Iatrogenic EffectIATROMEDNCT02916836
Effect of the Use of a Therapeutic Conciliation Document at the Outlet of Hospital, on the Emergency Use of Hospital Care in Patient Aged Over 75 Years Old.
An observational study of Iatrogenic Effect, run by Centre Hospitalier Universitaire de Nice.
Trial summary
The drug iatrogenesis represents an important public health problem. In the Iatromed project, we want to to assess a specific therapeutic drug conciliation sheet (TDC). This multicenter observational study is focus on 750 patients aged over 75 year old with polymedication. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Iatrogenic Effect
- What is being tested?
- therapeutic drug conciliation sheet (TDC) and No Use of therapeutic drug conciliation sheet (TDC)
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Jan 2020
- Phase
- Observational
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Hospitalized patient aged over 75 years old
Who may be able to join
- age ≥75 years
- patients with a medical prescription, including at least three different allopathic molecules including at least a treatment in one of the following therapeutic classes:
- cardiovascular treatment: antiarrhythmics, antihypertensive drugs, anticoagulants and antiplatelet all classes
- treatment of the central nervous system: analgesics, benzodiazepines, antidepressants, hypnotic, antipsychotic drugs of all classes.
- family practitioner identified
- trusted personne identified
- Hospital output project establishes
Who cannot join
- not speaking french patient
- short survival time
About this study
The drug iatrogenesis represents an important public health problem. In the Iatromed project, we want to to assess a specific therapeutic drug conciliation sheet (TDC). This multicenter observational study is focus on 750 patients aged over 75 year old with polymedication. The main objective will be to determine if the use of the TDC, at the discharge of hospital, allows to reduce the number of use in emergency care within the two month after their hospital discharge
Read the detailed description
The drug iatrogenesis represents an important public health problem with 5-10% of the grounds of hospitalization after age 65, and more than 20% after 80 years. Based on this observation, the health authority has proposed in 2011 the realization of therapeutic drug conciliation particularly in the elderly with multiple pathologies and multiple drugs. Taking into account the central role of the family practitioner in prescriptions, and the importance of coordination information such as output of hospitalization (vector of many malfunctions), we have achieved a therapeutic drug conciliation sheet (TDC) based primarily on the information needs by family practitioner after hospitalization of their patients. The issue of this study is to assess the interest for the use of a such TDC on the decrease in the rate of rehospitalization in the target population.
To do this, we are proposing a multicenter observational study. Randomization would be across the centres. The study would focus on 750 patients more of 75 with polymedication. The follow-up will last 6 months.
The main objective will be to determine if the use of the TDC, at the discharge of hospital, allows to reduce the number of use in emergency care within the two month after their hospital discharge. The first secondary objective will be identical to the main objective but rated at 6 months and the second secondary objective will be to assess the impact of the use of the TDC on overall mortality at 6 months.
- Conditions
- Iatrogenic Effect
- Being tested
- therapeutic drug conciliation sheet (TDC), No Use of therapeutic drug conciliation sheet (TDC)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
therapeutic drug conciliation sheet (TDC)Other
Use of therapeutic drug conciliation sheet (TDC)
No Use of therapeutic drug conciliation sheet (TDC)Other
| Study group | Role | What they receive |
|---|---|---|
| With TDC sheet | Use of therapeutic drug conciliation sheet (TDC) by the hospital and transmitted to the family practitioner with other usual documentation Receives: Other: therapeutic drug conciliation sheet (TDC) | |
| Without TDC Sheet | transmission of usual documentation only to the family practitioner Receives: Other: No Use of therapeutic drug conciliation sheet (TDC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of patient who will have used hospital care in emergency
The use of hospital care in emergency is defined as a consultation in an emergency room and/or an emergency hospitalization.
An emergency hospitalization is an hospitalization for which programing was made maximum 48h before the admission in hospital or clinic. The use will be documented by contact with the patient (or the support person if necessary) and his doctor. Here, it should be noted that deaths will be accounted for in the urgently use of to the hospital care regardless of the place of death. This in intended to take into account the possibility that a death may be related to a drug iatrogenic event for which the patient has not had time to resort to the hospital care in emergency.
