Integrating Patient Reported Outcomes (I-PRO) Study for Multidisciplinary Pain Care
I-PRO
An Integrative and Sustainable Approach to Pain Management in Primary Care
2 other identifiers
interventional
21
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2014
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 7, 2014
CompletedFirst Posted
Study publicly available on registry
July 11, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedMarch 30, 2016
March 1, 2016
1.7 years
July 7, 2014
March 29, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Provider Satisfaction Survey
This is a 16 item web based questionnaire about general experiences and satisfaction with providing care to patients with chronic noncancer pain. Data will be collected at baseline (June 2014) and monthly thereafter through the end of the study period (July 2014 - September 2015). Provider satisfaction data for both the treatment and control groups will be compared.
Up to 15 months
Patient Satisfaction Survey
This is a four to five question phone survey (depending on whether patient is seeing a provider in a treatment or control group) about general and pain-specific satisfaction with visit. Data will be collected after each visit for chronic noncancer pain through the study period (July 2014 - September 2015). Patient satisfaction data for both the treatment and control groups will be compared.
Up to 15 months
Secondary Outcomes (7)
Hospital Readmission Rates
Up to 5 years
Lab Orders and Results
Up to 5 years
Prescribed and Dispensed Medications
Up to 5 years
Pain Intensity
Up to 5 years
Medical Costs
Up to 5 years
- +2 more secondary outcomes
Study Arms (2)
Providers of Novel Care
ACTIVE COMPARATORProviders 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.
Providers of Usual Care
SHAM COMPARATORProviders 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Floridalead
- Pfizercollaborator
Study Sites (4)
Family Medicine at Hampton Oaks
Gainesville, Florida, 32607, United States
Family Medicine at Haile Plantation
Gainesville, Florida, 32608, United States
Eastside Community Practice
Gainesville, Florida, 32641, United States
Family Medicine at Jonesville
Gainesville, Florida, 32669, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christopher A Harle, PhD
University of Florida
- PRINCIPAL INVESTIGATOR
Robert W Hurley, MD, PhD
University of Florida
- PRINCIPAL INVESTIGATOR
Nicole Marlow, PhD
University of Florida
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 7, 2014
First Posted
July 11, 2014
Study Start
July 1, 2014
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
March 30, 2016
Record last verified: 2016-03