Incorporation of Patient Reported Outcomes Data in the Care of US Veterans With Rheumatoid Arthritis (PRO)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02326532|
Recruitment Status : Active, not recruiting
First Posted : December 29, 2014
Last Update Posted : May 27, 2019
|Condition or disease||Intervention/treatment||Phase|
|Rheumatoid Arthritis||Other: PRO data utilized Other: PRO data not utilized||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||143 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Health Services Research|
|Official Title:||Incorporation of Patient Reported Outcomes Data in the Care of US Veterans With Rheumatoid Arthritis|
|Study Start Date :||February 2015|
|Estimated Primary Completion Date :||June 1, 2019|
|Estimated Study Completion Date :||June 1, 2020|
Experimental: PRO data utilized
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
Data collected from a patient-completed MDHAQ/RAPID3 questionnaire is provided to the treating physician.
Sham Comparator: PRO data not 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 not provided to the treating physician.
- physician/lab-derived instruments of clinical efficacy as measured by DAS28 change and DAS28 remission. [ Time Frame: 1 year ]Physician/lab-derived instruments of clinical efficacy as measured by DAS28 change and DAS28 remission.
- patient satisfaction [ Time Frame: 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 [ Time Frame: 1 year ]Degree of medication compliance. Medication compliance will be assessed by the medication possession ratio (MPR) of Methotrexate (MTX), a drug most 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02326532
|United States, Florida|
|Malcom Randall VAMC|
|Gainesville, Florida, United States, 32608|
|Principal Investigator:||Michael R Bubb, MD||Veterans Health Administration, University of Florida|