Trial Outcomes & Findings for PRescribing INterventions for Chronic Pain Via the Electronic Health Record Study - Opioid-Naive Population (NCT NCT04601493)
NCT ID: NCT04601493
Last Updated: 2024-08-26
Results Overview
Outcome reported as the percent of Primary Care Appointments (PCAs) at each clinic during which an opioid is prescribed, without currently receiving a non-opioid alternative pain treatment (including a new order for a non-opioid pain treatment).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
631 participants
Primary outcome timeframe
12 months
Results posted on
2024-08-26
Participant Flow
The original study protocol included a potential second randomization period after six months into the trial. This secondary randomization did not occur, per the recommendation of the Data Monitoring Committee
Unit of analysis: primary care clinics
Participant milestones
| Measure |
Care as Usual
Clinics assigned to this arm will continue to care for the patients as usual in regards to opioid prescribing.
|
Choice Architecture Nudge
Clinics in this arm will receive the choice architecture nudge intervention.
Choice Architecture Nudge: During the choice architecture nudge intervention, Primary Care Providers (PCPs) will be sent alerts in the Electronic Health Record (EHR) system when they initiate an opioid order for a patient who has not had an opioid prescription within the past six months. The alert provides guidance language about opioid prescribing and prompts the PCP to open the "SmartSet" to order non-opioid treatment alternatives. PCPs can choose to ignore this, but opening the SmartSet is the default option. When the SmartSet is opened, PCPs can choose to click on a variety of treatment order options, including both non-opioid pharmacological options and non-pharmacological options (e.g., referral to physical therapy or pain clinic).
|
PMP Integration & Nudge
Clinics in this arm will receive the Prescription Drug Monitoring (PMP) Integration \& Nudge intervention.
PMP Integration \& Nudge: During the Prescription Drug Monitoring Program (PMP) integration \& nudge intervention, Primary Care Providers (PCPs) will have integrated access to the PMP embedded within the EHR. All clinicians can already access the PMP to look up a patient's prior opioid prescriptions and prescription fills. However, this process involves signing in to the separate PMP website and can be complicated and time-consuming within typical clinical workflow. The integrated PMP tool makes it much easier and faster for a PCP to access the PMP information for a given patient.
|
Choice Architecture Nudge + PMP Integration & Nudge
Clinics in this arm will receive both the choice architecture nudge and prescription drug monitoring (PMP) integration \& nudge interventions.
Choice Architecture Nudge: During the choice architecture nudge intervention, Primary Care Providers (PCPs) will be sent alerts in the Electronic Health Record (EHR) system when they initiate an opioid order for a patient who has not had an opioid prescription within the past six months. The alert provides guidance language about opioid prescribing and prompts the PCP to open the "SmartSet" to order non-opioid treatment alternatives. PCPs can choose to ignore this, but opening the SmartSet is the default option. When the SmartSet is opened, PCPs can choose to click on a variety of treatment order options, including both non-opioid pharmacological options and non-pharmacological options (e.g., referral to physical therapy or pain clinic).
PMP Integration \& Nudge: During the Prescription Drug Monitoring Program (PMP) integration \& nudge intervention, Primary Care Providers (PCPs) will have integrated access to the PMP embedded within the EHR. All clinicians can already access the PMP to look up a patient's prior opioid prescriptions and prescription fills. However, this process involves signing in to the separate PMP website and can be complicated and time-consuming within typical clinical workflow. The integrated PMP tool makes it much easier and faster for a PCP to access the PMP information for a given patient.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
126 10
|
112 11
|
104 9
|
131 11
|
|
Overall Study
COMPLETED
|
126 10
|
112 11
|
104 9
|
131 11
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Age information was not collected
Baseline characteristics by cohort
| Measure |
Care as Usual
n=126 Participants
Clinics assigned to this arm will continue to care for the patients as usual in regards to opioid prescribing.
|
Choice Architecture Nudge
n=112 Participants
Clinics in this arm will receive the choice architecture nudge intervention.
