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 |
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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) |
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Interventions |
Group 1 ‐ Focus 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 2 ‐ No 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 |
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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 |
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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") |
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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 |