Older AdultIATRO'MEDNCT04020692
Home Improvement Initiative of the TRaitement Optimisé Medicamenteux After Hospitalization
A study testing EOPC Intervention in people with Older Adult and Chronic Disease, run by University Hospital, Strasbourg, France at 2 sites in France.
Trial summary
The hypothesis is that the intervention of an operational clinical pharmacy team (EOPC), targeting both patients and hospital and health care professionals, allows: i) to initiate a therapeutic review during hospitalization, ii) to accompany the patients upon hospital discharge, iii) to maintain, in outpatient care… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Older Adult, Chronic Disease, Clinical Pharmacy
- What is being tested?
- EOPC Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 223 participants
- Where
- 2 sitesFrance
- Study dates
- 16 Jul 2019to 2 Feb 2023
- 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
- Patient (man or woman)
- age ≥ 65 years with more than 3 drugs taken for 3 months, stay in surgery with a duration of ≥ 1 days including urgent surgery;
- affiliated to a social health insurance scheme;
- for whom a return home is possible;
- able to understand the objectives of the research and give informed, dated and signed consent.
Who cannot join
- Patient (man or woman)
- with as a hospital discharge an entry into a nursing home or long-term care called "important medical and technical care (SMTI);
- with cognitive or other problems preventing consent (at the discretion of the geriatric expertise team);
- under the safeguard of justice;
- under tutorship or curatorship.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Groupe Hospitalier Saint Vincent
Strasbourg, 67000
Les Hôpitaux Universitaires de Strasbourg
Strasbourg, 67098
About this study
The hypothesis is that the intervention of an operational clinical pharmacy team (EOPC), targeting both patients and hospital and health care professionals, allows: i) to initiate a therapeutic review during hospitalization, ii) to accompany the patients upon hospital discharge, iii) to maintain, in outpatient care, the drug treatments that have been optimized during hospitalization.
The main objective of the study is to demonstrate that the intervention of an EOPC in surgical departments and then in outpatient care makes it possible to maintain, 45 days after the discharge of the patients aged 65 years and over, the chronic outpatient treatments revised and optimized during the hospital stay.
Read more
The secondary objectives are to measure the impacts of EOPC's intervention on:
- unexpected readmissions, emergency use, medical complications and adverse drug reactions;
- patient and health professional satisfactions (community pharmacists and physicians);
- the costs of drug treatments in ambulatory care.
- Conditions
- Older Adult, Chronic Disease, Clinical Pharmacy, Surgery, Ambulatory Care
- Being tested
- EOPC Intervention
- Keywords
- Multicenter study, Before-and-after type study, Minimal risks and constraints
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EOPC InterventionBehavioural
The issue of drug continuity after hospital discharge has become a major issue in recent years. When patients return home, the drugs taken do not correspond to the treatments prescribed at the end of the hospitalization. This is due to appropriate or inappropriate initiatives of the patients (or their relatives) and/or the physicians accompanying them. Prescribed medications, on the other hand, are almost always dispensed by community pharmacists.
The scope chosen in this project is that the intervention of an operational clinical pharmacy team (EOPC), targeting both patient and health care professionals (inpatient and outpatient), will maintain, in outpatient care, the drugs treatments that have been optimized during hospitalization.
| Study group | Role | What they receive |
|---|---|---|
| "intervention " group | Experimental | Patient At D0, the patient receives his discharge drugs prescription and benefits from a pharmaceutical counselling.
At D+3, he benefits from a telephone follow-up (good understanding of the methods of taking drugs, collection of difficulties).
Community pharmacist At D0, he receives the discharge drugs prescription. At D+3, he is contacted to collect information relating to drugs 'dispensation.
The attending physician At D0, he is informed of the patient's discharge and his drugs treatment
At D45, the data collection is based on telephone interviews [attending physician, pharmacist and patient (and if applicable the caregiver)].
It makes possible to collect drugs taken by the patient as well as significant events over the period (acute pathologies, re-hospitalizations, etc.). Receives: Behavioral: EOPC Intervention |
| Control group | No intervention | At D0, the patient receives his discharge drugs prescription. At D45, the data collection is based on telephone interviews [attending physician, pharmacist and patient (and if applicable the caregiver)]. It makes possible to collect drugs taken by the patient as well as significant events over the period (acute pathologies, re-hospitalizations, etc.). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance of patients' medication intake at 45 days (D45) compared to the discharge prescription (D0): drugs prescribed and taken by patients (chronic disease treatments only)
Compliance is defined as the absence of discrepancies between D0 and D+45. Conversely, the presence of a discrepancy is defined as the presence of at least one deviation of drug intake at D+45 from D0.
