Chronic PainNCT04295135

Chronic Pain OneSheet Clinical Trial

A study testing Chronic Pain OneSheet in people with Chronic Pain, run by Indiana University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Chronic Pain
What is being tested?: Chronic Pain OneSheet
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 137 participants
Where: 2 sitesUnited States
Study dates: 4 Aug 2020to 18 May 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Primary care provider (including Family Medicine, Internal Medicine, Med-Peds, and General Medicine)
Can 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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Indiana University
Indianapolis, Indiana, 46202
Wake Forest University
Winston-Salem, North Carolina, 27109

Other trials in United States

About this study

Official title: Nudging Primary Care Providers Toward Guideline-Recommended Opioid Prescribing Through Easier and More Convenient EHR Information Design

The purpose of the study is to determine whether and how having access to the Chronic Pain OneSheet clinical decision support tool in Epic affects the ordering, prescribing, goal-setting, risk monitoring, and outcome measuring behavior of participating primary care providers (PCPs) in visits with patients with chronic pain conditions. The investigators will also assess whether access to the Chronic Pain OneSheet results in PCPs 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.

Read the detailed description

The Chronic Pain OneSheet (OneSheet) is an electronic health record (EHR) based clinical support tool developed and built in Epic. The OneSheet is a dashboard designed to assist PCPs in treating patients with chronic pain conditions by providing an overview of patient information needed by PCPs when treating these patients. The dashboard does not provide new information to PCPs. Instead, it works by aggregating and structuring information already being collected, available in other places in the medical record. By aggregating and structuring this information more conveniently, the goal of the OneSheet is to make important information in clinical decision-making more readily available and reduce the time PCPs need to spend locating this information.

The study aimed 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 PCPs in visits with patients with chronic pain conditions. The investigators also assessed whether access to the Chronic Pain OneSheet results in PCPs making chronic pain treatment decisions that are more concordant with the CDC Guideline for Prescribing Opioids for Chronic Pain.

To test this, researchers conducted a two-arm pragmatic randomized controlled trial (RCT), enrolling PCPs across two health systems. The randomization occurred at the PCP level; the analysis occurred at the patient-visit level. The PCPs signed an informed consent form, while the data from patient visits was obtained through a waiver of informed consent. The investigators assessed outcomes by analyzing EHR usage log files and PCP ordering records extracted from the healthcare systems' clinical data warehouses.

Conditions: Chronic Pain
Being tested: Chronic Pain OneSheet
Keywords: Clinical Decision Support, Chronic pain care, Behavioral Economics, Provider behavior
Medical subject headings: Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Chronic Pain OneSheetBehavioural
Also called Pain Dashboard
The Chronic Pain OneSheet (OneSheet) is an EHR decision support tool that uses behavioral economics to increase adoption of chronic pain guideline recommendations. OneSheet works by aggregating and structuring information that is already collected, that PCPs often need while caring for patients with chronic pain conditions. By aggregating and structuring this information in a more convenient manner, the goal of OneSheet is to make the information that is important in clinical decision making more readily available, and to reduce the amount of time that PCPs need to spend locating this information.

Study groups in NCT04295135
Study group	Role	What they receive
OneSheet access	Experimental	PCPs who receive access to, and training in the Chronic Pain OneSheet, and use it while caring for patients with chronic pain. Receives: Behavioral: Chronic Pain OneSheet
Normal practice	No intervention	PCPs who do not receive access to, or training in the Chronic Pain OneSheet, and care for patients with chronic pain as they would normally.

What is being measured

The primary outcome is the main question the study is designed to answer.

Pain and Function Goal-setting
Proportion of visits for patients with chronic pain for whom the PCP documented pain and/or function goals in the EHR, as assessed by data extracted from the healthcare systems' clinical data warehouse.
Measured: Assessed at baseline (looked back at previous 12 months) and 18-month treatment period
Pain, Enjoyment of Life, and General Activity (PEG) Documentation
Proportion of visits for patients with chronic pain for whom the PCP documented the assessment of pain and/or function (e.g. Pain, Enjoyment, General Activity (PEG) scale in the EHR, as assessed by data extracted from the healthcare systems' clinical data warehouse. The PEG has a scale of 1-10, and is used to track an individual's changes over time. With effective therapy, an individual's score should decrease over time.
Measured: Assessed at baseline (looked back at previous 12 months) and 18-month treatment period
Urine Drug Screening (UDS) Results Ordered
Proportion of visits for patients with chronic pain on long term opioid therapy (LTOT) for whom the PCP ordered a UDS, as assessed by data extracted from the healthcare systems' clinical data warehouse.
Measured: Assessed at baseline (looked back at previous 12 months) and 18-month treatment period
Prescription Drug Monitoring Program (PDMP) Reports Reviewed
Proportion of visits for patients with chronic pain on LTOT for whom the PCP accessed the PDMP report, as assessed by data extracted from the healthcare systems' clinical data warehouse.
Measured: Assessed at baseline (looked back at previous 12 months) and 18-month treatment period

