Program of Integrated Care for Patients With Chronic Obstructive Pulmonary Disease and Multiple Comorbidities (PICCOPD+)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Chronic Obstructive Pulmonary Disease Multiple Comorbidity |
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 Behavioral: Action plan Respirologist Behavioral: Web based self management materials |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Program of Integrated Care for Patients With Chronic Obstructive Pulmonary Disease and Multiple Comorbidities: A Randomized Controlled Trial |
- The number of ED presentations [ Time Frame: 1 year after randomization. ] [ Designated as safety issue: No ]
- Hospital admission rates [ Time Frame: 1 year after randomization ] [ Designated as safety issue: No ]
- Number of hospitalized days over 1 year [ Time Frame: At one year after randomization ] [ Designated as safety issue: No ]
- Time to death [ Time Frame: During 12 months of intervention ] [ Designated as safety issue: Yes ]
- COPD severity measured by the BODE index [ Time Frame: at baseline, 6 months and 1 year ] [ Designated as safety issue: No ]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 [ Time Frame: baseline at 90 days, 6 months and 1 year ] [ Designated as safety issue: No ]Measured using the EQ5D, St George's Respiratory Questionnaire, Hospital Anxiety and Depression Scale (HADS)
- Change in COPD self-efficacy scale [ Time Frame: baseline at 90 days, 6 months and 1 year ] [ Designated as safety issue: No ]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 [ Time Frame: 90 days, 6 months and 1 year ] [ Designated as safety issue: No ]
- Caregiver impact (Caregiver Impact Scale) [ Time Frame: at baseline, 6 months and 1 year ] [ Designated as safety issue: No ]This questionnaire assesses the impact of caregiving on 14 different domains (health, employment, family relations), using a 7-point Likert scale.
- Adherence to chronic disease management measures [ Time Frame: at 1 year ] [ Designated as safety issue: No ]smoking cessation status (if applicable), influenza and pneumonia vaccination, up-to-date documented action plan, electronic medication reconciliation
| Estimated Enrollment: | 470 |
| Study Start Date: | August 2012 |
| Estimated Primary Completion Date: | August 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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.
|
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. 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:
Referral to a smoking cessation program (as applicable)
|
|
Active Comparator: 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.
|
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:
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)
|
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Louise Rose, PhD | 416 978 3492 | louise.rose@utoronto.ca |
| Contact: Ian Fraser, MD | ifras@tegh.on.ca |
| Canada, Ontario | |
| Southlake Regional Heath Centre | Recruiting |
| Newmarket, Ontario, Canada, L3Y 2P9 | |
| Principal Investigator: Roshan Shafai | |
| Toronto East General Hospital | Recruiting |
| Toronto, Ontario, Canada, M4C 3E7 | |
| Contact: Louise Rose, PhD 4169783492 louise.rose@utoronto.ca | |
| Contact: Ian Fraser, MD 4164696580 ext 6653 ifras@tegh.on.ca | |
| Principal Investigator: Louise Rose, PhD | |
| Principal Investigator: | Louise Rose, PhD | Toronto East General Hospital/University of Toronto |
| Principal Investigator: | Ian Fraser, MD | Toronto East General Hospital |
More Information
No publications provided
| Responsible Party: | Louise Rose, Director of Research, Prolonged ventilation Weaning Centre, Toronto East General Hospital |
| ClinicalTrials.gov Identifier: | NCT01648621 History of Changes |
| Other Study ID Numbers: | TEGH001 PIC COPD |
| Study First Received: | July 19, 2012 |
| Last Updated: | January 13, 2013 |
| Health Authority: | Canada: Ministry of Health & Long Term Care, Ontario |
Keywords provided by Toronto East General Hospital:
|
COPD case management |
Additional relevant MeSH terms:
|
Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 19, 2013