Trial Outcomes & Findings for A Health System Wide Evaluation of Clinical Decision Support Tools to Improve PDMP Utilization and Patient Outcomes (NCT NCT04918355)

Last Updated: 2025-09-16

Results Overview

Differences between groups in the percentage of opioid or benzodiazepine prescriptions with one or more high risk prescribing criteria for whom the health care provider consults the Prescription Drug Monitoring Program (PDMP) prior to signing, in line with prescribing best practices.

Recruitment status

COMPLETED

Target enrollment

3635 participants

Primary outcome timeframe

Total over the course of one year

Results posted on

2025-09-16

Participant Flow

Providers prescribing at least 12 opioids + benzodiazepines in the prior year were selected for inclusion. Providers primarily working in inpatient and emergency department settings were randomized individually. Providers primarily working in an outpatient setting were randomized to assure providers working in the same clinics were in the same randomization arm. Enrollment numbers reported reflect the number of providers involved in the study as patients were not exposed to the intervention.

Outpatient providers were not included in the mandated arm as the provider group felt the alerts would be too interruptive.

Unit of analysis: Health care encounters

Participant milestones

Participant milestones
Measure	Provider Group 1: no Alert Control group to enable tracking of temporal changes in prescribing. Providers will not see any alert. Providers were randomly assigned to an arm and any patients they saw as part of routine care were also considered to be in that arm during the encounter with the provider.	Provider Group 2: Mandated Alert Control group where providers will see a generic pop-up alert within the Electronic Health Record (EHR) whenever they initiate an opioid or benzodiazepine prescription without recording use of the PDMP. Patient risk factors are not assessed or presented in the alert. Providers in ambulatory clinics will not be assigned to this group. Alerts do not appear with patients with oncology or sickle cell diagnoses, or hospice discharge orders. Clinical Decision Support (CDS) alerts: CDS alerts are pop-up boxes integrated into the EHR. Each alert provides patient specific information, a link to the PDMP, instructions on how to dismiss the alert, a link to study-specific educational website, and a comment field.	Provider Group 3: PDMP Alert Providers will see a pop-up alert within the Electronic Health Record (EHR) when they initiate an opioid or benzodiazepine prescription without recording use of the PDMP and patients have one or more positive risk factors based on past/current prescriptions received. Patient risk factors are assessed and presented in the alert. Risk factors included are numbers of active or recent opioid and benzodiazepine prescriptions, overlapping prescriptions, co-prescribing of benzodiazepines and opioids, and use of long-acting opioids in opioid naïve patients. Alerts do not appear with patients with oncology or sickle cell diagnoses, or hospice discharge orders. Clinical Decision Support (CDS) alerts: CDS alerts are pop-up boxes integrated into the EHR. Each alert provides patient specific information, a link to the PDMP, instructions on how to dismiss the alert, a link to study-specific educational website, and a comment field.	Provider Group 4: PDMP + EHR Alert Providers will see a pop-up alert within the Electronic Health Record (EHR) when they initiate an opioid or benzodiazepine prescription without recording use of the PDMP and patients have one or more positive risk factors based on both prescriptions and other factors recorded in the patient's EHR. Patient risk factors are assessed and presented in the alert. Risk factors included the risks described in Group 3, along with a history of accidental opioid overdose, diagnosis of Opioid Use Disorder, multiple recent acute care incidents with opioid use, or high-risk psychiatric diagnoses. Alerts do not appear with patients with oncology or sickle cell diagnoses, or hospice discharge orders. Clinical Decision Support (CDS) alerts: CDS alerts are pop-up boxes integrated into the EHR. Each alert provides patient specific information, a link to the PDMP, instructions on how to dismiss the alert, a link to study-specific educational website, and a comment field.
Overall Study STARTED	1106 22226	468 17804	973 20840	1088 27177
Overall Study COMPLETED	609 22226	276 17804	535 20840	664 27177
Overall Study NOT COMPLETED	497 0	192 0	438 0	424 0

