Ritchie 2016.
| Study characteristics | ||
| Methods |
Study design: single‐centre, single‐blinded, parallel individual randomised controlled trial in the United States Duration: 12 weeks Setting: urban academic hospital |
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| Participants |
Population: 137 adults recruited from an urban academic hospital in Alabama that serves central and northern regions Baseline characteristics: % Male: 41.5 IC and 68.7 UC, Mean age: 63.8 IC and 63.4 UC, % White: 67.7 IC and 67.2 UC, % African: not reported, % LTOT: not reported, % Home oxygen: not reported, % Anxiety or depression: not reported, Baseline medications: not reported, FEV₁ (% mean): not reported, FVC (% mean): not reported, FEV₁/FVC (% mean): not reported, Current smokers (n): IC 18 and UC 21, GOLD stage: not reported, COPD exacerbations last 12 months: not reported, Hospitalisations in past 12 months: not reported Inclusion criteria: English‐speaking, admitted to hospital from home, > 6 months' prognosis of COPD or CHF, access to telephone, expected to be discharged to home, impaired cognition (on validated scale) 6+ (eligible to participate, with caregiver willing to act as proxy), Medicare beneficiary Exclusion criteria: prognosis < 6 months, cognitive impairment without proxy/caregiver, heart and lung transplants, dialysis, already in CF programme/receiving intensive monitored care, ventricular assist device, use of pre‐planned phone service |
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| Interventions |
Run‐in: 1 visit by care transition nurse prior to discharge; measurements at baseline and 30 days Treatment arms
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| Outcomes |
Primary outcomes: re‐hospitalisation in 30 days Secondary outcomes: mortality, number of patient days in hospital vs at home at 30 days |
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| Notes |
Funding: Agency for HealthCare Research and Quality of Care of Complex Patients Grant Other identifier: NCT01135381 Note: randomisation was stratified by condition; COPD only participants were the only group studied |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomisation was conducted stratified according to disease group in two independent trials (permuted block design), through a computer based random number generator. "For patients randomised to the intervention, a computer‐generated alert was sent to the CTNs, who then met with the patient prior to discharge" |
| Allocation concealment (selection bias) | Unclear risk | Research personnel recruiting participants were blinded to group assignment, but no description of how this was achieved is provided |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Due to the nature of the intervention, care transition nurses or participants could not be blinded to the intervention |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcome assessors were blinded to group assignment |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | There was low % withdrawal in each group; reasons for withdrawal in COPD subgroups remain unclear |
| Selective reporting (reporting bias) | High risk | Outcomes were reported according to the protocol; however in the publication, study authors stated that 2 deaths occurred in the usual care group at 30 days, but this is not reported at clinicaltrials.gov and is not clearly explained in the publication |
| Other bias | Low risk | Although not reported in the publication, AEs and SAEs were reported at clinicaltrials.gov |