Choice Architecture Nudge: During the choice architecture nudge intervention, Primary Care Providers (PCPs) will be sent alerts in the Electronic Health Record (EHR) system when they initiate an opioid order for a patient who has not had an opioid prescription within the past six months. The alert provides guidance language about opioid prescribing and prompts the PCP to open the "SmartSet" to order non-opioid treatment alternatives. PCPs can choose to ignore this, but opening the SmartSet is the default option. When the SmartSet is opened, PCPs can choose to click on a variety of treatment order options, including both non-opioid pharmacological options and non-pharmacological options (e.g., referral to physical therapy or pain clinic).
|
PMP Integration & Nudge
n=104 Participants
Clinics in this arm will receive the Prescription Drug Monitoring (PMP) Integration \& Nudge intervention.
PMP Integration \& Nudge: During the Prescription Drug Monitoring Program (PMP) integration \& nudge intervention, Primary Care Providers (PCPs) will have integrated access to the PMP embedded within the EHR. All clinicians can already access the PMP to look up a patient's prior opioid prescriptions and prescription fills. However, this process involves signing in to the separate PMP website and can be complicated and time-consuming within typical clinical workflow. The integrated PMP tool makes it much easier and faster for a PCP to access the PMP information for a given patient.
|
Choice Architecture Nudge + PMP Integration & Nudge
n=131 Participants
Clinics in this arm will receive both the choice architecture nudge and prescription drug monitoring (PMP) integration \& nudge interventions.
Choice Architecture Nudge: During the choice architecture nudge intervention, Primary Care Providers (PCPs) will be sent alerts in the Electronic Health Record (EHR) system when they initiate an opioid order for a patient who has not had an opioid prescription within the past six months. The alert provides guidance language about opioid prescribing and prompts the PCP to open the "SmartSet" to order non-opioid treatment alternatives. PCPs can choose to ignore this, but opening the SmartSet is the default option. When the SmartSet is opened, PCPs can choose to click on a variety of treatment order options, including both non-opioid pharmacological options and non-pharmacological options (e.g., referral to physical therapy or pain clinic).
PMP Integration \& Nudge: During the Prescription Drug Monitoring Program (PMP) integration \& nudge intervention, Primary Care Providers (PCPs) will have integrated access to the PMP embedded within the EHR. All clinicians can already access the PMP to look up a patient's prior opioid prescriptions and prescription fills. However, this process involves signing in to the separate PMP website and can be complicated and time-consuming within typical clinical workflow. The integrated PMP tool makes it much easier and faster for a PCP to access the PMP information for a given patient.
|
Total
n=473 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
Age information was not collected
|
0 Participants
Age information was not collected
|
0 Participants
Age information was not collected
|
0 Participants
Age information was not collected
|
0 Participants
Age information was not collected
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
Age information was not collected
|
0 Participants
Age information was not collected
|
0 Participants
Age information was not collected
|
0 Participants
Age information was not collected
|
0 Participants
Age information was not collected
|
|
Age, Categorical
>=65 years
|
0 Participants
Age information was not collected
|
0 Participants
Age information was not collected
|
0 Participants
Age information was not collected
|
0 Participants
Age information was not collected
|
0 Participants
Age information was not collected
|
|
Sex/Gender, Customized
Female
|
70 Participants
n=126 Participants
|
64 Participants
n=112 Participants
|
66 Participants
n=104 Participants
|
86 Participants
n=131 Participants
|
286 Participants
n=473 Participants
|
|
Sex/Gender, Customized
Male
|
49 Participants
n=126 Participants
|
44 Participants
n=112 Participants
|
38 Participants
n=104 Participants
|
42 Participants
n=131 Participants
|
173 Participants
n=473 Participants
|
|
Sex/Gender, Customized
Unkown
|
7 Participants
n=126 Participants
|
4 Participants
n=112 Participants
|
0 Participants
n=104 Participants
|
3 Participants
n=131 Participants
|
14 Participants
n=473 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 12 monthsOutcome reported as the percent of Primary Care Appointments (PCAs) at each clinic during which an opioid is prescribed, without currently receiving a non-opioid alternative pain treatment (including a new order for a non-opioid pain treatment).
Outcome measures
| Measure |
Care as Usual
n=123 Participants
Clinics assigned to this arm will continue to care for the patients as usual in regards to opioid prescribing.
|
Choice Architecture Nudge
n=107 Participants
Clinics in this arm will receive the choice architecture nudge intervention.
