Clinical trial NCT01648621: Program of Integrated Care for Patients With Chronic Obstructive Pulmonary Disease and Multiple Comorbidities
Official title: Program of Integrated Care for Patients With Chronic Obstructive Pulmonary Disease and Multiple Comorbidities: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Multiple Comorbidity
Keywords: COPD
case management
Lead sponsor: Michael Garron Hospital
Sponsor class: OTHER
Collaborators: name: Southlake Regional Health Centre
name: University of Toronto
name: Ontario Ministry of Health and Long Term Care
First posted: 2012-07-24
Enrollment: 470
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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\*

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

Primary outcomes:
measure: The number of ED presentations
timeFrame: 1 year after randomization.
Secondary outcomes:
measure: Hospital admission rates
timeFrame: 1 year after randomization
measure: Number of hospitalized days over 1 year
timeFrame: At one year after randomization
measure: Time to death
timeFrame: During 12 months of intervention
measure: COPD severity measured by the BODE index
timeFrame: at baseline, 6 months and 1 year
measure: Change in health-related quality of life
timeFrame: baseline at 90 days, 6 months and 1 year
measure: Change in COPD self-efficacy scale
timeFrame: baseline at 90 days, 6 months and 1 year
measure: Patient satisfaction using the CSQ8
timeFrame: 90 days, 6 months and 1 year
measure: Caregiver impact (Caregiver Impact Scale)
timeFrame: at baseline, 6 months and 1 year
Other outcomes:
measure: Adherence to chronic disease management measures
timeFrame: at 1 year
Locations:
city: Newmarket
country: Canada
facility: Southlake Regional Heath Centre
state: Ontario
city: Toronto
country: Canada
facility: Toronto East General Hospital
state: Ontario
Study officials:
affiliation: Toronto East General Hospital/University of Toronto
name: Louise Rose, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Michael Garron Hospital
name: Ian Fraser, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.