Trial Outcomes & Findings for PRescribing INterventions for Chronic Pain Via the Electronic Health Record Study - Primary Care Providers (NCT NCT04601506)
NCT ID: NCT04601506
Last Updated: 2024-06-27
Results Overview
Outcome is reported as the mean number of times an individual Primary Care Provider checks the Prescription Drug Monitoring Program per month.
COMPLETED
NA
472 participants
12 months
2024-06-27
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: 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: Primary Care Providers (PCPs) will be sent alerts in the Electronic Health Record 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. 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.
PCPs will also be sent alerts when they initiate an opioid order for a patient will a current opioid prescription. The alerts prompt PCPs to consider tapering the patient's opioid. The alert also displays the MME of the patient's current opioid prescription and automatically calculates what a 10% reduction in MME relative to the current prescription would be. The alert contains options to either cancel the refill order, or to continue with the order.
|
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: Primary Care Providers (PCPs) will be sent alerts in the Electronic Health Record 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 and prompts open the "SmartSet" to order non-opioid treatment alternatives.
PCPs will also be sent alerts when they initiate an opioid order for a patient will a current opioid prescription. The alerts prompt PCPs to consider tapering the patient's opioid. The alert also displays the MME of the patient's current opioid prescription and automatically calculates what a 10% reduction in MME relative to the current prescription would be.
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
|
79 11
|
69 11
|
74 10
|
87 11
|
|
Overall Study
COMPLETED
|
79 11
|
69 11
|
74 10
|
87 11
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Age information not collected
Baseline characteristics by cohort
| Measure |
Care as Usual
n=79 Participants
Clinics assigned to this arm will continue to care for the patients as usual in regards to opioid prescribing.
|
Choice Architecture Nudge
n=69 Participants
Clinics in this arm will receive the choice architecture nudge intervention.
Choice Architecture Nudge: Primary Care Providers (PCPs) will be sent alerts in the Electronic Health Record 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. 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.
PCPs will also be sent alerts when they initiate an opioid order for a patient will a current opioid prescription. The alerts prompt PCPs to consider tapering the patient's opioid. The alert also displays the MME of the patient's current opioid prescription and automatically calculates what a 10% reduction in MME relative to the current prescription would be. The alert contains options to either cancel the refill order, or to continue with the order.
|
PMP Integration & Nudge
n=74 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=87 Participants
Clinics in this arm will receive both the choice architecture nudge and prescription drug monitoring (PMP) integration \& nudge interventions.
Choice Architecture Nudge: Primary Care Providers (PCPs) will be sent alerts in the Electronic Health Record 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 and prompts open the "SmartSet" to order non-opioid treatment alternatives.
PCPs will also be sent alerts when they initiate an opioid order for a patient will a current opioid prescription. The alerts prompt PCPs to consider tapering the patient's opioid. The alert also displays the MME of the patient's current opioid prescription and automatically calculates what a 10% reduction in MME relative to the current prescription would be.
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=309 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Sex/Gender, Customized
Female
|
39 Participants
n=79 Participants
|
42 Participants
n=69 Participants
|
40 Participants
n=74 Participants
|
59 Participants
n=87 Participants
|
180 Participants
n=309 Participants
|
|
Sex/Gender, Customized
Male
|
36 Participants
n=79 Participants
|
25 Participants
n=69 Participants
|
32 Participants
n=74 Participants
|
27 Participants
n=87 Participants
|
120 Participants
n=309 Participants
|
|
Sex/Gender, Customized
Unknown
|
4 Participants
n=79 Participants
|
2 Participants
n=69 Participants
|
2 Participants
n=74 Participants
|
1 Participants
n=87 Participants
|
9 Participants
n=309 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 12 monthsOutcome is reported as the mean number of times an individual Primary Care Provider checks the Prescription Drug Monitoring Program per month.
Outcome measures
| Measure |
Care as Usual
n=79 Participants
Clinics assigned to this arm will continue to care for the patients as usual in regards to opioid prescribing.
|
Choice Architecture Nudge
n=69 Participants
Clinics in this arm will receive the choice architecture nudge intervention.
