The Effect of OPCSP on Adherence and Clinical Outcomes Among Patients With Rheumatic Diseases

RenJi Hospital242 enrolled

Overview

This is a randomised trial on the efficacy of an Outpatient Pharmacy Clinical Services Program (OPCSP) on adherence and clinical outcomes among patients with rheumatic diseases.The purpose of this study is to evaluate: 1. rates of medication adherence in the OPCSP program compared with usual care in an integrated health care system. 2. total direct costs and clinical outcomes in the OPCSP program compared with usual care in an integrated health care system.

This is a randomised trial on the efficacy of an Outpatient Pharmacy Clinical Services Program (OPCSP) on adherence and clinical outcomes among patients with rheumatic diseases.Three types of rheumatic diseases were included in the study, Systemic lupus erythematosus (SLE), Ankylosing spondylitis (AS), and Rheumatoid Arthritis(RA). The purpose of this study is to evaluate: 1. rates of medication adherence in the OPCSP program compared with usual care in an integrated health care system. 2. total direct costs and clinical outcomes in the OPCSP program compared with usual care in an integrated health care system.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

242

Conditions

Rheumatic Diseases

Interventions

pharmacists involved OPCSPOTHER

This was an open labelled randomised study. Rheumatic diseases patients were recruited and arbitrarily divided into the intervention group (usual care plus OPCSP) and the non-intervention group (usual care only). Those enrolled in the research were scheduled for follow-up for eight consecutive visits. Improvements in lab results and direct costs were compared longitudinally (pre and post analysis) between the groups.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Willingness of the subject to participate in the study, proven by signing the informed consent; * Systemic lupus erythematosus (SLE), as defined by meeting at least 4 of 11 classification criteria of American College of Rheumatology for the classification of systemic lupus erythematosus, either sequentially or coincidentally. The 4 criteria doesn't need to be present at the time of study enrollment; * Patients fulfilled the American College of Rheumatology criteria for RA and AS; Exclusion Criteria: * Patients who are unwilling to sign the inform consent; * Pregnancy or lactation

Locations (1)

South Campus, Ren Ji Hospital

Shanghai, China

Outcomes

Primary Outcomes

Medication adherence in the OPCSP program compared with usual care

Medication adherence would be evaluated by the questionnaire survey, CQR19. Scores of medication adherence would be calculated.

Time frame: 12 months

Secondary Outcomes

Changes in medical outcomes from baseline at each visit by EQ5D-3L

The influence of OPCSP on improving medical outcomes would be evaluated by EQ5D-3L. The TTO value would be compared between two arms

Time frame: 12 months

changes in direct costs from baseline at each visit

the influence of OPCSP on reducing direct costs

Time frame: 12 months

Data from ClinicalTrials.gov

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