Reasons for withdrawal

Reasons for withdrawal
Measure	Provider Group 1: no Alert Control group to enable tracking of temporal changes in prescribing. Providers will not see any alert. Providers were randomly assigned to an arm and any patients they saw as part of routine care were also considered to be in that arm during the encounter with the provider.	Provider Group 2: Mandated Alert Control group where providers will see a generic pop-up alert within the Electronic Health Record (EHR) whenever they initiate an opioid or benzodiazepine prescription without recording use of the PDMP. Patient risk factors are not assessed or presented in the alert. Providers in ambulatory clinics will not be assigned to this group. Alerts do not appear with patients with oncology or sickle cell diagnoses, or hospice discharge orders. Clinical Decision Support (CDS) alerts: CDS alerts are pop-up boxes integrated into the EHR. Each alert provides patient specific information, a link to the PDMP, instructions on how to dismiss the alert, a link to study-specific educational website, and a comment field.	Provider Group 3: PDMP Alert Providers will see a pop-up alert within the Electronic Health Record (EHR) when they initiate an opioid or benzodiazepine prescription without recording use of the PDMP and patients have one or more positive risk factors based on past/current prescriptions received. Patient risk factors are assessed and presented in the alert. Risk factors included are numbers of active or recent opioid and benzodiazepine prescriptions, overlapping prescriptions, co-prescribing of benzodiazepines and opioids, and use of long-acting opioids in opioid naïve patients. Alerts do not appear with patients with oncology or sickle cell diagnoses, or hospice discharge orders. Clinical Decision Support (CDS) alerts: CDS alerts are pop-up boxes integrated into the EHR. Each alert provides patient specific information, a link to the PDMP, instructions on how to dismiss the alert, a link to study-specific educational website, and a comment field.	Provider Group 4: PDMP + EHR Alert Providers will see a pop-up alert within the Electronic Health Record (EHR) when they initiate an opioid or benzodiazepine prescription without recording use of the PDMP and patients have one or more positive risk factors based on both prescriptions and other factors recorded in the patient's EHR. Patient risk factors are assessed and presented in the alert. Risk factors included the risks described in Group 3, along with a history of accidental opioid overdose, diagnosis of Opioid Use Disorder, multiple recent acute care incidents with opioid use, or high-risk psychiatric diagnoses. Alerts do not appear with patients with oncology or sickle cell diagnoses, or hospice discharge orders. Clinical Decision Support (CDS) alerts: CDS alerts are pop-up boxes integrated into the EHR. Each alert provides patient specific information, a link to the PDMP, instructions on how to dismiss the alert, a link to study-specific educational website, and a comment field.
Overall Study no qualifying health encounter	497	192	438	424

