Weber V, White A, McIlvried R. An electronic medical record (EMR)-based intervention to reduce polypharmacy and falls in an ambulatory rural elderly population. Journal of General Internal Medicine 2008;23:399-404
PubMed link: https://www.ncbi.nlm.nih.gov/pubmed/18373136
Full text article: https://link.springer.com/article/10.1007%2Fs11606-007-0482-z
| Methods | Study design: Cluster randomized controlled study
Number of groups: Two groups |
| Participants | Number of participants: 620 randomized, 495 completed
· Intervention deprescribing group: 413 randomized at 15 clinic sites, 337 completed · Control group: 207 randomized at three clinic sites, 158 completed Age: 76.9 years Sex: 492 female, 128 male Participants with dementia: Yes, seven participants – severity not noted Inclusion criteria: · Age 70 or older · Four or more active prescription medications prescribed within the past year · One or more psychoactive medications prescribed within the past year · Geisinger Health Plan Medicare+Choice coverage Exclusion criteria: · None stated Concomitant medicines: 7.65 per participant Country: United States of America Setting: Community – Geisinger Health System is an integrated delivery system that serves a 40-county area of over 2.5 million persons in largely rural central and north-eastern Pennsylvania |
| Interventions | Medicine: Polypharmacy, specific focus on psychoactive medications, presence of polypharmacy, and the presence of medications at inappropriate doses
Withdrawal schedule: Not described Comparator: Usual care Method to identify targets: Patient-specific intervention: medication review: Recommendation by clinical pharmacist or geriatrician with expertise in geriatric pharmacology with the review sent via an electronic medicines record Recommendation to primary physician Tool to identify deprescribing targets: No tool identified |
| Outcomes | Medication use
Falls, percentage of participants who reported at least one fall |
| Dates | Dates: Start October 2002
Follow-up duration: 15 months |
| Funding sources | Agency for Healthcare Research and Quality. The authors declare that “The sponsor had an advisory role in the design and methods. Data collection, analysis, and preparation of the paper were carried out independently by the researchers.” |
| Notes | The authors declared “Conflict of Interest: None disclosed.” |
Risk of bias table
| Bias | Authors’ judgment | Support for judgment |
| Random sequence generation (selection bias) | Unclear risk | Randomization method not described. Stated only:
“We then randomized clinic sites to receive either the intervention or usual care. Fifteen clinic sites received the electronic intervention, whereas three clinic sites served as controls. Randomization occurred according to clinic site, not physician, to avoid the potential confounding effect of communication about the intervention among physicians and/or cross-covering of patients within the practice. “ |
| Allocation concealment (selection bias) | High risk | Not concealed.
Avoidance of staff awareness of the activity at other sites. “No forums where fall prevention was discussed or the guideline was publicized were conducted.” |
| Blinding of participants and personnel (performance bias) | High risk | The study was not blinded, but through the separation of sites, it is unclear if the participants were aware of the interventions. The doctors, however, were aware of it as they were the targets of the intervention. |
| Blinding of outcome assessment (detection bias) | High risk | As above |
| Incomplete outcome data (attrition bias) | Unclear risk | It is not clear if there was an as-treated or intention-to-treat analysis. Although it was stated that the drop-outs were similar in both groups, reasons were not given. |
| Selective reporting (reporting bias) | Low risk | The study design was approved, but it is not known if there was a pre-specified analysis plan that the authors followed.
The two criteria specified in the method were falls and polypharmacy. These were both reported. |
| Other bias | High risk | No conflicts of interest. There are a number of weaknesses in the methodology based around the outcome criteria. The two chosen criteria are very general and leave no room for other confounding factors, which are likely to be significant. This is addressed in the discussion by the authors. The inclusion criterion was too broad in that any one psychoactive medication was the minimum. Similarly, the effect of compliance was not accounted for – patients may well have been handling their own medications in which case the total number of medications becomes significant. |
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