Medication Reconciliation in Pulmonary Hypertension
- Conditions
- Pulmonary Arterial HypertensionPulmonary Hypertension Chronic ThromboembolicPulmonary Hypertension
- Interventions
- Other: Medication reconciliation
- Registration Number
- NCT04744584
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 129
- 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients without medication reconciliation Medication reconciliation Patient without medication reconciliation (MR) at 1st hospitalization but with retrospective MR at the next one (3 to 6 months after) Patients with medication reconciliation Medication reconciliation Patient with medication reconciliation during 1st hospitalization
- Primary Outcome Measures
Name Time Method Proportion of patients having at least one medication error on discharge at the first hospitalization. 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 Outcome Measures
Name Time Method Emergency hospitalization 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
Estimate the time and resources spent on the conciliation process in the department 12 months Time measurement of the conciliation process in the group with CM (in minutes)
Identification of medication error severity 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.
Qualitative description of identified medication errors. 12 months Omission, dosing errors, drug interactions, substitution of another active compound
Medication errors status 12 Months corrected/not corrected
Therapeutic adherence within 12 months after first hospitalization for the diagnosis of the disease Observance Girerd auto-questionnaire
Satisfaction of community healthcare practitioners with study tools 12 months healthcare practitioners will be contacted by mail or phone
Improve vaccination coverage against influenza and pneumococcal disease within 12 months after first hospitalization for the diagnosis of the disease inclusion vaccination coverage rate vs EOS(Enhanced Outreach Strategy) vaccination coverage rate
Measure of Quality of life within 12 months after first hospitalization for the diagnosis of the disease Short Form 36 Questionnaire
Trial Locations
- Locations (1)
Hospital BICETRE
🇫🇷Le Kremlin-Bicêtre, France