Rheumatic Diseases
Conditions
Keywords
Pharmaceutical Care, Medication Adherence, Direct Costs
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.
Interventions
OTHERpharmacists 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.
Sponsors
RenJi Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Medication adherence in the OPCSP program compared with usual care | 12 months | Medication adherence would be evaluated by the questionnaire survey, CQR19. Scores of medication adherence would be calculated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in medical outcomes from baseline at each visit by EQ5D-3L | 12 months | 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 | 12 months | the influence of OPCSP on reducing direct costs |
Countries
China
Outcome results
None listed