Begley 1997.
Study characteristics | ||
Methods |
Aim of study: to evaluate the influence of domiciliary pharmacist visits on medication management in a sample of elderly people recently discharged from hospital to their own homes Study design: RCT (3 hospitals; unit of allocation: individual) Number of arms/groups: 3 |
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Participants |
Description: patient/consumer Geographic location: UK Setting: community (post discharge) Inclusion criteria: ≥ 75 years, ≥ 3 prescribed drugs, ≥ 2 doses/d, under care of participating consultant, consented to participate, discharged to own home Number of participants randomised: 222 (A: 74, B: 75, C: 73) Number of participants included in analysis: 190 (A: 61, B: 63, C: 66) Age: median (range) = A: 84 (75 to 94), B: 81 (75 to 96), C: 82 (76 to 92) Gender: female A: 61%, B: 65%, C: 56% Ethnicity: not specified Number of medications: mean (SD) prescribed: A: 4.6 (1.8), B: 4.8 (1.6), C: 5.5 (1.9); mean (SD) OTC: A: 2.6 (0.7), B: 4.1 (1.4), C: 2.2 (1.8) Frailty/Functional impairment: not specified Cognitive impairment: abbreviated mental test mean (SD): A: 8.4 (1.5), B: 8.8 (1.1), C: 7.9 (1.3) Comorbidities: not specified |
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Interventions |
Group 1 ‐ Domiciliary pharmacy medication management visit: interview consisted of 6 sections: patient information, drug knowledge, patient dexterity, abbreviated mental test, medication management, compliance. Following interview, intervention group (A) received structured counselling on correct use, storage, and compliance (including simplifying regimen, emphasising importance of compliance, positive reinforcement) Group 2‐ Group (B): control, with home interview but no counselling Group 3 ‐ Group (C): control with no home visit (i.e. usual care) Co‐intervention: N/A Provider: pharmacist (investigator) Where: home (post discharge) When and how often: home visits for A and B occurred at baseline, 2 weeks, 1 month, 3 months, and 12 months Intervention personalised: yes ‐ counselling tailored to needs of the patient |
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Outcomes |
Timing of outcome assessment: 12 months Medication adherence (objective): percentage of medications with which participant is compliant using pill count. Researcher counted remaining tablets and measured volume of liquid. To improve reliability and accuracy, patients were asked to retain all used medicine containers for removal by the investigator Medication‐taking ability (objective): dexterity medication management. 5‐task dexterity test (e.g. opening child‐resistant closure) assessed at baseline and at 12 months; 1 point awarded for each successfully completed activity Knowledge about medicines (subjective): drug knowledge. Percentage of correct answers. Patients asked about name, purpose, dose, dosage frequency, and side effects. Accuracy compared to hospital discharge or GP instructions |
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Notes | Trial registration: N/A Consumer involvement: not specified Funding source: not specified Dropout: 4 withdrew (refused), 28 were lost to follow‐up (7 death, 7 hospitalised, 10 nursing home, 4 moved out of area) For this review, group A vs group C was considered under Comparison 1 ‐ Intervention vs control; group A vs group B was considered under Comparison 2 ‐ Intervention vs intervention |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Recruitment staff blinded to identity of groups; allocated patients consecutively to group A, B, or C. No random sequence generation |
Allocation concealment (selection bias) | Unclear risk | Allocated sequentially by blinded recruiter |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Unable to blind participants; patients knew what they were getting (respondent bias) |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Intervention delivered by same pharmacist taking outcome assessment |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Lost to follow‐up; reported only completed patients; rates seem similar across groups but breakdown of reasons not available for each group |
Selective reporting (reporting bias) | High risk | Some outcomes not reported at follow‐up (e.g. dexterity). Unclear whether results for adherence are patient‐reported or pill count; gives only 'difference' ‐ not raw scores for both |
Other bias | Low risk | Required sample size achieved (61 per group) |