Secondary outcomes (2)

Naloxone Prescriptions Ordered
Proportion of visits for patients with chronic pain on LTOT for whom the PCP ordered naloxone, as assessed by data extracted from the healthcare systems' clinical data warehouse.
Measured: Assessed at baseline (looked back at previous 12 months) and 18-month treatment period
Medications for Opioid Use Disorder Prescription Ordered
Proportion of visits for patients with chronic pain on LTOT for whom the PCP ordered a medication for opioid use disorder, as assessed by data extracted from the healthcare systems' clinical data warehouse.
Measured: Assessed at baseline (looked back at previous 12 months) and 18-month treatment period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Aug 202018 May 2022

First posted4 Mar 2020
Study start4 Aug 2020
Primary completion18 May 2022
Study completion18 May 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Chronic PainStudies of the same condition, open and under way.
More trials run by Indiana UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 137 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04295135
Sponsor's protocol ID: 1911922583
Other IDs: 5R33DA046085-05
Status last verified: May 2024
First submitted: 15 Feb 2020
Last updated: 24 May 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 35484491

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Chronic Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Nudging Primary Care Providers Toward Guideline-Recommended Opioid Prescribing Through Easier and More Convenient EHR Information Design
ClinicalTrials.gov ID: NCT04295135
Acronym / sponsor ID: 1911922583
Conditions: Chronic Pain
Keywords: Clinical Decision Support, Chronic pain care, Behavioral Economics, Provider behavior
Study type: Interventional
Recruitment status: Completed
Enrolment: 137 participants (actual)
Lead sponsor: Indiana UniversityUniversity, hospital or other
Collaborators: Eskenazi Health, Wake Forest University, Wake Forest University Health Sciences, University of Florida, National Institute on Drug Abuse (NIDA)
Study start: 4 Aug 2020 (actual)
Primary completion: 18 May 2022 (actual)
Study completion: 18 May 2022 (actual)
First posted: 4 Mar 2020 (actual)
Results: Posted 24 May 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
OneSheet access	Experimental	Behavioral: Chronic Pain OneSheetPCPs who receive access to, and training in the Chronic Pain OneSheet, and use it while caring for patients with chronic pain.
Normal practice	No intervention	–PCPs who do not receive access to, or training in the Chronic Pain OneSheet, and care for patients with chronic pain as they would normally.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Primary care provider (including Family Medicine, Internal Medicine, Med-Peds, and General Medicine)
Can 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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Chronic Pain OneSheetAlso: Pain DashboardThe Chronic Pain OneSheet (OneSheet) is an EHR decision support tool that uses behavioral economics to increase adoption of chronic pain guideline recommendations. OneSheet works by aggregating and structuring information that is already collected, that PCPs often need while caring for patients with chronic pain conditions. By aggregating and structuring this information in a more convenient manner, the goal of OneSheet is to make the information that is important in clinical decision making more readily available, and to reduce the amount of time that PCPs need to spend locating this information.	Behavioural	OneSheet access

Primary outcome

Pain and Function Goal-setting
Time frame: Assessed at baseline (looked back at previous 12 months) and 18-month treatment period
Proportion of visits for patients with chronic pain for whom the PCP documented pain and/or function goals in the EHR, as assessed by data extracted from the healthcare systems' clinical data warehouse.
Pain, Enjoyment of Life, and General Activity (PEG) Documentation
Time frame: Assessed at baseline (looked back at previous 12 months) and 18-month treatment period
Proportion of visits for patients with chronic pain for whom the PCP documented the assessment of pain and/or function (e.g. Pain, Enjoyment, General Activity (PEG) scale in the EHR, as assessed by data extracted from the healthcare systems' clinical data warehouse. The PEG has a scale of 1-10, and is used to track an individual's changes over time. With effective therapy, an individual's score should decrease over time.
Urine Drug Screening (UDS) Results Ordered
Time frame: Assessed at baseline (looked back at previous 12 months) and 18-month treatment period
Proportion of visits for patients with chronic pain on long term opioid therapy (LTOT) for whom the PCP ordered a UDS, as assessed by data extracted from the healthcare systems' clinical data warehouse.
Prescription Drug Monitoring Program (PDMP) Reports Reviewed
Time frame: Assessed at baseline (looked back at previous 12 months) and 18-month treatment period
Proportion of visits for patients with chronic pain on LTOT for whom the PCP accessed the PDMP report, as assessed by data extracted from the healthcare systems' clinical data warehouse.

