Rice 2010.
Study characteristics | |
Methods | Design: RCT Follow‐up: 12 months Control group: usual care |
Participants |
Recruitment: hospital (Veterans Affairs medical centres) Assessed for eligibility: 1739 Randomly assigned: SM: 372; UC: 371 Completed: SM: 336; UC: 323 Mean age: SM: 69.1 (SD 9.4) years; UC: 70.7 (SD 9.7) years Gender (% male): SM: 97.6%; UC: 98.4% COPD diagnosis: clinical diagnosis of COPD with post‐bronchodilator spirometry showing a FEV₁ < 70% predicted and a FEV₁/FVC < 0.70 Inclusion of participants in the acute phase: not reported Major inclusion criteria: a diagnosis of COPD at high risk of hospitalisation as predicted by one or more of the following during the previous year: hospital admission or ED visit for COPD, chronic home oxygen use or course of systemic corticosteroids for COPD Major exclusion criteria: inability to have access to a home telephone line or sign a consent form, any condition that would preclude effective participation in the study or likely to reduce life expectancy to less than a year |
Interventions |
Mode: group sessions at an outpatient clinic, one‐page handout summary and number for help line, telephone calls Duration: one face‐to‐face group session (60 to 90 min) by a respiratory therapist case manager, 12 monthly phone calls (10 to 15 minutes each) Professional: respiratory therapist case manager Assignment of case managers: "case managers were respiratory therapists who had completed a one‐day training session.” Appendix 1, p. 2. The case manager was 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 Self‐management topics: exercise, oximetry, recommendation concerning influenza and pneumococcal vaccinations, instruction in hand hygiene Behavioural change techniques: 4 clusters: goals and planning, feedback and monitoring, social support, shaping knowledge |
Outcomes | 1. Hospital admissions and ED visits for COPD 2. All‐cause hospitalisations and all‐cause ED visits 3. Hospital and intensive care unit lengths of stay 4. Respiratory medication use 5. Change in respiratory quality of life (SGRQ) 6. All‐cause mortality |
Notes | Source of funding: this study was supported by an unrestricted grant from the Veterans Integrated Service Network 23 Primary Care and Research Services and by the Center for Chronic Disease Outcomes Research, a Veterans Affairs Health Services Research and Development Center of Excellence Conflict of interest: several study authors (i.e. K.L.R., M.C., D.E.N.) reported that they or family members received financial benefits from a commercial entity. The other study authors (i.e. H.E.B., J.G., T.M.S., D.B.N., S.K., M.T., L.J.G., C.B., do not have financial relationships with a commercial entity that has an interest in the subject of this manuscript |