Allen 2009.
| Study characteristics | ||
| Methods | RCT Unit of randomisation: participant |
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| Participants | Place of recruitment: hospital acute stroke department Numbers randomised: total: 380 (I: 190; C: 190) % Completing final follow‐up: 84% to 100% depending on outcome measure Inclusion criteria: ischaemic stroke; NIHSS ≥ 1; discharged to home or short‐term rehabilitation/nursing facility (for < 8 weeks); no other illnesses that would dominate post‐discharge care; English‐speaking; no planned carotid endarterectomy Type of stroke: ischaemic (100%) Mean age (SE): I: 68 (1); C: 69 (1) Gender (% men): I: 48%; C: 52% Ethnicity (% African American): I: 17%; C: 15% Socio‐economic or socio‐demographic status (% married): I: 47%; C: 46% |
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| Interventions | Intervention details: participant received home assessment at 1 week from APN; individualised patient care plans developed by interdisciplinary team using evidence‐based recommendations; ongoing care management provided by APN for 6 months (telephone contact every week for first month and monthly thereafter; home visits as needed; physical therapist visits arranged as needed; liaison with social services; participants provided with personalised health record and pill organisers for risk factor management); primary care physicians provided with care plans/evidence‐based recommendations Location: community Mode of delivery: home visits and telephone follow‐up Personnel responsible for delivery: APN and interdisciplinary team Timing post‐stroke: discharge home Control: usual care provided by primary care physician; received postal stroke‐related educational materials every 2 months Usual care before discharge (I and C): organised stroke department care with enhanced discharge planning. Involved physical and psychological evaluation using standardised assessment tools; initiation of appropriate medication; development of individualised discharge plan; discharge summary sent to primary care physician |
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| Outcomes | 6 months: SBP > 140 mmHg; DBP > 90 mmHg; total cholesterol > 180 mg/dL; Hb1Ac > 6.5%; proportion of participants on anticoagulant; proportion of participants using method for medication compliance | |
| General Information | Funding: not reported Country of origin: USA Publication language: English |
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| Notes | Analysis method: stated intention‐to‐treat Risk of bias: unclear |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "The randomization sequence was by permuted blocks of fixed size (10) generated by study biostatisticians" |
| Allocation concealment (selection bias) | Low risk | "Group assignment was made by a research assistant using the sealed envelope method" |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Missing data reported by group but reasons not fully described Attrition (dependent on outcome): I: range 0/90 to 25/190 (reasons unclear); C: range 0/190 to 36/190 (reasons unclear) Judgement: not enough information to permit judgement (reasons for missing data not provided) |
| Selective reporting (reporting bias) | Low risk | Examination of study reports suggests that all outcomes were reported in the pre‐specified way |
| Other bias | Low risk | The study appears to be free of other sources of bias |