Incorporation of Patient Reported Outcomes Data in the Care of US Veterans With Rheumatoid Arthritis (PRO)
Primary Purpose
Rheumatoid Arthritis
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PRO data utilized
PRO data not utilized
Sponsored by
About this trial
This is an interventional health services research trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis, Veterans
Eligibility Criteria
Inclusion Criteria:
- US veteran
- Within North Florida/South Georgia (NF/SG) Veterans Integrated Service Network
Exclusion Criteria:
- Outside of service network
- Non-veteran
Sites / Locations
- Malcom Randall VAMC
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
PRO data utilized
PRO data not utilized
Arm Description
PRO data derived from the patient-completed MDHAQ/RAPID3 questionnaire will be collected from this arm and provided to the treating physicians.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
patient satisfaction
Patient reported satisfaction with medical care. A validated patient satisfaction survey will be collected at study completion with the Leeds Satisfaction Questionnaire.
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.
Full Information
NCT ID
NCT02326532
First Posted
December 9, 2014
Last Updated
September 8, 2020
Sponsor
North Florida Foundation for Research and Education
Collaborators
Pfizer, US Department of Veterans Affairs
1. Study Identification
Unique Protocol Identification Number
NCT02326532
Brief Title
Incorporation of Patient Reported Outcomes Data in the Care of US Veterans With Rheumatoid Arthritis
Acronym
PRO
Official Title
Incorporation of Patient Reported Outcomes Data in the Care of US Veterans With Rheumatoid Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 2015 (undefined)
Primary Completion Date
June 1, 2021 (Anticipated)
Study Completion Date
June 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
North Florida Foundation for Research and Education
Collaborators
Pfizer, US Department of Veterans Affairs
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Rheumatoid Arthritis, Veterans
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
143 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PRO data utilized
Arm Type
Experimental
Arm Description
PRO data derived from the patient-completed MDHAQ/RAPID3 questionnaire will be collected from this arm and provided to the treating physicians.
Arm Title
PRO data not utilized
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
PRO data utilized
Intervention Description
Data collected from a patient-completed MDHAQ/RAPID3 questionnaire is provided to the treating physician.
Intervention Type
Other
Intervention Name(s)
PRO data not utilized
Intervention Description
Data collected from a patient-completed MDHAQ/RAPID3 questionnaire is not provided to the treating physician.
Primary Outcome Measure Information:
Title
physician/lab-derived instruments of clinical efficacy as measured by DAS28 change and DAS28 remission.
Description
Physician/lab-derived instruments of clinical efficacy as measured by DAS28 change and DAS28 remission.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
patient satisfaction
Description
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
Title
medication compliance
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
US veteran
Within North Florida/South Georgia (NF/SG) Veterans Integrated Service Network
Exclusion Criteria:
Outside of service network
Non-veteran
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael R Bubb, MD
Organizational Affiliation
Veterans Health Administration, University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
Malcom Randall VAMC
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Incorporation of Patient Reported Outcomes Data in the Care of US Veterans With Rheumatoid Arthritis
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