Pulmonary HypertensionOPTICARE-HTPNCT04744584
Medication Reconciliation in Pulmonary Hypertension
An observational study of Pulmonary Hypertension and Pulmonary Hypertension Chronic Thromboembolic, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Pulmonary hypertension (PH) is a life threatening condition. In PH, pulmonary arterial hypertension (PAH) and chronic thrombo-embolic chronic pulmonary hypertension (CTEPH) are two rare diseases requiring specific and complex drug management. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension, Pulmonary Hypertension Chronic Thromboembolic, Pulmonary Arterial Hypertension
- What is being tested?
- Medication reconciliation
- How many people
- 129 participants
- Where
- 1 siteFrance
- Study dates
- 16 Feb 2021to 15 Jun 2024
- 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: Patients hospitalized in the French referal center to confirm PAH or CETPH diagnosis or coming back after diagnosis hospitalization
Who may be able to join
- Patient affiliated or entitled to a social security scheme
- At least 18 years old
- Patient with enlightened information of the study and not opposed with it.
- For patient without MR: patient hospitalized for the first re-evaluation of PAH or CTEPH within 12 months following the first assessment hospitalization (ie: first right heart catheterization at bicetre Hospital).
- For patient with MR: patient hospitalized for first assessment (first right heart catheterization at bicetre Hospital) of PAH or CTEPH
Who cannot join
- Patient suffering from another form of PH
- Patient under guardianship or curator
- Inability to give information to the patient either due to language barrier or to cognitive impairment
- Patient hosted in institution on discharge from hospital (follow-up care and long-term rehabilitation)
- Patient with a life expectancy of less than 1 year
- Patient on transplant list
- Patient refusal
- Length of stay < 48 hours
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimizing Drug Management of Patients Suffering From Rare Disease Through Medication Reconciliation: Proof of Concept in Pulmonary Hypertension
Pulmonary hypertension (PH) is a life threatening condition. In PH, pulmonary arterial hypertension (PAH) and chronic thrombo-embolic chronic pulmonary hypertension (CTEPH) are two rare diseases requiring specific and complex drug management. In France ,a part of these treatments ,only available in hospital pharmacies, are generally unknown from community health care professionals despite the high risk of drug-interactions and side effects. Anticipating medication errors at the begging of the disease is therefore important, and could be done through medication reconciliation.
Read the detailed description
Medication reconciliation (MR) will be done for patients hospitalized in the French referral center for PH for PAH or CTEPH. Detected medication errors will be tracked and fixed by the physician before the end of hospitalization. A synthesis of new/stopped and modified treatments will be given to the patient as well as his related healthcare professionals (community pharmacist and general practioner) to ensure the maintaining of the new therapeutic management and the understanding of drugs modification. To compare the potential decrease of medication errors promoted by MR, a retrospective MR will be also done for patients without MR at 1st hospitalization but at the next one (3 to 12 months after).
- Conditions
- Pulmonary Hypertension, Pulmonary Hypertension Chronic Thromboembolic, Pulmonary Arterial Hypertension
- Being tested
- Medication reconciliation
- Keywords
- pulmonary hypertension, medication reconciliation, medication errors, pharmacist, rare disease
- Medical subject headings
- Hypertension, Pulmonary, Pulmonary Arterial Hypertension, Rare Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medication reconciliationOther
MR will be performed directly upon entering the patient's hospital for a first PAH or HTP-Thrombo embolic assessment, just after inclusion. Information regarding the treatments taken by the patient at the time of admission will be retrieved. The entry medication assessment will then be compared with the first medical prescription in order to identify whether medications have been forgotten, prescribed at a different dosage or prescribed when not indicated, etc. All of these differences will be considered medication errors if the reason for the discrepancy is not entered in the patient medical file.
