Medication Reconciliation in Pulmonary Hypertension

Pulmonary Hypertension Clinical Trial

— OPTICARE-HTP  

Official title:

Optimizing Drug Management of Patients Suffering From Rare Disease Through Medication Reconciliation: Proof of Concept in Pulmonary Hypertension

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04744584
• Other study ID #: APHP201214
• Secondary ID: 2020-A02455-34
• Status: Active, not recruiting
• Start date: February 15, 2021
• Est. completion date: June 15, 2024

Study information

• Verified date: December 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 127
• Est. completion date: June 15, 2024
• Est. primary completion date: June 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Arterial Hypertension
• Pulmonary Hypertension
• Pulmonary Hypertension Chronic Thromboembolic

Intervention

Other:
• 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.
• 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).

Locations

Country	Name	City	State
France	Hospital BICETRE	Le Kremlin-Bicêtre

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Agence Regionale de Sante d'Ile de France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	12months
Secondary	Qualitative description of identified medication errors.	Omission, dosing errors, drug interactions, substitution of another active compound	12 months
Secondary	Medication errors status	corrected/not corrected	12 Months
Secondary	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.	12 months
Secondary	Satisfaction of community healthcare practitioners with study tools	healthcare practitioners will be contacted by mail or phone	12 months
Secondary	Therapeutic adherence	Observance Girerd auto-questionnaire	within 12 months after first hospitalization for the diagnosis of the disease
Secondary	Measure of Quality of life	Short Form 36 Questionnaire	within 12 months after first hospitalization for the diagnosis of the disease
Secondary	Improve vaccination coverage against influenza and pneumococcal disease	inclusion vaccination coverage rate vs EOS(Enhanced Outreach Strategy) vaccination coverage rate	within 12 months after first hospitalization for the diagnosis of the disease
Secondary	Emergency hospitalization	Number of emergency hospitalizations between first assessment hospitalization (diagnosis) and first reassessment hospitalization	within 12 months after first hospitalization for the diagnosis of the disease
Secondary	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)	12 months