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| ID | Type | Description | Link |
|---|---|---|---|
| 5R33DA046085-05 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eskenazi Health | OTHER |
| Wake Forest University | OTHER |
| Wake Forest University Health Sciences | OTHER |
| University of Florida |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chronic Pain OneSheet | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | Assessed at baseline (looked back at previous 12 months) and 18-month treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Assessed at baseline (looked back at previous 12 months) and 18-month treatment period |
| Medications for Opioid Use Disorder Prescription Ordered |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher A Harle, PhD | Indiana University | Principal Investigator |
| Olena Mazurenko, MD, PhD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University | Indianapolis | Indiana | 46202 | United States | ||
| Wake Forest University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35484491 | Derived | 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. |
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Primary care providers (PCP) were recruited after virtual staff meetings. PCP recruitment occurred in two phases: Phase 1(health system 1: Aug-Oct 2020; health system 2: Sept-Nov 2020) and Phase 2 (Sep-Dec 2021). Phase 2 recruited more PCPs to increase the sample size and allow new PCPs to participate. PCPs were randomly assigned to either a treatment or a control group (permanent assignment). We combined data from PCPs recruited in both phases for analysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | OneSheet Access | PCPs who receive access to, and training in the Chronic Pain OneSheet, and use it while caring for patients with chronic pain. Chronic Pain OneSheet: The Chronic Pain OneSheet (OneSheet) is an electronic health record (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. |
| FG001 | Normal Practice | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | OneSheet Access | PCPs who receive access to, and training in the Chronic Pain OneSheet, and use it while caring for patients with chronic pain. Chronic Pain OneSheet: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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). | Posted | Mean | Standard Deviation | Proportion of patient visits | Assessed at baseline (looked back at previous 12 months) and 18-month treatment period | Patient visits | Patient visits |
|
18 month treatment period
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | OneSheet Access | PCPs who receive access to, and training in the Chronic Pain OneSheet, and use it while caring for patients with chronic pain. Chronic Pain OneSheet: 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Christopher A. Harle | Indiana University | 317 278 3245 | charle@iu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 9, 2024 | Mar 7, 2024 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 5, 2024 | Mar 7, 2024 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 27, 2021 | Apr 10, 2024 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| OTHER |
| National Institute on Drug Abuse (NIDA) | NIH |
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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. |
| Assessed at baseline (looked back at previous 12 months) and 18-month treatment period |
| Winston-Salem |
| North Carolina |
| 27109 |
| United States |
| BG001 | Normal Practice | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Years practicing medicine | Mean | Standard Deviation | years |
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| OG001 | Normal Practice | 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. |
|
|
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| Primary | 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. | 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). | Posted | Mean | Standard Deviation | Proportion of patient visits | Assessed at baseline (looked back at previous 12 months) and 18-month treatment period | Patient visits | Patient visits |
|
|
|
|
| Primary | 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. | 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. | Posted | Mean | Standard Deviation | Proportion of patient visits | Assessed at baseline (looked back at previous 12 months) and 18-month treatment period | Patient visits | Patient visits |
|
|
|
|
| Primary | 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. | 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. | Posted | Mean | Standard Deviation | Proportion of patient visits | Assessed at baseline (looked back at previous 12 months) and 18-month treatment period | Patient visits | Patient visits |
|
|
|
|
| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | Proportion of patient visits | Assessed at baseline (looked back at previous 12 months) and 18-month treatment period | Patient visits | Patient visits |
|
|
|
|
| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | Proportion of patient visits | Assessed at baseline (looked back at previous 12 months) and 18-month treatment period | Patient visits | Patient visits |
|
|
|
|
| 0 |
| 69 |
| 0 |
| 69 |
| 0 |
| 69 |
| EG001 | Normal Practice | 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. | 0 | 68 | 0 | 68 | 0 | 68 |
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| Post OneSheet Go-Live |
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| Post OneSheet Go-Live |
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| Post OneSheet Go-Live |
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| Post OneSheet Go-Live |
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| Post OneSheet Go-Live |
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