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

NCT ID: NCT02326532

Last Updated: 2020-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

143 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2021-06-01

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.

Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

PRO data utilized

Intervention Type OTHER

Data collected from a patient-completed MDHAQ/RAPID3 questionnaire is provided to the treating physician.

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.

Group Type SHAM_COMPARATOR

PRO data not utilized

Intervention Type OTHER

Data collected from a patient-completed MDHAQ/RAPID3 questionnaire is not provided to the treating physician.

Interventions

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PRO data utilized

Data collected from a patient-completed MDHAQ/RAPID3 questionnaire is provided to the treating physician.

Intervention Type OTHER

PRO data not utilized

Data collected from a patient-completed MDHAQ/RAPID3 questionnaire is not provided to the treating physician.

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

US Department of Veterans Affairs

FED

Sponsor Role collaborator

North Florida Foundation for Research and Education

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael R Bubb, MD

Role: PRINCIPAL_INVESTIGATOR

Veterans Health Administration, University of Florida

Locations

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Malcom Randall VAMC

Gainesville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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IRB2014002 18

Identifier Type: -

Identifier Source: org_study_id

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