Clinical trial NCT04744584: Medication Reconciliation in Pulmonary Hypertension
Official title: Optimizing Drug Management of Patients Suffering From Rare Disease Through Medication Reconciliation: Proof of Concept in Pulmonary Hypertension
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Hypertension
Pulmonary Hypertension Chronic Thromboembolic
Pulmonary Arterial Hypertension
Keywords: pulmonary hypertension
medication reconciliation
medication errors
pharmacist
rare disease
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Agence Regionale de Sante d'Ile de France
First posted: 2021-02-09
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalized in the French referal center to confirm PAH or CETPH diagnosis or coming back after diagnosis hospitalization

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).

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

Primary outcomes:
measure: Proportion of patients having at least one medication error on discharge at the first hospitalization.
timeFrame: 12months
Secondary outcomes:
measure: Qualitative description of identified medication errors.
timeFrame: 12 months
measure: Medication errors status
timeFrame: 12 Months
measure: Identification of medication error severity
timeFrame: 12 months
measure: Satisfaction of community healthcare practitioners with study tools
timeFrame: 12 months
measure: Therapeutic adherence
timeFrame: within 12 months after first hospitalization for the diagnosis of the disease
measure: Measure of Quality of life
timeFrame: within 12 months after first hospitalization for the diagnosis of the disease
measure: Improve vaccination coverage against influenza and pneumococcal disease
timeFrame: within 12 months after first hospitalization for the diagnosis of the disease
measure: Emergency hospitalization
timeFrame: within 12 months after first hospitalization for the diagnosis of the disease
measure: Estimate the time and resources spent on the conciliation process in the department
timeFrame: 12 months
Other outcomes:
Locations:
city: Le Kremlin-Bicêtre
country: France
facility: Hospital BICETRE
Study officials:
affiliation: APHP
name: Marie-camille CHAUMAIS, PharmaD, PHD
role: PRINCIPAL_INVESTIGATOR
References: