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

NCT01648621 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 470

Last updated 2016-11-11

No results posted yet for this study

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

Interventions

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)

Sponsors & Collaborators

  • Southlake Regional Health Centre

    collaborator OTHER
  • University of Toronto

    collaborator OTHER
  • Ontario Ministry of Health and Long Term Care

    collaborator OTHER_GOV
  • Michael Garron Hospital

    lead OTHER

Principal Investigators

  • Louise Rose, PhD · Toronto East General Hospital/University of Toronto

  • Ian Fraser, MD · Michael Garron Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01648621 on ClinicalTrials.gov