Choice Architecture Nudge: Primary Care Providers (PCPs) will be sent alerts in the Electronic Health Record 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. 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.
PCPs will also be sent alerts when they initiate an opioid order for a patient will a current opioid prescription. The alerts prompt PCPs to consider tapering the patient's opioid. The alert also displays the MME of the patient's current opioid prescription and automatically calculates what a 10% reduction in MME relative to the current prescription would be. The alert contains options to either cancel the refill order, or to continue with the order.
|
PMP Integration & Nudge
n=74 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=87 Participants
Clinics in this arm will receive both the choice architecture nudge and prescription drug monitoring (PMP) integration \& nudge interventions.
Choice Architecture Nudge: Primary Care Providers (PCPs) will be sent alerts in the Electronic Health Record 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 and prompts open the "SmartSet" to order non-opioid treatment alternatives.
PCPs will also be sent alerts when they initiate an opioid order for a patient will a current opioid prescription. The alerts prompt PCPs to consider tapering the patient's opioid. The alert also displays the MME of the patient's current opioid prescription and automatically calculates what a 10% reduction in MME relative to the current prescription would be.
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.
|
|---|---|---|---|---|
|
Frequency of PDMP Checks
|
19 PDMP queries per PCP per month
Standard Deviation 89.2
|
23 PDMP queries per PCP per month
Standard Deviation 28.2
|
31.9 PDMP queries per PCP per month
Standard Deviation 26.7
|
22.1 PDMP queries per PCP per month
Standard Deviation 32.3
|
SECONDARY outcome
Timeframe: 12 monthsIn order to assess satisfaction with the electronic health record-based decision support tools, Primary Care Providers (PCP) will be asked to answer the following question on a scale from 1 (very unsatisfied) to 5 (very satisfied): "How would you rate your overall satisfaction with the best practice (BPA) alerts (pop-ups) and clinical decision support you received in the EHR for opioid prescribing for patients with acute pain?"
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsIn order to assess satisfaction with the electronic health record-based decision support tools, Primary Care Providers (PCP) will be asked to answer the following question on a scale from 1 (very unsatisfied) to 5 (very satisfied): "How would you rate your overall satisfaction with the best practice (BPA) alerts (pop-ups) and clinical decision support you received in the EHR for opioid prescribing for patients with chronic pain?"
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsIn order to assess satisfaction with the electronic health record-based decision support tools, Primary Care Providers (PCP) will be asked to answer the following question on a scale from 1 (very unsatisfied) to 5 (very satisfied): "How would you rate your overall satisfaction with the PDMP when prescribing opioids for patients with acute pain?"
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsIn order to assess satisfaction with the electronic health record-based decision support tools, Primary Care Providers (PCP) will be asked to answer the following question on a scale from 1 (very unsatisfied) to 5 (very satisfied): "How would you rate your overall satisfaction with the PDMP when prescribing opioids for patients with chronic pain?"
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsIn order to assess satisfaction with the electronic health record-based decision support tools, Primary Care Providers (PCP) will be asked to answer the following question on a scale from 1 (very easy) to 5 (very difficult): "Over the past year, how easy or difficult was it to access information on prescription drug use for your own patients in the PDMP?"
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsIn order to assess satisfaction with the electronic health record-based decision support tools, Primary Care Providers (PCP) will be asked to answer the following question on a scale from 1 (not useful at all) to 5 (very useful): "Over the past year, how useful was the information that you accessed from the PDMP?"
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsIn order to assess satisfaction with the electronic health record-based decision support tools, Primary Care Providers (PCP) will be asked to answer the following question on a scale from 1 (a lot more) to 5 (a lot less): "Compared to 12 months ago, how frequently are you engaging patients in discussions about opioids?"
Outcome measures
Outcome data not reported
Adverse Events
Care as Usual
Choice Architecture Nudge
PMP Integration & Nudge
Choice Architecture Nudge + PMP Integration & Nudge
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