Program of Integrated Care for Patients With Chronic Obstructive Pulmonary Disease and Multiple Comorbidities
- Conditions
- Multiple ComorbidityChronic Obstructive Pulmonary Disease
- Registration Number
- NCT01648621
- Lead Sponsor
- Michael Garron Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 470
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The number of ED presentations 1 year after randomization.
- Secondary Outcome Measures
Name Time Method Hospital admission rates 1 year after randomization Number of hospitalized days over 1 year At one year after randomization Time to death During 12 months of intervention COPD severity measured by the BODE index at baseline, 6 months and 1 year 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).
Caregiver impact (Caregiver Impact Scale) at baseline, 6 months and 1 year This questionnaire assesses the impact of caregiving on 14 different domains (health, employment, family relations), using a 7-point Likert scale.
Change in health-related quality of life baseline at 90 days, 6 months and 1 year Measured using the EQ5D, St George's Respiratory Questionnaire, Hospital Anxiety and Depression Scale (HADS)
Change in COPD self-efficacy scale baseline at 90 days, 6 months and 1 year 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 90 days, 6 months and 1 year
Trial Locations
- Locations (2)
Southlake Regional Heath Centre
🇨🇦Newmarket, Ontario, Canada
Toronto East General Hospital
🇨🇦Toronto, Ontario, Canada
Southlake Regional Heath Centre🇨🇦Newmarket, Ontario, Canada