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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Other: PRO data utilized
* Other: PRO data not utilized


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: US veteran Within North Florida/South Georgia (NF/SG) Veterans Integrated Service Network Exclusion Criteria: Outside of service network Non-veteran

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRO data utilized<br>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<br>* Data collected from a patient-completed MDHAQ/RAPID3 questionnaire is provided to the treating physician.<br>|
| Sham Comparator: PRO data not utilized<br>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<br>* Data collected from a patient-completed MDHAQ/RAPID3 questionnaire is not provided to the treating physician.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient satisfaction | Patient reported satisfaction with medical care. A validated patient satisfaction survey will be collected at study completion with the Leeds Satisfaction Questionnaire. | 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. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rheumatoid Arthritis, Veterans