Trial Outcomes & Findings for Chronic Pain OneSheet Clinical Trial (NCT NCT04295135)
NCT ID: NCT04295135
Last Updated: 2024-05-24
Results Overview
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.
COMPLETED
NA
137 participants
Assessed at baseline (looked back at previous 12 months) and 18-month treatment period
2024-05-24
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
69
|
68
|
|
Overall Study
COMPLETED
|
59
|
63
|
|
Overall Study
NOT COMPLETED
|
10
|
5
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
|
Overall Study
Subject left organization
|
8
|
4
|
Baseline Characteristics
Chronic Pain OneSheet Clinical Trial
Baseline characteristics by cohort
| Measure |
OneSheet Access
n=69 Participants
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.
|
Normal Practice
n=68 Participants
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.
|
Total
n=137 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
68 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
136 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
54 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
52 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
69 participants
n=5 Participants
|
68 participants
n=7 Participants
|
137 participants
n=5 Participants
|
|
Years practicing medicine
|
10.2 years
STANDARD_DEVIATION 9.94 • n=5 Participants
|
9.7 years
STANDARD_DEVIATION 9.39 • n=7 Participants
|
10.0 years
STANDARD_DEVIATION 9.64 • n=5 Participants
|
PRIMARY outcome
Timeframe: Assessed at baseline (looked back at previous 12 months) and 18-month treatment periodPopulation: 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).
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.
Outcome measures
| Measure |
OneSheet Access
n=252625 Patient visits
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.
|
Normal Practice
n=220179 Patient visits
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.
|
|---|---|---|
|
Pain and Function Goal-setting
Pre OneSheet Go-Live
|
0.0081 Proportion of patient visits
Standard Deviation 0.0898
|
0.0016 Proportion of patient visits
Standard Deviation 0.0404
|
|
Pain and Function Goal-setting
Post OneSheet Go-Live
|
0.0364 Proportion of patient visits
Standard Deviation 0.1873
|
0.0283 Proportion of patient visits
Standard Deviation 0.1659
|
PRIMARY outcome
Timeframe: Assessed at baseline (looked back at previous 12 months) and 18-month treatment periodPopulation: 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).
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.
Outcome measures
| Measure |
OneSheet Access
n=252625 Patient visits
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.
|
Normal Practice
n=220179 Patient visits
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.
|
|---|---|---|
|
Pain, Enjoyment of Life, and General Activity (PEG) Documentation
Pre OneSheet Go-Live
|
0.0086 Proportion of patient visits
Standard Deviation 0.0923
|
0.0096 Proportion of patient visits
Standard Deviation 0.0973
|
|
Pain, Enjoyment of Life, and General Activity (PEG) Documentation
Post OneSheet Go-Live
|
0.0313 Proportion of patient visits
Standard Deviation 0.1741
|
0.0253 Proportion of patient visits
Standard Deviation 0.1572
|
PRIMARY outcome
Timeframe: Assessed at baseline (looked back at previous 12 months) and 18-month treatment periodPopulation: 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.
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.
Outcome measures
| Measure |
OneSheet Access
n=26942 Patient visits
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.
|
Normal Practice
n=23492 Patient visits
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.
|
|---|---|---|
|
Urine Drug Screening (UDS) Results Ordered
Pre OneSheet Go-Live
|
0.4175 Proportion of patient visits
Standard Deviation 0.4932
|
0.5486 Proportion of patient visits
Standard Deviation 0.4977
|
|
Urine Drug Screening (UDS) Results Ordered
Post OneSheet Go-Live
|
0.3746 Proportion of patient visits
Standard Deviation 0.4840
|
0.4705 Proportion of patient visits
Standard Deviation 0.4991
|
PRIMARY outcome
Timeframe: Assessed at baseline (looked back at previous 12 months) and 18-month treatment periodPopulation: 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.
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.
Outcome measures
| Measure |
OneSheet Access
n=26942 Patient visits
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.
|
Normal Practice
n=23492 Patient visits
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.
|
|---|---|---|
|
Prescription Drug Monitoring Program (PDMP) Reports Reviewed
Pre OneSheet Go-Live
|
0.7457 Proportion of patient visits
Standard Deviation 0.4355
|
0.7962 Proportion of patient visits
Standard Deviation 0.4028
|
|
Prescription Drug Monitoring Program (PDMP) Reports Reviewed
Post OneSheet Go-Live
|
0.8008 Proportion of patient visits
Standard Deviation 0.3994
|
0.8461 Proportion of patient visits
Standard Deviation 0.3609
|
SECONDARY outcome
Timeframe: Assessed at baseline (looked back at previous 12 months) and 18-month treatment periodPopulation: 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.
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.
Outcome measures
| Measure |
OneSheet Access
n=26942 Patient visits
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.
|
Normal Practice
n=23492 Patient visits
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.
|
|---|---|---|
|
Naloxone Prescriptions Ordered
Post OneSheet Go-Live
|
0.0054 Proportion of patient visits
Standard Deviation 0.0730
|
0.0090 Proportion of patient visits
Standard Deviation 0.0944
|
|
Naloxone Prescriptions Ordered
Pre OneSheet Go-Live
|
0.0012 Proportion of patient visits
Standard Deviation 0.0349
|
0.0004 Proportion of patient visits
Standard Deviation 0.0195
|
SECONDARY outcome
Timeframe: Assessed at baseline (looked back at previous 12 months) and 18-month treatment periodPopulation: 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.
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.
Outcome measures
| Measure |
OneSheet Access
n=26942 Patient visits
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.
|
Normal Practice
n=23492 Patient visits
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.
|
|---|---|---|
|
Medications for Opioid Use Disorder Prescription Ordered
Pre OneSheet Go-Live
|
0.0119 Proportion of patient visits
Standard Deviation 0.1083
|
0.0092 Proportion of patient visits
Standard Deviation 0.0957
|
|
Medications for Opioid Use Disorder Prescription Ordered
Post OneSheet Go-Live
|
0.0383 Proportion of patient visits
Standard Deviation 0.1919
|
0.0373 Proportion of patient visits
Standard Deviation 0.1895
|
Adverse Events
OneSheet Access
Normal Practice
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place