Baseline Characteristics

A Health System Wide Evaluation of Clinical Decision Support Tools to Improve PDMP Utilization and Patient Outcomes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Provider Group 1: no Alert n=22226 health care encounter Control group to enable tracking of temporal changes in prescribing. Providers will not see any alert.	Provider Group 2: Mandated Alert n=17804 health care encounter Control group where providers will see a generic pop-up alert within the Electronic Health Record (EHR) whenever they initiate an opioid or benzodiazepine prescription without recording use of the PDMP. Patient risk factors are not assessed or presented in the alert. Providers in ambulatory clinics will not be assigned to this group. Alerts do not appear with patients with oncology or sickle cell diagnoses, or hospice discharge orders. Clinical Decision Support (CDS) alerts: CDS alerts are pop-up boxes integrated into the EHR. Each alert provides patient specific information, a link to the PDMP, instructions on how to dismiss the alert, a link to study-specific educational website, and a comment field.	Provider Group 3: PDMP Alert n=20840 health care encounter Providers will see a pop-up alert within the EHR when they initiate an opioid or benzodiazepine prescription without recording use of the PDMP and patients have one or more positive risk factors based on past/current prescriptions received. Patient risk factors are assessed and presented in the alert. Risk factors included are numbers of active or recent opioid and benzodiazepine prescriptions, overlapping prescriptions, co-prescribing of benzodiazepines and opioids, and use of long-acting opioids in opioid naïve patients. Alerts are seen only once regardless of the number of positive risk factors and do not appear with patients with oncology or sickle cell diagnoses, or hospice discharge orders. Clinical Decision Support (CDS) alerts: CDS alerts are pop-up boxes integrated into the EHR. Each alert provides patient specific information, a link to the PDMP, instructions on how to dismiss the alert, a link to study-specific educational website, and a comment field.	Provider Group 4: PDMP + EHR Alert n=27177 health care encounter Providers will see a pop-up alert within the EHR when they initiate an opioid or benzodiazepine prescription without recording use of the PDMP and patients have one or more positive risk factors based on both prescriptions and other factors recorded in the patient's Electronic Health Record. Patient risk factors are assessed and presented in the alert. Risk factors included the risks described as in Group 3, along with a history of accidental opioid overdose, diagnosis of Opioid Use Disorder, multiple recent acute care incidents with opioid use, or high risk psychiatric diagnoses. Alerts are seen only once regardless of the number of positive risk factors and do not appear with patients with oncology or sickle cell diagnoses, or hospice discharge orders. Clinical Decision Support (CDS) alerts: CDS alerts are pop-up boxes integrated into the EHR. Each alert provides patient specific information, a link to the PDMP, instructions on how to dismiss the alert, a link to study-specific educational website, and a comment field.	Total n=88047 health care encounter Total of all reporting groups
Age, Customized Age · 18-64 years	18410 health care encounter n=22226 health care encounter	15794 health care encounter n=17804 health care encounter	17327 health care encounter n=20840 health care encounter	22545 health care encounter n=27177 health care encounter	74076 health care encounter n=88047 health care encounter
Age, Customized Age · 65 and over years	3816 health care encounter n=22226 health care encounter	2010 health care encounter n=17804 health care encounter	3513 health care encounter n=20840 health care encounter	4632 health care encounter n=27177 health care encounter	13971 health care encounter n=88047 health care encounter
Sex: Female, Male Female	14392 health care encounter n=22226 health care encounter	9739 health care encounter n=17804 health care encounter	13293 health care encounter n=20840 health care encounter	17166 health care encounter n=27177 health care encounter	54590 health care encounter n=88047 health care encounter
Sex: Female, Male Male	7834 health care encounter n=22226 health care encounter	8065 health care encounter n=17804 health care encounter	7547 health care encounter n=20840 health care encounter	10011 health care encounter n=27177 health care encounter	33457 health care encounter n=88047 health care encounter
