Evaluation of an Outpatient Pharmacy Clinical Services Program on Adherence and Clinical Outcomes Among Patients With Rheumatic Diseases
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- RenJi Hospital
- Enrollment
- 242
- Locations
- 1
- Primary Endpoint
- Medication adherence in the OPCSP program compared with usual care
Study Overview
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:
- rates of medication adherence in the OPCSP program compared with usual care in an integrated health care system.
- 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:
- rates of medication adherence in the OPCSP program compared with usual care in an integrated health care system.
- total direct costs and clinical outcomes in the OPCSP program compared with usual care in an integrated health care system.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Medication adherence in the OPCSP program compared with usual care
Time Frame: 12 months
Medication adherence would be evaluated by the questionnaire survey, CQR19. Scores of medication adherence would be calculated.
Secondary Outcomes
- Changes in medical outcomes from baseline at each visit by EQ5D-3L(12 months)
- changes in direct costs from baseline at each visit(12 months)
Investigators
Ting Li
Doctor
RenJi Hospital