Optimizing Drug Management of Patients Suffering From Rare Disease Through Medication Reconciliation: Proof of Concept in Pulmonary Hypertension
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 129
- Locations
- 1
- Primary Endpoint
- Proportion of patients having at least one medication error on discharge at the first hospitalization.
Study Overview
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).
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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
- Measure of Quality of life(within 12 months after first hospitalization for the diagnosis of the disease)
- Emergency 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(12 months)
- Identification of medication error severity(12 months)
- Qualitative description of identified medication errors.(12 months)
- Medication errors status(12 Months)
- Therapeutic adherence(within 12 months after first hospitalization for the diagnosis of the disease)
- Satisfaction of community healthcare practitioners with study tools(12 months)
- Improve vaccination coverage against influenza and pneumococcal disease(within 12 months after first hospitalization for the diagnosis of the disease)