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

Rheumatoid Arthritis Clinical Trial

— PRO  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02326532
• Other study ID #: IRB2014002 18
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 2015
• Est. completion date: June 1, 2021

Study information

• Verified date: September 2020
• Source: North Florida Foundation for Research and Education
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 143
• Est. completion date: June 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• US veteran

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

Exclusion Criteria:

• Outside of service network

• Non-veteran

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Other:
• PRO data utilized
Data collected from a patient-completed MDHAQ/RAPID3 questionnaire is provided to the treating physician.
• PRO data not utilized
Data collected from a patient-completed MDHAQ/RAPID3 questionnaire is not provided to the treating physician.

Locations

Country	Name	City	State
United States	Malcom Randall VAMC	Gainesville	Florida

Sponsors (3)

Lead Sponsor	Collaborator
North Florida Foundation for Research and Education	Pfizer, US Department of Veterans Affairs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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