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Chronic Pain OneSheet Clinical Trial

Primary Purpose

Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Chronic Pain OneSheet
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Chronic Pain focused on measuring Clinical Decision Support, Chronic pain care, Behavioral Economics, Provider behavior

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Primary care provider (including Family Medicine, Internal Medicine, Med-Peds, and General Medicine)
  • Is able to prescribe medication (i.e., Doctor of Medicine (MD), Nurse Practitioner (NP), Physicians Assistant (PA))
  • Sees patients at a primary care clinic at one of the two participating hospital systems

Exclusion Criteria:

  • Does not practice primary care
  • Does not regularly see patients at a primary care clinic at one of the two participating hospital systems
  • Is not able to prescribe medication

Sites / Locations

  • Indiana University
  • Wake Forest University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

OneSheet access

Normal practice

Arm Description

Clinics or providers who receive access to, and training in the Chronic Pain OneSheet, and use it while caring for patients with chronic pain.

Clinics or providers who do not receive access to, or training in the Chronic Pain OneSheet, and care for patients with chronic pain as they would normally.

Outcomes

Primary Outcome Measures

Pain and function goal-setting
Proportion of patients with chronic pain for whom the provider documented pain and/or function goals in the EHR, as assessed by data extracted from the healthcare systems' clinical data warehouse.
Pain and function assessment
Proportion of patients with chronic pain for whom the provider documented the assessment of pain and/or function (e.g. Pain, Enjoyment, General Activity (PEG) scale, scale of 1-10, used to track an individual's changes over time, with effective therapy, an individual's score should decrease over time) in the EHR, as assessed by data extracted from the healthcare systems' clinical data warehouse.
Opioid-related risk assessment
Proportion of patients with chronic pain for whom the provider documented the assessment of opioid-related risk (e.g. prescription drug monitoring program (PDMP) and/or urine drug screen (UDS)) in the EHR, as assessed by data extracted from the healthcare systems' clinical data warehouse.

Secondary Outcome Measures

Urine drug screens (UDS) ordered
Proportion of patients with chronic opioid patients for whom the provider ordered a UDS, as assessed by data extracted from the healthcare systems' clinical data warehouse.
Prescription drug monitoring program (PDMP) reports accessed
Proportion of patients with chronic opioid patients for whom the provider accessed the PDMP report, as assessed by data extracted from the healthcare systems' clinical data warehouse.
Naloxone prescriptions ordered
Proportion of patients with chronic opioid patients at high risk of overdose, or on high dosages of opioid medications, for whom the provider ordered naloxone, as assessed by data extracted from the healthcare systems' clinical data warehouse.
Referral for medication-assisted therapy
Proportion of patients who exhibit symptoms of opioid use disorder for whom the provider ordered medication-assisted therapy, as assessed by data extracted from the healthcare systems' clinical data warehouse.

Full Information

First Posted
February 15, 2020
Last Updated
June 16, 2023
Sponsor
Indiana University
Collaborators
Eskenazi Health, Wake Forest University, Wake Forest University Health Sciences, University of Florida, National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT04295135
Brief Title
Chronic Pain OneSheet Clinical Trial
Official Title
Nudging Primary Care Providers Toward Guideline-Recommended Opioid Prescribing Through Easier and More Convenient EHR Information Design
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
August 4, 2020 (Actual)
Primary Completion Date
May 18, 2022 (Actual)
Study Completion Date
May 18, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
Collaborators
Eskenazi Health, Wake Forest University, Wake Forest University Health Sciences, University of Florida, National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of the study is to determine whether and how having access to the Chronic Pain OneSheet activity in Epic affects the ordering, prescribing, goal-setting, risk monitoring, and outcome measuring behavior of participating providers in visits with patients with chronic pain conditions. The investigators will also assess whether access to the Chronic Pain OneSheet results in primary care providers making chronic pain treatment decisions that are more concordant with the Centers for Disease Control and Prevention (CDC) Guideline for Prescribing Opioids for Chronic Pain.
Detailed Description
The Chronic Pain OneSheet (OneSheet) is an electronic health record (EHR) based clinical support tool that was developed and built in Epic. The OneSheet is a dashboard that was designed to assist providers in treating patients with chronic pain conditions, by providing an overview of patient information needed by providers when treating these patients. The dashboard does not provide new information to providers, but rather works by aggregating and structuring information that is already being collected, and that is available in other places in the medical record. By aggregating and structuring this information in a more convenient manner, the goal of the OneSheet is to make the information that is important in clinical decision-making more readily available, and to reduce the amount of time that providers need to spend locating this information. The purpose of the study is to determine whether and how having access to the Chronic Pain OneSheet activity in Epic affects the ordering, prescribing, goal-setting, risk monitoring, and outcome measuring behavior of participating providers in visits with patients with chronic pain conditions. The investigators will also assess whether access to the Chronic Pain OneSheet results in primary care providers making chronic pain treatment decisions that are more concordant with the CDC Guideline for Prescribing Opioids for Chronic Pain. To test this, researchers will conduct a two-arm pragmatic cluster randomized controlled trial (RCT) with 80 primary care providers (PCP) across two health systems. The investigators will assess outcomes by analyzing EHR usage log files and PCP ordering records extracted from the healthcare systems' clinical data warehouses.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
Clinical Decision Support, Chronic pain care, Behavioral Economics, Provider behavior

