| Study characteristics |
| Methods |
RCT |
| Participants |
Setting: New York and Los Angeles, USA
N = 317
Sample: participants enrolled from home health care agencies client lists if agency office agreed to participate (75% women)
Age (years): mean 80 (SD 8)
Inclusion criteria: Medicare patients; aged ≥ 65; registered with home health care offices in defined period; having one of 4 study medication problems; having an identifiable physician; expected home health care for at least 4 wks
Exclusion criteria: not expected to survive through follow‐up; unable to understand spoken English; resident in an unsafe area that requires an escort for visits |
| Interventions |
1. Medication review by pharmacist and participant's nurse based on reported problems relating to medication use (including falls). Targetted therapeutic duplication, cardiovascular, psychotropic, and NSAID use. A plan to reduce medication problem presented to physician in person by nurse or pharmacist. Nurse assisted participant with the medication changes and monitored effect
2. Control: usual care, which might include review of medications and adverse effects if relevant |
| Outcomes |
1. Number of people falling |
| Duration of the study |
Follow‐up interview as close to 6 wks as possible, but up to 90 days after randomisation |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Assigment generated by computer random number generator (SAS v 6.10). Balanced block randomisation, stratified by the 2 areas. |
| Allocation concealment (selection bias) |
Unclear risk |
Randomised off site but insufficient information to permit judgement |
| Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
Participants and personnel implementing the intervention not blind to allocated group, but impact of non‐blinding unclear |
| Blinding of outcome assessment (detection bias)
Falls and fallers |
Low risk |
Falls data collected at 6 weeks by study research assistants, who "supervised by the data coordinator, collected the data; all were masked as to patient group assignment" |
| Incomplete outcome data (attrition bias)
Fallers |
Low risk |
SeeAppendix 3 for method of assessment |
| Risk of bias in recall of falls |
High risk |
No description of how falls ascertained; presumably retrospectively at follow‐up interview |
