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Trial record 3 of 10 for:    honore | France

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

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ClinicalTrials.gov Identifier: NCT03640845
Recruitment Status : Recruiting
First Posted : August 21, 2018
Last Update Posted : March 10, 2020
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

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.


Condition or disease Intervention/treatment Phase
Age Problem Other: tele-expertise Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 364 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Impact of a Hospital Medication Expertise on the Rate of Unplanned Hospitalizations at 3 Months of Patients Residing in Nursing Homes (EPAD)
Actual Study Start Date : May 16, 2019
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. number of unplanned hospitalizations [ Time Frame: 6 months ]
    The main endpoint is the rate of unplanned hospitalizations (all structures) of nursing home residents


Secondary Outcome Measures :
  1. Assessment of unplanned hospital admission [ Time Frame: 6 months ]
    Number of unplanned hospital admissions

  2. Quality of life (QoL) of nursing home residents [ Time Frame: 3 months ]
    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. Quality of life (QoL) of nursing home residents [ Time Frame: 6 months ]
    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)

  4. Incidence of behavioral disturbances [ Time Frame: 3 months ]
    assessed by the NeuroPsychiatric Inventory (NPI) questionnaire. The total NPI score is the sum of the subscale scores (min 0 - max 120).

  5. Incidence of behavioral disturbances [ Time Frame: 6 months ]
    assessed by the NeuroPsychiatric Inventory (NPI) questionnaire. The total NPI score is the sum of the subscale scores (min 0 - max 120).

  6. Proportion of residents subjected to at least 1 potentially inappropriate prescription [ Time Frame: 3 months ]
    STOPP and START tool will be used for explicit criteria (French version 2).

  7. Proportion of residents subjected to at least 1 potentially inappropriate prescription [ Time Frame: 6 months ]
    STOPP and START tool will be used for explicit criteria (French version 2).

  8. Nursing staff satisfaction with oral medications dispensed [ Time Frame: 3 months ]
    Satisfaction is evaluated using 5-point Likert scales (Very satisfied - Satisfied - neutral - Dissatisfied - Very Dissatisfied)

  9. Fall rate [ Time Frame: 3 months ]
    Number of falls

  10. Fall rate [ Time Frame: 6 months ]
    Number of falls

  11. Acceptation rate of general physician to therapeutic recommandations [ Time Frame: 3 months ]
    Proportion of therapeutic recommendations accepted by general physician

  12. Acceptation rate of general physician to therapeutic recommandations [ Time Frame: 6 months ]
    Proportion of therapeutic recommendations accepted by general physician

  13. Residents with at least 1 potentially inappropriate prescription [ Time Frame: 3 months ]
    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

  14. Residents with at least 1 potentially inappropriate prescription [ Time Frame: 6 months ]
    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

  15. Description of patients whose general physician have taken account of recommendations [ Time Frame: 3 months ]
    Demographics, diseases, medications and types of recommendations made from patients for whom at least 50% of recommendations have been accepted

  16. Characteristics of patients whose GP have taken account of TMR recommendations [ Time Frame: 3 months ]
    : Demographics, diseases, medications and types of recommendations made from patients for whom at least 50% of recommendations have been accepted

  17. Incremental cost-effectiveness ratio [ Time Frame: 6 months ]
    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

  18. Qualitative acceptability intervention survey [ Time Frame: 6 months ]
    Intervention acceptability survey is carried out to determine care provider acceptance and expectations of intervention in nursing homes.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03640845


Contacts
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Contact: stephane HONORE, md +33 491387065 Stephane.HONORE@ap-hm.fr

Locations
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France
Assistance Publique Des Hopitaux de Marseille Recruiting
Marseille, Paca, France, 13354
Contact: STEPHANE HONORE, MD    +33 491387065    Stephane.HONORE@ap-hm.fr   
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
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Study Director: EMILIE GARRIDO PRADALIE, MD APHM
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT03640845    
Other Study ID Numbers: 2018-16
First Posted: August 21, 2018    Key Record Dates
Last Update Posted: March 10, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No