Ethnicity (NIH/OMB) Hispanic or Latino	2899 health care encounter n=22226 health care encounter	3343 health care encounter n=17804 health care encounter	2510 health care encounter n=20840 health care encounter	3462 health care encounter n=27177 health care encounter	12214 health care encounter n=88047 health care encounter
Ethnicity (NIH/OMB) Not Hispanic or Latino	19105 health care encounter n=22226 health care encounter	14236 health care encounter n=17804 health care encounter	18152 health care encounter n=20840 health care encounter	23354 health care encounter n=27177 health care encounter	74847 health care encounter n=88047 health care encounter
Ethnicity (NIH/OMB) Unknown or Not Reported	222 health care encounter n=22226 health care encounter	225 health care encounter n=17804 health care encounter	178 health care encounter n=20840 health care encounter	361 health care encounter n=27177 health care encounter	986 health care encounter n=88047 health care encounter
Race (NIH/OMB) American Indian or Alaska Native	104 health care encounter n=22226 health care encounter	97 health care encounter n=17804 health care encounter	129 health care encounter n=20840 health care encounter	171 health care encounter n=27177 health care encounter	501 health care encounter n=88047 health care encounter
Race (NIH/OMB) Asian	37 health care encounter n=22226 health care encounter	76 health care encounter n=17804 health care encounter	39 health care encounter n=20840 health care encounter	53 health care encounter n=27177 health care encounter	205 health care encounter n=88047 health care encounter
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 health care encounter n=22226 health care encounter	0 health care encounter n=17804 health care encounter	0 health care encounter n=20840 health care encounter	0 health care encounter n=27177 health care encounter	0 health care encounter n=88047 health care encounter
Race (NIH/OMB) Black or African American	1065 health care encounter n=22226 health care encounter	1119 health care encounter n=17804 health care encounter	953 health care encounter n=20840 health care encounter	1023 health care encounter n=27177 health care encounter	4160 health care encounter n=88047 health care encounter
Race (NIH/OMB) White	18225 health care encounter n=22226 health care encounter	13362 health care encounter n=17804 health care encounter	17386 health care encounter n=20840 health care encounter	22859 health care encounter n=27177 health care encounter	71832 health care encounter n=88047 health care encounter
Race (NIH/OMB) More than one race	819 health care encounter n=22226 health care encounter	753 health care encounter n=17804 health care encounter	733 health care encounter n=20840 health care encounter	946 health care encounter n=27177 health care encounter	3251 health care encounter n=88047 health care encounter
Race (NIH/OMB) Unknown or Not Reported	1976 health care encounter n=22226 health care encounter	2397 health care encounter n=17804 health care encounter	1600 health care encounter n=20840 health care encounter	2125 health care encounter n=27177 health care encounter	8098 health care encounter n=88047 health care encounter
Region of Enrollment United States	22226 health care encounter n=22226 health care encounter	17804 health care encounter n=17804 health care encounter	20840 health care encounter n=20840 health care encounter	27177 health care encounter n=27177 health care encounter	88047 health care encounter n=88047 health care encounter
Medication type triggering alert benzodiazepine	6088 health care encounter n=22226 health care encounter	1946 health care encounter n=17804 health care encounter	6814 health care encounter n=20840 health care encounter	8285 health care encounter n=27177 health care encounter	23133 health care encounter n=88047 health care encounter
Medication type triggering alert opioid	15545 health care encounter n=22226 health care encounter	15655 health care encounter n=17804 health care encounter	13333 health care encounter n=20840 health care encounter	18345 health care encounter n=27177 health care encounter	62878 health care encounter n=88047 health care encounter
Medication type triggering alert benzodiazepine and opioid	593 health care encounter n=22226 health care encounter	203 health care encounter n=17804 health care encounter	693 health care encounter n=20840 health care encounter	547 health care encounter n=27177 health care encounter	2036 health care encounter n=88047 health care encounter

