Iatrogenic EffectOPTIM-EHPADNCT05179642
OPTIM-EHPAD Optimization of Drug Prescription for Each Resident Entering in Nursing Home (EHPAD).
An observational study of Iatrogenic Effect, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Elderly people are at high risk of multiple medication which increases drug interactions and side effects. This problem is accentuated in EHPAD due to the multiplication of prescribers (the referring physician, the hospital physician, the specialist, the emergency physician, the coordinating physician). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Iatrogenic Effect
- What is being tested?
- OPTIM-EHPAD tool
- How many people
- 2,000 participants
- Where
- 1 siteFrance
- Study dates
- 15 May 2019to 31 Dec 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The eligible population is made up of EHPAD coordinating physicians who don't have an indoor pharmacy (PUI) from the Languedoc-Roussillon-Midi-Pyrénées region and the Auvergne-Rhône-Alpes region. Any new resident entering a participating EHPAD. Residents who don't have a referring physician when entering EHPAD will be excluded.
Who may be able to join
- - Coordinating physician of EHPAD who don't have an indoor pharmacy (PUI) from the Languedoc-Roussillon-Midi-Pyrénées region and the Auvergne-Rhône-Alpes region.
- New resident entering a participating EHPAD
Who cannot join
- - Residents who don't have a referring physician when entering EHPAD
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of a Consultation Between a Coordinating Physician and a Referring Physician About the Optimization of Drug Prescription for Each Resident Entering in Nursing Home (EHPAD).
Elderly people are at high risk of multiple medication which increases drug interactions and side effects. This problem is accentuated in EHPAD due to the multiplication of prescribers (the referring physician, the hospital physician, the specialist, the emergency physician, the coordinating physician). The lack of optimization of drug prescriptions in EHPAD can be responsible for iatrogenic, underuse and overuse of treatment, impacting the autonomy and quality of life of residents in EHPAD in France.
A method for optimizing diagnostic and drug management at the entry of a new EHPAD resident, called OPTIM EHPAD, has been tested in Languedoc-Roussillon (France) and validated. This is a consultation between the referring physician and the EHPAD coordinating physician. Some improvements have been made to this method in order to have an optimized version.
Read more
Physician's cooperation seems to promote decision-making and change in therapies. The objective of this study is to assess the theoretical effectiveness and efficiency of this approach.
It is supposed that the provision to the EHPAD coordinating physician of a method for optimizing the diagnostic and drug management of the new EHPAD resident (based on a decision following consultation between the referring doctor and the coordinating doctor) would impact on the resident care process, on their care results and on communication and coordination between the coordinating physician and the referring physician.
- Conditions
- Iatrogenic Effect
- Being tested
- OPTIM-EHPAD tool
- Keywords
- coordinating physician, referring physician, optimization of drug prescription, nursing home, inappropriate prescription
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPTIM-EHPAD toolOther
This is a randomized, cluster stepped wedge study. Residents entering EHPAD during the pre-interventional inclusion period will be treated as usual in EHPAD. They will constitute the control group.
Residents entering EHPAD during the post-intervention inclusion period will have the optimization of their diagnostic and drug management, following a consultation between their referring physician and the coordinating physician based on the OPTIM-EHPAD method. They will constitute the intervention group.
The intervention is based on the utilization of the OPTIM-EHPAD method. It consists in training for coordinating physician and, optionally, for referring physician. It's a pedagogic tool proposing a rigorous methodology for reviewing prescriptions in chronological stages, associated with memos, constituting a form of clinical path for improving the quality and safety of prescriptions for EHPAD residents.
| Study group | Role | What they receive |
|---|---|---|
| Control group | This is a randomized, cluster stepped wedge study. The cluster will be made up of coordinating physicians grouped together according to the geographical area of their EHPAD. Residents entering EHPAD during the pre-interventional inclusion period will be treated as usual in EHPAD. They will constitute the control group. | |
| Tool OPTIM-EHPAD | This is a randomized, cluster stepped wedge study. The cluster will be made up of coordinating physicians grouped together according to the geographical area of their EHPAD.
Residents entering EHPAD during the post-intervention inclusion period will have the optimization of their diagnostic and drug management, following a consultation between their referring physician and the coordinating physician based on the OPTIM-EHPAD method. They will constitute the intervention group.
The intervention is based on the utilization of the OPTIM-EHPAD method. It consists in training for coordinating physician and, optionally, for referring physician. It's a pedagogic tool proposing a rigorous methodology for reviewing prescriptions in chronological stages, associated with memos, constituting a form of clinical path for improving the quality and safety of prescriptions for EHPAD residents. Receives: Other: OPTIM-EHPAD tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inappropriate prescription line and average number of days of hospitalization
hierarchical sequential approach on the following criteria according to the predefined order :
- Proportion of residents with at least one inappropriate prescription line in residents' drug dispensations during months M3 to M6 following their entry into EHPAD.
