Incorporation of Patient Reported Outcomes Data in the Care of US Veterans With Rheumatoid Arthritis

Not Applicable

• Conditions: Rheumatoid Arthritis
• Interventions: Other: PRO data utilized; Other: PRO data not utilized

• Registration Number: NCT02326532
• Lead Sponsor: North Florida Foundation for Research and Education

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.

Study Timeline

• Study First Submitted: 2014-12-09
• Study First Submitted QC: 2014-12-22
• Study First Posted: 2014-12-29
• Study Start: 2015-02
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-08
• Last Update Posted: 2020-09-09
• Primary Completion: 2021-06-01
• Study Completion: 2021-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 143

Inclusion Criteria

• US veteran
• Within North Florida/South Georgia (NF/SG) Veterans Integrated Service Network

Exclusion Criteria

• Outside of service network
• Non-veteran

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PRO data utilized	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.
PRO data not utilized	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Malcom Randall VAMC; 🇺🇸 Gainesville, Florida, United States