Choice Architecture Nudge: During the choice architecture nudge intervention, Primary Care Providers (PCPs) will be sent alerts in the Electronic Health Record (EHR) system when they initiate an opioid order for a patient who has not had an opioid prescription within the past six months. The alert provides guidance language about opioid prescribing and prompts the PCP to open the "SmartSet" to order non-opioid treatment alternatives. PCPs can choose to ignore this, but opening the SmartSet is the default option. When the SmartSet is opened, PCPs can choose to click on a variety of treatment order options, including both non-opioid pharmacological options and non-pharmacological options (e.g., referral to physical therapy or pain clinic).
|
PMP Integration & Nudge
n=102 Participants
Clinics in this arm will receive the Prescription Drug Monitoring (PMP) Integration \& Nudge intervention.
PMP Integration \& Nudge: During the Prescription Drug Monitoring Program (PMP) integration \& nudge intervention, Primary Care Providers (PCPs) will have integrated access to the PMP embedded within the EHR. All clinicians can already access the PMP to look up a patient's prior opioid prescriptions and prescription fills. However, this process involves signing in to the separate PMP website and can be complicated and time-consuming within typical clinical workflow. The integrated PMP tool makes it much easier and faster for a PCP to access the PMP information for a given patient.
|
Choice Architecture Nudge + PMP Integration & Nudge
n=127 Participants
Clinics in this arm will receive both the choice architecture nudge and prescription drug monitoring (PMP) integration \& nudge interventions.
Choice Architecture Nudge: During the choice architecture nudge intervention, Primary Care Providers (PCPs) will be sent alerts in the Electronic Health Record (EHR) system when they initiate an opioid order for a patient who has not had an opioid prescription within the past six months. The alert provides guidance language about opioid prescribing and prompts the PCP to open the "SmartSet" to order non-opioid treatment alternatives. PCPs can choose to ignore this, but opening the SmartSet is the default option. When the SmartSet is opened, PCPs can choose to click on a variety of treatment order options, including both non-opioid pharmacological options and non-pharmacological options (e.g., referral to physical therapy or pain clinic).
PMP Integration \& Nudge: During the Prescription Drug Monitoring Program (PMP) integration \& nudge intervention, Primary Care Providers (PCPs) will have integrated access to the PMP embedded within the EHR. All clinicians can already access the PMP to look up a patient's prior opioid prescriptions and prescription fills. However, this process involves signing in to the separate PMP website and can be complicated and time-consuming within typical clinical workflow. The integrated PMP tool makes it much easier and faster for a PCP to access the PMP information for a given patient.
|
|---|---|---|---|---|
|
Opioid Prescription Rate
|
0.0159 percent
Standard Deviation 0.125
|
0.0141 percent
Standard Deviation 0.118
|
0.0161 percent
Standard Deviation 0.129
|
0.0120 percent
Standard Deviation 0.109
|
SECONDARY outcome
Timeframe: 12 monthsOutcome reported as the percent of Primary Care Appointments (PCAs) at each clinic during which a CDC-recommended non-opioid treatment in ordered
Outcome measures
| Measure |
Care as Usual
n=123 Participants
Clinics assigned to this arm will continue to care for the patients as usual in regards to opioid prescribing.
|
Choice Architecture Nudge
n=107 Participants
Clinics in this arm will receive the choice architecture nudge intervention.
Choice Architecture Nudge: During the choice architecture nudge intervention, Primary Care Providers (PCPs) will be sent alerts in the Electronic Health Record (EHR) system when they initiate an opioid order for a patient who has not had an opioid prescription within the past six months. The alert provides guidance language about opioid prescribing and prompts the PCP to open the "SmartSet" to order non-opioid treatment alternatives. PCPs can choose to ignore this, but opening the SmartSet is the default option. When the SmartSet is opened, PCPs can choose to click on a variety of treatment order options, including both non-opioid pharmacological options and non-pharmacological options (e.g., referral to physical therapy or pain clinic).
|
PMP Integration & Nudge
n=102 Participants
Clinics in this arm will receive the Prescription Drug Monitoring (PMP) Integration \& Nudge intervention.
PMP Integration \& Nudge: During the Prescription Drug Monitoring Program (PMP) integration \& nudge intervention, Primary Care Providers (PCPs) will have integrated access to the PMP embedded within the EHR. All clinicians can already access the PMP to look up a patient's prior opioid prescriptions and prescription fills. However, this process involves signing in to the separate PMP website and can be complicated and time-consuming within typical clinical workflow. The integrated PMP tool makes it much easier and faster for a PCP to access the PMP information for a given patient.
|
Choice Architecture Nudge + PMP Integration & Nudge
n=127 Participants
Clinics in this arm will receive both the choice architecture nudge and prescription drug monitoring (PMP) integration \& nudge interventions.
