Clinical trial NCT03024307: The Effect of OPCSP on Adherence and Clinical Outcomes Among Patients With Rheumatic Diseases
Official title: Evaluation of an Outpatient Pharmacy Clinical Services Program on Adherence and Clinical Outcomes Among Patients With Rheumatic Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatic Diseases
Keywords: Pharmaceutical Care
Medication Adherence
Direct Costs
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2017-01-18
Enrollment: 242
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Medication adherence in the OPCSP program compared with usual care
timeFrame: 12 months
Secondary outcomes:
measure: Changes in medical outcomes from baseline at each visit by EQ5D-3L
timeFrame: 12 months
measure: changes in direct costs from baseline at each visit
timeFrame: 12 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: South Campus, Ren Ji Hospital
Study officials:
affiliation: RenJi Hospital
name: Shuang Ye, MD
role: STUDY_CHAIR
References:
citation: Zhang L, Luan W, Geng S, Ye S, Wang X, Qian L, Ding Y, Li T, Jiang A. Lack of patient education is risk factor of disease flare in patients with systemic lupus erythematosus in China. BMC Health Serv Res. 2019 Jun 13;19(1):378. doi: 10.1186/s12913-019-4206-y.