Lee 2006.
| Study characteristics | ||
| Methods |
Aim of study: to test the efficacy of a comprehensive pharmacy care programme to improve medication adherence and its associated effects on BP and LDL‐C Study design: RCT (multi‐phase prospective study with observational and RCT components) Number of arms/groups: 2 |
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| Participants |
Description: patient/consumer Geographic location: USA Setting: outpatient pharmacy clinics (outpatient medicine service of Army Medical Centre and Armed Forces Retirement Home (independently living military healthcare beneficiaries)) Inclusion criteria: ≥ 65 years, ≥ 4 long‐term medications daily, at increased risk for non‐adherence Exclusion criteria: not living independently (assisted living or nursing home residents excluded), had serious medical condition with unlikely 1‐year survival Number of participants randomised: 159 (83 vs 76) enrolled in RCT phase Number of participants included in analysis: 159 (83 vs 76) Age: mean SD 77 ± 10.5 vs 78 ± 6.2 Gender: female: 21 (25.3%) vs 20 (26.3%) Ethnicity: white: 51 (61.4%) vs 43 (56.6%), black: 29 (34.9%) vs 31 (40.8%) Number of medications: long‐term medications: 9.1 ± 3.2 vs 8.3 ± 2.8 Frailty/Functional impairment: not specified Cognitive impairment: taking medication for memory problems: 6 (3.8%) vs 2 (1.3%) Comorbidities: ≥ 4 health problems: 52 (62.7%) vs 38 (50%) |
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| Interventions |
Group 1 ‐ Comprehensive pharmacy care programme: clinical pharmacist meeting every 2 months; medications continued to be blister‐packed (phase 2) Group 2 ‐ Return to usual care (no adherence aid, new pill bottles with 90‐day supply and 1 refill prescription given) Co‐intervention: run‐in: (months 1 and 2) = baseline data collection (adherence, BP, LDL‐C); phase 1 (months 3 to 8): prospective observational study of comprehensive pharmacy care programme including individualised medication education, medications dispensed via adherence aid, and regular follow‐up with clinical pharmacist every 2 months Provider: pharmacist Where: pharmacy clinics at outpatient medical centre and retirement home When and how often: 2 monthly clinical pharmacist follow‐ups Intervention personalised: yes |
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| Outcomes |
Timing of outcome assessment: baseline (end of phase 1; 8 months) and conclusion (end of phase 2; 14 months) Medication adherence (objective):pill count adherence: sustained mean medication adherence Condition‐specific outcomes (objective): blood pressure: change in systolic and diastolic blood pressure ‐ mmHg Condition‐specific outcomes (objective): LDL cholesterol: change in LDL‐C ‐ mg/dL |
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| Notes | Trial registration: NCT00393419 Consumer involvement: not specified Funding source: competitive junior investigator grant from American Society of Health‐System Pharmacists Research and Education Foundation Dropout: 13 lost to follow‐up (6 and 7), last observation carried forward |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomised in 1:1 ratio via a computer‐generated random number sequence. Patients randomised in blocks based on level of baseline medication adherence (above or below 55%) |
| Allocation concealment (selection bias) | Low risk | Allocation was concealed to both patients and study personnel and was revealed at end of phase 1 |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Not possible to blind participants |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Not possible to blind pharmacists assessing outcomes |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Figure 1 shows participant flow, last observation carried forward for analysis |
| Selective reporting (reporting bias) | Unclear risk | Results at baseline not split based on intervention or control; hard to compare intervention effect |
| Other bias | Low risk | None apparent |