- Average number of days of hospitalization per resident in internal medicine/surgery/obstetrics wards, follow-up care and rehabilitation or in a psychiatric establishment during the 6 months following entry into EHPAD
Measured: 6 months after the entering patient in EHPAD
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2022
- Study start15 May 2019
- Primary completion15 Oct 2020
- Study completion31 Dec 2021 (estimated)
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 Hospices Civils de LyonThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05179642
- Sponsor's protocol ID
- 69HCL17_0009
- Acronym
- OPTIM-EHPAD
- Status last verified
- Nov 2021
- First submitted
- 8 Nov 2021
- Last updated
- 5 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Consultation Between a Coordinating Physician and a Referring Physician About the Optimization of Drug Prescription for Each Resident Entering in Nursing Home (EHPAD).
- ClinicalTrials.gov ID
- NCT05179642
- Acronym / sponsor ID
- OPTIM-EHPAD / 69HCL17_0009
- Conditions
- Iatrogenic Effect
- Keywords
- coordinating physician, referring physician, optimization of drug prescription, nursing home, inappropriate prescription
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 15 May 2019 (actual)
- Primary completion
- 15 Oct 2020 (actual)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 5 Jan 2022 (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.
Elderly people are at high risk of multiple medication which increases drug interactions and side effects. This problem is accentuated in EHPAD due to the multiplication of prescribers (the referring physician, the hospital physician, the specialist, the emergency physician, the coordinating physician). The lack of optimization of drug prescriptions in EHPAD can be responsible for iatrogenic, underuse and overuse of treatment, impacting the autonomy and quality of life of residents in EHPAD in France.
A method for optimizing diagnostic and drug management at the entry of a new EHPAD resident, called OPTIM EHPAD, has been tested in Languedoc-Roussillon (France) and validated. This is a consultation between the referring physician and the EHPAD coordinating physician. Some improvements have been made to this method in order to have an optimized version.
Physician's cooperation seems to promote decision-making and change in therapies. The objective of this study is to assess the theoretical effectiveness and efficiency of this approach.
It is supposed that the provision to the EHPAD coordinating physician of a method for optimizing the diagnostic and drug management of the new EHPAD resident (based on a decision following consultation between the referring doctor and the coordinating doctor) would impact on the resident care process, on their care results and on communication and coordination between the coordinating physician and the referring physician.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | – | –This is a randomized, cluster stepped wedge study. The cluster will be made up of coordinating physicians grouped together according to the geographical area of their EHPAD. Residents entering EHPAD during the pre-interventional inclusion period will be treated as usual in EHPAD. They will constitute the control group. |
| Tool OPTIM-EHPAD | – | Other: OPTIM-EHPAD toolThis is a randomized, cluster stepped wedge study. The cluster will be made up of coordinating physicians grouped together according to the geographical area of their EHPAD. Residents entering EHPAD during the post-intervention inclusion period will have the optimization of their diagnostic and drug management, following a consultation between their referring physician and the coordinating physician based on the OPTIM-EHPAD method. They will constitute the intervention group. The intervention is based on the utilization of the OPTIM-EHPAD method. It consists in training for coordinating physician and, optionally, for referring physician. It's a pedagogic tool proposing a rigorous methodology for reviewing prescriptions in chronological stages, associated with memos, constituting a form of clinical path for improving the quality and safety of prescriptions for EHPAD residents. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The eligible population is made up of EHPAD coordinating physicians who don't have an indoor pharmacy (PUI) from the Languedoc-Roussillon-Midi-Pyrénées region and the Auvergne-Rhône-Alpes region. Any new resident entering a participating EHPAD. Residents who don't have a referring physician when entering EHPAD will be excluded.
Key inclusion criteria (2 listed)
- - Coordinating physician of EHPAD who don't have an indoor pharmacy (PUI) from the Languedoc-Roussillon-Midi-Pyrénées region and the Auvergne-Rhône-Alpes region.
- New resident entering a participating EHPAD
Key exclusion criteria (1 listed)
- - Residents who don't have a referring physician when entering EHPAD
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 |
|---|---|---|
| OPTIM-EHPAD toolThis is a randomized, cluster stepped wedge study. Residents entering EHPAD during the pre-interventional inclusion period will be treated as usual in EHPAD. They will constitute the control group. Residents entering EHPAD during the post-intervention inclusion period will have the optimization of their diagnostic and drug management, following a consultation between their referring physician and the coordinating physician based on the OPTIM-EHPAD method. They will constitute the intervention group. The intervention is based on the utilization of the OPTIM-EHPAD method. It consists in training for coordinating physician and, optionally, for referring physician. It's a pedagogic tool proposing a rigorous methodology for reviewing prescriptions in chronological stages, associated with memos, constituting a form of clinical path for improving the quality and safety of prescriptions for EHPAD residents. | Other | Tool OPTIM-EHPAD |
Primary outcome
Inappropriate prescription line and average number of days of hospitalization
Time frame: 6 months after the entering patient in EHPAD
hierarchical sequential approach on the following criteria according to the predefined order : 1. Proportion of residents with at least one inappropriate prescription line in residents' drug dispensations during months M3 to M6 following their entry into EHPAD. 2. Average number of days of hospitalization per resident in internal medicine/surgery/obstetrics wards, follow-up care and rehabilitation or in a psychiatric establishment during the 6 months following entry into EHPAD
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Iatrogenic Effect, run by Hospices Civils de Lyon 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 2 inclusion and 1 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 5 Jan 2022. 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?
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?
Inappropriate prescription line and average number of days of hospitalization (time frame: 6 months after the entering patient in EHPAD). 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 5 Jan 2022.