Medication AbuseNCT04918355
A Health System Wide Evaluation of Clinical Decision Support Tools to Improve PDMP Utilization and Patient Outcomes
An observational study of Medication Abuse, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This is a study comparing three clinical decision support (CDS) tools to enhance care by easing health care provider review of the Colorado prescription drug monitoring program (PDMP) prior to prescribing opioids (pain medications often called narcotics) or benzodiazepines (sedatives or muscle relaxants). Read more about this study
- Who is it for?
- Ages 12 to 89 years
- Conditions the study is for
- Medication Abuse
- What is being tested?
- Clinical Decision Support (CDS) alerts
- How many people
- 3,635 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Feb 2021to 30 Nov 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 89 years
- All sexes
- Child, Adult, Older adult
Study population: Provider population: Health care providers in Colorado who work in the University of Colorado Health (UCHealth) system. Patient population: Residents and visitors to the state of Colorado who seek healthcare within the UCHealth system.
Two populations are included in the study description. Providers and the patients seen by those providers.
Providers are randomized to one of the four groups described previously.
Provider Inclusion Criteria:
- Licensed health care providers within the UCHealth system with a history (previous year) of prescribing opioids and/or benzodiazepines.
Provider Exclusion Criteria:
- Majority of prescribing is done at a facility outside the state of Colorado
- Provider specialty of oncology or pediatrics as recorded in the EHR
- Provider in an ambulatory clinic where a total of <50 opioid or benzodiazepine prescriptions were written in the year before study initiation
Patient Inclusion Criteria:
- Patient seen by a randomized provider within the UCHealth system who may receive an opioid prescription
Patient Exclusion Criteria:
- Less than 12 years of age or greater than 89 years of age at the time of the first study associated visit
- Active oncology or sickle cell diagnosis
- Active end of life care (defined as discharge to hospice or palliative care facility or specific palliative care orders in the medical record)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Hospital
Aurora, Colorado, 80045
About this study
Official title: A Health System Wide Evaluation of Mandated Use and Clinical Decision Support Tools to Improve PDMP Utilization and Patient Outcomes
This is a study comparing three clinical decision support (CDS) tools to enhance care by easing health care provider review of the Colorado prescription drug monitoring program (PDMP) prior to prescribing opioids (pain medications often called narcotics) or benzodiazepines (sedatives or muscle relaxants). The tools screen information from the PDMP (a statewide database of filled controlled medication) and a patient's medical record to identify high-risk factors for overdose.
The tools only appear when relevant, are purely informational to facilitate an evidence-based practice (PDMP review) and do not dictate care or suggest changes in treatment.
The study will track how each of the tools are used and if providers use the PDMP. Secondary outcomes include if a controlled medication prescription was written and future opioid use by patients.
Read the detailed description
Prior research by this team has shown that when emergency department (ED) prescribers are less likely to prescribe an opioid analgesic to patients at high-risk of overdose or misuse when they consult the Colorado Prescription Drug Monitoring Program (PDMP). Despite extensive work to reduce workflow and accessibility barriers to use of the PDMP, the majority of providers still do not use the PDMP when making prescription decisions. Clinical decision support (CDS) that is embedded in the Electronic Health Record (EHR) has promise as a tool to increase PDMP use, advance presentation of important PDMP data to providers and improve opioid safety without interrupting provider workflow.
This pragmatic, randomized study is designed to determine if:
- CDS tools that deliver focused, timely clinical information about high risk prescriptions to prescribers can improve use of the PDMP
- The use of focused CDS tools can decrease high-risk opioid prescribing
- The use of focused CDS tools is associated with better patient outcomes: decreasing high-risk, long-term, and aberrant opioid use
Specifically, we will test the hypotheses that:
- Focused CDS tools will increase the percentage of high-risk prescriptions with a PDMP review, compared to the control group.
- Focused CDS tools will decrease the percentage of high-risk controlled medication prescriptions, compared to the control group.
