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

Rheumatic Diseases Clinical Trial

Official title:

Evaluation of an Outpatient Pharmacy Clinical Services Program on Adherence and Clinical Outcomes Among Patients With Rheumatic Diseases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03024307
• Other study ID #: OPCSP2016
• Status: Completed
• Phase: N/A
• Start date: January 18, 2017
• Est. completion date: December 31, 2020

Study information

• Verified date: January 2020
• Source: RenJi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 242
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Collagen Diseases
• Rheumatic Diseases

Intervention

Other:
• pharmacists involved OPCSP
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.

Locations

Country	Name	City	State
China	South Campus, Ren Ji Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months
Secondary	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	12 months
Secondary	changes in direct costs from baseline at each visit	the influence of OPCSP on reducing direct costs	12 months