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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Rheumatic Diseases

Intervention / Treatment
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* Other: pharmacists involved OPCSP


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Involvement of pharmacists in improving medication<br>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<br>* 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.<br>|
| No Intervention: usual care only<br>Patients were provided with usual care. | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmaceutical Care, Medication Adherence, Direct Costs