Research

Pilot Study of a Multidisciplinary Gout Patient Education and Monitoring Program: Finding the Optimal Team for Gout Management

IRB Number: 14073

Institutional Review Board, Hospital for Special Surgery

August 18, 2014

The safety of study participants is our top priority. The trial is approved and periodically reviewed by an Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.

Before enrolling in a clinical trial, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.

For further information, see Understanding Clinical Trials.

Principal Investigator

Theodore R. Fields, MD, FACP

Co-Investigators

Katherine Kim, RN
Arthur M. F. Yee, MD, PhD
Dalit Ashany, MD
Monica Richey, NP
Matthew Tobin, RPh
Nicole Oliva, RPh
Adena Batterman, MSW, LCSW
Kara Fields, MS
Adam Rifaat, MS
Shanthini Kasturi, MD

Summary

45 patients. Enrollment 8/11/14 until reach 45 patients. One year follow-up.

Inclusion/Exclusion Criteria

Inclusion Criteria

  1. Must have reached their 18th birthday by the date of entry.
  2. Meets 1977 ARA Criteria for Diagnosing Gout (see Appendix H)
  3. Is a new outpatient for the rheumatologist or NP who is entering them into the study.  The patient may have been seen previously by the entering rheumatologist or NP in the hospital or emergency room at any prior time, but must be entered into the study within 2 weeks of first outpatient visit.  The patient may have been seen in the past for gout by a different internist or rheumatologist, and may be entered whether taking or not taking urate-lowering therapy at study entry.
  4. Willing to participate in educational and monitoring program and complete  entry questionnaires before first visit and 6 and 12 months later. 
  5. Speak English to the extent that they can fill out questionnaires which will only be in English and have phone conversations with investigators who speak only English.

Exclusion Criteria

  1. a. Have not reached their 18th birthday at time of project entry
  2. b. Are pregnant at the time of entry or are a female of child-bearing potential who will not be using birth control methods during the study period.
  3. c. Non-English speaking

Contact Information

Adam Rifaat, MS, Research Assistant
646.714.6280
rifaata@hss.edu



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