Program of Integrated Care for Patients With Chronic Obstructive Pulmonary Disease and Multiple Comorbidities
NCT ID: NCT01648621
Last Updated: 2016-11-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
470 participants
INTERVENTIONAL
2012-08-31
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Case Management
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.
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
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.
Individualized care plan
Individualized care plan for management of COPD and comorbidities developed by the case manager in consultation with family physician and specialists.
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.
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.
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
Priority access
Priority access to ambulatory clinics (Respirology and other specialties as required including Psychiatry) facilitated through the case manager.
Dictated patient summary
Dictated patient summary sent by specialists (e.g. respirologists) to family physicians following each respiratory centre visit (every 12 weeks)
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.
Smoking cessation
Referral to a smoking cessation program (as applicable)
Usual care
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.
Dictated patient summary
Dictated patient summary sent by specialists (e.g. respirologists) to family physicians following each respiratory centre visit (every 12 weeks)
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.
Smoking cessation
Referral to a smoking cessation program (as applicable)
Action plan Respirologist
Individualized action plan developed with treating respirologist at the discretion of the attending respirologist.
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)
Interventions
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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
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.
Individualized care plan
Individualized care plan for management of COPD and comorbidities developed by the case manager in consultation with family physician and specialists.
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.
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.
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
Priority access
Priority access to ambulatory clinics (Respirology and other specialties as required including Psychiatry) facilitated through the case manager.
Dictated patient summary
Dictated patient summary sent by specialists (e.g. respirologists) to family physicians following each respiratory centre visit (every 12 weeks)
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.
Smoking cessation
Referral to a smoking cessation program (as applicable)
Action plan Respirologist
Individualized action plan developed with treating respirologist at the discretion of the attending respirologist.
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)
Eligibility Criteria
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Inclusion Criteria
Plus ≥ 2 comorbidities commonly associated with COPD as identified in the Canadian Thoracic Society COPD guidelines\*
1. Cardiovascular disease
2. Osteopenia and osteoporosis
3. Glaucoma and cataracts
4. Cachexia and malnutrition
5. Peripheral muscle dysfunction
6. Lung cancer
7. Metabolic syndrome (diabetes mellitus)
8. Depression
9. Chronic kidney disease OR Other conditions as primary admitting/presenting diagnosis + COPD as significant comorbidity + ≥ 1 other comorbidity
THAT
1. Get admitted to participating hospital; or
2. Present to participating hospital ED; or
3. Have first referral to Respiratory Centre/Respirology team
AND HAVE
1. ≥ 1 ED presentation/hospital admission in previous 12 months
2. ≥ 50 years age
Exclusion Criteria
2. Primary diagnosis of asthma
3. Terminal diagnosis (metastatic disease with a life expectancy of ≤ 6 months)
4. Dementia and absence of family caregiver able to assist with activation of the action plan and feedback on ongoing status and care coordination
5. Uncontrolled psychiatric illness
6. Inability to understand, read, and write English
7. No access to a phone
8. Inability to attend follow up at one of the participating sites
50 Years
ALL
No
Sponsors
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Southlake Regional Health Centre
OTHER
University of Toronto
OTHER
Ontario Ministry of Health and Long Term Care
OTHER_GOV
Michael Garron Hospital
OTHER
Responsible Party
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Louise Rose
Director of Research, Prolonged ventilation Weaning Centre
Principal Investigators
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Louise Rose, PhD
Role: PRINCIPAL_INVESTIGATOR
Toronto East General Hospital/University of Toronto
Ian Fraser, MD
Role: PRINCIPAL_INVESTIGATOR
Michael Garron Hospital
Locations
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Southlake Regional Heath Centre
Newmarket, Ontario, Canada
Toronto East General Hospital
Toronto, Ontario, Canada
Countries
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References
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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.
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.
Other Identifiers
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TEGH001 PIC COPD
Identifier Type: -
Identifier Source: org_study_id