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

Age Problem Clinical Trial

— TEM-EHPAD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03640845
• Other study ID #: 2018-16
• Status: Recruiting
• Phase: N/A
• Start date: May 16, 2019
• Est. completion date: September 16, 2025

Study information

• Verified date: July 2023
• Source: Assistance Publique Hopitaux De Marseille
• Contact: stephane HONORE, md
• Phone: +33 491387065
• Email: Stephane.HONORE[@]ap-hm.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 364
• Est. completion date: September 16, 2025
• Est. primary completion date: March 16, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Age Problem

Intervention

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

Locations

Country	Name	City	State
France	Assistance Publique Des Hopitaux de Marseille	Marseille	Paca

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of unplanned hospitalizations	The main endpoint is the rate of unplanned hospitalizations (all structures) of nursing home residents	6 months
Secondary	Assessment of unplanned hospital admission	Number of unplanned hospital admissions	6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Nursing staff satisfaction with oral medications dispensed	Satisfaction is evaluated using 5-point Likert scales (Very satisfied - Satisfied - neutral - Dissatisfied - Very Dissatisfied)	3 months
Secondary	Fall rate	Number of falls	3 months
Secondary	Fall rate	Number of falls	6 months
Secondary	Acceptation rate of general physician to therapeutic recommandations	Proportion of therapeutic recommendations accepted by general physician	3 months
Secondary	Acceptation rate of general physician to therapeutic recommandations	Proportion of therapeutic recommendations accepted by general physician	6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Qualitative acceptability intervention survey	Intervention acceptability survey is carried out to determine care provider acceptance and expectations of intervention in nursing homes.	6 months