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

Chronic Noncancer Pain Clinical Trial

— I-PRO  

Official title:

An Integrative and Sustainable Approach to Pain Management in Primary Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02188667
• Other study ID #: IRB201300433
• Secondary ID: 8578749
• Status: Completed
• Phase: N/A
• First received: July 7, 2014
• Last updated: March 29, 2016
• Start date: July 2014
• Est. completion date: March 2016

Study information

• Verified date: March 2016
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 89 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Noncancer Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Eastside Community Practice	Gainesville	Florida
United States	Family Medicine at Haile Plantation	Gainesville	Florida
United States	Family Medicine at Hampton Oaks	Gainesville	Florida
United States	Family Medicine at Jonesville	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Hospital Readmission Rates	The data will be collected retrospectively for a history of hospital readmission rates (June 2011 - June 2014). Once the new care model starts for the clinicians, data will be collected at baseline (July 2014) and at the end of the study period (September 2015) for an indication of trends. Data for both the treatment and control groups will be compared.	Up to 5 years	No
Secondary	Lab Orders and Results	The data will be collected retrospectively for a history of lab orders and results (June 2011 - June 2014). Once the new care model starts for the clinicians, data will be collected at baseline (July 2014) and at the end of the study period (September 2015) for an indication of trends. Data will be	Up to 5 years	No
Secondary	Prescribed and Dispensed Medications	The data will be collected retrospectively for a history of prescribed and dispensed medications (June 2011 - June 2015). Once the new care model starts for the clinicians, data will be collected at baseline (July 2014) and at the end of the study period (September 2015) for an indication of trends. Data for both the treatment and control groups will be compared.	Up to 5 years	No
Secondary	Pain Intensity	The data will be collected retrospectively for a history of pain intensity (June 2011 - June 2014). Once the new care model starts for the clinicians, data will be collected at baseline (July 2014) and at the end of the study period (September 2015) for an indication of trends. Data for both the treatment and control groups will be compared.	Up to 5 years	No
Secondary	Medical Costs	The data will be collected retrospectively for a history of medical costs (June 2011 - June 2014). Once the new care model starts for the clinicians, data will be collected at baseline (July 2014) and at the end of the study period (September 2015) for an indication of trends.This will include cost of pain related care for charge amounts and billed amounts for specialist services, hospital services, and utilization of non-physician services (e.g., pharmacy, physical therapy, etc.). Data for both the treatment and control groups will be compared.	Up to 5 years	No
Secondary	Health Care Utilization	The data will be collected retrospectively for a history of health care utilization (June 2011 - June 2014). Once the new care model starts for the clinicians, data will be collected at baseline (July 2014) and at the end of the study period (September 2015) for an indication of trends. This will include utilization of specialist services, hospital services, and utilization of non-physician services (e.g., pharmacy, physical therapy, etc.). Data for both the treatment and control groups will be compared.	Up to 5 years	No
Secondary	Pain Specialist Referral Rates	The data will be collected retrospectively for a history of pain specialist referral rates (June 2011 - June 2014). Once the new care model starts for the clinicians, data will be collected at baseline (July 2014) and at the end of the study period (September 2015) for an indication of trends. Data for both the treatment and control groups will be compared.	Up to 5 years	No