Skip to content

Medication Reconciliation in Pulmonary Hypertension

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04744584
Acronym
OPTICARE-HTP
Enrollment
129
Registered
2021-02-09
Start date
2021-02-16
Completion date
2024-06-15
Last updated
2024-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Arterial Hypertension, Pulmonary Hypertension, Pulmonary Hypertension Chronic Thromboembolic

Keywords

pulmonary hypertension, medication reconciliation, medication errors, pharmacist, rare disease

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).

Interventions

OTHERMedication 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.

Sponsors

Agence Regionale de Sante d'Ile de France
CollaboratorOTHER_GOV
Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Proportion of patients having at least one medication error on discharge at the first hospitalization.12monthsThis group will be compared to patients without prospective MR. For the latter group, MR is retrospective (3 to 6 months after discharge).

Secondary

MeasureTime frameDescription
Medication errors status12 Monthscorrected/not corrected
Identification of medication error severity12 monthsCornish 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.
Satisfaction of community healthcare practitioners with study tools12 monthshealthcare practitioners will be contacted by mail or phone
Therapeutic adherencewithin 12 months after first hospitalization for the diagnosis of the diseaseObservance Girerd auto-questionnaire
Qualitative description of identified medication errors.12 monthsOmission, dosing errors, drug interactions, substitution of another active compound
Improve vaccination coverage against influenza and pneumococcal diseasewithin 12 months after first hospitalization for the diagnosis of the diseaseinclusion vaccination coverage rate vs EOS(Enhanced Outreach Strategy) vaccination coverage rate
Emergency hospitalizationwithin 12 months after first hospitalization for the diagnosis of the diseaseNumber of emergency hospitalizations between first assessment hospitalization (diagnosis) and first reassessment hospitalization
Estimate the time and resources spent on the conciliation process in the department12 monthsTime measurement of the conciliation process in the group with CM (in minutes)
Measure of Quality of lifewithin 12 months after first hospitalization for the diagnosis of the diseaseShort Form 36 Questionnaire

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026