Pitkala KH, Juola A-L, Kautiainen H, et al. Education to Reduce Potentially Harmful Medication Use Among Residents of Assisted Living Facilities: A Randomized Controlled Trial. Journal of the American Medical Directors Association 2014;15(12):892-98.
PubMed link: https://www.ncbi.nlm.nih.gov/pubmed/24814043
Pitkala KH, Juola A-L, Soini H, et al. Reducing inappropriate, anticholinergic and psychotropic drugs among older residents in assisted living facilities: Study protocol for a randomized controlled trial. Trials 2012;13(85):7-7.
PubMed link: https://www.ncbi.nlm.nih.gov/pubmed/22709731
Full text article: https://trialsjournal.biomedcentral.com/articles/10.1186/1745-6215-13-85
| Methods | Study design: Cluster randomized controlled study
Number of groups: Two groups |
| Participants | Number of participants: 227 randomized, 189 completed
· Intervention group: 118 randomized, 93 completed · Control group: 109 randomized, 96 completed Sex: 161 female, 66 male Age: 82.9 ± 7.5 years Participants with dementia: Yes, 211 participants (93%) were diagnosed with dementia Inclusion criteria · 65 years or older, · Living permanently in residential aged care facilities in Helsinki · Native speaker of the Finnish language · Uses at least one drug · No terminal illness (estimated prognosis >6 months), and · Voluntary participation, written informed consent to participate in the study given by participant or her/ his closest proxy. Exclusion criteria · Not described Concomitant medicines: 7.5 ± 2.8 Country: Finland Setting: Residential aged care facilities |
| Interventions | Medicine: Polypharmacy
Withdrawal schedule: Not described Education program Trainer: Trainee: Nursing staff in the intervention ward Training material: Appropriate use of drugs among frail older people Training duration: Two four-hour training sessions Tool to identify deprescribing targets: Beers Criteria |
| Outcomes | · Proportion of persons using inappropriate, anticholinergic or more than two psychotropic drugs
· Change in the mean number of inappropriate, anticholinergic and psychotropic drugs · Number of hospitalizations/follow-up time · Ambulatory service utilization · 15D HRQOL measure |
| Dates | Dates: Not described
Follow-up duration: Twelve months |
| Funding sources | Sohlberg Foundation and Helsinki University Hospital development grant |
| Notes | “The authors declare no conflicts of interest.” |
Risk of bias table
| Bias | Authors’ judgment | Support for judgment |
| Random sequence generation (selection bias) | Low risk | 20 wards were paired into ten dyads. The wards in each dyad shared similar resident characteristics. A computerized random number generator was then used to randomize one ward in each dyad to the intervention arm and the other to the control arm. |
| Allocation concealment (selection bias) | Unclear risk | A person independent of assessment procedure telephoned another person not familiar with the wardsor residents to receive the randomization number (intervention or control) for each ward. |
| Blinding of participants and personnel (performance bias) | High risk | Participants were not described a blinded.
The intervention was such that patients were given obviously different treatment to the controls |
| Blinding of outcome assessment (detection bias) | Unclear risk | The paper stated that outcome assessors were blinded at baseline. It was not stated if this occurred at follow-up. “At the baseline study nurse visit, the nurses retrieved participating residents’ demographic data, diagnoses, and medication data. These nurses were independent of the study intervention and unaware of the randomization procedures.” “The research nurses performed their assessments at 0, 6, and 12 months.” |
| Incomplete outcome data (attrition bias) | Low risk | Participants are all accounted for. The patients refusing to participate were included in the analysis according to the ‘intention-to-treat’ approach. |
| Selective reporting (reporting bias) | Unclear risk | The protocol was pre-published, and the pre-specified outcomes were all reported. |
| Other bias | Unclear risk | There could be the potential for contamination if health professionals worked between multiple wards.
Deprescribing was not the only intervention that the intervention group received. The reduction of polypharmacy was an add-on intervention to the intensive day therapy that the participants were receiving. Control group: Before the trial all the primary care physicians who were treating participating control patients were given Therefore, potential for both groups results to be skewed by additional intervention. The groups were not treated equally. |
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