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
137 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OneSheet access
Arm Type
Experimental
Arm Description
Clinics or providers who receive access to, and training in the Chronic Pain OneSheet, and use it while caring for patients with chronic pain.
Arm Title
Normal practice
Arm Type
No Intervention
Arm Description
Clinics or providers who do not receive access to, or training in the Chronic Pain OneSheet, and care for patients with chronic pain as they would normally.
Intervention Type
Behavioral
Intervention Name(s)
Chronic Pain OneSheet
Other Intervention Name(s)
Pain Dashboard
Intervention Description
The Chronic Pain OneSheet (OneSheet) is an EHR decision support tool that uses behavioral economics to increase adoption of chronic pain guideline recommendations. The OneSheet works by aggregating and structuring information that is already collected, that providers often need while caring for patients with chronic pain conditions. By aggregating and structuring this information in a more convenient manner, the goal of the OneSheet is to make the information that is important in clinical decisionmaking more readily available, and to reduce the amount of time that providers need to spend locating this information.
Primary Outcome Measure Information:
Title
Pain and function goal-setting
Description
Proportion of patients with chronic pain for whom the provider documented pain and/or function goals in the EHR, as assessed by data extracted from the healthcare systems' clinical data warehouse.
Time Frame
Up to 2 years
Title
Pain and function assessment
Description
Proportion of patients with chronic pain for whom the provider documented the assessment of pain and/or function (e.g. Pain, Enjoyment, General Activity (PEG) scale, scale of 1-10, used to track an individual's changes over time, with effective therapy, an individual's score should decrease over time) in the EHR, as assessed by data extracted from the healthcare systems' clinical data warehouse.
Time Frame
Up to 2 years
Title
Opioid-related risk assessment
Description
Proportion of patients with chronic pain for whom the provider documented the assessment of opioid-related risk (e.g. prescription drug monitoring program (PDMP) and/or urine drug screen (UDS)) in the EHR, as assessed by data extracted from the healthcare systems' clinical data warehouse.
Time Frame
Up to 2 years
Secondary Outcome Measure Information:
Title
Urine drug screens (UDS) ordered
Description
Proportion of patients with chronic opioid patients for whom the provider ordered a UDS, as assessed by data extracted from the healthcare systems' clinical data warehouse.
Time Frame
Up to 2 years
Title
Prescription drug monitoring program (PDMP) reports accessed
Description
Proportion of patients with chronic opioid patients for whom the provider accessed the PDMP report, as assessed by data extracted from the healthcare systems' clinical data warehouse.
Time Frame
Up to 2 years
Title
Naloxone prescriptions ordered
Description
Proportion of patients with chronic opioid patients at high risk of overdose, or on high dosages of opioid medications, for whom the provider ordered naloxone, as assessed by data extracted from the healthcare systems' clinical data warehouse.
Time Frame
Up to 2 years
Title
Referral for medication-assisted therapy
Description
Proportion of patients who exhibit symptoms of opioid use disorder for whom the provider ordered medication-assisted therapy, as assessed by data extracted from the healthcare systems' clinical data warehouse.
Time Frame
Up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Primary care provider (including Family Medicine, Internal Medicine, Med-Peds, and General Medicine) Is able to prescribe medication (i.e., Doctor of Medicine (MD), Nurse Practitioner (NP), Physicians Assistant (PA)) Sees patients at a primary care clinic at one of the two participating hospital systems Exclusion Criteria: Does not practice primary care Does not regularly see patients at a primary care clinic at one of the two participating hospital systems Is not able to prescribe medication
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harle Christopher, PhD
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Olena Mazurenko, MD, PhD
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35484491
Citation
Mazurenko O, Sanner L, Apathy NC, Mamlin BW, Menachemi N, Adams MCB, Hurley RW, Erazo SF, Harle CA. Evaluation of electronic recruitment efforts of primary care providers as research subjects during the COVID-19 pandemic. BMC Prim Care. 2022 Apr 28;23(1):95. doi: 10.1186/s12875-022-01705-y.
Results Reference
derived

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Chronic Pain OneSheet Clinical Trial

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