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

Shimp 2012.

Study characteristics
Methods Aim of study: to evaluate a patient‐centred employer‐based medication therapy management (MTM) programme
Study design: RCT (unit of allocation: individual)
Number of arms/groups: 2
Participants Description: patient/consumer
Geographic location: USA
Setting: community (University)
Inclusion criteria: University of Michigan beneficiaries (employees, retirees, and their dependents), taking ≥ 7 prescription medications. Patients with a University of Michigan primary care provider were preferentially invited
Number of participants randomised: 133 (intervention); "a similar number who consented but were not invited formed control"
Number of participants included in analysis: 128 (intervention)
Age: mean age: 70 years (intervention)
Gender: 55% female (intervention)
Ethnicity: not specified
Number of medications: prescription medications: 9.2 ± 3.2 (intervention)
Frailty/Functional impairment: not specified
Cognitive impairment: not specified
Comorbidities: 3 ± 1.4 medical conditions (intervention)
Interventions Group 1Focus on Medicines (FOM) Medication Therapy Management (MTM): 2 face‐to‐face meetings with University of Michigan clinical pharmacists. First visit was comprehensive review of all medications. Patients with DM, HT, dyslipidaemia, asthma, arthritis, chronic pain, and OP were asked disease‐specific questions. Patient questions were answered. Second visit patient and pharmacist discussed recommendations and a medication action plan (MAP). This detailed DRPs, recommended actions, and person responsible
Group 2No intervention
Co‐intervention: N/A
Provider: pharmacist
Where: unclear ‐ University or home ?
When and how often: twice, unsure of timing
Intervention personalised: yes ‐ patient‐centred medication action plan
Outcomes Timing of outcome assessment: baseline (1 year pre‐study) and final (1 year post study)
Medication adherence (objective) : medication possession ratio: MPR defined as sum of all days of medication supply received during 1 year pre‐study and 1 year post‐study periods, divided by the total number of days supply needed during 365 days. MPR calculated for top 8 drug classes for chronic conditions
Notes Trial registration: N/A
Consumer involvement: not specified
Funding source: University of Michigan
Dropout: 5 withdrew
Further information required: raw data on MRPs (author correspondence successful, but no further data were available; study authors said "results showed no significant change")
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Not specified; those who agreed to participate compared with similar number of individuals meeting selection criteria but not invited to participate (control group)
Allocation concealment (selection bias) High risk Not specified ‐ patients randomly selected by study team ?
Blinding of participants and personnel (performance bias)
All outcomes High risk Not blinded
Blinding of outcome assessment (detection bias)
All outcomes High risk Not blinded
Incomplete outcome data (attrition bias)
All outcomes High risk No details on attrition of control group, etc. Would assume some people would change jobs
Selective reporting (reporting bias) High risk Adherence outcomes ‐ both BMQ and Treatment Satisfaction Questionnaire for Medication ‐ not included despite being a main outcome and listed in methods
Other bias Unclear risk Funded by University of Michigan; preference given to people with primary practitioner who worked at University of Michigan