Medication Reconciliation in Pulmonary Hypertension

NCT04744584 | Completed

• 2 other identifiers: APHP2012142020-A02455-34
• Study Type: observational
• Target: 129
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Hypertension; Pulmonary Hypertension Chronic Thromboembolic; Pulmonary Arterial Hypertension

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Qualitative description of identified medication errors.

  12 months

• Medication errors status

  12 Months

• Identification of medication error severity

  12 months

• Satisfaction of community healthcare practitioners with study tools

  12 months

• Therapeutic adherence

  within 12 months after first hospitalization for the diagnosis of the disease

Study Arms (2)

Patients with medication reconciliation

Patient with medication reconciliation during 1st hospitalization

Other: Medication reconciliation

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

Interventions

Medication reconciliation 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 with medication reconciliation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Agence Regionale de Sante d'Ile de France: collaborator

Study Sites (1)

Hospital BICETRE

Le Kremlin-Bicêtre, 94275, France

Location

MeSH Terms

Conditions

Hypertension, Pulmonary; Pulmonary Arterial Hypertension; Rare Diseases

Interventions

Medication Reconciliation

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Medication Errors; Drug Therapy; Therapeutics; Medical Errors; Health Services; Health Care Facilities Workforce and Services; Medication Systems; Organization and Administration; Health Services Administration; Patient Care Management

Study Officials

• Marie-camille CHAUMAIS, PharmaD, PHD

  APHP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2021
• First Posted: February 9, 2021
• Study Start: February 16, 2021
• Primary Completion: June 15, 2024
• Study Completion: June 15, 2024
• Last Updated: July 16, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)