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

Not Applicable

Completed

• Conditions: Rheumatic Diseases
• Interventions: Other: pharmacists involved OPCSP

• Registration Number: NCT03024307
• Lead Sponsor: RenJi Hospital

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2016-10-11
• Study First Submitted QC: 2017-01-15
• Study Start: 2017-01-18
• Study First Posted: 2017-01-18
• Status Verified: 2020-01
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Last Update Submitted: 2021-03-03
• Last Update Posted: 2021-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 242

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Involvement of pharmacists in improving medication	pharmacists involved OPCSP	Pharmacists involved care group. Tools used to improve medication adherence, (1)Patient medication guide (2)tailored Short Messaging Service (SMS) (3)Pharmaceutical follow-up

Primary Outcome Measures

Name	Time	Method
Medication adherence in the OPCSP program compared with usual care	12 months	Medication adherence would be evaluated by the questionnaire survey, CQR19. Scores of medication adherence would be calculated.

Secondary Outcome Measures

Name	Time	Method
Changes in medical outcomes from baseline at each visit by EQ5D-3L	12 months	The influence of OPCSP on improving medical outcomes would be evaluated by EQ5D-3L. The TTO value would be compared between two arms
changes in direct costs from baseline at each visit	12 months	the influence of OPCSP on reducing direct costs

Trial Locations

Locations (1)

South Campus, Ren Ji Hospital; 🇨🇳 Shanghai, China