2 secondary outcomes

Naloxone Prescriptions Ordered
Time frame: Assessed at baseline (looked back at previous 12 months) and 18-month treatment period
Medications for Opioid Use Disorder Prescription Ordered
Time frame: Assessed at baseline (looked back at previous 12 months) and 18-month treatment period

Results and safety

Results posted to the registry on 24 May 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
OneSheet Access	69	59
Normal Practice	68	63

Primary outcome: Pain and Function Goal-setting

Time frame: Assessed at baseline (looked back at previous 12 months) and 18-month treatment period. Mean (Standard Deviation). Unit: Proportion of patient visits

Measure	OneSheet Access n = 69	Normal Practice n = 66
Pre OneSheet Go-Live	0.0081 (0.0898)	0.0016 (0.0404)
Post OneSheet Go-Live	0.0364 (0.1873)	0.0283 (0.1659)

OneSheet Access vs Normal Practice: Mean Difference (Net): 0.002, p <0.05, Regression, Linear

Population analysed: PCPs enrolled during both recruitment phases and their visits with adult patients with chronic pain starting at the baseline (looked back at previous 12 months; pre-OneSheet Go-Live) and 18-month treatment period (post-OneSheet Go-Live).

Primary outcome: Pain, Enjoyment of Life, and General Activity (PEG) Documentation

Time frame: Assessed at baseline (looked back at previous 12 months) and 18-month treatment period. Mean (Standard Deviation). Unit: Proportion of patient visits

Measure	OneSheet Access n = 69	Normal Practice n = 66
Pre OneSheet Go-Live	0.0086 (0.0923)	0.0096 (0.0973)
Post OneSheet Go-Live	0.0313 (0.1741)	0.0253 (0.1572)

OneSheet Access vs Normal Practice: Median Difference (Net): 0.007, p <0.01, Regression, Linear

Primary outcome: Urine Drug Screening (UDS) Results Ordered

Time frame: Assessed at baseline (looked back at previous 12 months) and 18-month treatment period. Mean (Standard Deviation). Unit: Proportion of patient visits

Measure	OneSheet Access n = 67	Normal Practice n = 65
Pre OneSheet Go-Live	0.4175 (0.4932)	0.5486 (0.4977)
Post OneSheet Go-Live	0.3746 (0.4840)	0.4705 (0.4991)

OneSheet Access vs Normal Practice: Mean Difference (Net): 0.022, p <0.01, Regression, Linear

Population analysed: PCPs enrolled during both recruitment phases and their visits with adult patients with chronic pain on LTOT starting at the baseline (looked back at previous 12 months; pre-OneSheet Go-Live) and 18-month treatment period (post-OneSheet Go-Live). The number of units (patient visits and participant counts) analyzed differs between the pre-OneSheet Go-Live and post-OneSheet Go-Live periods due to some PCPs only having qualifying visits in either the pre- or post- intervention period.

Primary outcome: Prescription Drug Monitoring Program (PDMP) Reports Reviewed

Time frame: Assessed at baseline (looked back at previous 12 months) and 18-month treatment period. Mean (Standard Deviation). Unit: Proportion of patient visits

Measure	OneSheet Access n = 67	Normal Practice n = 65
Pre OneSheet Go-Live	0.7457 (0.4355)	0.7962 (0.4028)
Post OneSheet Go-Live	0.8008 (0.3994)	0.8461 (0.3609)

OneSheet Access vs Normal Practice: Median Difference (Net): -0.005, p >0.05, Regression, Linear

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 18 month treatment period. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
OneSheet Access	0 of 69 (0%)	0 of 69 (0%)	0 of 69
Normal Practice	0 of 68 (0%)	0 of 68 (0%)	0 of 68

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35484491Mazurenko 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Christopher A Harle, PhD principal investigator

Indiana University

Olena Mazurenko, MD, PhD principal investigator

Indiana University

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Chronic Pain OneSheet in people with Chronic Pain, run by Indiana University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain and Function Goal-setting (time frame: Assessed at baseline (looked back at previous 12 months) and 18-month treatment period). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04295135, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2024.