The effect of a discontinuation protocol on the use of clonazepam in the elderly
- Conditions
- ClonazepamAgedPotentially Inappropriate Medication List
- Registration Number
- RBR-524ys9
- Lead Sponsor
- niversidade Federal de São João del-Rei (UFSJ)
- Brief Summary
Background: Inappropriate use of clonazepam by the elderly is associated with cognitive impairment, delirium, and falls. Strategies to optimize its use are important to increase patient safety. Thus, the objective was to evaluate the feasibility of a clonazepam deprescription protocol in the elderly. Methods: This is a quasi-experimental study. Elderly people with chronic use of clonazepam and attended in primary care units in two Brazilian municipalities were selected. A deprescription protocol was used, which included five fortnightly meetings between the elderly and the research team, to reduce the dose by 25 %. Patients received instructions on sleep hygiene behaviors and the advantages of clonazepam deprescription; doctors followed the flowchart for gradual dose reduction. In the 1st and 5th meetings, there were medical appointments for anamnesis and discharge. The monitoring of patients and the application of tests were carried out by the research team. Results: Of the 35 elderly people included in the study, 27 reached the end; 81.5 % achieved deprescription: 22.2 % stopped completely and 59.3 % decreased the dose. At the last meeting, 20 % of elderly patients reported an increase in blood pressure. A “very good” quality of life was declared by 17.6 % and 24 % of the elderly before and after the deprescription, respectively. Conclusions: The high rate of deprescription and the little relevance of clonazepam withdrawal reactions, showed that the use of the protocol was effective. However, the increase in blood pressure and the worsening of sleep quality in the last meeting show the need for adjustment in the last stage of deprescription.It was observed that between the fourth and the fifth meetings, 19.2 % (n = 5) of the patients (already hypertensive) reported changes in blood pressure, with three of them seeking the emergency service. After the episodes, they were examined by doctors from their respective health units, who did not consider it necessary to return with a full dose of clonazepam, thus proceeding with the deprescription according to the protocol (dose immediately before the signs and symptoms presented). An average variation in sleep quality was observed with each reduction in the dose of clonazepam. In the first meeting, before the intervention, 64.7 % of the elderly had poor sleep quality and 20.6 % had some sleep disorder. Comparing pre and post-intervention, 14.7 % of the participating patients had good sleep quality and at the end of the deprescription this number rose to 28 %. Sleep disorders in contrast, had lower levels in intermediate meetings. Regarding the average daily dose of clonazepam, before the intervention it was 1.8 mg (SD ± 1.2) and at the end this dose was 1 mg (SD ± 1.6). The frequency of patients with good sleep quality was 14.7 % in the first meeting and, by the end, it had risen to 28 %. Before the intervention, 61.75 % of the patients self-perceived their quality of life “as good” and at the end, that number was 72% %. In addition, 64 % self-reported “satisfied” with their health status at the end of the intervention.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
Elderly patients in clinical use of clonazepam will be included for anxiety and insomnia;
administered daily for at least three months; which were attended at the Basic Health Units in question.
Epileptic patients will be excluded; patients in psychiatric treatment and / or with a history of psychosis;
patients dependent on alcohol and illicit drugs;
patients who are not cognitively competent and do not have a caregiver, according to the mini mental state examination;
other unforeseen situations will be analyzed, in an individualized way, by the doctor of the health unit
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint is to assess the proportion of elderly people who were able to reduce the dose of clonazepam or the total withdrawal of the drug as measured by the Clonazepam Deprescription Protocol in the elderly
- Secondary Outcome Measures
Name Time Method To identify abstinence symptoms of clonazepam, as measured by the Benzodiazepine withdrawal symptom questionnaire;To verify if there was a change in quality of life before and after the depression, evaluated through the World Health Organization Quality of Life Group (WHOQOL-bref)