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. 2020 May 8;2020(5):CD012419. doi: 10.1002/14651858.CD012419.pub2

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
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
Interventions Group 1Inpatient 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 2Usualcare: 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
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%)
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
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