RecruitingNot ApplicableNCT05413759

RhEumatoid Arthritis MEDIcation Adherence

Collaborative Pharmaceutical Care Initiated in Hospital and Continued in Primary Care to Improve Medication Adherence of Patients With Rheumatoid Arthritis


Sponsor

Hospices Civils de Lyon

Enrollment

200 participants

Start Date

Jun 28, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

Rheumatoid arthritis (RA) is a public health issue because of its frequency, its functional consequences, the risk of morbidity and mortality and the costs incurred. A collaborative multiprofessional intervention initiated during hospitalization and continued after hospital discharge (ambulatory care ) would improve medication adherence in RA and therefore the health status of patients. Main objective: To compare, 12 months after the index hospitalization or consultation, the impact of pharmaceutical care provided in multiprofessional collaboration (pharmacist-physician) on medication adherence to disease-modifying treatments of patients with RA compared to usual care without pharmaceutical care and specific multi-professional collaboration. Medication adherence to disease-modifying treatments will be assessed by the rate of coverage of disease-modifying treatments (or Medication Possession Ratio (MPR)). METHODOLOGY: Interventional, multicenter, controlled, randomized, open label study, comparing in parallel 2 groups of patients with rheumatoid arthritis initially hospitalized in a rheumatology department (pharmaceutical care provided in multiprofessional collaboration (pharmacist-physician), initiated in the hospital and continued after hospital discharge (ambulatory care) vs traditional follow-up.


Eligibility

Min Age: 18 Years

Inclusion Criteria8

  • Patient with diagnosed rheumatoid arthritis (RA),
  • Patient, male or female, aged 18 or over,
  • Patient hospitalized or coming for a consultation in a rheumatology department, and returned home at hospital discharge
  • Patient having DMARDs for RA (continuation or initiation) comprising at least methotrexate and/or a tsDMARD (targeted synthetic DMARD, JAK inhibitor) and/or subcutaneous bDMARD (biologic DMARD),
  • Autonomous patient in the management of his drug treatment,
  • Patient understanding and speaking French,
  • Patient affiliated to the French general national health insurance or similar,
  • Patient having given his free, informed and signed consent.

Exclusion Criteria8

  • Patient whose usual pharmacy already has or has had a patient included in the INTERVENTION group in the study,
  • Patient whose regular pharmacy is currently treating another patient.
  • Patient with obvious significant cognitive or psychiatric disorders incompatible with the study (according to the judgment of the investigator),
  • Patient whose management of his drug treatment at home is carried out exclusively by a carer,
  • Patient participating in another research that may interfere (investigator's judgement) with the results of the present study,
  • Adult patient protected under the terms of the law (Public Health Code),
  • Patient not fit to carry out the follow-up, according to the judgment of the investigator,
  • Pregnant or breastfeeding women.

Interventions

OTHERPharmaceutical care in multiprofessional collaboration

In addition to usual practices: medication reconciliation and pharmaceutical motivational interviews with patients (discharge, 2 \& 6 months). Objective of medication reconciliation (admission): to detect and resolve unintended medication discrepancies between home medication list and treatment and hospital admission medication orders. Objective of medication reconciliation (discharge): to obtain an exact list of medication, to explain the medication modifications during hospitalization. Objective of the Disease-Modifying Antirheumatic Drugs information interview (discharge): to provide information and to answer questions on the management of treatment, to deal with practical situations to assess patients' self-management skills. Objective of interviews (2 \& 6 months): to evaluate medications and their daily management, benefits and problems that patient may encounter, to assess the patient's ability to manage the treatment.


Locations(2)

Service de rhumatologie, Centre Hospitalier Lyon Sud, Groupement Hospitalier Sud, Hospices Civils de Lyon

Pierre-Bénite, Lyon, France

Service de rhumatologie et pathologie osseuse - Hôpital Edouard Herriot

Lyon, France

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NCT05413759


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