García-Gollarte F, Baleriola-Júlvez J, Ferrero-López I, et al. An educational intervention on drug use in nursing homes improves health outcomes resource utilization and reduces inappropriate drug prescription. Journal of the American Medical Directors Association 2014;15(12):885-91
PubMed link: https://www.ncbi.nlm.nih.gov/pubmed/24895001
| Methods | Study design: Randomized controlled trial with a parallel-design
Number of groups: Two groups |
| Participants | Number of participants: 1018 randomized, 716 completed
Age: 84.4 ± 12.7 years Sex: 744 female, 274 male Participants with dementia: Yes, 1010 (99%) Inclusion criteria: · Persons older than 65 years, · Living in the nursing home for at least 3 months · Expected to stay in the nursing home for the length of the study · Clinically stable (no changes in prescription in the last 2 months) · Accepted that their clinical data were used for the study · Exclusion criteria: · Residents receiving palliative care · Those usually cared by other primary care providers outside the nursing home were excluded.
Concomitant medicines: 8.25 ± 3.39 medicines Country: Spain Setting: Residential aged care facilities |
| Interventions | Medicine: Polypharmacy
Comparator: Usual care Withdrawal schedule: Not described Method to identify target: Education program Trainer: A nursing home physician Trainee: “0 physicians working in nursing homes Training material: · general aspects of prescription and drug use in geriatric patients · how to reduce the number of drugs · to perform a regular review of medications · to avoid inappropriate drug use · to discontinue drugs that do not show benefits · to avoid undertreatment with drugs that have shown benefits · drugs frequently related to adverse drug reactions in older people · two 1-hour workshops reviewed practical real life cases · The educator offered further on-demand advice on prescription for the next 6 months Training duration: 10 hours, followed by phone support Tool to identify deprescribing targets: STOPP/START criteria |
| Outcomes | STOPP/START criteria – participants with at least one item Falls
Delirium, number of episodes Death Physician visits Emergency department visits Hospital in-patient days |
| Dates | Dates: Not stated
Follow-up duration: 6 months |
| Funding sources | Not declared |
| Notes |
Risk of bias table
| Bias | Authors’ judgment | Support for judgment |
| Random sequence generation (selection bias) | Low risk | Randomization was done using random number tables and was not based on characteristics of nursing homes, as they were mostly homogeneous.
Up to 17 residents were randomly chosen from the list of residents cared by each participating physician, using random number tables.
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| Allocation concealment (selection bias) | High risk | Not described
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| Blinding of participants and personnel (performance bias) | High risk | Participants and nursing staff were apparently not blinded.
Physicians in both groups were informedthat there was a company program aimed to improve drug prescription (to explain why data on prescription were collected in their centers) but were blinded to the fact that the educational intervention was being assessed. |
| Blinding of outcome assessment (detection bias) | High risk | “Outcomeswere assessedin a random group of residents cared by the physicians involved in the study.”
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| Incomplete outcome data (attrition bias) | Low risk | There is no obvious missing data. |
| Selective reporting (reporting bias) | Low risk | No a priori published protocol found, but all statedoutcomes reported. |
| Other bias | Unclear risk | “Immediately after randomization, one of the nursing homes, where a physician randomly assigned to the control group was working, was unexpectedly closed. Finally, 1018 residents were randomly chosen, based on the treating physician (516 in the intervention group, 502 in the control group)…During the study, 4 physicians left their job in the study nursing homes (2 in the intervention group, 2 in the control group). They were immediately replaced, and the two new physicians assigned to the intervention group received the structured education program.”
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