Impact of the Decrease of Exposure to Hypnosedative Drugs in the Elderly Through the Discontinuation of Hospital-initiated Prescription

NCT02296957 | Unknown

• 1 other identifier: HYPAGE
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

Brief Summary Context. Sleep disorders complaints are common in elderly and hypnosedative drugs are widely prescribed in community-dwelling elderly. Furthermore, acute hospitalisation may induce sleep disorders and hypnosedative initiation occurs in 14 to 29% of elderly during a hospital stay. These hospital-induced sleep disorders should spontaneously disappear after discharge and, because of their potential impact on falls, hip fractures, psychiatric side effects and induced dependence, hypnosedative drugs should therefore be discontinued at discharge in these naïve-treated patients. Adhesion to this recommendation is poor. Recent and on-going research on this topic mostly concerns adverse effects although these are already substantially documented and evidence-based, while there is a poor interest on developing research on potential strategies susceptible to practically improve the current adhesion to recommendations. Design and objectives. This project proposes multi-component intervention and is directed towards hospital prescribers, patients, and their general practitioner. It aims at discontinuing, at hospital discharge, the hypnosedative treatment that was initiated during hospitalization in naïve-treated elderly (age≥65) patients. The value of the intervention, as compared to usual care management, will be estimated in a multicentre (6 hospitals gathering 8 centres: 5 internal medicine departments, 3 cardiology departments) randomised, cross-over, two-period trial. Two hospitals will gather 2 centres (2x2 centres) and 4 hospitals will gather only 1 centre (4x1 centres). An equilibrated randomization will be applied to the 8 centres, making sure that, in hospitals gathering 2 centres, these 2 centres will apply the same strategy in a given period and that the 2 hospitals will apply alternative strategies. This randomisation is set up to avoid the risk of a potential contamination between the 2 strategies from one centre to the other within the same hospital. As a result, 3 hospitals (including 4 medical departments) will apply the intervention during the first 11-month period, while the 3 others (including 4 medical departments) will apply usual care during this period, as a result of an equilibrated hospitals randomization. During the second 11-month period, each hospital will apply the alternative management. The two periods will be separated by a 1-month wash-out period. In all 240 patients (15 patients / centre) will be enrolled (120 in the intervention group and 120 in the usual care group). Patient follow-up duration will be 12 months after discharge. Patient status in regards with quality of sleep (study primary objective), hypnosedative consumption and frequency of falls (secondary objectives) will be collected by telephone interviews 1, 3, 6 12 months after discharge. Expected results. The results of the study should contribute to guide research and public decisions to practically decrease hypnosedative prescription and consumption, and associated adverse events.

Conditions

Sleep Disorders

Outcome Measures

Primary Outcomes (4)

• Number of patients with deterioration of the quality of sleep in the intervention group compared to control at one year after discharge, assessed by the ISI scale

  12 months after discharge

• Number of patients with deterioration of the quality of sleep in the intervention group compared to control at 1 month after discharge, assessed by the ISI scale

  1 month after discharge

• Number of patients with deterioration of the quality of sleep in the intervention group compared to control at 3 months after discharge, assessed by the ISI scale

  3 months after discharge

• Number of patients with deterioration of the quality of sleep in the intervention group compared to control at 6 months after discharge, assessed by the ISI scale

  6 months after discharge

Secondary Outcomes (4)

• Frequency of falls in the intervention group compared to usual care at 1 year after discharge, assessed by a fall diary

  12 months after discharge

• Frequency of falls in the intervention group compared to usual care at 1 month after discharge, assessed by a fall diary

  1 month after discharge

• Frequency of falls in the intervention group compared to usual care at 3 months after discharge, assessed by a fall diary

  3 months after discharge

• Frequency of falls in the intervention group compared to usual care at 6 months after discharge, assessed by a fall diary

  6 months after discharge

Study Arms (2)

Intervention

EXPERIMENTAL

Intervention towards hospital physicians to promote hypnosedative discontinuation in patients initiated during the hospital stay, intervention towards patients and their general practitioners to heighten awareness about the hypnosedative-related risks.

Procedure: Hypnosedative discontinuation

Control

NO INTERVENTION

Usual Care

Interventions

Hypnosedative discontinuation PROCEDURE

Intervention towards hospital physicians to promote hypnosedative discontinuation in patients initiated during the hospital stay, intervention towards patients and their general practitioners to heighten awareness about the hypnosedative-related risks.

Intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients hospitalized in one of the investigation centres
• Individuals (male and female) aged 65 years and above
• Patients prescribed an hypnosedative drug during the hospitalization (after the first 48 hours)
• Patients from whom a non-opposition of participation in the research is obtained
• Patients with no history of hypnosedative at the admission (and during the first 48 hours of hospitalization)
• Individuals not suffering from cognitive impairment suggested by a score of less than 24 on the Mini-Mental State Examination
• Patients returning home at discharge
• Patients reachable by phone

You may not qualify if:

• Patients who gave their opposition to participate in the study
• Patient with physical disability
• Patients suffering from severe depression with suicide risk or other severe psychopathologic conditions
• Individuals suffering from cognitive impairment suggested by a score of less than 24 on the Mini-Mental State Examination
• Patients suffering from metastatic/terminal cancer or undergoing parenteral treatment (cytotoxic or targeted therapy) for cancer or in palliative care program
• Patients with severe alcohol or drug dependence
• Patients unable to answer a questionnaire in French
• Patients unable to undergo the intervention
• Patients not available by phone at discharge
• Patients not returning home at discharge

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator
• Pierre and Marie Curie University: collaborator

Study Sites (1)

Assistance Publique Hopitaux de Paris - Hopital Saint Antoine

Paris, 75012, France

RECRUITING

MeSH Terms

Conditions

Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Christine Fernandez, PharmD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christine Fernandez, PharmD, PhD

CONTACT

(33-1) 49 28 21 66; christine.fernandez@sat.aphp.fr

Patrick Hindlet, PharmD, PhD

CONTACT

(33-1) 49 28 30 34; Patrick.hindlet@sat.aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2014
• First Posted: November 21, 2014
• Study Start: November 1, 2014
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: October 10, 2016

Record last verified: 2016-10

Locations

FR (1)