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

NCT ID: NCT02188667

Last Updated: 2016-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2016-03-31

Brief Summary

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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

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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.

Conditions

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Chronic Noncancer Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Providers of Novel Care

Intervention Type OTHER

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.

Group Type SHAM_COMPARATOR

Providers of Usual Care

Intervention Type OTHER

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.

Interventions

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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 Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christopher A Harle, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Robert W Hurley, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Nicole Marlow, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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Family Medicine at Hampton Oaks

Gainesville, Florida, United States

Site Status

Family Medicine at Haile Plantation

Gainesville, Florida, United States

Site Status

Eastside Community Practice

Gainesville, Florida, United States

Site Status

Family Medicine at Jonesville

Gainesville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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8578749

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB201300433

Identifier Type: -

Identifier Source: org_study_id

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