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| Methods | Study design: Randomised controlled trial with three arms
Number of groups: 3 |
| Participants | Number of participants: 150
Active group 1: 50 Active group 2: 50 Control group: 50 Age: 70 Sex: 99 female (66%) Participants with dementia: None Inclusion criteria: ≥64 years old 2-3 dispensings of a z-drug (eszopiclone, zolpidem, zaleplon) in 2016 Exclusion criteria: ≤6 months Health Plan enrolment Received ≤6 doses of medications Palliative care/hospice care Resided in residential care during the year before randomisation Diagnosis of cancer, severe mental illness, dementia Current cholinesterase inhibitor or memantine use Current antipsychotic use Concomitant medicines: Country: US Setting: Community |
| Interventions | Medicine: Z-drugs
Intervention: Patients received a letter and brochure about z-drug harms. The second active group received a phone call from a pharmacist at 2-4 weeks Withdrawal schedule: Personally tapered Comparator: No education or phone call |
| Outcomes | Discontinuation of z-drug
Odds of discontinuation between groups Health care utilization (hospitalization, outpatient visit, urgent care or emergency department presentation) |
| Dates | Dates: Jan 2017 to Sept 2017
Follow-up duration: 6 months |
| Funding sources | Kaiser Permanente Northwest Center for Health Research |
| Notes | The methods describe this as a quality improvement activity which later became a research project. Ethics was granted retrospectively. |
Risk of bias table
| Bias | Authors’ judgment | Support for judgment |
| Random sequence generation (selection bias) | Unclear | Randomization method not described, and some differences apparent between groups |
| Allocation concealment (selection bias) | Unclear | Allocation method not described |
| Blinding of participants and personnel (performance bias) | High | Patients and personnel were unblinded |
| Blinding of outcome assessment (detection bias) | Unclear | Outcome assessors not described |
| Incomplete outcome data (attrition bias) | Low | One participant withdrew, no further loss to follow-up |
| Selective reporting (reporting bias) | High | No pre-specified outcomes, ethics approval appears to have been granted retrospectively |
| Other bias | High | Appears to be a QI activity which was later published. |
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