Medication Reconciliation in Pulmonary Hypertension (OPTICARE-HTP)

July 15, 2024 updated by: Assistance Publique - Hôpitaux de Paris

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
129

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
12months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Qualitative description of identified medication errors.
Time Frame: 12 months
Omission, dosing errors, drug interactions, substitution of another active compound
12 months
Medication errors status
Time Frame: 12 Months
corrected/not corrected
12 Months
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.
12 months
Satisfaction of community healthcare practitioners with study tools
Time Frame: 12 months
healthcare practitioners will be contacted by mail or phone
12 months
Therapeutic adherence
Time Frame: within 12 months after first hospitalization for the diagnosis of the disease
Observance Girerd auto-questionnaire
within 12 months after first hospitalization for the diagnosis of the disease
Measure of Quality of life
Time Frame: within 12 months after first hospitalization for the diagnosis of the disease
Short Form 36 Questionnaire
within 12 months after first hospitalization for the diagnosis of the disease
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
within 12 months after first hospitalization for the diagnosis of the disease
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
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 Frame: 12 months
Time measurement of the conciliation process in the group with CM (in minutes)
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assistance Publique - Hôpitaux de Paris

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Agence Regionale de Sante d'Ile de France

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marie-camille CHAUMAIS, PharmaD, PHD, APHP

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 16, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 15, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 15, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 9, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 16, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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