# Brief Intervention for Discontinuing Inappropriate Z-Hypnotic Use Among Older Patients in Primary Care: Protocol for a Cluster Randomized Controlled Trial With a Single Crossover

## TL;DR

This study tests a brief intervention method to help older patients stop misusing sleeping pills in a primary care setting.

## Contribution

The study introduces a behavioral intervention protocol for GPs to address inappropriate Z-hypnotic use in older patients.

## Key findings

- A behavioral intervention will be tested to reduce inappropriate Z-hypnotic use in older patients.
- The trial will assess outcomes like cognitive function, sleep quality, and quality of life.
- Results will determine if the intervention is effective and transferable for broader implementation.

## Abstract

Older patients are frequent users of Z-hypnotics despite consensus recommendations against extended use. Inappropriate Z-hypnotic use among older patients is frequently reported, posing risks of side effects and dependence. Interventions have been mainly at the population level and through prescription regulations. There are few instruments helping general practitioners (GPs) deal with inappropriate use among individual patients.

Through a randomized controlled trial (RCT), we aim to test the effectiveness of a behavioral brief intervention (BI) method used by trained GPs for reducing inappropriate Z-hypnotic use among their patients.

We will conduct a double-blind RCT with a single crossover. Patients (aged >60 years) on participating GPs’ lists who are using Z-hypnotics inappropriately, do not have serious mental or physical disorders, and can provide valid informed consent are eligible. GPs randomized to the BI arm will be trained to administer the BI, and those randomized to business as usual (BAU) will not receive training. GPs’ patient lists will be screened for inappropriate Z-hypnotic users through an electronic questionnaire. The GP will be informed of patients who should be given an appointment and administered the BI. Untrained GPs will continue BAU. Randomization-blinded outcome evaluation will be conducted at 6 weeks, 6 months, and 1 year in both the study groups.

The main outcome is the proportion of patients with inappropriate Z-hypnotic use, comparing BI versus BAU, after 6 weeks. Secondary outcomes are cognitive function, pain, self-reported sleep evaluation, sleep efficiency (actigraphy) and quality of life, and change compared to baseline. We will also report on the characteristics of the screened GP patient population. Other variables are other medication use or polypharmacy, anxiety and depression, severity of dependence, and mortality.

If RCT-level evidence demonstrates the effectiveness of the BI for reducing inappropriate Z-hypnotic use among older patients without worsening of secondary outcomes, this could be a simple, transferable intervention to implement on a larger scale among GPs, other physicians, and health workers.

DERR1-10.2196/75670