Haag 2016.

Study characteristics
Methods	Aim of study: to assess the impact of comprehensive pharmacist‐provided telephonic MTM on care quality in an outpatient care transition programme (CTP) for high‐risk adults aged ≥ 60 years Study design: RCT (unit of allocation: individual) Number of arms/groups: 2
Participants	Description: patient/consumer Geographic location: USA Setting: outpatient clinic (primary care work group at tertiary care academic medical centre) Inclusion criteria: ≥ 60 years, independent living, enrolled in local care transition programme (CTP). Enrolled in CTP during hospitalisation if in primary care work group, resided within 20 minutes drive, and predicted high risk of health utilisation) Number of participants randomised: 25 Number of participants included in analysis: 22 Age: median (IQR): 81 (78 to 85) intervention vs 86 (79.5 to 87) control Gender: female: 4 (31%) vs 2 (17%) Ethnicity: white: 13 (100%) vs 11 (92%) Number of medications: all medications listed on home medication list (prescription, non‐prescription, and herbal); median (IQR): 17 (12 to 20) intervention vs 15.5 (13 to 18.5) control Frailty/Functional impairment: Elder Risk Assessment Index score: median (IQR) 18 (17 to 20) vs 20 (17.5 to 22.5) Cognitive impairment: dementia excluded Comorbidities: not specified
Interventions	Group 1 ‐ Medication therapy management (MTM): MTM consultation with a pharmacist by telephone 3 to 7 business days after hospital discharge. Intervention complemented existing CTP (care transition programme). Pharmacist completed comprehensive review of all prescription, non‐prescription, and herbal medications to identify, resolve, and prevent DRPs (e.g. PIM, ADEs, prescribing omissions). Recommendations sent via secure messaging function within electronic medical record to CTP provider Group 2 ‐ Usual care ‐ defined as pre‐existing CTP without pharmacist intervention Co‐intervention: pre‐existing CTP programme: home visit by nurse practitioner within 3 business days after discharge. As part of the visit, the nurse practitioner reviewed the patient's medications and made changes as deemed appropriate. Changes were implemented directly or were discussed with the patient's primary care provider, depending on clinical judgement Provider: pharmacist Where: by telephone (phone call to patient's home) When and how often: once, 3 to 7 days after discharge Intervention personalised: yes
Outcomes	Timing of outcome assessment: baseline and 5 weeks (or 30 days) Medication adherence (subjective) : adapted Morisky Medication Adherence Scale (MMAS): self‐reported by questionnaire over phone. 6 yes/no questions ‐ number of no's (no = indicating good adherence behaviour). Validated Adverse clinical health outcomes (objective): ED visits or hospital re‐admissions: re‐admissions assessed by blinded, independent pharmacists
Notes	Trial registration: N/A Consumer involvement: not specified Funding source: Grant # UL1 TR000135 from National Center for Advancing Translational Sciences, NIH, and US DHHS Dropout: 1 withdrew, 2 died
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Study statistician used a random number generator to determine allocation sequence
Allocation concealment (selection bias)	Low risk	Randomisation completed during phone call with study co‐ordinator, who opened a sealed envelope that contained an indication of which group the patient was assigned to
Blinding of participants and personnel (performance bias) All outcomes	High risk	Trial was unblinded (participants and investigators) ‐ but was unable to blind
Blinding of outcome assessment (detection bias) All outcomes	Low risk	All outcomes were assessed while blinded to intervention or usual care group allocations
Incomplete outcome data (attrition bias) All outcomes	Low risk	3 participants lost ‐ balanced across groups
Selective reporting (reporting bias)	Low risk	All outcomes reported, including NS outcomes
Other bias	Unclear risk	2 of the 12 patients who were randomised to the usual care group had participated in MTM in the past 12 months