Kelly 2000.
Methods | STUDY DESIGN: Parallel group alternate allocation trial
LOCATION, NUMBER OF CENTRES: USA, Children's hospital
DURATION OF STUDY: 12 months No blinding of outcome assessor |
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Participants | N SCREENED: 102 families N RANDOMISED: 80 (baseline reported for 78 children who completed) N COMPLETED: 78 M = 54 F = 24 MEAN AGE: 2 to 5 years: 32; 6 to 10 years: 26; 11 to 15: 20 BASELINE DETAILS: 94% African American; all had Medicaid insurance; regular maintenance therapy: 47%; smoker in household: 48% INCLUSION CRITERIA: 2 to 16 years; ED presentation 2 or more times/hospitalised at least once in previous year; insurance coverage through Medicaid; primary care received in hospital outpatient clinic; not evaluated by an asthma specialist in preceding 2 years EXCLUSION CRITERIA: Not reported | |
Interventions | EDUCATION GROUP: One‐on‐one session with physician and outreach nurse including emphasis on regular medication use, action plan. Education reinforced during follow‐up by physician and outreach nurse. Outreach nurse followed up with families by phone (or left messages with friends/neighbours where no phone access was possible). Setting: Outpatient clinic and home CONTROL GROUP: Usual care as provided by primary care provider TREATMENT PERIOD: 1 session and subsequent phone calls during data collection (12 months) FOLLOW‐UP PERIOD: 12 months |
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Outcomes | ED visits, hospitalisation, quality of life, cost | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | High risk | Alternate allocation |
Allocation concealment? | High risk | Alternate allocation |
Incomplete outcome data addressed? All outcomes | High risk | Available case |