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

NCT01648621 | Completed DMC

• 1 other identifier: TEGH001 PIC COPD
• Study Type: interventional
• Target: 470
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

COPD; case management

Outcome Measures

Primary Outcomes (1)

• The number of ED presentations

  1 year after randomization.

Secondary Outcomes (8)

• Hospital admission rates

  1 year after randomization

• Number of hospitalized days over 1 year

  At one year after randomization

• Time to death

  During 12 months of intervention

• COPD severity measured by the BODE index

  at baseline, 6 months and 1 year

• Change in health-related quality of life

  baseline at 90 days, 6 months and 1 year

Other Outcomes (1)

• Adherence to chronic disease management measures

  at 1 year

Study Arms (2)

Case Management

EXPERIMENTAL

In addition to usual care, the intervention group will receive case management that includes: 40 minute standardized education session, an individualized action plan, an individualized care plan for management of COPD and comorbidities, standardized reinforcement/motivational interviewing and action plan teach-back sessions and assessment of symptoms, progress and problems, and problem solving by phone weekly for 12 weeks, then monthly for 9 months (21 sessions), tele-home monitoring, coordinated and improved communication between the patient, family caregivers, family physicians, specialists, and CCAC facilitated by the case manager, priority access to ambulatory clinics.

Behavioral: 40 minute standardized education session; Behavioral: Individualized action plan; Behavioral: Individualized care plan; Behavioral: Standardized reinforcement/motivational interviewing and action plan teach-back sessions; Behavioral: Tele-home monitoring; Behavioral: Coordinated and improved communication; Behavioral: Priority access; Behavioral: Dictated patient summary; Behavioral: in-hospital rehabilitation/self-management program; Behavioral: Smoking cessation

Usual care

ACTIVE COMPARATOR

Usual care for these patients comprises: Dictated patient summary, referral to an 8 week in-hospital rehabilitation and self-management education program, referral to a smoking cessation program (as applicable), individualized action plan developed with treating respirologist at the discretion of the attending respirologist, Referral to web based educational materials and resources.

Behavioral: Dictated patient summary; Behavioral: in-hospital rehabilitation/self-management program; Behavioral: Smoking cessation; Behavioral: Action plan Respirologist; Behavioral: Web based self management materials

Interventions

40 minute standardized education session BEHAVIORAL

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

Case Management

Individualized action plan BEHAVIORAL

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.

Case Management

Individualized care plan BEHAVIORAL

Individualized care plan for management of COPD and comorbidities developed by the case manager in consultation with family physician and specialists.

Case Management

Standardized reinforcement/motivational interviewing and action plan teach-back sessions BEHAVIORAL

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.

Case Management

Tele-home monitoring BEHAVIORAL

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.

Case Management

Coordinated and improved communication BEHAVIORAL

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

Case Management

Priority access BEHAVIORAL

Priority access to ambulatory clinics (Respirology and other specialties as required including Psychiatry) facilitated through the case manager.

Case Management

Dictated patient summary BEHAVIORAL

Dictated patient summary sent by specialists (e.g. respirologists) to family physicians following each respiratory centre visit (every 12 weeks)

Case Management; Usual care

in-hospital rehabilitation/self-management program BEHAVIORAL

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.

Case Management; Usual care

Smoking cessation BEHAVIORAL

Referral to a smoking cessation program (as applicable)

Case Management; Usual care

Action plan Respirologist BEHAVIORAL

Individualized action plan developed with treating respirologist at the discretion of the attending respirologist.

Usual care

Web based self management materials BEHAVIORAL

Referral to educational materials and resources (Living Well with COPD module printouts provided during COPD rehabilitation classes at a cost to the individual)

Usual care

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• COPD defined as chronic irreversible airflow limitation with FEV1 \< lower limit of normal for age as % predicted and a FEV1/FVC ratio \< than lower limit of normal (usually 70%) \[5\]
• Plus ≥ 2 comorbidities commonly associated with COPD as identified in the Canadian Thoracic Society COPD guidelines\*
• Cardiovascular disease
• Osteopenia and osteoporosis
• Glaucoma and cataracts
• Cachexia and malnutrition
• Peripheral muscle dysfunction
• Lung cancer
• Metabolic syndrome (diabetes mellitus)
• Depression
• Chronic kidney disease OR Other conditions as primary admitting/presenting diagnosis + COPD as significant comorbidity + ≥ 1 other comorbidity
• THAT
• Get admitted to participating hospital; or
• Present to participating hospital ED; or
• Have first referral to Respiratory Centre/Respirology team

You may not qualify if:

• No access to primary care physician
• Primary diagnosis of asthma
• Terminal diagnosis (metastatic disease with a life expectancy of ≤ 6 months)
• Dementia and absence of family caregiver able to assist with activation of the action plan and feedback on ongoing status and care coordination
• Uncontrolled psychiatric illness
• Inability to understand, read, and write English
• No access to a phone
• Inability to attend follow up at one of the participating sites

Sponsors & Collaborators

• Michael Garron Hospital: lead
• Southlake Regional Health Centre: collaborator
• University of Toronto: collaborator
• Ontario Ministry of Health and Long Term Care: collaborator

Study Sites (2)

Southlake Regional Heath Centre

Newmarket, Ontario, L3Y 2P9, Canada

Location

Toronto East General Hospital

Toronto, Ontario, M4C 3E7, Canada

Location

Related Publications (2)

• Poot CC, Meijer E, Kruis AL, Smidt N, Chavannes NH, Honkoop PJ. Integrated disease management interventions for patients with chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2021 Sep 8;9(9):CD009437. doi: 10.1002/14651858.CD009437.pub3.

  PMID: 34495549 DERIVED

• Rose L, Istanboulian L, Carriere L, Thomas A, Lee HB, Rezaie S, Shafai R, Fraser I. Program of Integrated Care for Patients with Chronic Obstructive Pulmonary Disease and Multiple Comorbidities (PIC COPD+): a randomised controlled trial. Eur Respir J. 2018 Jan 11;51(1):1701567. doi: 10.1183/13993003.01567-2017. Print 2018 Jan.

  PMID: 29326330 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Louise Rose, PhD

  Toronto East General Hospital/University of Toronto

  PRINCIPAL INVESTIGATOR

• Ian Fraser, MD

  Michael Garron Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research, Prolonged ventilation Weaning Centre

Study Record Dates

• First Submitted: July 19, 2012
• First Posted: July 24, 2012
• Study Start: August 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: November 11, 2016

Record last verified: 2016-11

Locations

CA (2)