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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2016 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Collaborators:
Institut National de la Santé Et de la Recherche Médicale, France
Pierre and Marie Curie University
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT02296957
First received: November 13, 2014
Last updated: October 7, 2016
Last verified: October 2016
  Purpose

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.


Condition Intervention
Sleep Disorders
Procedure: Hypnosedative discontinuation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Decrease of Exposure to Hypnosedative Drugs in the Elderly Through the Discontinuation of Hospital-initiated Prescription: Impact on the Quality of Sleep and Fall Frequency

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 6 months after discharge ]

Secondary Outcome Measures:
  • Frequency of falls in the intervention group compared to usual care at 1 year after discharge, assessed by a fall diary [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 6 months after discharge ]

Estimated Enrollment: 240
Study Start Date: November 2014
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention
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
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.
No Intervention: Control
Usual Care

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02296957

Contacts
Contact: Christine Fernandez, PharmD, PhD (33-1) 49 28 21 66 christine.fernandez@sat.aphp.fr
Contact: Patrick Hindlet, PharmD, PhD (33-1) 49 28 30 34 Patrick.hindlet@sat.aphp.fr

Locations
France
Assistance Publique Hopitaux de Paris - Hopital Saint Antoine Recruiting
Paris, France, 75012
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Institut National de la Santé Et de la Recherche Médicale, France
Pierre and Marie Curie University
Investigators
Principal Investigator: Christine Fernandez, PharmD, PhD Assistance Publique - Hôpitaux de Paris
  More Information

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02296957     History of Changes
Other Study ID Numbers: HYPAGE
Study First Received: November 13, 2014
Last Updated: October 7, 2016

Additional relevant MeSH terms:
Sleep Wake Disorders
Parasomnias
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders

ClinicalTrials.gov processed this record on March 24, 2017