attending respirologist.
BEHAVIORAL	Web based self management materials	Referral to educational materials and resources (Living Well with COPD module printouts provided during COPD rehabilitation classes at a cost to the individual)

Timeline

• Start date: 2012-08-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2012-07-24
• Last updated: 2016-11-11

Locations

2 sites across 1 country: Canada