Clinical trial NCT02188667: Integrating Patient Reported Outcomes (I-PRO) Study for Multidisciplinary Pain Care
Official title: An Integrative and Sustainable Approach to Pain Management in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Noncancer Pain
Keywords: Chronic Noncancer Pain
Musculoskeletal Pain
Neuropathic Pain
Headache Pain
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2014-07-11
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Provider Satisfaction Survey
timeFrame: Up to 15 months
measure: Patient Satisfaction Survey
timeFrame: Up to 15 months
Secondary outcomes:
measure: Hospital Readmission Rates
timeFrame: Up to 5 years
measure: Lab Orders and Results
timeFrame: Up to 5 years
measure: Prescribed and Dispensed Medications
timeFrame: Up to 5 years
measure: Pain Intensity
timeFrame: Up to 5 years
measure: Medical Costs
timeFrame: Up to 5 years
measure: Health Care Utilization
timeFrame: Up to 5 years
measure: Pain Specialist Referral Rates
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Family Medicine at Hampton Oaks
state: Florida
city: Gainesville
country: United States
facility: Family Medicine at Haile Plantation
state: Florida
city: Gainesville
country: United States
facility: Eastside Community Practice
state: Florida
city: Gainesville
country: United States
facility: Family Medicine at Jonesville
state: Florida
Study officials:
affiliation: University of Florida
name: Christopher A Harle, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Florida
name: Robert W Hurley, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Florida
name: Nicole Marlow, PhD
role: PRINCIPAL_INVESTIGATOR
References: