Nazareth 2001.

Study characteristics
Methods	Aim of study: to evaluate the effectiveness of a co‐ordinated hospital and community pharmacy discharge care plan for elderly patients (75+) on ≥ 4 medications discharged from hospital Study design: RCT (4 hospitals; individual block randomisation) Number of arms/groups: 2
Participants	Description: both patient/consumer and carer Geographic location: UK Setting: hospital discharge (hospital and patient's home) Inclusion criteria: 75+ years, ≥ 4 medications, discharged home from elderly care wards (3 acute general and 1 long‐stay hospital) to a catchment area of the 4 participating hospitals Exclusion criteria: could not speak English, too ill (no definition) Number of participants randomised: 362 (181 and 181) Number of participants included in analysis: 6 months: 306 (149 vs 157), interviewed: 132 vs 135 Age: mean ± SD: 84 ± 5.2 vs 84 ± 5.4 Gender: female: 62% vs 66% Ethnicity: 97% white; not reported for individual groups but not significantly different Number of medications: oral prescribed medications at discharge: mean 6, SD 2 overall (not reported for individual groups, but not significantly different) Frailty/Functional impairment: not specified Cognitive impairment: MMSE ≤ 15 (n = 39) excluded from interview process Comorbidities: mean 3 chronic medical conditions (not reported for individual groups, but not significantly different)
Interventions	Group 1 ‐ Co‐ordinated hospital and community pharmacy discharge: hospital pharmacist pre‐discharge intervention: assessment of medication, rationalisation of drug treatment, assessment of patients' ability to manage their medication, provision of information on current drugs, and liaison with carers and community professionals (pharmacy, GP, etc., where appropriate). Written discharge plan given to patient, community pharmacist, and GP. Community pharmacist intervention: home visit at days 7 to 14 to check for discrepancies between what patient is taking vs that prescribed on discharge, assessment of patient knowledge ad adherence, patient counselling, removal of excess medications, and additional visits prn Group 2 ‐ Usual care: standard procedures. Discharge letter to GP. Pharmacists did not provide review of discharge medications nor community follow‐up (Unclear what services the hospital pharmacy did provide ‐ presumably some discharge counselling) Co‐intervention: N/A Provider: pharmacist (hospital and community) Where: discharge and home When and how often: pre‐discharge in hospital and at home 7 to 14 days after discharge Intervention personalised: yes (mostly standardised, but intervention tailored to address individual patient's medication management problems)
Outcomes	Timing of outcome assessment: baseline and 6 months Medication adherence (subjective) : self‐reported adherence: obtained through prescription medicine interview; adherence to prescribed drugs in the previous week; validated self‐report semi‐structured interview (adherence score is out of 1, with 1 being 'total/highest' adherence); mean (SD) out of 1 Knowledge about medicines (subjective): self‐reported medication knowledge: prescription medicine interview ‐ patient's knowledge of prescribed drugs; validated self‐report semi‐structured interview (knowledge score is out of 1, with 1 being 'total/highest' knowledge); mean (SD) out of 1 Satisfaction with intervention (subjective): validated patient satisfaction questionnaire ‐ each item scored 1 to 4; mean score per item calculated Adverse clinical health outcomes (objective): service usage: hospital re‐admission, death, outpatient department attendance, GP attendance. Data from hospital and GP surveys
Notes	Trial registration: ISRCTN66700837 Consumer involvement: not specified Funding source: National Health Service Research and Development programme on the primary/secondary care interface Dropout: 32 vs 24 died Fidelity: discharge plans were 'misplaced' for 36/181 patients, and 52/181 patients did not receive the home visit
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	After consent, independently randomised by health authority's central community pharmacy office using computer‐generated random numbers. Block randomisation, stratified by trial centre
Allocation concealment (selection bias)	Low risk	Randomisation done by an independent group after consent obtained
Blinding of participants and personnel (performance bias) All outcomes	High risk	Not blinded
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Research assistant remained blinded to allocation or patient
Incomplete outcome data (attrition bias) All outcomes	High risk	High loss to follow‐up ‐ only 44% answered; 6‐month adherence
Selective reporting (reporting bias)	Low risk	As per methods
Other bias	High risk	Poor fidelity of the intervention: discharge plans were 'misplaced' for 36/181 patients, and 52/181 patients did not receive the home visit Sample size: "195 patients were required in each group" ‐ not reached