Back to resultsThe Effect of OPCSP on Adherence and Clinical Outcomes Among Patients With Rheumatic Diseases
Primary Purpose
Rheumatic Diseases
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
pharmacists involved OPCSP
Sponsored by
About this trial
This is an interventional supportive care trial for Rheumatic Diseases focused on measuring Pharmaceutical Care, Medication Adherence, Direct Costs
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
Sites / Locations
- South Campus, Ren Ji Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Involvement of pharmacists in improving medication
usual care only
Arm Description
Pharmacists involved care group. Tools used to improve medication adherence, (1)Patient medication guide (2)tailored Short Messaging Service (SMS) (3)Pharmaceutical follow-up
Patients were provided with usual care.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
changes in direct costs from baseline at each visit
the influence of OPCSP on reducing direct costs
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03024307
Brief Title
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
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
January 18, 2017 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
RenJi Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatic Diseases
Keywords
Pharmaceutical Care, Medication Adherence, Direct Costs
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
242 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Involvement of pharmacists in improving medication
Arm Type
Experimental
Arm Description
Pharmacists involved care group. Tools used to improve medication adherence, (1)Patient medication guide (2)tailored Short Messaging Service (SMS) (3)Pharmaceutical follow-up
Arm Title
usual care only
Arm Type
No Intervention
Arm Description
Patients were provided with usual care.
Intervention Type
Other
Intervention Name(s)
pharmacists involved OPCSP
Intervention Description
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.
Primary Outcome Measure Information:
Title
Medication adherence in the OPCSP program compared with usual care
Description
Medication adherence would be evaluated by the questionnaire survey, CQR19. Scores of medication adherence would be calculated.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Changes in medical outcomes from baseline at each visit by EQ5D-3L
Description
The influence of OPCSP on improving medical outcomes would be evaluated by EQ5D-3L. The TTO value would be compared between two arms
Time Frame
12 months
Title
changes in direct costs from baseline at each visit
Description
the influence of OPCSP on reducing direct costs
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shuang Ye, MD
Organizational Affiliation
RenJi Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
South Campus, Ren Ji Hospital
City
Shanghai
ZIP/Postal Code
201112
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31196083
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.
Results Reference
derived
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The Effect of OPCSP on Adherence and Clinical Outcomes Among Patients With Rheumatic Diseases
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