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Age ProblemTEM-EHPADNCT03640845

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

A study testing tele-expertise in people with Age Problem, run by Assistance Publique Hopitaux De Marseille at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Age Problem
What is being tested?
tele-expertise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
364 participants
Where
1 siteFrance
Study dates
16 May 2019to 16 Sep 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

stephane HONORE, md contact

+33 491387065

Stephane.HONORE@ap-hm.fr

France1 site, 1 recruiting
  • Assistance Publique Des Hopitaux de Marseille

    Marseille, PACA, 13354

    STEPHANE HONORE, MD, +33 491387065, Stephane.HONORE@ap-hm.fr

    Recruiting

Other trials in France

About this study

Official title: 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.

Read more

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.

Read the 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.

Conditions
Age Problem
Being tested
tele-expertise

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • tele-expertiseOther

    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
Study groups in NCT03640845
Study groupRoleWhat they receive
experimental groupExperimentalPatient living in nursing homes a tele-expertise will be performed
Receives: Other: tele-expertise
control groupNo interventionPatient living in nursing homes will performed a normal care.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. number of unplanned hospitalizations

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

    Measured: 6 months

Secondary outcomes (18)
  1. Assessment of unplanned hospital admission

    Number of unplanned hospital admissions

    Measured: 6 months

  2. 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)

    Measured: 3 months

  3. 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)

    Measured: 6 months

  4. 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).

    Measured: 3 months

  5. 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).

    Measured: 6 months

  6. Proportion of residents subjected to at least 1 potentially inappropriate prescription

    STOPP and START tool will be used for explicit criteria (French version 2).

    Measured: 3 months

  7. Proportion of residents subjected to at least 1 potentially inappropriate prescription

    STOPP and START tool will be used for explicit criteria (French version 2).

    Measured: 6 months

  8. Nursing staff satisfaction with oral medications dispensed

    Satisfaction is evaluated using 5-point Likert scales (Very satisfied - Satisfied - neutral - Dissatisfied - Very Dissatisfied)

    Measured: 3 months

  9. Fall rate

    Number of falls

    Measured: 3 months

  10. Fall rate

    Number of falls

    Measured: 6 months

  11. Acceptation rate of general physician to therapeutic recommandations

    Proportion of therapeutic recommendations accepted by general physician

    Measured: 3 months

  12. Acceptation rate of general physician to therapeutic recommandations

    Proportion of therapeutic recommendations accepted by general physician

    Measured: 6 months

  13. 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

    Measured: 3 months

  14. 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

    Measured: 6 months

  15. 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

    Measured: 3 months

  16. 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

    Measured: 3 months

  17. 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

    Measured: 6 months

  18. Qualitative acceptability intervention survey

    Intervention acceptability survey is carried out to determine care provider acceptance and expectations of intervention in nursing homes.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2018
  2. Study start16 May 2019
  3. Primary completion16 Mar 2025 (estimated)
  4. Study completion16 Sep 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
364 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03640845
Sponsor's protocol ID
2018-16
Acronym
TEM-EHPAD
Status last verified
Jul 2023
First submitted
17 Aug 2018
Last updated
27 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 34958258
  • 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.

    PubMed 32312242

Questions about this trial

What is this clinical trial studying?

A study testing tele-expertise in people with Age Problem, run by Assistance Publique Hopitaux De Marseille at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact stephane HONORE, md (+33 491387065, Stephane.HONORE@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

number of unplanned hospitalizations (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03640845, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.

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