Collaborative Pharmaceutical Care Initiated in Hospital and Continued in Primary Care to Improve Medication Adherence of Patients With Rheumatoid Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Medication adherence to rheumatoid arthritis treatment
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Medication adherence to rheumatoid arthritis treatment
时间窗: Month 12
The primary endpoint is the rate of adherent patients to DMARDs after 12 months of follow-up assessed by the Medication Possession Ratio (MPR). The MPR is calculated for each drug: total quantity of dose units dispensed compared to the theoretical quantity of dose units necessary for compliance with the prescribed dosage. The calculation will be made from: * dispensing data collected from the patient's community pharmacist (control and intervention group), * prescription data from all prescriptions (between Month 0 and Month 12), reported by the patient during the visit to Month 12, * and hospitalization data from the medicalized information system program (PMSI:) and the patient log. A patient is considered adherent to his treatment if the MPR is greater than or equal to 80%. For patients with more than one DMARD drug prescribed, they will be considered adherent if the MPR of each DMARD is greater than or equal to 80%.
次要结局
- Criteria for patient behavior in relation to their disease-modifying antirheumatic drugs (DMARDs) - Medication Possession Ratio for each disease-modifying antirheumatic drug (DMARD)(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)(Month 12)
- Clinical criteria - Evolution of the Disease Activity Score DAS28(Day 0 and Month 12)
- Clinical criteria - Number of Rheumatoid Arthritis-related re-hospitalizations(Month 0 and Month 12)
- Clinical criteria - Number of adverse effects related to drug treatments leading to hospitalization.(Month 0 and Month 12)
- Functional and quality of life criteria - Evolution of the Health Assessment Questionnaire (HAQ) score(Day 0 and Month 12)
- Functional and quality of life criteria - Evolution of the EuroQol 5-Dimensional score (EQ-5D)(Day 0 and 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)(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(Day 0 and Month 12)
- Economic criterion(Month 12)
- Intervention implementation and acceptability criteria - Satisfaction of pharmacists and general practitioners through semi-structured interviews(Month 12)
- Intervention implementation and acceptability criteria - Duration of follow-up interviews measured by community pharmacist(Month 2 and Month 6)
- Intervention implementation and acceptability criteria - Number of patients having benefited from a complete follow-up by the town pharmacist (participation in the 2 scheduled meetings to reinforce medication adherence)(Month 12)
- Intervention implementation and acceptability criteria - Patient satisfaction by questionnaire(Month 12)
- Functional and quality of life criteria - Evolution of the Health Assessment Questionnaire (HAQ) score(Day 0 and Month 12)
- Functional and quality of life criteria - Evolution of the EuroQol 5-Dimensional score (EQ-5D)(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)(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)(Month 12)
- Clinical criteria - Evolution of the Disease Activity Score DAS28(Day 0 and Month 12)
- Clinical criteria - Number of Rheumatoid Arthritis-related re-hospitalizations(Month 0 and Month 12)
- Clinical criteria - Number of adverse effects related to drug treatments leading to hospitalization.(Month 0 and 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)(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(Day 0 and Month 12)
- Economic criterion(Month 12)
- Intervention implementation and acceptability criteria - Satisfaction of pharmacists and general practitioners through semi-structured interviews(Month 12)
- Intervention implementation and acceptability criteria - Duration of follow-up interviews measured by community pharmacist(Month 2 and Month 6)
- Intervention implementation and acceptability criteria - Number of patients having benefited from a complete follow-up by the town pharmacist (participation in the 2 scheduled meetings to reinforce medication adherence)(Month 12)
- Intervention implementation and acceptability criteria - Patient satisfaction by questionnaire(Month 12)