PRIMARY outcome

Timeframe: Total over the course of one year

Population: Health encounter with a high-risk prescription written

Outcome measures

Outcome measures
Measure	Provider Group 1: no Alert n=22226 health care encounters Control group to enable tracking of temporal changes in prescribing. Providers will not see any alert.	Provider Group 2: Mandated Alert n=7622 health care encounters Control group where providers will see a generic pop-up alert within the Electronic Health Record (EHR) whenever they initiate an opioid or benzodiazepine prescription without recording use of the PDMP. Patient risk factors are not assessed or presented in the alert. Providers in ambulatory clinics will not be assigned to this group. Alerts do not appear with patients with oncology or sickle cell diagnoses, or hospice discharge orders. Clinical Decision Support (CDS) alerts: CDS alerts are pop-up boxes integrated into the EHR. Each alert provides patient specific information, a link to the PDMP, instructions on how to dismiss the alert, a link to study-specific educational website, and a comment field.	Provider Group 3: PDMP Alert n=20840 health care encounters Providers will see a pop-up alert within the EHR when they initiate an opioid or benzodiazepine prescription without recording use of the PDMP and patients have one or more positive risk factors based on past/current prescriptions received. Patient risk factors are assessed and presented in the alert. Risk factors included are numbers of active or recent opioid and benzodiazepine prescriptions, overlapping prescriptions, co-prescribing of benzodiazepines and opioids, and use of long-acting opioids in opioid naïve patients. Alerts are seen only once regardless of the number of positive risk factors and do not appear with patients with oncology or sickle cell diagnoses, or hospice discharge orders. Clinical Decision Support (CDS) alerts: CDS alerts are pop-up boxes integrated into the EHR. Each alert provides patient specific information, a link to the PDMP, instructions on how to dismiss the alert, a link to study-specific educational website, and a comment field.	Provider Group 4: PDMP + EHR Alert n=27177 health care encounters Providers will see a pop-up alert within the EHR when they initiate an opioid or benzodiazepine prescription without recording use of the PDMP and patients have one or more positive risk factors based on both prescriptions and other factors recorded in the patient's Electronic Health Record. Patient risk factors are assessed and presented in the alert. Risk factors included the risks described as in Group 3, along with a history of accidental opioid overdose, diagnosis of Opioid Use Disorder, multiple recent acute care incidents with opioid use, or high risk psychiatric diagnoses. Alerts are seen only once regardless of the number of positive risk factors and do not appear with patients with oncology or sickle cell diagnoses, or hospice discharge orders. Clinical Decision Support (CDS) alerts: CDS alerts are pop-up boxes integrated into the EHR. Each alert provides patient specific information, a link to the PDMP, instructions on how to dismiss the alert, a link to study-specific educational website, and a comment field.
Percentage of PDMP Checks Conducted During High-risk Prescriptions	8187 health care encounters	6322 health care encounters	13360 health care encounters	23328 health care encounters

SECONDARY outcome

Timeframe: Total over the course of one year

Population: Health care encounters with a high risk prescribed medication that triggered clinical decision support alert.

Differences between groups in the percentage of encounters with one or more high risk prescribing criteria where the provider does not sign a prescription for an opioid after initiating the prescription and seeing the intervention reminding the provider to check the PDMP (CDS tool fires).

Outcome measures

Outcome measures
Measure	Provider Group 1: no Alert n=16138 health care encounters Control group to enable tracking of temporal changes in prescribing. Providers will not see any alert.	Provider Group 2: Mandated Alert n=6522 health care encounters Control group where providers will see a generic pop-up alert within the Electronic Health Record (EHR) whenever they initiate an opioid or benzodiazepine prescription without recording use of the PDMP. Patient risk factors are not assessed or presented in the alert. Providers in ambulatory clinics will not be assigned to this group. Alerts do not appear with patients with oncology or sickle cell diagnoses, or hospice discharge orders. Clinical Decision Support (CDS) alerts: CDS alerts are pop-up boxes integrated into the EHR. Each alert provides patient specific information, a link to the PDMP, instructions on how to dismiss the alert, a link to study-specific educational website, and a comment field.	Provider Group 3: PDMP Alert n=14026 health care encounters Providers will see a pop-up alert within the EHR when they initiate an opioid or benzodiazepine prescription without recording use of the PDMP and patients have one or more positive risk factors based on past/current prescriptions received. Patient risk factors are assessed and presented in the alert. Risk factors included are numbers of active or recent opioid and benzodiazepine prescriptions, overlapping prescriptions, co-prescribing of benzodiazepines and opioids, and use of long-acting opioids in opioid naïve patients. Alerts are seen only once regardless of the number of positive risk factors and do not appear with patients with oncology or sickle cell diagnoses, or hospice discharge orders. Clinical Decision Support (CDS) alerts: CDS alerts are pop-up boxes integrated into the EHR. Each alert provides patient specific information, a link to the PDMP, instructions on how to dismiss the alert, a link to study-specific educational website, and a comment field.	Provider Group 4: PDMP + EHR Alert n=18892 health care encounters Providers will see a pop-up alert within the EHR when they initiate an opioid or benzodiazepine prescription without recording use of the PDMP and patients have one or more positive risk factors based on both prescriptions and other factors recorded in the patient's Electronic Health Record. Patient risk factors are assessed and presented in the alert. Risk factors included the risks described as in Group 3, along with a history of accidental opioid overdose, diagnosis of Opioid Use Disorder, multiple recent acute care incidents with opioid use, or high risk psychiatric diagnoses. Alerts are seen only once regardless of the number of positive risk factors and do not appear with patients with oncology or sickle cell diagnoses, or hospice discharge orders. Clinical Decision Support (CDS) alerts: CDS alerts are pop-up boxes integrated into the EHR. Each alert provides patient specific information, a link to the PDMP, instructions on how to dismiss the alert, a link to study-specific educational website, and a comment field.
Percentage of High-risk Controlled Medication Prescriptions Abandoned	538 health care encounters	605 health care encounters	768 health care encounters	1314 health care encounters

