Impact of a Hospital Medication Expertise on Unplanned Hospitalizations at 3 Months of Nursing Homes Patients (TEM-EHPAD)

Impact of a Hospital Medication Expertise on the Rate of Unplanned Hospitalizations at 3 Months of Patients Residing in Nursing Homes (EPAD)

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.

Study Overview

• Status: Recruiting
• Conditions: Age Problem
• Intervention / Treatment: Other: tele-expertise

Detailed Description

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 , in collaboration with certain clinical departments, the setting up of clinical pharmacy activities for patients at high iatrogenic risk. These activities were established and formalized in close collaboration with the doctors of the departments concerned, the geriatrics center and the geriatric mobile teams in particular, and were the subject of specific funding within the framework of the Instruction N ° DGOS / PF2 / 2016/49 of the 19/02/2016 relating to the call for project of implementation of the clinical pharmacy in health facility.

The contribution of clinical pharmacists to mobile geriatric teams (intra-hospital and outpatient), 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. In order to promote the physician-pharmacist action synergy observed in practice, the investigators decided to integrate the pharmaceutical evaluation (medication review) 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 (choice of the adapted galenic forms), to reduce the risks of iatrogenic medicinal increase the acceptance of therapeutic interventions by the health care team (attending physician, coordinator, nurse). 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 (Marseille) is located. In order to increase the number of evaluations, the investigators propose to develop a tele-expertise of a medico-pharmaceutical hospital team (EHMP) and evaluate the impact for patients residing in nursing homes in the context of a high-level study.

• Study Type: Interventional
• Enrollment (Estimated): 364
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: STEPHANE HONORE, MD; Phone Number: +33 491387065; Email: Stephane.HONORE@ap-hm.fr

Study Locations

• France
  • Paca
    • Marseille, Paca, France, 13354
      • Recruiting
      • Assistance Publique Des Hopitaux de Marseille
      • Contact: STEPHANE HONORE, MD; Phone Number: +33 491387065; Email: Stephane.HONORE@ap-hm.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: experimental group; Patient living in nursing homes a tele-expertise will be performed	Other: tele-expertise; 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
No Intervention: control group; Patient living in nursing homes will performed a normal care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of unplanned hospitalizations	The main endpoint is the rate of unplanned hospitalizations (all structures) of nursing home residents	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of unplanned hospital admission	Number of unplanned hospital admissions	6 months
Quality of life (QoL) of nursing home residents	evaluated by the EuroQol 5-Dimension 3-Level (EQ-5D-3L) generic quality-of-life questionnaire. The EQ-5D-3L questionnaire will be administered (min 11111 - max 33333)	3 months
Quality of life (QoL) of nursing home residents	evaluated by the EuroQol 5-Dimension 3-Level (EQ-5D-3L) generic quality-of-life questionnaire. The EQ-5D-3L questionnaire will be administered (min 11111 - max 33333)	6 months
Incidence of behavioral disturbances	assessed by the NeuroPsychiatric Inventory (NPI) questionnaire. The total NPI score is the sum of the subscale scores (min 0 - max 120).	3 months
Incidence of behavioral disturbances	assessed by the NeuroPsychiatric Inventory (NPI) questionnaire. The total NPI score is the sum of the subscale scores (min 0 - max 120).	6 months
Proportion of residents subjected to at least 1 potentially inappropriate prescription	STOPP and START tool will be used for explicit criteria (French version 2).	3 months
Proportion of residents subjected to at least 1 potentially inappropriate prescription	STOPP and START tool will be used for explicit criteria (French version 2).	6 months
Nursing staff satisfaction with oral medications dispensed	Satisfaction is evaluated using 5-point Likert scales (Very satisfied - Satisfied - neutral - Dissatisfied - Very Dissatisfied)	3 months
Fall rate	Number of falls	3 months
Fall rate	Number of falls	6 months
Acceptation rate of general physician to therapeutic recommandations	Proportion of therapeutic recommendations accepted by general physician	3 months
Acceptation rate of general physician to therapeutic recommandations	Proportion of therapeutic recommendations accepted by general physician	6 months
Residents with at least 1 potentially inappropriate prescription	STOPP and START tool is used for explicit criteria (French version 2). The implicit approach includes all available medical data, potential self-medication, and questions from the Medication Appropriateness Index	3 months
Residents with at least 1 potentially inappropriate prescription	STOPP and START tool is used for explicit criteria (French version 2). The implicit approach includes all available medical data, potential self-medication, and questions from the Medication Appropriateness Index	6 months
Description of patients whose general physician have taken account of recommendations	Demographics, diseases, medications and types of recommendations made from patients for whom at least 50% of recommendations have been accepted	3 months
Characteristics of patients whose GP have taken account of TMR recommendations	: Demographics, diseases, medications and types of recommendations made from patients for whom at least 50% of recommendations have been accepted	3 months
Incremental cost-effectiveness ratio	Incremental cost-effectiveness ratio (ICER) is used to compare the cost effectiveness of the experimental strategy with that of standard care. It is the ratio of the difference in costs between groups to the difference in effectiveness	6 months
Qualitative acceptability intervention survey	Intervention acceptability survey is carried out to determine care provider acceptance and expectations of intervention in nursing homes.	6 months

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille
• Investigators: Study Director: EMILIE GARRIDO PRADALIE, MD, APHM

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2019
• Primary Completion (Estimated): March 16, 2025
• Study Completion (Estimated): September 16, 2025

Study Registration Dates

• First Submitted: August 17, 2018
• First Submitted That Met QC Criteria: August 17, 2018
• First Posted (Actual): August 21, 2018

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 25, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2018-16

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No