Measured: 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2019
- Study start16 Jul 2019
- Primary completion2 Feb 2023
- Study completion2 Feb 2023
Why it stopped: Delays were caused by the covid-19 pandemic and a lack of staff on the saint vincent hospital site to take charge of the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Older AdultStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The issue of drug continuity after hospital discharge has become a major issue in recent years. When patients return home, the drugs taken do not correspond to the treatments prescribed at the end of the hospitalization. This is due to appropriate or inappropriate initiatives of the patients (or their relatives) and/or the physicians accompanying them. Prescribed medications, on the other hand, are almost always dispensed by community pharmacists. The scope chosen in this project is that the intervention of an operational clinical pharmacy team (EOPC), targeting both patient and health care professionals (inpatient and outpatient), will maintain, in outpatient care, the drugs treatments that have been optimized during hospitalization
- Masking
- None (open label)
- Enrolment
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04020692
- Sponsor's protocol ID
- 7363
- Acronym
- IATRO'MED
- Status last verified
- Nov 2024
- First submitted
- 9 Jul 2019
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Improvement Initiative of the TRaitement Optimisé Medicamenteux After Hospitalization
- ClinicalTrials.gov ID
- NCT04020692
- Acronym / sponsor ID
- IATRO'MED / 7363
- Conditions
- Older Adult, Chronic Disease, Clinical Pharmacy, Surgery, Ambulatory Care
- Keywords
- Multicenter study, Before-and-after type study, Minimal risks and constraints
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Delays were caused by the covid-19 pandemic and a lack of staff on the saint vincent hospital site to take charge of the study
- Enrolment
- 223 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 16 Jul 2019 (actual)
- Primary completion
- 2 Feb 2023 (actual)
- Study completion
- 2 Feb 2023 (actual)
- First posted
- 16 Jul 2019 (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 hypothesis is that the intervention of an operational clinical pharmacy team (EOPC), targeting both patients and hospital and health care professionals, allows: i) to initiate a therapeutic review during hospitalization, ii) to accompany the patients upon hospital discharge, iii) to maintain, in outpatient care, the drug treatments that have been optimized during hospitalization.
The main objective of the study is to demonstrate that the intervention of an EOPC in surgical departments and then in outpatient care makes it possible to maintain, 45 days after the discharge of the patients aged 65 years and over, the chronic outpatient treatments revised and optimized during the hospital stay.
The secondary objectives are to measure the impacts of EOPC's intervention on:
- unexpected readmissions, emergency use, medical complications and adverse drug reactions;
- patient and health professional satisfactions (community pharmacists and physicians);
- the costs of drug treatments in ambulatory care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The issue of drug continuity after hospital discharge has become a major issue in recent years. When patients return home, the drugs taken do not correspond to the treatments prescribed at the end of the hospitalization. This is due to appropriate or inappropriate initiatives of the patients (or their relatives) and/or the physicians accompanying them. Prescribed medications, on the other hand, are almost always dispensed by community pharmacists. The scope chosen in this project is that the intervention of an operational clinical pharmacy team (EOPC), targeting both patient and health care professionals (inpatient and outpatient), will maintain, in outpatient care, the drugs treatments that have been optimized during hospitalization
| Arm | Type | Receives |
|---|---|---|
| "intervention " group | Experimental | Behavioral: EOPC InterventionPatient At D0, the patient receives his discharge drugs prescription and benefits from a pharmaceutical counselling. At D+3, he benefits from a telephone follow-up (good understanding of the methods of taking drugs, collection of difficulties). Community pharmacist At D0, he receives the discharge drugs prescription. At D+3, he is contacted to collect information relating to drugs 'dispensation. The attending physician At D0, he is informed of the patient's discharge and his drugs treatment At D45, the data collection is based on telephone interviews [attending physician, pharmacist and patient (and if applicable the caregiver)]. It makes possible to collect drugs taken by the patient as well as significant events over the period (acute pathologies, re-hospitalizations, etc.). |
| Control group | No intervention | –At D0, the patient receives his discharge drugs prescription. At D45, the data collection is based on telephone interviews [attending physician, pharmacist and patient (and if applicable the caregiver)]. It makes possible to collect drugs taken by the patient as well as significant events over the period (acute pathologies, re-hospitalizations, etc.). |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Patient (man or woman)
- age ≥ 65 years with more than 3 drugs taken for 3 months, stay in surgery with a duration of ≥ 1 days including urgent surgery;
- affiliated to a social health insurance scheme;
- for whom a return home is possible;
- able to understand the objectives of the research and give informed, dated and signed consent.
Key exclusion criteria (5 listed)
- Patient (man or woman)
- with as a hospital discharge an entry into a nursing home or long-term care called "important medical and technical care (SMTI);
- with cognitive or other problems preventing consent (at the discretion of the geriatric expertise team);
- under the safeguard of justice;
- under tutorship or curatorship.
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 |
|---|---|---|
| EOPC InterventionThe issue of drug continuity after hospital discharge has become a major issue in recent years. When patients return home, the drugs taken do not correspond to the treatments prescribed at the end of the hospitalization. This is due to appropriate or inappropriate initiatives of the patients (or their relatives) and/or the physicians accompanying them. Prescribed medications, on the other hand, are almost always dispensed by community pharmacists. The scope chosen in this project is that the intervention of an operational clinical pharmacy team (EOPC), targeting both patient and health care professionals (inpatient and outpatient), will maintain, in outpatient care, the drugs treatments that have been optimized during hospitalization. | Behavioural | "intervention " group |
Primary outcome
Compliance of patients' medication intake at 45 days (D45) compared to the discharge prescription (D0): drugs prescribed and taken by patients (chronic disease treatments only)
Time frame: 45 days
Compliance is defined as the absence of discrepancies between D0 and D+45. Conversely, the presence of a discrepancy is defined as the presence of at least one deviation of drug intake at D+45 from D0.
Results and safety
The study was stopped early (reason given: Delays were caused by the covid-19 pandemic and a lack of staff on the saint vincent hospital site to take charge of the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EOPC Intervention in people with Older Adult and Chronic Disease, run by University Hospital, Strasbourg, France at 2 sites 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 5 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: stopped early, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study was stopped early (reason given: Delays were caused by the covid-19 pandemic and a lack of staff on the saint vincent hospital site to take charge of the study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance of patients' medication intake at 45 days (D45) compared to the discharge prescription (D0): drugs prescribed and taken by patients (chronic disease treatments only) (time frame: 45 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Nov 2024.