SECONDARY outcome

Timeframe: Total over the course of one year

Population: high risk opioid prescription medical visits for patients seen again in the hospital system

Number of encounters where the patient experiences long term or aberrant opioid use (combined metric).

Outcome measures

Outcome measures
Measure	Provider Group 1: no Alert n=16138 health care encounters Control group to enable tracking of temporal changes in prescribing. Providers will not see any alert.	Provider Group 2: Mandated Alert n=18892 health care encounters Control group where providers will see a generic pop-up alert within the Electronic Health Record (EHR) whenever they initiate an opioid or benzodiazepine prescription without recording use of the PDMP. Patient risk factors are not assessed or presented in the alert. Providers in ambulatory clinics will not be assigned to this group. Alerts do not appear with patients with oncology or sickle cell diagnoses, or hospice discharge orders. Clinical Decision Support (CDS) alerts: CDS alerts are pop-up boxes integrated into the EHR. Each alert provides patient specific information, a link to the PDMP, instructions on how to dismiss the alert, a link to study-specific educational website, and a comment field.	Provider Group 3: PDMP Alert n=6522 health care encounters Providers will see a pop-up alert within the EHR when they initiate an opioid or benzodiazepine prescription without recording use of the PDMP and patients have one or more positive risk factors based on past/current prescriptions received. Patient risk factors are assessed and presented in the alert. Risk factors included are numbers of active or recent opioid and benzodiazepine prescriptions, overlapping prescriptions, co-prescribing of benzodiazepines and opioids, and use of long-acting opioids in opioid naïve patients. Alerts are seen only once regardless of the number of positive risk factors and do not appear with patients with oncology or sickle cell diagnoses, or hospice discharge orders. Clinical Decision Support (CDS) alerts: CDS alerts are pop-up boxes integrated into the EHR. Each alert provides patient specific information, a link to the PDMP, instructions on how to dismiss the alert, a link to study-specific educational website, and a comment field.	Provider Group 4: PDMP + EHR Alert n=14026 health care encounters Providers will see a pop-up alert within the EHR when they initiate an opioid or benzodiazepine prescription without recording use of the PDMP and patients have one or more positive risk factors based on both prescriptions and other factors recorded in the patient's Electronic Health Record. Patient risk factors are assessed and presented in the alert. Risk factors included the risks described as in Group 3, along with a history of accidental opioid overdose, diagnosis of Opioid Use Disorder, multiple recent acute care incidents with opioid use, or high risk psychiatric diagnoses. Alerts are seen only once regardless of the number of positive risk factors and do not appear with patients with oncology or sickle cell diagnoses, or hospice discharge orders. Clinical Decision Support (CDS) alerts: CDS alerts are pop-up boxes integrated into the EHR. Each alert provides patient specific information, a link to the PDMP, instructions on how to dismiss the alert, a link to study-specific educational website, and a comment field.
Long Term Opioid Use aberrant opioid use	503 health care encounters	731 health care encounters	310 health care encounters	433 health care encounters
Long Term Opioid Use chronic opioid use	3,233 health care encounters	5,565 health care encounters	573 health care encounters	2,414 health care encounters

Adverse Events

Provider Group 1: no Alert

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Provider Group 2: Mandated Alert

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Provider Group 3: PDMP Alert

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Provider Group 4: PDMP + EHR Alert

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

Heather Tolle

University of Colorado

Phone: 303-724-9924

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place