Choice Architecture Nudge: During the choice architecture nudge intervention, Primary Care Providers (PCPs) will be sent alerts in the Electronic Health Record (EHR) system when they initiate an opioid order for a patient who has not had an opioid prescription within the past six months. The alert provides guidance language about opioid prescribing and prompts the PCP to open the "SmartSet" to order non-opioid treatment alternatives. PCPs can choose to ignore this, but opening the SmartSet is the default option. When the SmartSet is opened, PCPs can choose to click on a variety of treatment order options, including both non-opioid pharmacological options and non-pharmacological options (e.g., referral to physical therapy or pain clinic).
PMP Integration \& Nudge: During the Prescription Drug Monitoring Program (PMP) integration \& nudge intervention, Primary Care Providers (PCPs) will have integrated access to the PMP embedded within the EHR. All clinicians can already access the PMP to look up a patient's prior opioid prescriptions and prescription fills. However, this process involves signing in to the separate PMP website and can be complicated and time-consuming within typical clinical workflow. The integrated PMP tool makes it much easier and faster for a PCP to access the PMP information for a given patient.
|
|---|---|---|---|---|
|
Rate of Non-Opioid Treatment Prescription
|
0.239 percent
Standard Deviation 0.426
|
0.227 percent
Standard Deviation 0.419
|
0.23 percent
Standard Deviation 0.421
|
0.228 percent
Standard Deviation 0.419
|
SECONDARY outcome
Timeframe: 12 monthsOutcome reported as the mean length of opioid prescription (in days) given during Primary Care Appointments
Outcome measures
| Measure |
Care as Usual
n=123 Participants
Clinics assigned to this arm will continue to care for the patients as usual in regards to opioid prescribing.
|
Choice Architecture Nudge
n=107 Participants
Clinics in this arm will receive the choice architecture nudge intervention.
Choice Architecture Nudge: During the choice architecture nudge intervention, Primary Care Providers (PCPs) will be sent alerts in the Electronic Health Record (EHR) system when they initiate an opioid order for a patient who has not had an opioid prescription within the past six months. The alert provides guidance language about opioid prescribing and prompts the PCP to open the "SmartSet" to order non-opioid treatment alternatives. PCPs can choose to ignore this, but opening the SmartSet is the default option. When the SmartSet is opened, PCPs can choose to click on a variety of treatment order options, including both non-opioid pharmacological options and non-pharmacological options (e.g., referral to physical therapy or pain clinic).
|
PMP Integration & Nudge
n=102 Participants
Clinics in this arm will receive the Prescription Drug Monitoring (PMP) Integration \& Nudge intervention.
PMP Integration \& Nudge: During the Prescription Drug Monitoring Program (PMP) integration \& nudge intervention, Primary Care Providers (PCPs) will have integrated access to the PMP embedded within the EHR. All clinicians can already access the PMP to look up a patient's prior opioid prescriptions and prescription fills. However, this process involves signing in to the separate PMP website and can be complicated and time-consuming within typical clinical workflow. The integrated PMP tool makes it much easier and faster for a PCP to access the PMP information for a given patient.
|
Choice Architecture Nudge + PMP Integration & Nudge
n=127 Participants
Clinics in this arm will receive both the choice architecture nudge and prescription drug monitoring (PMP) integration \& nudge interventions.
Choice Architecture Nudge: During the choice architecture nudge intervention, Primary Care Providers (PCPs) will be sent alerts in the Electronic Health Record (EHR) system when they initiate an opioid order for a patient who has not had an opioid prescription within the past six months. The alert provides guidance language about opioid prescribing and prompts the PCP to open the "SmartSet" to order non-opioid treatment alternatives. PCPs can choose to ignore this, but opening the SmartSet is the default option. When the SmartSet is opened, PCPs can choose to click on a variety of treatment order options, including both non-opioid pharmacological options and non-pharmacological options (e.g., referral to physical therapy or pain clinic).