The alerts will fire for discharge prescriptions in all system emergency departments, inpatient facilities and ambulatory care facilities. Evaluation of patient risk as described below will be conducted automatically and for two of the three visible alerts, the provider will only see the alert if the patient meets high risk criteria. Providers in emergency departments and inpatient facilities will be randomized at the individual level, while providers selected to participate in the ambulatory setting will be randomized so that providers who prescribe at the same site or set of sets ( such as a series of primary care clinics staffed by an identifiable set of providers) will be in the arm to reduce contamination between the groups. Approximately 4000 providers will be included, based on historical staffing of UCHealth facilities.
Health encounters will be identified on the basis of an encounter with an enrolled provider. Automated risk assessment steps will be carried out on patients seen at included UCHealth facilities in the course of the year-long activation of the alerts. Based on historical patient counts, this is approximately 950,000 unique patients. Visit data will be retrospectively collected. This population is expected to be approximately 200,000 individuals.
The CDS only changes the provider interface with the PDMP and does not include any treatment recommendations or limit providers in any way from providing opioids or benzodiazepines if that is the best course of action in the provider's clinical judgement. Providers are not required to check the PDMP. The CDS is designed to enable access to the PDMP specifically focused on high risk prescriptions.
As the study implements an automated CDS, which is routinely introduced into clinical practice with no consent process, and does not make any treatment recommendations or requirements, it is being conducted at the provider level under a waiver of informed consent. Patient outcome determination will be conducted as secondary research, with patients to be included identified on the basis of their interaction with an enrolled health care provider. Only data collected as part of routine care will be collected to measure secondary outcomes. All patient data will be de-identified by the research team's Honest Broker and a de-identified data set provided for analysis.
- Conditions
- Medication Abuse
- Being tested
- Clinical Decision Support (CDS) alerts
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical Decision Support (CDS) alertsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Provider Group 1: no alert | Control group to enable tracking of temporal changes in prescribing. Providers will not see any alert. | |
| 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. Receives: Other: Clinical Decision Support (CDS) alerts | |
| 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. Receives: Other: Clinical Decision Support (CDS) alerts | |
| 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. Receives: Other: Clinical Decision Support (CDS) alerts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of PDMP Checks Conducted During High-risk Prescriptions
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.
Measured: Total over the course of one year
Secondary outcomes (2)
Percentage of High-risk Controlled Medication Prescriptions Abandoned
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).
Measured: Total over the course of one year
Long Term Opioid Use
Number of encounters where the patient experiences long term or aberrant opioid use (combined metric).
Measured: Total over the course of one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2021
- Study start16 Feb 2021
- Primary completion30 May 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Medication AbuseStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 3,635 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jason A Hoppe, DO, Principal investigator, University of Colorado School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04918355
- Sponsor's protocol ID
- 19-1130
- Other IDs
- 20-0072
- Status last verified
- Aug 2025
- First submitted
- 2 Jun 2021
- Last updated
- 16 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Health System Wide Evaluation of Mandated Use and Clinical Decision Support Tools to Improve PDMP Utilization and Patient Outcomes
- ClinicalTrials.gov ID
- NCT04918355
- Acronym / sponsor ID
- 19-1130
- Conditions
- Medication Abuse
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,635 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 16 Feb 2021 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 8 Jun 2021 (actual)
- Results
- Posted 16 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study comparing three clinical decision support (CDS) tools to enhance care by easing health care provider review of the Colorado prescription drug monitoring program (PDMP) prior to prescribing opioids (pain medications often called narcotics) or benzodiazepines (sedatives or muscle relaxants). The tools screen information from the PDMP (a statewide database of filled controlled medication) and a patient's medical record to identify high-risk factors for overdose.
The tools only appear when relevant, are purely informational to facilitate an evidence-based practice (PDMP review) and do not dictate care or suggest changes in treatment.
The study will track how each of the tools are used and if providers use the PDMP. Secondary outcomes include if a controlled medication prescription was written and future opioid use by patients.
