An interventional study of PRO data utilized and PRO data not utilized in Rheumatoid Arthritis, sponsored by North Florida Foundation for Research and Education. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-09-09.
Sponsored by North Florida Foundation for Research and Education · Not applicable, Interventional, and Health services research
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.
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.
3,332 studies on the registry are indexed under Arthritis, Rheumatoid; 443 are open to participants now.
This study's enrollment of 143 is above the median of 96 across 2,220 interventional studies indexed under Arthritis, Rheumatoid.
Browse Arthritis, Rheumatoid studies →North Florida Foundation for Research and Education is the lead sponsor of 12 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
PRO data derived from the patient-completed MDHAQ/RAPID3 questionnaire will be collected from this arm and provided to the treating physicians.
Other: PRO data utilized
PRO data derived from the patient-completed MDHAQ/RAPID3 questionnaire will be collected from this arm but will not be provided to the treating physicians.
Other: PRO data not utilized
Data collected from a patient-completed MDHAQ/RAPID3 questionnaire is provided to the treating physician.
Data collected from a patient-completed MDHAQ/RAPID3 questionnaire is not provided to the treating physician.
physician/lab-derived instruments of clinical efficacy as measured by DAS28 change and DAS28 remission.
Physician/lab-derived instruments of clinical efficacy as measured by DAS28 change and DAS28 remission.
Time frame: 1 year
patient satisfaction
Patient reported satisfaction with medical care. A validated patient satisfaction survey will be collected at study completion with the Leeds Satisfaction Questionnaire.
Time frame: 1 year
medication compliance
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.
Time frame: 1 year
This study is status unknown, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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North Florida Foundation for Research and Education