Medication Reconciliation in Pulmonary Hypertension (OPTICARE-HTP)

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Arterial Hypertension; Pulmonary Hypertension; Pulmonary Hypertension Chronic Thromboembolic
• Intervention / Treatment: Other: Medication reconciliation; Other: 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 Type: Observational
• Enrollment (Actual): 129

Contacts and Locations

Study Locations

• France
  • Le Kremlin-Bicêtre, France, 94275
    • Hospital Bicêtre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with medication reconciliation; Patient with medication reconciliation during 1st hospitalization	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.; 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).
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)	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.; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qualitative description of identified medication errors.	Omission, dosing errors, drug interactions, substitution of another active compound	12 months
Medication errors status	corrected/not corrected	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.	12 months
Satisfaction of community healthcare practitioners with study tools	healthcare practitioners will be contacted by mail or phone	12 months
Therapeutic adherence	Observance Girerd auto-questionnaire	within 12 months after first hospitalization for the diagnosis of the disease
Measure of Quality of life	Short Form 36 Questionnaire	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	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	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)	12 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Agence Regionale de Sante d'Ile de France
• Investigators: Principal Investigator: Marie-camille CHAUMAIS, PharmaD, PHD, APHP

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2021
• Primary Completion (Actual): June 15, 2024
• Study Completion (Actual): June 15, 2024

Study Registration Dates

• First Submitted: January 15, 2021
• First Submitted That Met QC Criteria: February 6, 2021
• First Posted (Actual): February 9, 2021

Study Record Updates

• Last Update Posted (Actual): July 16, 2024
• Last Update Submitted That Met QC Criteria: July 15, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: rare disease; pharmacist; pulmonary hypertension; medication reconciliation; medication errors
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Pulmonary Arterial Hypertension; Hypertension, Pulmonary
• Other Study ID Numbers: APHP201214; 2020-A02455-34 (Other Identifier: IDRCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No sharing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No