Patient-centered treatment method to reduce the use of sleeping pills to improve patient safety (BE-SAFE study)

Descrizione riassuntiva dello studio

In older adults (≥65 years), the use of benzodiazepines and other sedative hypnotics (BHS) for treating sleep problems is widespread. Although BHS are effective in the first weeks of use, their effectiveness decreases significantly thereafter. In particular, older adults are susceptible to significant adverse effects such as an increased risk of falls, fractures, hospitalizations, cognitive impairment, and mortality. However, discontinuing BHS is a challenge. The BE-SAFE study aims to test a patient-centered intervention to reduce the use of BHS and improve patient safety and quality of care. The primary objectives are: 1) to determine whether the intervention leads to increased discontinuation of BHS and 2) to determine whether the intervention does not harm patients, i.e., does not negatively affect sleep quality. The study will be conducted in six European countries (Belgium, Greece, Norway, Poland, Spain, and Switzerland). Participating physicians will be randomly assigned either to the intervention group (with training and additional informational material to address sleep problems and support participants in discontinuing BHS) or to the control group (treatment according to standard care without training or additional material).

(BASEC)

Intervento studiato

The intervention focuses on the main barriers to discontinuing BHS prescriptions, both at the level of patients and at the level of physicians.

Physicians assigned to the intervention group will receive informational and educational materials as well as training, including guidelines and implementation recommendations for discontinuing medications, for communicating decisions to patients, and for treating sleep problems with alternative methods. The decisions made and suggestions for further treatment will be communicated to primary care providers (general practitioners). Patients treated by a physician assigned to the intervention group will receive brochures on how to sleep well without medication and on the "why and how" of a possible discontinuation of BHS. They will participate in the physician-led shared decision-making process and receive information on follow-up care. Family members or informal caregivers will also receive a leaflet with relevant information about discontinuing BHS.

(BASEC)

Malattie studiate

Sleep disorders

(BASEC)

Sponsor

non disponibile

Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)

Commissione d'etica Berna

(BASEC)

Data di approvazione del comitato etico

01.10.2024

(BASEC)

Risultati dello studio