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

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

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.

Study Overview

• Status: Completed
• Conditions: Rheumatic Diseases
• Intervention / Treatment: Other: pharmacists involved OPCSP

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 Type: Interventional
• Enrollment (Actual): 242
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 201112
    • South Campus, Ren Ji Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Involvement of pharmacists in improving medication; Pharmacists involved care group. Tools used to improve medication adherence, (1)Patient medication guide (2)tailored Short Messaging Service (SMS) (3)Pharmaceutical follow-up	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.
No Intervention: usual care only; Patients were provided with usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
changes in direct costs from baseline at each visit	the influence of OPCSP on reducing direct costs	12 months

Collaborators and Investigators

• Sponsor: RenJi Hospital
• Investigators: Study Chair: Shuang Ye, MD, RenJi Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2017
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: October 11, 2016
• First Submitted That Met QC Criteria: January 15, 2017
• First Posted (Estimate): January 18, 2017

Study Record Updates

• Last Update Posted (Actual): March 4, 2021
• Last Update Submitted That Met QC Criteria: March 3, 2021
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Medication Adherence; Pharmaceutical Care; Direct Costs
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Connective Tissue Diseases; Rheumatic Diseases; Collagen Diseases
• Other Study ID Numbers: OPCSP2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No