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Trial record 77 of 5439 for:    veterans

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

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ClinicalTrials.gov Identifier: NCT02326532
Recruitment Status : Active, not recruiting
First Posted : December 29, 2014
Last Update Posted : May 27, 2019
Sponsor:
Collaborators:
Pfizer
US Department of Veterans Affairs
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Other: PRO data utilized Other: PRO data not utilized Not Applicable

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 MDHAQ/RAPID3 questionnaire will change patient-centric outcomes such as patient reported well-being, patient satisfaction and medication compliance.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 143 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • US veteran
  • Within NF/SG Veterans Integrated Service Network

Exclusion Criteria:

  • Outside of service network
  • Non-veteran

Information from the National Library of Medicine

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


Locations
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United States, Florida
Malcom Randall VAMC
Gainesville, Florida, United States, 32608
Sponsors and Collaborators
North Florida Foundation for Research and Education
Pfizer
US Department of Veterans Affairs
Investigators
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Principal Investigator: Michael R Bubb, MD Veterans Health Administration, University of Florida

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Responsible Party: North Florida Foundation for Research and Education
ClinicalTrials.gov Identifier: NCT02326532     History of Changes
Other Study ID Numbers: IRB2014002 18
First Posted: December 29, 2014    Key Record Dates
Last Update Posted: May 27, 2019
Last Verified: May 2019

Keywords provided by North Florida Foundation for Research and Education:
Rheumatoid Arthritis
Veterans

Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases