Medication Reconciliation in Pulmonary Hypertension (OPTICARE-HTP)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04744584 |
|
Recruitment Status :
Recruiting
First Posted : February 9, 2021
Last Update Posted : May 3, 2021
|
Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborator:
Agence Regionale de Sante d'Ile de France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
| Condition or disease | Intervention/treatment |
|---|---|
| Pulmonary Hypertension Pulmonary Hypertension Chronic Thromboembolic Pulmonary Arterial Hypertension | Other: Medication reconciliation |
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 6 months after).
| Study Type : | Observational |
| Estimated Enrollment : | 160 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Optimizing Drug Management of Patients Suffering From Rare Disease Through Medication Reconciliation: Proof of Concept in Pulmonary Hypertension |
| Actual Study Start Date : | February 15, 2021 |
| Estimated Primary Completion Date : | August 1, 2022 |
| Estimated Study Completion Date : | August 1, 2022 |
Resource links provided by the National Library of Medicine
| 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. |
|
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
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 3 to 6 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). |
Primary Outcome Measures :
- Proportion of patients having at least one medication error on discharge at the first hospitalization. [ Time Frame: 6 months ]This group will be compared to patients without prospective MR. For the latter group, MR is retrospective (3 to 6 months after discharge).
Secondary Outcome Measures :
- Qualitative description of identified medication errors. [ Time Frame: 6 months ]Omission, dosing errors, drug interactions, substitution of another active compound
- Medication errors status [ Time Frame: 6 Months ]corrected/not corrected
- Identification of medication error severity [ Time Frame: 6 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.
- Satisfaction of community healthcare practitioners with study tools [ Time Frame: 6 months ]healthcare practitioners will be contacted by mail or phone
- Therapeutic adherence [ Time Frame: between 3 to 6 months after first hospitalization for the diagnosis of the disease ]Observance Girerd auto-questionnaire
- Measure of Quality of life [ Time Frame: between 3 to 6 months after first hospitalization for the diagnosis of the disease ]Short Form 36 Questionnaire
- Increased of vaccination coverage rate [ Time Frame: between 3 to 6 months after first hospitalization for the diagnosis of the disease ]inclusion vaccination coverage rate vs EOS(Enhanced Outreach Strategy) vaccination coverage rate
- Emergency hospitalization [ Time Frame: between 3 to 6 months after first hospitalization for the diagnosis of the disease ]Number of emergency hospitalizations between first assessment hospitalization (diagnosis) and first reassessment hospitalization
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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
Criteria
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 3 to 6 months following the first assessment hospitalization (ie: diagnosis).
- For patient with MR: patient hospitalized for first assessment (diagnosis) 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04744584
Contacts
| Contact: Marie-Camille Chaumais, PharmD, PhD | 01 45 21 71 72 | mariecamille.chaumais@aphp.fr | |
| Contact: Xavier Jais, MD, PhD | 01 45 21 78 95 | xavier.jais@aphp.fr |
Locations
| France | |
| Hospital BICETRE | Recruiting |
| Le Kremlin-Bicêtre, France, 94275 | |
| Contact: Marie-Camille Chaumais, PharmD, PhD 01 45 21 71 72 mariecamille.chaumais@aphp.fr | |
| Contact: Xavier Jais, MD, PhD 01 45 21 78 95 xavier.jais@aphp.fr | |
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Agence Regionale de Sante d'Ile de France
Investigators
| Principal Investigator: | Marie-camille CHAUMAIS, PharmaD, PHD | APHP |
| Responsible Party: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT04744584 |
| Other Study ID Numbers: |
APHP201214 2020-A02455-34 ( Other Identifier: IDRCB ) |
| First Posted: | February 9, 2021 Key Record Dates |
| Last Update Posted: | May 3, 2021 |
| Last Verified: | January 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Plan Description: | No sharing |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Assistance Publique - Hôpitaux de Paris:
|
pulmonary hypertension medication reconciliation medication errors pharmacist rare disease |
Additional relevant MeSH terms:
|
Hypertension, Pulmonary Pulmonary Arterial Hypertension Hypertension Vascular Diseases |
Cardiovascular Diseases Lung Diseases Respiratory Tract Diseases |