Back to resultsProgram of Integrated Care for Patients With Chronic Obstructive Pulmonary Disease and Multiple Comorbidities (PICCOPD+)
Primary Purpose
Chronic Obstructive Pulmonary Disease, Multiple Comorbidity
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
40 minute standardized education session
Individualized action plan
Individualized care plan
Standardized reinforcement/motivational interviewing and action plan teach-back sessions
Tele-home monitoring
Coordinated and improved communication
Priority access
Dictated patient summary
in-hospital rehabilitation/self-management program
Smoking cessation
Action plan Respirologist
Web based self management materials
Sponsored by
About this trial
This is an interventional prevention trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, case management
Eligibility Criteria
Inclusion Criteria:
- 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
AND HAVE
- ≥ 1 ED presentation/hospital admission in previous 12 months
- ≥ 50 years age
Exclusion Criteria:
- 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
Sites / Locations
- Southlake Regional Heath Centre
- Toronto East General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Case Management
Usual care
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
The number of ED presentations
Secondary Outcome Measures
Hospital admission rates
Number of hospitalized days over 1 year
Time to death
COPD severity measured by the BODE index
The BODE Index is a simple grading system for COPD comprising the Six Minute Walk Distance (6MWD), the Medical Research Council Dyspnea Scale (MMRC) and body mass index (BMI).
Change in health-related quality of life
Measured using the EQ5D, St George's Respiratory Questionnaire, Hospital Anxiety and Depression Scale (HADS)
Change in COPD self-efficacy scale
The COPD SES provides items with sufficient complexity in relation to the specific situation of managing with COPD. The CSES consists of Likert scale with 5 responses from "very confident" to "not at all confident" scoring 5 to 1 with 5 representing higher self-efficacy.
Patient satisfaction using the CSQ8
Caregiver impact (Caregiver Impact Scale)
This questionnaire assesses the impact of caregiving on 14 different domains (health, employment, family relations), using a 7-point Likert scale.
Full Information
NCT ID
NCT01648621
First Posted
July 19, 2012
Last Updated
November 10, 2016
Sponsor
Michael Garron Hospital
Collaborators
Southlake Regional Health Centre, University of Toronto, Ontario Ministry of Health and Long Term Care
1. Study Identification
Unique Protocol Identification Number
NCT01648621
Brief Title
Program of Integrated Care for Patients With Chronic Obstructive Pulmonary Disease and Multiple Comorbidities
Acronym
PICCOPD+
Official Title
Program of Integrated Care for Patients With Chronic Obstructive Pulmonary Disease and Multiple Comorbidities: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Michael Garron Hospital
Collaborators
Southlake Regional Health Centre, University of Toronto, Ontario Ministry of Health and Long Term Care
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease, Multiple Comorbidity
Keywords
COPD, case management
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
470 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Case Management
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
40 minute standardized education session
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Individualized action plan
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Individualized care plan
Intervention Description
Individualized care plan for management of COPD and comorbidities developed by the case manager in consultation with family physician and specialists.
Intervention Type
Behavioral
Intervention Name(s)
Standardized reinforcement/motivational interviewing and action plan teach-back sessions
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Tele-home monitoring
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Coordinated and improved communication
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Priority access
Intervention Description
Priority access to ambulatory clinics (Respirology and other specialties as required including Psychiatry) facilitated through the case manager.
Intervention Type
Behavioral
Intervention Name(s)
Dictated patient summary
Intervention Description
Dictated patient summary sent by specialists (e.g. respirologists) to family physicians following each respiratory centre visit (every 12 weeks)
Intervention Type
Behavioral
Intervention Name(s)
in-hospital rehabilitation/self-management program
Intervention Description
Referral to an 8 week in-hospital rehabilitation and self-management education program for patients that are:
have had a recent exacerbation, but are now clinically stable;
symptomatic COPD including reduced activity levels and increased dyspnea despite pharmacological treatment;
have stabilized comorbidity (no evidence of active ischemic, musculoskeletal, psychiatric or other systemic disease); and
have sufficient motivation to participate.
Intervention Type
Behavioral
Intervention Name(s)
Smoking cessation
Intervention Description
Referral to a smoking cessation program (as applicable)
Intervention Type
Behavioral
Intervention Name(s)
Action plan Respirologist
Intervention Description
Individualized action plan developed with treating respirologist at the discretion of the attending respirologist.
Intervention Type
Behavioral
Intervention Name(s)
Web based self management materials
Intervention Description
Referral to educational materials and resources (Living Well with COPD module printouts provided during COPD rehabilitation classes at a cost to the individual)
Primary Outcome Measure Information:
Title
The number of ED presentations
Time Frame
1 year after randomization.
Secondary Outcome Measure Information:
Title
Hospital admission rates
Time Frame
1 year after randomization
Title
Number of hospitalized days over 1 year
Time Frame
At one year after randomization
Title
Time to death
Time Frame
During 12 months of intervention
Title
COPD severity measured by the BODE index
Description
The BODE Index is a simple grading system for COPD comprising the Six Minute Walk Distance (6MWD), the Medical Research Council Dyspnea Scale (MMRC) and body mass index (BMI).
Time Frame
at baseline, 6 months and 1 year
Title
Change in health-related quality of life
Description
Measured using the EQ5D, St George's Respiratory Questionnaire, Hospital Anxiety and Depression Scale (HADS)
Time Frame
baseline at 90 days, 6 months and 1 year
Title
Change in COPD self-efficacy scale
Description
The COPD SES provides items with sufficient complexity in relation to the specific situation of managing with COPD. The CSES consists of Likert scale with 5 responses from "very confident" to "not at all confident" scoring 5 to 1 with 5 representing higher self-efficacy.
Time Frame
baseline at 90 days, 6 months and 1 year
Title
Patient satisfaction using the CSQ8
Time Frame
90 days, 6 months and 1 year
Title
Caregiver impact (Caregiver Impact Scale)
Description
This questionnaire assesses the impact of caregiving on 14 different domains (health, employment, family relations), using a 7-point Likert scale.
Time Frame
at baseline, 6 months and 1 year
Other Pre-specified Outcome Measures:
Title
Adherence to chronic disease management measures
Description
smoking cessation status (if applicable), influenza and pneumonia vaccination, up-to-date documented action plan, electronic medication reconciliation
Time Frame
at 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
AND HAVE
≥ 1 ED presentation/hospital admission in previous 12 months
≥ 50 years age
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Louise Rose, PhD
Organizational Affiliation
Toronto East General Hospital/University of Toronto
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ian Fraser, MD
Organizational Affiliation
Michael Garron Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southlake Regional Heath Centre
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y 2P9
Country
Canada
Facility Name
Toronto East General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4C 3E7
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
34495549
Citation
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.
Results Reference
derived
PubMed Identifier
29326330
Citation
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.
Results Reference
derived
Learn more about this trial
Program of Integrated Care for Patients With Chronic Obstructive Pulmonary Disease and Multiple Comorbidities
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