Medication reconciliationOther
After inclusion of the patient, the MR will be carried out retrospectively, that is to say that the information concerning the treatments taken by the patient at the time of the first assessment will be retrieved during the period of the first reassessment (therefore with a delay of 12 months depending on the deadline for the first assessment). All these discrepancies will be considered medication errors if the reason for the discrepancy was not entered in the patient's computerized medical record (IMR).
| Study group | Role | What they receive |
|---|---|---|
| Patients with medication reconciliation | Patient with medication reconciliation during 1st hospitalization Receives: Other: Medication reconciliation | |
| Patients without medication reconciliation | Patient without medication reconciliation (MR) at 1st hospitalization but with retrospective MR at the next one (3 to 6 months after) Receives: Other: Medication reconciliation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients having at least one medication error on discharge at the first hospitalization.
This group will be compared to patients without prospective MR. For the latter group, MR is retrospective (3 to 6 months after discharge).
Measured: 12months
Secondary outcomes (9)
Qualitative description of identified medication errors.
Omission, dosing errors, drug interactions, substitution of another active compound
Measured: 12 months
Medication errors status
corrected/not corrected
Measured: 12 Months
Identification of medication error severity
Cornish scale is the title of the scale which include 3 levels of gravity (from 1 to 3). The first one describes no relevant clinical impact and the third one describes a severe clinical impact.
Measured: 12 months
Satisfaction of community healthcare practitioners with study tools
healthcare practitioners will be contacted by mail or phone
Measured: 12 months
Therapeutic adherence
Observance Girerd auto-questionnaire
Measured: within 12 months after first hospitalization for the diagnosis of the disease
Measure of Quality of life
Short Form 36 Questionnaire
Measured: within 12 months after first hospitalization for the diagnosis of the disease
Improve vaccination coverage against influenza and pneumococcal disease
inclusion vaccination coverage rate vs EOS(Enhanced Outreach Strategy) vaccination coverage rate
Measured: within 12 months after first hospitalization for the diagnosis of the disease
Emergency hospitalization
Number of emergency hospitalizations between first assessment hospitalization (diagnosis) and first reassessment hospitalization
Measured: within 12 months after first hospitalization for the diagnosis of the disease
Estimate the time and resources spent on the conciliation process in the department
Time measurement of the conciliation process in the group with CM (in minutes)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study start16 Feb 2021
- Primary completion15 Jun 2024
- Study completion15 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Agence Regionale de Sante d'Ile de France
- Responsible party
- Sponsor
- Investigators
- Marie-camille CHAUMAIS, PharmaD, PHD, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04744584
- Sponsor's protocol ID
- APHP201214
- Other IDs
- 2020-A02455-34
- Acronym
- OPTICARE-HTP
- Status last verified
- Jul 2024
- First submitted
- 15 Jan 2021
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No sharing
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Drug Management of Patients Suffering From Rare Disease Through Medication Reconciliation: Proof of Concept in Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT04744584
- Acronym / sponsor ID
- OPTICARE-HTP / APHP201214
- Conditions
- Pulmonary Hypertension, Pulmonary Hypertension Chronic Thromboembolic, Pulmonary Arterial Hypertension
- Keywords
- pulmonary hypertension, medication reconciliation, medication errors, pharmacist, rare disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Agence Regionale de Sante d'Ile de France
- Study start
- 16 Feb 2021 (actual)
- Primary completion
- 15 Jun 2024 (actual)
- Study completion
- 15 Jun 2024 (actual)
- First posted
- 9 Feb 2021 (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.
Pulmonary hypertension (PH) is a life threatening condition. In PH, pulmonary arterial hypertension (PAH) and chronic thrombo-embolic chronic pulmonary hypertension (CTEPH) are two rare diseases requiring specific and complex drug management. In France ,a part of these treatments ,only available in hospital pharmacies, are generally unknown from community health care professionals despite the high risk of drug-interactions and side effects. Anticipating medication errors at the begging of the disease is therefore important, and could be done through medication reconciliation.
