Wood 1992.
Study characteristics | ||
Methods |
Aim of study: to determine the effects of an inpatient self‐administration of medication programme on compliance post discharge among elderly patients Study design: cluster‐RCT (2 wards intervention, 2 wards control, 1 intervention and 1 control per hospital) Number of arms/groups: 2 |
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Participants |
Description: patient/consumer Geographic location: UK Setting: hospital inpatient (pre‐discharge) from rehabilitation wards Inclusion criteria: rehabilitating with the ultimate aim of discharge to own home to live alone Exclusion criteria: nil mentioned Number of participants randomised: 33 (18 and 15) Number of participants included in analysis: 22 (11 and 11) Age: 85.4 ± 6.0 vs 84.8 ± 5.8 Gender: M:F = 1:8 (88.8% F) vs 1:6.5 (86.7%) Ethnicity: not specified Number of medications: number of dose‐taking events per day: 8.1 ± 5.0 vs 6.17 ± 5.0 Frailty/Functional impairment: not specified Cognitive impairment: abbreviated mental test score: 9.1 vs 9.4 Comorbidities: not specified |
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Interventions |
Group 1 ‐ Inpatient self‐administration: 3 distinct phases ‐ phase 1: medicine containers labelled as for discharge, drugs handed to patient at appropriate times, and full supervision of medication selection and ingestion. After 7 days, or earlier if appropriate, patient moved to phase 2; phase 2: patient required to request medication at appropriate times. After 7 error‐free days, patient moves on; phase 3: patient becomes totally responsible for his/her own medication. Medicines stored in locked cupboard. Compliance checked by tablet count Group 2 ‐ Usualcare: discharge medicines issued by nursing staff immediately before discharge Co‐intervention: N/A Provider: care team ‐ including pharmacist and nurse Where: hospital inpatient (pre‐discharge) When and how often: up to 3 weeks, inpatient Intervention personalised: yes ‐ moved through phases only if able to self‐administer medications |
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Outcomes |
Timing of outcome assessment: 2 weeks and 3 months post discharge Medication adherence (objective) : pill count: average percentage of non‐compliance calculated by pill count. No errors made, few errors (1% to 15% non‐compliance), and many errors (> 15%) |
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Notes | Trial registration: N/A Consumer involvement: not specified Funding source: not specified Dropout: 8 lost to follow‐up (4 and 4) plus 3 intervention could not be analysed ICC value unclear; unsuccessful contact with study authors likely due to age of study. Thus unit of analysis error exists |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Wards allocated ‐ randomisation method not stated |
Allocation concealment (selection bias) | Unclear risk | Not specified |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not blinded. Blinding was not possible for the type of intervention provided unless the researcher was not involved in providing the intervention; unclear if this had any impact on the outcome |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not specified whether home visit staff were blinded |
Incomplete outcome data (attrition bias) All outcomes | High risk | 4 lost to follow‐up from both groups, 3 intervention patients excluded because they had received new medications but transferred them to original containers = potentially unbalanced analysis |
Selective reporting (reporting bias) | Unclear risk | Additional data in results that are not specified in methods (e.g. errors sufficient to be detrimental to health) |
Other bias | Low risk | Recruitment bias (selective recruitment of cluster participants): low risk, recruitment occurred after allocation but all patients on the ward were included in the study (no exclusions), thus limited risk of recruitment bias |