PMP Integration \& Nudge: During the Prescription Drug Monitoring Program (PMP) integration \& nudge intervention, Primary Care Providers (PCPs) will have integrated access to the PMP embedded within the EHR. All clinicians can already access the PMP to look up a patient's prior opioid prescriptions and prescription fills. However, this process involves signing in to the separate PMP website and can be complicated and time-consuming within typical clinical workflow. The integrated PMP tool makes it much easier and faster for a PCP to access the PMP information for a given patient.
|
|---|---|---|---|---|
|
Opioid Prescription Length
|
9.63 Days
Standard Deviation 18.66
|
11.85 Days
Standard Deviation 21.4
|
13.43 Days
Standard Deviation 35.86
|
11.75 Days
Standard Deviation 25.39
|
SECONDARY outcome
Timeframe: 12 monthsOutcome reported as the mean Milligram Morphine Equivalents (MME) of opioid prescriptions given during Primary Care Appointments
Outcome measures
| Measure |
Care as Usual
n=123 Participants
Clinics assigned to this arm will continue to care for the patients as usual in regards to opioid prescribing.
|
Choice Architecture Nudge
n=107 Participants
Clinics in this arm will receive the choice architecture nudge intervention.
Choice Architecture Nudge: During the choice architecture nudge intervention, Primary Care Providers (PCPs) will be sent alerts in the Electronic Health Record (EHR) system when they initiate an opioid order for a patient who has not had an opioid prescription within the past six months. The alert provides guidance language about opioid prescribing and prompts the PCP to open the "SmartSet" to order non-opioid treatment alternatives. PCPs can choose to ignore this, but opening the SmartSet is the default option. When the SmartSet is opened, PCPs can choose to click on a variety of treatment order options, including both non-opioid pharmacological options and non-pharmacological options (e.g., referral to physical therapy or pain clinic).
|
PMP Integration & Nudge
n=102 Participants
Clinics in this arm will receive the Prescription Drug Monitoring (PMP) Integration \& Nudge intervention.
PMP Integration \& Nudge: During the Prescription Drug Monitoring Program (PMP) integration \& nudge intervention, Primary Care Providers (PCPs) will have integrated access to the PMP embedded within the EHR. All clinicians can already access the PMP to look up a patient's prior opioid prescriptions and prescription fills. However, this process involves signing in to the separate PMP website and can be complicated and time-consuming within typical clinical workflow. The integrated PMP tool makes it much easier and faster for a PCP to access the PMP information for a given patient.
|
Choice Architecture Nudge + PMP Integration & Nudge
n=127 Participants
Clinics in this arm will receive both the choice architecture nudge and prescription drug monitoring (PMP) integration \& nudge interventions.
Choice Architecture Nudge: During the choice architecture nudge intervention, Primary Care Providers (PCPs) will be sent alerts in the Electronic Health Record (EHR) system when they initiate an opioid order for a patient who has not had an opioid prescription within the past six months. The alert provides guidance language about opioid prescribing and prompts the PCP to open the "SmartSet" to order non-opioid treatment alternatives. PCPs can choose to ignore this, but opening the SmartSet is the default option. When the SmartSet is opened, PCPs can choose to click on a variety of treatment order options, including both non-opioid pharmacological options and non-pharmacological options (e.g., referral to physical therapy or pain clinic).
PMP Integration \& Nudge: During the Prescription Drug Monitoring Program (PMP) integration \& nudge intervention, Primary Care Providers (PCPs) will have integrated access to the PMP embedded within the EHR. All clinicians can already access the PMP to look up a patient's prior opioid prescriptions and prescription fills. However, this process involves signing in to the separate PMP website and can be complicated and time-consuming within typical clinical workflow. The integrated PMP tool makes it much easier and faster for a PCP to access the PMP information for a given patient.
|
|---|---|---|---|---|
|
Opioid Prescription MME
|
23.41 Milligram Morphine Equivalents
Standard Deviation 14.9
|
23.89 Milligram Morphine Equivalents
Standard Deviation 18.3
|
21.6 Milligram Morphine Equivalents
Standard Deviation 12.1
|
23.89 Milligram Morphine Equivalents
Standard Deviation 15.9
|
Adverse Events
Care as Usual
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Choice Architecture Nudge
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
PMP Integration & Nudge
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Choice Architecture Nudge + PMP Integration & Nudge
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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