Detailed description
Medication reconciliation (MR) will be done for patients hospitalized in the French referral center for PH for PAH or CTEPH. Detected medication errors will be tracked and fixed by the physician before the end of hospitalization. A synthesis of new/stopped and modified treatments will be given to the patient as well as his related healthcare professionals (community pharmacist and general practioner) to ensure the maintaining of the new therapeutic management and the understanding of drugs modification. To compare the potential decrease of medication errors promoted by MR, a retrospective MR will be also done for patients without MR at 1st hospitalization but at the next one (3 to 12 months after).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with medication reconciliation | – | Other: Medication reconciliationPatient with medication reconciliation during 1st hospitalization |
| Patients without medication reconciliation | – | Other: Medication reconciliationPatient without medication reconciliation (MR) at 1st hospitalization but with retrospective MR at the next one (3 to 6 months after) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized in the French referal center to confirm PAH or CETPH diagnosis or coming back after diagnosis hospitalization
Key inclusion criteria (5 listed)
- Patient affiliated or entitled to a social security scheme
- At least 18 years old
- Patient with enlightened information of the study and not opposed with it.
- For patient without MR: patient hospitalized for the first re-evaluation of PAH or CTEPH within 12 months following the first assessment hospitalization (ie: first right heart catheterization at bicetre Hospital).
- For patient with MR: patient hospitalized for first assessment (first right heart catheterization at bicetre Hospital) of PAH or CTEPH
Key exclusion criteria (8 listed)
- Patient suffering from another form of PH
- Patient under guardianship or curator
- Inability to give information to the patient either due to language barrier or to cognitive impairment
- Patient hosted in institution on discharge from hospital (follow-up care and long-term rehabilitation)
- Patient with a life expectancy of less than 1 year
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 |
|---|---|---|
| Medication reconciliationMR will be performed directly upon entering the patient's hospital for a first PAH or HTP-Thrombo embolic assessment, just after inclusion. Information regarding the treatments taken by the patient at the time of admission will be retrieved. The entry medication assessment will then be compared with the first medical prescription in order to identify whether medications have been forgotten, prescribed at a different dosage or prescribed when not indicated, etc. All of these differences will be considered medication errors if the reason for the discrepancy is not entered in the patient medical file. | Other | Patients with medication reconciliation |
| Medication reconciliationAfter inclusion of the patient, the MR will be carried out retrospectively, that is to say that the information concerning the treatments taken by the patient at the time of the first assessment will be retrieved during the period of the first reassessment (therefore with a delay of 12 months depending on the deadline for the first assessment). All these discrepancies will be considered medication errors if the reason for the discrepancy was not entered in the patient's computerized medical record (IMR). | Other | Patients without medication reconciliation |
Primary outcome
Proportion of patients having at least one medication error on discharge at the first hospitalization.
Time frame: 12months
This group will be compared to patients without prospective MR. For the latter group, MR is retrospective (3 to 6 months after discharge).
9 secondary outcomes
Qualitative description of identified medication errors.
Time frame: 12 months
Medication errors status
Time frame: 12 Months
Identification of medication error severity
Time frame: 12 months
Satisfaction of community healthcare practitioners with study tools
Time frame: 12 months
Therapeutic adherence
Time frame: within 12 months after first hospitalization for the diagnosis of the disease
Measure of Quality of life
Time frame: within 12 months after first hospitalization for the diagnosis of the disease
Improve vaccination coverage against influenza and pneumococcal disease
Time frame: within 12 months after first hospitalization for the diagnosis of the disease
Emergency hospitalization
Time frame: within 12 months after first hospitalization for the diagnosis of the disease
Estimate the time and resources spent on the conciliation process in the department
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
- Individual participant dataSharing planned: No. No sharing
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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.
Marie-camille CHAUMAIS, PharmaD, PHD principal investigator
APHP
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 Pulmonary Hypertension and Pulmonary Hypertension Chronic Thromboembolic, run by Assistance Publique - Hôpitaux de Paris 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 8 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: finished, as of the sponsor's last update on 16 Jul 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of patients having at least one medication error on discharge at the first hospitalization. (time frame: 12months). 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 16 Jul 2024.