Rheumatoid Arthritis
Conditions
Keywords
Rheumatoid Arthritis, Veterans
Brief summary
The overall goal of this proposal is to address barriers to the use of patient reported outcome (PRO) data in the Dept. of Veterans Affairs (VA) health care system.
Detailed description
This is a randomized, controlled, single-blinded study that compares outcome data in patients for whom PRO data either is or is not made available to the treating physician. The question addressed by this proposal is whether patient reported outcome (PRO) data change patient's outcomes. The hypothesis is that the availability of these data in the form of the patient-completed Multidimensional Health Assessment Questionnaire/routine assessment of patient index data (MDHAQ/RAPID3) questionnaire will change patient-centric outcomes such as patient reported well-being, patient satisfaction and medication compliance.
Interventions
OTHERPRO data utilized
Data collected from a patient-completed MDHAQ/RAPID3 questionnaire is provided to the treating physician.
OTHERPRO data not utilized
Data collected from a patient-completed MDHAQ/RAPID3 questionnaire is not provided to the treating physician.
Sponsors
Pfizer
US Department of Veterans Affairs
North Florida Foundation for Research and Education
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* US veteran * Within North Florida/South Georgia (NF/SG) Veterans Integrated Service Network
Exclusion criteria
* Outside of service network * Non-veteran
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| physician/lab-derived instruments of clinical efficacy as measured by DAS28 change and DAS28 remission. | 1 year | Physician/lab-derived instruments of clinical efficacy as measured by DAS28 change and DAS28 remission. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| patient satisfaction | 1 year | Patient reported satisfaction with medical care. A validated patient satisfaction survey will be collected at study completion with the Leeds Satisfaction Questionnaire. |
| medication compliance | 1 year | Degree of medication compliance. Medication compliance will be assessed by the medication possession ratio (MPR) of Methotrexate (MTX), a drug most Rheumatoid Arthritis (RA) patients are prescribed. The VA Pharmacy Benefits Management (PBM) database collects information on medications dispensed and when refills are needed. Thus, a delay in refill will reflect MTX non-compliance. If it MTX is discontinued due to an adverse reaction, it is noted in the electronic medical record. The MPR is calculated as the number of days of prescribed MTX divided by the total number of days of a course. |
Countries
United States
Outcome results
None listed