Measured: at least one time within the two month after their hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2016 (estimated)
- Study startJan 2017 (estimated)
- Primary completionJan 2018 (estimated)
- Study completionJan 2020 (estimated)
Why it stopped: Withdrawal of the associated centers
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iatrogenic EffectStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier GUERIN, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02916836
- Sponsor's protocol ID
- 14-PREPS-01
- Acronym
- IATROMED
- Status last verified
- Feb 2018
- First submitted
- 26 Sep 2016
- Last updated
- 19 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Use of a Therapeutic Conciliation Document at the Outlet of Hospital, on the Emergency Use of Hospital Care in Patient Aged Over 75 Years Old.
- ClinicalTrials.gov ID
- NCT02916836
- Acronym / sponsor ID
- IATROMED / 14-PREPS-01
- Conditions
- Iatrogenic Effect
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Withdrawal of the associated centers
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- Jan 2017 (estimated)
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 28 Sep 2016 (estimated)
- 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 drug iatrogenesis represents an important public health problem. In the Iatromed project, we want to to assess a specific therapeutic drug conciliation sheet (TDC). This multicenter observational study is focus on 750 patients aged over 75 year old with polymedication. The main objective will be to determine if the use of the TDC, at the discharge of hospital, allows to reduce the number of use in emergency care within the two month after their hospital discharge
Detailed description
The drug iatrogenesis represents an important public health problem with 5-10% of the grounds of hospitalization after age 65, and more than 20% after 80 years. Based on this observation, the health authority has proposed in 2011 the realization of therapeutic drug conciliation particularly in the elderly with multiple pathologies and multiple drugs. Taking into account the central role of the family practitioner in prescriptions, and the importance of coordination information such as output of hospitalization (vector of many malfunctions), we have achieved a therapeutic drug conciliation sheet (TDC) based primarily on the information needs by family practitioner after hospitalization of their patients. The issue of this study is to assess the interest for the use of a such TDC on the decrease in the rate of rehospitalization in the target population.
To do this, we are proposing a multicenter observational study. Randomization would be across the centres. The study would focus on 750 patients more of 75 with polymedication. The follow-up will last 6 months.
The main objective will be to determine if the use of the TDC, at the discharge of hospital, allows to reduce the number of use in emergency care within the two month after their hospital discharge. The first secondary objective will be identical to the main objective but rated at 6 months and the second secondary objective will be to assess the impact of the use of the TDC on overall mortality at 6 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With TDC sheet | – | Other: therapeutic drug conciliation sheet (TDC)Use of therapeutic drug conciliation sheet (TDC) by the hospital and transmitted to the family practitioner with other usual documentation |
| Without TDC Sheet | – | Other: No Use of therapeutic drug conciliation sheet (TDC)transmission of usual documentation only to the family practitioner |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Hospitalized patient aged over 75 years old
Key inclusion criteria (7 listed)
- age ≥75 years
- patients with a medical prescription, including at least three different allopathic molecules including at least a treatment in one of the following therapeutic classes:
- cardiovascular treatment: antiarrhythmics, antihypertensive drugs, anticoagulants and antiplatelet all classes
- treatment of the central nervous system: analgesics, benzodiazepines, antidepressants, hypnotic, antipsychotic drugs of all classes.
Key exclusion criteria (2 listed)
- not speaking french patient
- short survival time
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 |
|---|---|---|
| therapeutic drug conciliation sheet (TDC)Use of therapeutic drug conciliation sheet (TDC) | Other | With TDC sheet |
| No Use of therapeutic drug conciliation sheet (TDC) | Other | Without TDC Sheet |
Primary outcome
rate of patient who will have used hospital care in emergency
Time frame: at least one time within the two month after their hospital discharge
The use of hospital care in emergency is defined as a consultation in an emergency room and/or an emergency hospitalization. An emergency hospitalization is an hospitalization for which programing was made maximum 48h before the admission in hospital or clinic. The use will be documented by contact with the patient (or the support person if necessary) and his doctor. Here, it should be noted that deaths will be accounted for in the urgently use of to the hospital care regardless of the place of death. This in intended to take into account the possibility that a death may be related to a drug iatrogenic event for which the patient has not had time to resort to the hospital care in emergency.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2018.
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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.
Olivier GUERIN principal investigator
Centre Hospitalier Universitaire de Nice
Questions about this trial
What is this clinical trial studying?
An observational study of Iatrogenic Effect, run by Centre Hospitalier Universitaire de Nice.
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 7 inclusion and 2 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: withdrawn, as of the sponsor's last update on 19 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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?
rate of patient who will have used hospital care in emergency (time frame: at least one time within the two month after their hospital discharge). 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 19 Feb 2018.