RhEumatoid Arthritis MEDIcation Adherence

Official title

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

Overview

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.

Interventions

• Other Pharmaceutical 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. Objec

Primary outcome measures

• Medication adherence to rheumatoid arthritis treatment [Time frame: Month 12]

Secondary outcome measures (12)

• Clinical criteria - Evolution of the Disease Activity Score DAS28 [Time frame: Day 0 and Month 12]
• Clinical criteria - Number of Rheumatoid Arthritis-related re-hospitalizations [Time frame: Month 0 and Month 12]
• Clinical criteria - Number of adverse effects related to drug treatments leading to hospitalization. [Time frame: Month 0 and Month 12]
• Functional and quality of life criteria - Evolution of the Health Assessment Questionnaire (HAQ) score [Time frame: Day 0 and Month 12]
• Functional and quality of life criteria - Evolution of the EuroQol 5-Dimensional score (EQ-5D) [Time frame: Day 0 and Month 12]
• Criteria for patient behavior in relation to their disease-modifying antirheumatic drugs (DMARDs) - Medication Possession Ratio for each disease-modifying antirheumatic drug (DMARD) [Time frame: Month 12]
• Criteria for patient behavior in relation to their disease-modifying antirheumatic drugs (DMARDs) - Adherent rate according to the Compliance Questionnaire on Rheumatology (CQR) [Time frame: Month 12]
• Criteria for patient behavior in relation to their disease-modifying antirheumatic drugs (DMARDs) - Evolution of the BioSecure score or Knowledge score (Methotrexate and/or anti-JAK) [Time frame: Day 0 and Month 12]
• Criteria for patient behavior in relation to their disease-modifying antirheumatic drugs (DMARDs) - Evolution of the Beliefs about Medicines Questionnaire (BMQ) score [Time frame: Day 0 and Month 12]
• Economic criterion [Time frame: Month 12]
• Intervention implementation and acceptability criteria - Satisfaction of pharmacists and general practitioners through semi-structured interviews [Time frame: Month 12]
• Intervention implementation and acceptability criteria - Duration of follow-up interviews measured by community pharmacist [Time frame: Month 2 and Month 6]

Eligibility criteria

Inclusion criteria

• 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 criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Health services research

Study locations

France · 2 centers

• Service de rhumatologie, Centre Hospitalier Lyon Sud, Groupement Hospitalier Sud, Hospices — Pierre-Bénite
• Service de rhumatologie et pathologie osseuse - Hôpital Edouard Herriot — Lyon

Identifiers

NCT: NCT05413759 · 69HCL20_0272

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