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OpenTrials
Completed

NCT Number: NCT04744584

Medication Reconciliation 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.

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Proportion of patients having at least one medication error on discharge at the first hospitalization.

    Time frame: 12months

    This group will be compared to patients without prospective MR. For the latter group, MR is retrospective (3 to 6 months after discharge).

Secondary outcomes

  1. Qualitative description of identified medication errors.

    Time frame: 12 months

    Omission, dosing errors, drug interactions, substitution of another active compound

  2. Medication errors status

    Time frame: 12 Months

    corrected/not corrected

  3. Identification of medication error severity

    Time frame: 12 months

    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.

  4. Satisfaction of community healthcare practitioners with study tools

    Time frame: 12 months

    healthcare practitioners will be contacted by mail or phone

  5. Therapeutic adherence

    Time frame: within 12 months after first hospitalization for the diagnosis of the disease

    Observance Girerd auto-questionnaire

  6. Measure of Quality of life

    Time frame: within 12 months after first hospitalization for the diagnosis of the disease

    Short Form 36 Questionnaire

  7. Improve vaccination coverage against influenza and pneumococcal disease

    Time frame: within 12 months after first hospitalization for the diagnosis of the disease

    inclusion vaccination coverage rate vs EOS(Enhanced Outreach Strategy) vaccination coverage rate

  8. Emergency hospitalization

    Time frame: within 12 months after first hospitalization for the diagnosis of the disease

    Number of emergency hospitalizations between first assessment hospitalization (diagnosis) and first reassessment hospitalization

  9. Estimate the time and resources spent on the conciliation process in the department

    Time frame: 12 months

    Time measurement of the conciliation process in the group with CM (in minutes)

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Agence Regionale de Sante d'Ile de France

Registry information

Official study title

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

Acronym: OPTICARE-HTP

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Feb 9, 2021
Registry last updated
Jul 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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