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.
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.
France1 site, 1 recruiting
- Recruiting
Assistance Publique Des Hopitaux de Marseille
Marseille, PACA, 13354
STEPHANE HONORE, MD, +33 491387065, Stephane.HONORE@ap-hm.fr
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 group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Patient living in nursing homes a tele-expertise will be performed Receives: Other: tele-expertise |
| control group | No intervention | Patient 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.
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)
Assessment of unplanned hospital admission
Number of unplanned hospital admissions
Measured: 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)
Measured: 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)
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 6 months
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
Fall rate
Number of falls
Measured: 3 months
Fall rate
Number of falls
Measured: 6 months
Acceptation rate of general physician to therapeutic recommandations
Proportion of therapeutic recommendations accepted by general physician
Measured: 3 months
Acceptation rate of general physician to therapeutic recommandations
Proportion of therapeutic recommendations accepted by general physician
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 6 months
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.
- First posted21 Aug 2018
- Study start16 May 2019
- Primary completion16 Mar 2025 (estimated)
- Study completion16 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Age ProblemStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- EMILIE GARRIDO PRADALIE, MD, Study director, APHM
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 34958258Correard 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
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Hospital Medication Expertise on the Rate of Unplanned Hospitalizations at 3 Months of Patients Residing in Nursing Homes (EPAD)
- ClinicalTrials.gov ID
- NCT03640845
- Acronym / sponsor ID
- TEM-EHPAD / 2018-16
- Conditions
- Age Problem
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 364 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 16 May 2019 (actual)
- Primary completion
- 16 Mar 2025 (estimated)
- Study completion
- 16 Sep 2025 (estimated)
- First posted
- 21 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Other: tele-expertisePatient living in nursing homes a tele-expertise will be performed |
| control group | No intervention | –Patient living in nursing homes will performed a normal care. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tele-expertiseTele-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 | Other | experimental group |
Primary outcome
number of unplanned hospitalizations
Time frame: 6 months
The main endpoint is the rate of unplanned hospitalizations (all structures) of nursing home residents
18 secondary outcomes
Assessment of unplanned hospital admission
Time frame: 6 months
Quality of life (QoL) of nursing home residents
Time frame: 3 months
Quality of life (QoL) of nursing home residents
Time frame: 6 months
Incidence of behavioral disturbances
Time frame: 3 months
Incidence of behavioral disturbances
Time frame: 6 months
Proportion of residents subjected to at least 1 potentially inappropriate prescription
Time frame: 3 months
Proportion of residents subjected to at least 1 potentially inappropriate prescription
Time frame: 6 months
Nursing staff satisfaction with oral medications dispensed
Time frame: 3 months
Fall rate
Time frame: 3 months
Fall rate
Time frame: 6 months
Acceptation rate of general physician to therapeutic recommandations
Time frame: 3 months
Acceptation rate of general physician to therapeutic recommandations
Time frame: 6 months
Residents with at least 1 potentially inappropriate prescription
Time frame: 3 months
Residents with at least 1 potentially inappropriate prescription
Time frame: 6 months
Description of patients whose general physician have taken account of recommendations
Time frame: 3 months
Characteristics of patients whose GP have taken account of TMR recommendations
Time frame: 3 months
Incremental cost-effectiveness ratio
Time frame: 6 months
Qualitative acceptability intervention survey
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Derived from this study: PubMed 34958258Berard 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.
- Derived from this study: PubMed 32312242Correard 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
EMILIE GARRIDO PRADALIE, MD study director
APHM
1 site in 1 country: see every site and its status.
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.