Rose 2018.
Study characteristics | |
Methods | Design: RCT Follow‐up: 12 months Control group: usual care |
Participants |
Recruitment: hospital (inpatient) Assessed for eligibility: 8696 (2100 documented COPD diagnosis) Randomly assigned: SM: 237; UC: 238 Completed: SM: 207; UC: 191 Mean age: SM: 71 (SD 9.2) years; UC: 71 (SD 9.7) years Gender (% male): SM: 50; UC: 44 COPD diagnosis: GOLD criteria, confirmed with spirometry (FEV1/FVC ratio < 0.7) Inclusion of participants in acute phase: yes, on emergency department presentation and/or hospital admission for COPD exacerbation, or during attendance at respirology outpatient clinic Major inclusion criteria: COPD diagnosis according to GOLD criteria and published Canadian reference values confirmed by a respirologist or internist, ≥ 50 years of age, 1 or more emergency department visits or hospital admissions for COPD exacerbation in previous 12 months, and ≥ 2 prognostically‐important COPD‐associated comorbidities (as defined by GOLD and Canadian Thoracic Society Guidelines) identified via medical record screening Major exclusion criteria: primary diagnosis of asthma (action plans differ substantially), terminal diagnosis, dementia, uncontrolled psychiatric illness, inability to understand English, no telephone access, inability to attend follow‐up, resident in a long‐term care facility, enrolled in the provincial tele‐home monitoring programme, and no family physician |
Interventions |
Mode: individual session (standardised education session based on 'Living Well with COPD') at an outpatient clinic; telephone calls Duration: 1 face‐to‐face individual session (40 min), 21 phone calls (duration not specified). Professional: Case manager (nurse practitioner or respiratory therapist, both trained as COPD educators) Assignment of case managers: yes, accessible to participants during the complete follow‐up period Self‐management components: smoking cessation (optional), self‐recognition of COPD exacerbations, use of a COPD exacerbation action plan, COPD medication intake (i.e. adherence, inhalation technique), advance care planning Self‐management topics: exercise Behavioural change techniques: 3 clusters: goals and planning, feedback and monitoring, social support |
Outcomes | 1. Number of ED visits 2. Number of hospital admissions and hospitalised days 3. Mortality 4. Time to first ED presentation 5. BODE index 6. Quality of life (EQ‐5D‐3L, SGRQ) 7. Anxiety and depression (HADS) 8. Self‐efficacy (CSES) 9. Satisfaction (CSQ8) 10. Caregiver impact |
Notes | Source of funding: this trial was funded through the Building Bridges to Integrate Care (BRIDGES) program led by the University of Toronto’s Departments of Medicine and Family and Community Medicine and funded through the Ministry of Health and Long Term Care. L. Rose holds a CIHR New Investigator Award. Funding information for this article has been deposited with the Crossref Funder Registry. Conflict of interest: none declared |