Blalock 2010.
Study characteristics | ||
Methods |
Aim of study: to assess effects of a community pharmacy‐based falls prevention programme targeting high‐risk older adults on rates of recurrent falls, recurrent injurious falls, and filling prescriptions for medications that have been associated with increased risk of falls Study design: RCT (1 year look back and 1 year follow‐up after RCT; unit of allocation: individual) Number of arms/groups: 2 |
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Participants |
Description: patient/consumer Geographic location: USA Setting: community pharmacy Inclusion criteria: those at high risk of falling (≥ 65 years, ≥ 1 fall not attributable to syncope within the 1 year preceding, ≥ 4 long‐term prescription medications, ≥ 1 CNS‐active medication) Exclusion criteria: housebound, in long‐term care facility, not able to read and write English, exhibited significant cognitive impairment Number of participants randomised: 186 (93 intervention, 93 control) Number of participants included in analysis: 93 and 93 (ITT), 73 and 113 (as treated) Age: mean (SD): I: 75.5 (7.0) vs C: 74.1 (6.8) Gender: female: 78.5% intervention vs 65.4% control Ethnicity: white: 91.4% intervention vs 86.0% control Number of medications: unclear (inclusion criteria ≥ 4 long‐term prescriptions) Frailty/Functional impairment: use of cane or walker: 37 (39.8%) vs 43 (46.2%) (P = 0.37) Cognitive impairment: not specified Comorbidities: high‐risk conditions (dizziness, diabetes, incontinence, arthritis, Parkinson, stroke): mean (SD): 1.65 ± 1.19 intervention vs 1.58 ± 1.06 control |
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Interventions |
Group 1 ‐ Enhanced pharmacologic care. Invitation to participate in free face‐to‐face medication consultation (~ 45 minutes) with community pharmacy resident. Pharmacist reviewed medications and identified potential problems (emphasis on CNS‐active medications) using structured algorithms. If problem identified and patient interested in making a change, pharmacist contacted physician to seek prescriber approval of the recommended changes Group 2 ‐ Usual care: no medication consultation Co‐intervention: both groups received 2 brochures on prevention of falls Provider: pharmacist (community) Where: local health care centre When and how often: once Intervention personalised: yes, personalised medication review |
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Outcomes |
Timing of outcome assessment: baseline and 12 months Medication adherence (subjective): BMQ (validated), 5‐item regimen screen that assesses how medication is used Condition‐specific outcomes (subjective): 1 or more falls. Calculated using monthly fall calendar; patients recorded each fall "a sudden, accidental change in position where you land on the ground, floor, or an object" |
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Notes | Trial registration: N/A Consumer involvement: not specified Funding source: National Center for Injury Prevention and Control at the Centers for Disease Control and Prevention Dropout: 20 did not receive intervention, 27 dropped out (17 vs 10), 9 unable to contact (6 vs 3), 5 died (3 vs 2) Further information required: BMQ results (email correspondence with trial author ‐ unsuccessful) |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomised to either intervention or control ‐ unclear how |
Allocation concealment (selection bias) | Unclear risk | Not specified |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Unable to blind; patients knew if they had the intervention |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No mention of blinding |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | ITT, although no BMQ data, so difficult to assess if/how ITT was done |
Selective reporting (reporting bias) | High risk | "BMQ was readministered at 4 monthly intervals, ending 12 months after the baseline assessment" ‐ results not listed. However BMQ listed as a data source ‐ not an outcome in methods |
Other bias | Unclear risk | Initial sample size was 262; "interim power analyses were conducted when it became apparent that it would be difficult to reach target sample size" Sample size changed to 95 per group. Sample size based on falls risk |