Detailed description
Prior research by this team has shown that when emergency department (ED) prescribers are less likely to prescribe an opioid analgesic to patients at high-risk of overdose or misuse when they consult the Colorado Prescription Drug Monitoring Program (PDMP). Despite extensive work to reduce workflow and accessibility barriers to use of the PDMP, the majority of providers still do not use the PDMP when making prescription decisions. Clinical decision support (CDS) that is embedded in the Electronic Health Record (EHR) has promise as a tool to increase PDMP use, advance presentation of important PDMP data to providers and improve opioid safety without interrupting provider workflow.
This pragmatic, randomized study is designed to determine if:
- CDS tools that deliver focused, timely clinical information about high risk prescriptions to prescribers can improve use of the PDMP
- The use of focused CDS tools can decrease high-risk opioid prescribing
- The use of focused CDS tools is associated with better patient outcomes: decreasing high-risk, long-term, and aberrant opioid use
Specifically, we will test the hypotheses that:
- Focused CDS tools will increase the percentage of high-risk prescriptions with a PDMP review, compared to the control group.
- Focused CDS tools will decrease the percentage of high-risk controlled medication prescriptions, compared to the control group.
The alerts will fire for discharge prescriptions in all system emergency departments, inpatient facilities and ambulatory care facilities. Evaluation of patient risk as described below will be conducted automatically and for two of the three visible alerts, the provider will only see the alert if the patient meets high risk criteria. Providers in emergency departments and inpatient facilities will be randomized at the individual level, while providers selected to participate in the ambulatory setting will be randomized so that providers who prescribe at the same site or set of sets ( such as a series of primary care clinics staffed by an identifiable set of providers) will be in the arm to reduce contamination between the groups. Approximately 4000 providers will be included, based on historical staffing of UCHealth facilities.
Health encounters will be identified on the basis of an encounter with an enrolled provider. Automated risk assessment steps will be carried out on patients seen at included UCHealth facilities in the course of the year-long activation of the alerts. Based on historical patient counts, this is approximately 950,000 unique patients. Visit data will be retrospectively collected. This population is expected to be approximately 200,000 individuals.
The CDS only changes the provider interface with the PDMP and does not include any treatment recommendations or limit providers in any way from providing opioids or benzodiazepines if that is the best course of action in the provider's clinical judgement. Providers are not required to check the PDMP. The CDS is designed to enable access to the PDMP specifically focused on high risk prescriptions.
As the study implements an automated CDS, which is routinely introduced into clinical practice with no consent process, and does not make any treatment recommendations or requirements, it is being conducted at the provider level under a waiver of informed consent. Patient outcome determination will be conducted as secondary research, with patients to be included identified on the basis of their interaction with an enrolled health care provider. Only data collected as part of routine care will be collected to measure secondary outcomes. All patient data will be de-identified by the research team's Honest Broker and a de-identified data set provided for analysis.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Provider Group 1: no alert | – | –Control group to enable tracking of temporal changes in prescribing. Providers will not see any alert. |
| Provider Group 2: Mandated alert | – | Other: Clinical Decision Support (CDS) alertsControl 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 | – | Other: Clinical Decision Support (CDS) alertsProviders 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 | – | Other: Clinical Decision Support (CDS) alertsProviders 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. |
Who may qualify
- Ages
- 12 to 89 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Provider population: Health care providers in Colorado who work in the University of Colorado Health (UCHealth) system. Patient population: Residents and visitors to the state of Colorado who seek healthcare within the UCHealth system.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical Decision Support (CDS) alertsCDS 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. | Other | Provider Group 2: Mandated alert, Provider Group 3: PDMP alert, Provider Group 4: PDMP + EHR alert |
Primary outcome
Percentage of PDMP Checks Conducted During High-risk Prescriptions
Time frame: Total over the course of one year
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.
2 secondary outcomes
Percentage of High-risk Controlled Medication Prescriptions Abandoned
Time frame: Total over the course of one year
Long Term Opioid Use
Time frame: Total over the course of one year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason A Hoppe, DO principal investigator
University of Colorado School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Medication Abuse, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of PDMP Checks Conducted During High-risk Prescriptions (time frame: Total over the course of one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.