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| ID | Type | Description | Link |
|---|---|---|---|
| 20-0072 | Other Grant/Funding Number | Bureau of Justice Administration |
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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.
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:
Specifically, we will test the hypotheses that:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinical Decision Support (CDS) alerts | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Total over the course of one year |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Total over the course of one year |
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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:
Provider Exclusion Criteria:
Patient Inclusion Criteria:
Patient Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Jason A Hoppe, DO | University of Colorado School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Hospital | Aurora | Colorado | 80045 | United States |
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Outpatient providers were not included in the mandated arm as the provider group felt the alerts would be too interruptive.
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.
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline data was generated for patient characteristics of qualifying health care encounters. Randomized provider baseline data was not assessed.
| ID | Title | Description |
|---|---|---|
| BG000 | Provider Group 1: no Alert | Control group to enable tracking of temporal changes in prescribing. Providers will not see any alert. |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Units |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Health encounter with a high-risk prescription written | Posted | Count of Units | health care encounters | Total over the course of one year | health care encounters | health care encounters |
|
Approximately 15 minutes, during health encounter
Adverse evens were extracted from the healthcare encounters. The number at risk represents the total number of healthcare encounters analyzed for adverse events.
Providers were not assessed for deaths or adverse events as the intervention is an electronic display of data within the providers' typical workflow within the electronic health record system. Patient outcomes were considered the outcome of routine health care, not of the intervention being studied.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Provider Group 1: no Alert | Control group to enable tracking of temporal changes in prescribing. Providers will not see any alert. |
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Providers were randomized, health visits in which an opioid or benzodiazepine was prescribed were analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Heather Tolle | University of Colorado | 303-724-9924 | heather.tolle@cuanschutz.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 3, 2021 | Jan 15, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D016250 | Compact Disks |
| D002110 | Caffeine |
| ID | Term |
|---|---|
| D014742 | Videodisc Recording |
| D016249 | Optical Storage Devices |
| D001296 | Audiovisual Aids |
| D018961 | Educational Technology |
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| 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. |
|
| Long Term Opioid Use | Number of encounters where the patient experiences long term or aberrant opioid use (combined metric). | Total over the course of one year |
| BG002 | Provider Group 3: PDMP Alert | 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. |
| BG003 | Provider Group 4: PDMP + EHR Alert | 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. |
| BG004 | Total | Total of all reporting groups |
| health care encounter |
|
| health care encounter |
| health care encounter |
|
| Sex: Female, Male | Count of Units | health care encounter | health care encounter |
|
| Ethnicity (NIH/OMB) | Count of Units | health care encounter | health care encounter |
|
| Race (NIH/OMB) | Count of Units | health care encounter | health care encounter |
|
| Region of Enrollment | Number | health care encounter | health care encounter |
|
| Medication type triggering alert | Count of Units | health care encounter | 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. |
| OG002 | Provider Group 3: PDMP Alert | 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. |
| OG003 | Provider Group 4: PDMP + EHR Alert | 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. |
|
|
| Secondary | 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). | Health care encounters with a high risk prescribed medication that triggered clinical decision support alert. | Posted | Count of Units | health care encounters | Total over the course of one year | health care encounters | health care encounters |
|
|
|
| Secondary | Long Term Opioid Use | Number of encounters where the patient experiences long term or aberrant opioid use (combined metric). | high risk opioid prescription medical visits for patients seen again in the hospital system | Posted | Count of Units | health care encounters | Total over the course of one year | health care encounters | health care encounters |
|
|
|
| 0 |
| 22,226 |
| 0 |
| 22,226 |
| 0 |
| 22,226 |
| EG001 | 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. | 0 | 17,804 | 0 | 17,804 | 0 | 17,804 |
| EG002 | Provider Group 3: PDMP Alert | 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. | 0 | 20,840 | 0 | 20,840 | 0 | 20,840 |
| EG003 | Provider Group 4: PDMP + EHR Alert | 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. | 0 | 27,177 | 0 | 27,177 | 0 | 27,177 |
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| D013672 |
| Technology |
| D013676 | Technology, Industry, and Agriculture |
| D013690 | Television |
| D014970 | Xanthines |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| health care encounters |
|
| health care encounters |
|
| aberrant opioid use |
|