Medication Reconciliation in Pulmonary Hypertension

NCT ID: NCT04744584

Last Updated: 2024-07-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 129 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-02-16
• Study Completion Date: 2024-06-15

Brief 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. 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).

Conditions

Pulmonary Hypertension; Pulmonary Hypertension Chronic Thromboembolic; Pulmonary Arterial Hypertension

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with medication reconciliation

Patient with medication reconciliation during 1st hospitalization

Medication reconciliation

Intervention Type: OTHER

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.

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)

Medication reconciliation

Intervention Type: OTHER

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).

Interventions

Medication reconciliation

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.

Intervention Type: OTHER

Medication reconciliation

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).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Agence Regionale de Sante d'Ile de France

OTHER_GOV

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marie-camille CHAUMAIS, PharmaD, PHD

Role: PRINCIPAL_INVESTIGATOR

APHP

Locations

Hospital BICETRE

Le Kremlin-Bicêtre, , France

Countries

France

Other Identifiers

2020-A02455-34

Identifier Type: OTHER

Identifier Source: secondary_id

APHP201214

Identifier Type: -

Identifier Source: org_study_id