Impact of a Hospital Medication Expertise on Unplanned Hospitalizations at 3 Months of Nursing Homes Patients

NCT03640845 | Unknown

• 1 other identifier: 2018-16
• Study Type: interventional
• Target: 364
• Locations: 1 country
• Sites: 1

Brief Summary

The use of drugs in the elderly population remains a major public health problem worldwide. Technological advances and the development of new drugs have helped to extend life expectancy. However, the complex process of aging, resulting in changes in physiological functions, may affect the pharmacodynamics and kinetics of medications taken by the elderly. In addition, polypharmacy, due to multiple comorbidities, may also lead to an increased risk of drug or field interaction and the use of potentially inappropriate drugs (PID), increasing the risk of drug iatrogenic use in older users. With a view to optimizing drug prescriptions and preventing drug iatrogenic disease in the elderly, and in the context of a university-based research and teaching approach, the AP-HM pharmacy initiated the setting up of clinical pharmacy activities for patients at high iatrogenic risk. The contribution of clinical pharmacists to mobile geriatric teams who carry out more than 2,200 geriatric assessments a year, is a way to optimize the efficiency of the medication management of the elderly person hospitalized out of hospital. geriatric service and EHPAD. TIn order to promote the physician-pharmacist action synergy observed in practice, the investigators decided to integrate the pharmaceutical evaluation with the geriatric evaluation. This new cooperation makes it possible to improve the knowledge of the treatments taken by the patients, to raise awareness on the observance of the treatments and to facilitate the administration of the drugs, to reduce the risks of iatrogenic medicinal increase the acceptance of therapeutic interventions by the health care team. Indeed, the first results show that the mobile team's medico-pharmaceutical interventions have a much higher acceptance rate than medical or pharmaceutical interventions alone. However, the economic context and the human resources allocated do not make it possible to ensure an efficient service throughout the territory and in particular in nursing homes outside the city where the CHU is located. In order to increase the number of evaluations, the investigators propose to develop a tele-expertise of a medico-pharmaceutical hospital team (MPHT) and evaluate the impact for patients residing in nursing homes in the context of a high-level study.

Conditions

Age Problem

Outcome Measures

Primary Outcomes (1)

• number of unplanned hospitalizations

  The main endpoint is the rate of unplanned hospitalizations (all structures) of nursing home residents

  6 months

Secondary Outcomes (18)

• Assessment of unplanned hospital admission

  6 months

• Quality of life (QoL) of nursing home residents

  3 months

• Quality of life (QoL) of nursing home residents

  6 months

• Incidence of behavioral disturbances

  3 months

• Incidence of behavioral disturbances

  6 months

Study Arms (2)

experimental group

EXPERIMENTAL

Patient living in nursing homes a tele-expertise will be performed

Other: tele-expertise

control group

NO INTERVENTION

Patient living in nursing homes will performed a normal care.

Interventions

tele-expertise OTHER

Tele-expertise consists of the remote realization of a multi-professional medication review (clinical pharmacist and doctor / geriatrician), ie a complete and systematic analysis of sociodemographic, clinical, biological and pharmaceutical data transmitted in such a way standardized at the EHMP and aimed at optimizing the therapeutics of the resident patient of the EHPAD requesting tele-expertise. Tele-expertise is realized in three stages, that are * the transmission, the collection and the organization of the data, * the analysis of the data and their confrontation with the referential and recommendations * the writing of a Personalized Pharmaceutical Plan

experimental group

Eligibility Criteria

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

You may qualify if:

• Age greater than or equal to 65
• Resident in EHPAD
• presenting a high iatrogenic drug risk (Trivalle score between 6-10).
• Ability to provide free, informed and express consent (patient and / or trusted person)
• Affiliated to a social security scheme

You may not qualify if:

• Patient with a life expectancy \<3 months
• Patient under 65 years
• Trivale score \<6
• Vulnerable persons within the meaning of French law (adults under guardianship or trusteeship, persons deprived of their liberty)
• Participation in another research protocol in progress
• Patient who has had a medication review (or medication review) known in the last 6 months.
• Patient with severe dementia (MMSE \<18)

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Des Hopitaux de Marseille

Marseille, PACA, 13354, France

RECRUITING

Related Publications (2)

• Berard C, Di Mascio T, Montaleytang M, Couderc AL, Villani P, Honore S, Daumas A, Correard F. Telemedication Reviews to Optimize Medication Prescription for Older People in Nursing Homes. Telemed J E Health. 2022 Aug;28(8):1225-1232. doi: 10.1089/tmj.2021.0288. Epub 2021 Dec 24.

  PMID: 34958258 DERIVED

• Correard F, Montaleytang M, Costa M, Astolfi M, Baumstarck K, Loubiere S, Amichi K, Auquier P, Verger P, Villani P, Honore S, Daumas A. Impact of medication review via tele-expertise on unplanned hospitalizations at 3 months of nursing homes patients (TEM-EHPAD): study protocol for a randomized controlled trial. BMC Geriatr. 2020 Apr 20;20(1):147. doi: 10.1186/s12877-020-01546-3.

  PMID: 32312242 DERIVED

Study Officials

• EMILIE GARRIDO PRADALIE, MD

  APHM

  STUDY DIRECTOR

Central Study Contacts

stephane HONORE, md

CONTACT

+33 491387065; Stephane.HONORE@ap-hm.fr

Study Design

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

Study Record Dates

• First Submitted: August 17, 2018
• First Posted: August 21, 2018
• Study Start: May 16, 2019
• Primary Completion: March 16, 2025
• Study Completion: September 16, 2025
• Last Updated: July 27, 2023

Record last verified: 2023-07

Locations

FR (1)