Olesen 2014.

Study characteristics
Methods	Aim of study: this paper: to investigate the impact of pharmaceutical care on medication adherence, hospitalisation, and mortality of home‐living elderly (65+) patients prescribed polypharmacy. Overall study aim also included a third arm designed to assess the impact of an electronic reminder device on adherence Study design: RCT (2‐arm results from 3‐arm RCT; individual allocation) Number of arms/groups: 3 (2 discussed)
Participants	Description: patient/consumer Geographic location: Denmark Setting: patient's home (community) Inclusion criteria: ≥ 65 years, ≥ 5 current prescription drugs taken without assistance Exclusion criteria: residence in a nursing home, terminal illness, cognitive disorders such as dementia, medication supervised by healthcare providers, immigration to Denmark after January 2005, and severe motor impairment. Patients hospitalised longer than 7 days during the study were excluded before the final adherence evaluation Number of participants randomised: 630 (315, 315) Number of participants included in analysis: 517 (253, 264) Age: median (IQR, range): 74 (70 to 80, 65 to 94) vs 74 (70 to 80, 65 to 91) Gender: female: 133 (53%) vs 134 (51%) Ethnicity: not specified (recent immigrants excluded) Number of medications: oral prescription medications: median (IQR, range): 7 (5 to 8, 1 to 16) vs 7 (5 to 8, 3 to 18) Note: only meds taken throughout the 12‐month study period were included in the adherence assessment Frailty/Functional impairment: not specified Cognitive impairment: cognitive impairment such as dementia excluded Comorbidities: not specified
Interventions	Group 1 ‐ Pharmaceutical care: pharmacist home visit to deliver patient education, motivation, and regimen simplification. There was also a medication review to identify DRPs, but this was a minor component. Pharmacist examined medicines list with regard to possible side effects, interactions, and administration, then tried to make the regimen less complex, informed patients meanwhile about the drugs, listened to questions concerning the drugs, handed over information leaflets, and motivated adherence. Phone call at 3, 6, and 9 months to inquire about patient's condition and changes in the medicine, to uncover problems, and to answer questions Group 2 ‐ Reminder device: patient was given an e‐reminder device the size of a mobile phone that beeps when medications are due, and patient presses a button to indicate medications are taken Group 3 ‐ Usual care: no intervention (not described) Co‐intervention: all groups had regular nurse home visits to collect data for medication counts Provider: pharmacist Where: home and telephone When and how often: home at baseline, phone call at 3, 6, and 9 months Intervention personalised: yes ‐ personalised based on medication, but broad intervention the same
Outcomes	Timing of outcome assessment: 12 months (adherence), 24 months (health outcomes) Medication adherence (objective) : pill count of oral prescription drugs. Nurse visited patients at baseline, 6 months, and 12 months to photograph pills, which were counted later by a 'counter pen' (combination of a marker and a digital camera). Adherence rate (%) per drug calculated as mean adherence rate during 1 year. < 80% pills taken as prescribed = non‐adherence (> 100% pills taken was regarded as 100%, i.e. adherent) Adverse clinical health outcomes (objective): unplanned hospital admissions to medical departments obtained from Danish e‐Health Portal Adverse clinical health outcomes (objective): mortality data obtained from hospital e‐journal (electronic hospital record that automatically records information on all deceased patients)
Notes	Trial registration: N/A Consumer involvement: not specified Funding source: supported by the Danish Ministry of Health and the Association of Danish Pharmacies Dropout: excluded before intervention 31 and 31 (hospitalised or medications administered), withdrew 15 and 5 (lack of interest), lost to follow‐up 16 and 15 (outside region, no adherence count, died) Fidelity: poor ‐ adherence measured for only 48% of medications. No data provided regarding whether pharmacists delivered the intervention exactly as intended, nor whether all phone follow‐ups occurred Further information required:hospitalisation, mortality, and adherence data for electronic reminder group (email correspondence ‐ successful, but did not collect hospitalisation or mortality data; adherence was measured by a different method ‐ see Harbig 2012)
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	945 envelopes prepared, with each containing a study inclusion code. Patients selected an envelope at first home visit ‐ inadequate details provided re randomisation method
Allocation concealment (selection bias)	Unclear risk	At first home visit by a project nurse, patients were asked to select 1 envelope. Unclear if opaque envelopes, or order, or if nurse had knowledge
Blinding of participants and personnel (performance bias) All outcomes	High risk	Impossible to conceal the identity of patients in the pharmaceutical care group
Blinding of outcome assessment (detection bias) All outcomes	High risk	Does not specify any blinding ‐ project nurse photographed pills to be counted later by a counter pen
Incomplete outcome data (attrition bias) All outcomes	High risk	Able to assess adherence for only 48% of medications; insufficient detail as to why hospitalised patients were excluded
Selective reporting (reporting bias)	High risk	Three‐arm study but only 2 arms described. Outcomes mostly per methods, although additional adherence calculations were conducted that were not specified in methods (e.g. within‐group comparisons). Harbig paper describes third arm adherence by a different method
Other bias	Low risk	None noted ‐ adherence was very high in the control group, leaving little room for improvement