Integrating Patient Reported Outcomes (I-PRO) Study for Multidisciplinary Pain Care

NCT02188667

Last updated date
Study Location
Family Medicine at Hampton Oaks
Gainesville, Florida, 32607, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Chronic Noncancer Pain
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-89 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Providers at one of six active Community Health and Family Medicine locations in the University of Florida Health system Gainesville service area (Hampton Oaks, Eastside, Jonesville, and Haile) between May 1, 2014 and September 1, 2015

- Doctor of Medicine (MD), Doctor of Osteopathic Medicine (DO), Advanced Registered Nurse Practitioner (ARNP), Physician Assistant (PA) or other faculty professional providing primary care services

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Residents or other trainees at one of four active Community Health and Family Medicine
locations in the University of Florida Health system Gainesville service area (Hampton
Oaks, Eastside, Jonesville, and Haile) between May 1, 2014 and September 1, 2015

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Chronic Noncancer PainIntegrating Patient Reported Outcomes (I-PRO) Study for Multidisciplinary Pain Care
NCT02188667
  1. Gainesville, Florida
  2. Gainesville, Florida
  3. Gainesville, Florida
  4. Gainesville, Florida
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Chronic Noncancer PainSafety Study of Oxycodone Hydrochloride and Naltrexone Hydrochloride Extended-Release Capsules in Subjects With Moderate to Severe Chronic Noncancer Pain
NCT01428583
  1. Deland, Florida
  2. Jacksonville, Florida
  3. Jupiter, Florida
  4. Ormond Beach, Florida
  5. Ormond Beach, Florida
  6. Port Orange, Florida
  7. Sarasota, Florida
  8. Tampa, Florida
  9. Atlanta, Georgia
  10. Marietta, Georgia
  11. Marietta, Georgia
  12. Lexington, Kentucky
  13. Madisonville, Kentucky
  14. Owings Mills, Maryland
  15. Springfield, Massachusetts
  16. Edina, Minnesota
  17. Southaven, Mississippi
  18. Hazelwood, Missouri
  19. Missoula, Montana
  20. Berlin, New Jersey
  21. Hartsdale, New York
  22. North Syracuse, New York
  23. Williamsville, New York
  24. Winston-Salem, North Carolina
  25. Columbus, Ohio
  26. Altoona, Pennsylvania
  27. Austin, Texas
  28. Dallas, Texas
  29. Fort Worth, Texas
  30. San Antonio, Texas
  31. Salt Lake City, Utah
  32. Roanoke, Virginia
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Integrating Patient Reported Outcomes (I-PRO) Study for Multidisciplinary Pain Care
Official Title  ICMJE An Integrative and Sustainable Approach to Pain Management in Primary Care
Brief Summary The purpose of this study is to assess the impact of clinician education, electronic health record integrated patient reported outcomes, and electronic health record integrated decision support on pain-related care quality, outcomes, and service utilization.
Detailed Description

The initiative has three components to aid clinicians' care of patients with chronic noncancer pain: (1) education, (2) standardized patient reported outcomes data collection, and (3) evidence-based brief treatment reminders. Practices will be randomized to either receive the three novel components (treatment group) or continue with usual care (control group).

Providers in the treatment group will be asked (a) to complete a series of six online education modules in pain care, (b) will be given access to new patient reported outcomes questionnaire data collected from patients within the electronic health record, (c) asked to review this data and related care recommendations during the patient visit, and (d) asked to complete baseline and monthly online surveys related to experiences and satisfaction with providing care to patients with chronic noncancer pain.

Providers in the control group will provide care as usual to patients and will be asked to complete baseline and monthly online surveys related to experiences and satisfaction with providing care to patients with chronic noncancer pain.

Primary study outcomes include comparison of treatment and control group provider and patient satisfaction surveys. Secondary outcome measures include provider referral rates, patient outcomes, patient treatments recommended/ordered, and patient service utilization/costs.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Noncancer Pain
Intervention  ICMJE
  • Other: Providers of Novel Care
    Providers in the treatment group will be asked (1) to complete a series of six online education modules in pain care, (2) will be given access to new patient reported outcomes questionnaire data collected from patients within the electronic health record, (3) asked to review this data and related care recommendations during the patient visit, and (4) asked to complete baseline and monthly online surveys related to experiences and satisfaction with providing care to patients with chronic noncancer pain.
  • Other: Providers of Usual Care
    Providers in the control group will provide care as usual to patients and will be asked to complete baseline and monthly online surveys related to experiences and satisfaction with providing care to patients with chronic noncancer pain.
Study Arms  ICMJE
  • Active Comparator: Providers of Novel Care
    Providers in the treatment group will be asked (1) to complete a series of six online education modules in pain care, (2) will be given access to new patient reported outcomes questionnaire data collected from patients within the electronic health record, (3) asked to review this data and related care recommendations during the patient visit, and (4) asked to complete baseline and monthly online surveys related to experiences and satisfaction with providing care to patients with chronic noncancer pain.
    Intervention: Other: Providers of Novel Care
  • Sham Comparator: Providers of Usual Care
    Providers in the control group will provide care as usual to patients and will be asked to complete baseline and monthly online surveys related to experiences and satisfaction with providing care to patients with chronic noncancer pain.
    Intervention: Other: Providers of Usual Care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 29, 2016)
21
Original Estimated Enrollment  ICMJE
 (submitted: July 9, 2014)
50
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Providers at one of six active Community Health and Family Medicine locations in the University of Florida Health system Gainesville service area (Hampton Oaks, Eastside, Jonesville, and Haile) between May 1, 2014 and September 1, 2015
  • Doctor of Medicine (MD), Doctor of Osteopathic Medicine (DO), Advanced Registered Nurse Practitioner (ARNP), Physician Assistant (PA) or other faculty professional providing primary care services

Exclusion Criteria:

  • Residents or other trainees at one of four active Community Health and Family Medicine locations in the University of Florida Health system Gainesville service area (Hampton Oaks, Eastside, Jonesville, and Haile) between May 1, 2014 and September 1, 2015
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 89 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02188667
Other Study ID Numbers  ICMJE IRB201300433
8578749 ( Other Grant/Funding Number: Pfizer, Inc. )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:Undecided
Responsible Party University of Florida
Study Sponsor  ICMJE University of Florida
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Christopher A Harle, PhDUniversity of Florida
Principal Investigator:Robert W Hurley, MD, PhDUniversity of Florida
Principal Investigator:Nicole Marlow, PhDUniversity of Florida
PRS Account University of Florida
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP