JMIR Publications

ABSTRACT

Background:

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

Objective:

We aim, in an RCT, to test the effectiveness of a behavioural Brief Intervention (BI) method used by trained GPs for reducing inappropriate Z-hypnotics use among their patients.

Methods:

We will conduct a double-blind randomised control trial with crossover. Patients (>age 60) on participating GPs lists, who are using Z-hypnotics inappropriately, do not have serious mental or physical disorders and can give valid informed consent, are eligible. GPs randomised to the BI arm are trained to perform the BI, those randomised to business as usual (BAU) will not receive training. GPs patient lists are screened for inappropriate Z-hypnotics users through an electronic questionnaire. The GP is informed of patients that should be given an appointment and performs the BI. Untrained GPs continue BAU. Randomisation-blinded outcome evaluation will be at 6 weeks, 6 months and one year by the study group.

Results:

We will conduct a double-blind randomised control trial with crossover. Patients (>age 60) on participating GPs lists, who are using Z-hypnotics inappropriately, do not have serious mental or physical disorders and can give valid informed consent, are eligible. GPs randomised to the BI arm are trained to perform the BI, those randomised to business as usual (BAU) will not receive training. GPs patient lists are screened for inappropriate Z-hypnotics users through an electronic questionnaire. The GP is informed of patients that should be given an appointment and performs the BI. Untrained GPs continue BAU. Randomisation-blinded outcome evaluation will be at 6 weeks, 6 months and one year by the study group. Outcomes: Main outcome is proportion of patients with inappropriate Z-hypnotics use comparing BI vs. BAU after six 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/polypharmacy, anxiety and depression, severity of dependence and mortality.

Conclusions:

If RCT level evidence demonstrates the effectiveness of BI for reducing inappropriate Zhypnotics use among older patients without worsening of secondary outcomes, it could provide a simple, transferable intervention to implement on a larger scale among GPs, other physicians and health workers. Clinical Trial: NCT06032715 (registered 17th Aug 2023)