Clinical trial NCT03640845: Impact of a Hospital Medication Expertise on Unplanned Hospitalizations at 3 Months of Nursing Homes Patients
Official title: Impact of a Hospital Medication Expertise on the Rate of Unplanned Hospitalizations at 3 Months of Patients Residing in Nursing Homes (EPAD)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Age Problem
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2018-08-21
Enrollment: 364
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: number of unplanned hospitalizations
timeFrame: 6 months
Secondary outcomes:
measure: Assessment of unplanned hospital admission
timeFrame: 6 months
measure: Quality of life (QoL) of nursing home residents
timeFrame: 3 months
measure: Quality of life (QoL) of nursing home residents
timeFrame: 6 months
measure: Incidence of behavioral disturbances
timeFrame: 3 months
measure: Incidence of behavioral disturbances
timeFrame: 6 months
measure: Proportion of residents subjected to at least 1 potentially inappropriate prescription
timeFrame: 3 months
measure: Proportion of residents subjected to at least 1 potentially inappropriate prescription
timeFrame: 6 months
measure: Nursing staff satisfaction with oral medications dispensed
timeFrame: 3 months
measure: Fall rate
timeFrame: 3 months
measure: Fall rate
timeFrame: 6 months
measure: Acceptation rate of general physician to therapeutic recommandations
timeFrame: 3 months
measure: Acceptation rate of general physician to therapeutic recommandations
timeFrame: 6 months
measure: Residents with at least 1 potentially inappropriate prescription
timeFrame: 3 months
measure: Residents with at least 1 potentially inappropriate prescription
timeFrame: 6 months
measure: Description of patients whose general physician have taken account of recommendations
timeFrame: 3 months
measure: Characteristics of patients whose GP have taken account of TMR recommendations
timeFrame: 3 months
measure: Incremental cost-effectiveness ratio
timeFrame: 6 months
measure: Qualitative acceptability intervention survey
timeFrame: 6 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Des Hopitaux de Marseille
state: Paca
Study officials:
affiliation: APHM
name: EMILIE GARRIDO PRADALIE, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.