Program of Integrated Care for Patients With Chronic Obstructive Pulmonary Disease and Multiple Comorbidities (PICCOPD+)

This study is currently recruiting participants.
Verified January 2013 by Toronto East General Hospital
Sponsor:
Collaborators:
Southlake Regional Health Centre
University of Toronto
Ontario Ministry of Health and Long Term Care
Information provided by (Responsible Party):
Louise Rose, Toronto East General Hospital
ClinicalTrials.gov Identifier:
NCT01648621
First received: July 19, 2012
Last updated: January 13, 2013
Last verified: January 2013
  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

Resource links provided by NLM:


Further study details as provided by Toronto East General Hospital:

Primary Outcome Measures:
  • The number of ED presentations [ Time Frame: 1 year after randomization. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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.

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)
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:

  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)

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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*

  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:

  1. No access to primary care physician
  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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01648621

Contacts
Contact: Louise Rose, PhD 416 978 3492 louise.rose@utoronto.ca
Contact: Ian Fraser, MD ifras@tegh.on.ca

Locations
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         
Sponsors and Collaborators
Toronto East General Hospital
Southlake Regional Health Centre
University of Toronto
Ontario Ministry of Health and Long Term Care
Investigators
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 April 22, 2014