Chronic Pain
Conditions
Keywords
Clinical Decision Support, Chronic pain care, Behavioral Economics, Provider behavior
Brief summary
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.
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.
Interventions
BEHAVIORALChronic 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.
Sponsors
Eskenazi Health
Wake Forest University
Wake Forest University Health Sciences
University of Florida
National Institute on Drug Abuse (NIDA)
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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
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 * Cannot prescribe medication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain and Function Goal-setting | 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 | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Naloxone Prescriptions Ordered | 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 ordered naloxone, as assessed by data extracted from the healthcare systems' clinical data warehouse. |
| Medications for Opioid Use Disorder Prescription Ordered | 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 ordered a medication for opioid use disorder, as assessed by data extracted from the healthcare systems' clinical data warehouse. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 69 |
| 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. | 68 |
| Total | 137 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Subject left organization | 8 | 4 |
| Overall Study | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | OneSheet Access | Normal Practice | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 68 Participants | 68 Participants | 136 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 8 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 54 Participants | 47 Participants | 101 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 11 Participants | 13 Participants | 24 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 7 Participants | 2 Participants | 9 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 6 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 8 Participants | 13 Participants |
| Race (NIH/OMB) White | 52 Participants | 52 Participants | 104 Participants |
| Region of Enrollment United States | 69 participants | 68 participants | 137 participants |
| Sex: Female, Male Female | 48 Participants | 40 Participants | 88 Participants |
| Sex: Female, Male Male | 21 Participants | 28 Participants | 49 Participants |
| Years practicing medicine | 10.2 years STANDARD_DEVIATION 9.94 | 9.7 years STANDARD_DEVIATION 9.39 | 10.0 years STANDARD_DEVIATION 9.64 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 69 | 0 / 68 |
| other Total, other adverse events | 0 / 69 | 0 / 68 |
| serious Total, serious adverse events | 0 / 69 | 0 / 68 |
Outcome results
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.
Time frame: Assessed at baseline (looked back at previous 12 months) and 18-month treatment period
Population: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OneSheet Access | Pain and Function Goal-setting | Pre OneSheet Go-Live | 0.0081 Proportion of patient visits | Standard Deviation 0.0898 |
| OneSheet Access | Pain and Function Goal-setting | Post OneSheet Go-Live | 0.0364 Proportion of patient visits | Standard Deviation 0.1873 |
| Normal Practice | Pain and Function Goal-setting | Pre OneSheet Go-Live | 0.0016 Proportion of patient visits | Standard Deviation 0.0404 |
| Normal Practice | Pain and Function Goal-setting | Post OneSheet Go-Live | 0.0283 Proportion of patient visits | Standard Deviation 0.1659 |
p-value: <0.05Regression, Linear
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.
Time frame: Assessed at baseline (looked back at previous 12 months) and 18-month treatment period
Population: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OneSheet Access | Pain, Enjoyment of Life, and General Activity (PEG) Documentation | Pre OneSheet Go-Live | 0.0086 Proportion of patient visits | Standard Deviation 0.0923 |
| OneSheet Access | Pain, Enjoyment of Life, and General Activity (PEG) Documentation | Post OneSheet Go-Live | 0.0313 Proportion of patient visits | Standard Deviation 0.1741 |
| Normal Practice | Pain, Enjoyment of Life, and General Activity (PEG) Documentation | Pre OneSheet Go-Live | 0.0096 Proportion of patient visits | Standard Deviation 0.0973 |
| Normal Practice | Pain, Enjoyment of Life, and General Activity (PEG) Documentation | Post OneSheet Go-Live | 0.0253 Proportion of patient visits | Standard Deviation 0.1572 |
p-value: <0.01Regression, Linear
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.
Time frame: Assessed at baseline (looked back at previous 12 months) and 18-month treatment period
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OneSheet Access | Prescription Drug Monitoring Program (PDMP) Reports Reviewed | Pre OneSheet Go-Live | 0.7457 Proportion of patient visits | Standard Deviation 0.4355 |
| OneSheet Access | Prescription Drug Monitoring Program (PDMP) Reports Reviewed | Post OneSheet Go-Live | 0.8008 Proportion of patient visits | Standard Deviation 0.3994 |
| Normal Practice | Prescription Drug Monitoring Program (PDMP) Reports Reviewed | Pre OneSheet Go-Live | 0.7962 Proportion of patient visits | Standard Deviation 0.4028 |
| Normal Practice | Prescription Drug Monitoring Program (PDMP) Reports Reviewed | Post OneSheet Go-Live | 0.8461 Proportion of patient visits | Standard Deviation 0.3609 |
p-value: >0.05Regression, Linear
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.
Time frame: Assessed at baseline (looked back at previous 12 months) and 18-month treatment period
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OneSheet Access | Urine Drug Screening (UDS) Results Ordered | Pre OneSheet Go-Live | 0.4175 Proportion of patient visits | Standard Deviation 0.4932 |
| OneSheet Access | Urine Drug Screening (UDS) Results Ordered | Post OneSheet Go-Live | 0.3746 Proportion of patient visits | Standard Deviation 0.484 |
| Normal Practice | Urine Drug Screening (UDS) Results Ordered | Pre OneSheet Go-Live | 0.5486 Proportion of patient visits | Standard Deviation 0.4977 |
| Normal Practice | Urine Drug Screening (UDS) Results Ordered | Post OneSheet Go-Live | 0.4705 Proportion of patient visits | Standard Deviation 0.4991 |
p-value: <0.01Regression, Linear
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.
Time frame: Assessed at baseline (looked back at previous 12 months) and 18-month treatment period
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OneSheet Access | Medications for Opioid Use Disorder Prescription Ordered | Pre OneSheet Go-Live | 0.0119 Proportion of patient visits | Standard Deviation 0.1083 |
| OneSheet Access | Medications for Opioid Use Disorder Prescription Ordered | Post OneSheet Go-Live | 0.0383 Proportion of patient visits | Standard Deviation 0.1919 |
| Normal Practice | Medications for Opioid Use Disorder Prescription Ordered | Pre OneSheet Go-Live | 0.0092 Proportion of patient visits | Standard Deviation 0.0957 |
| Normal Practice | Medications for Opioid Use Disorder Prescription Ordered | Post OneSheet Go-Live | 0.0373 Proportion of patient visits | Standard Deviation 0.1895 |
p-value: >0.05Regression, Linear
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.
Time frame: Assessed at baseline (looked back at previous 12 months) and 18-month treatment period
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OneSheet Access | Naloxone Prescriptions Ordered | Pre OneSheet Go-Live | 0.0012 Proportion of patient visits | Standard Deviation 0.0349 |
| OneSheet Access | Naloxone Prescriptions Ordered | Post OneSheet Go-Live | 0.0054 Proportion of patient visits | Standard Deviation 0.073 |
| Normal Practice | Naloxone Prescriptions Ordered | Pre OneSheet Go-Live | 0.0004 Proportion of patient visits | Standard Deviation 0.0195 |
| Normal Practice | Naloxone Prescriptions Ordered | Post OneSheet Go-Live | 0.0090 Proportion of patient visits | Standard Deviation 0.0944 |
p-value: <0.01Regression, Linear