Medication Abuse
Conditions
Brief 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). 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: 1. Focused CDS tools will increase the percentage of high-risk prescriptions with a PDMP review, compared to the control group. 2. 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.
Interventions
OTHERClinical 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.
Sponsors
University of Colorado, Denver
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Years to 89 Years
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of PDMP Checks Conducted During High-risk Prescriptions | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of High-risk Controlled Medication Prescriptions Abandoned | Total over the course of one year | 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). |
| Long Term Opioid Use | Total over the course of one year | Number of encounters where the patient experiences long term or aberrant opioid use (combined metric). |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
Outpatient providers were not included in the mandated arm as the provider group felt the alerts would be too interruptive.
Participants by arm
| Arm | Count |
|---|---|
| Provider Group 1: no Alert Control group to enable tracking of temporal changes in prescribing. Providers will not see any alert. | 0 |
| Provider Group 1: no Alert Control group to enable tracking of temporal changes in prescribing. Providers will not see any alert. | 22,226 |
| 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 |
| 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. | 17,804 |
| 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 |
| 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. | 20,840 |
| 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 |
| 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. | 27,177 |
| Total | 88,047 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | no qualifying health encounter | 497 | 192 | 438 | 424 |
Baseline characteristics
| Characteristic | Total | Provider Group 4: PDMP + EHR Alert | Provider Group 1: no Alert | Provider Group 2: Mandated Alert | Provider Group 3: PDMP Alert |
|---|---|---|---|---|---|
| Age, Customized Age 18-64 years | 74076 health care encounter | 22545 health care encounter | 18410 health care encounter | 15794 health care encounter | 17327 health care encounter |
| Age, Customized Age 65 and over years | 13971 health care encounter | 4632 health care encounter | 3816 health care encounter | 2010 health care encounter | 3513 health care encounter |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12214 health care encounter | 3462 health care encounter | 2899 health care encounter | 3343 health care encounter | 2510 health care encounter |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 74847 health care encounter | 23354 health care encounter | 19105 health care encounter | 14236 health care encounter | 18152 health care encounter |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 986 health care encounter | 361 health care encounter | 222 health care encounter | 225 health care encounter | 178 health care encounter |
| Medication type triggering alert benzodiazepine | 23133 health care encounter | 8285 health care encounter | 6088 health care encounter | 1946 health care encounter | 6814 health care encounter |
| Medication type triggering alert benzodiazepine and opioid | 2036 health care encounter | 547 health care encounter | 593 health care encounter | 203 health care encounter | 693 health care encounter |
| Medication type triggering alert opioid | 62878 health care encounter | 18345 health care encounter | 15545 health care encounter | 15655 health care encounter | 13333 health care encounter |
| Race (NIH/OMB) American Indian or Alaska Native | 501 health care encounter | 171 health care encounter | 104 health care encounter | 97 health care encounter | 129 health care encounter |
| Race (NIH/OMB) Asian | 205 health care encounter | 53 health care encounter | 37 health care encounter | 76 health care encounter | 39 health care encounter |
| Race (NIH/OMB) Black or African American | 4160 health care encounter | 1023 health care encounter | 1065 health care encounter | 1119 health care encounter | 953 health care encounter |
| Race (NIH/OMB) More than one race | 3251 health care encounter | 946 health care encounter | 819 health care encounter | 753 health care encounter | 733 health care encounter |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 health care encounter | 0 health care encounter | 0 health care encounter | 0 health care encounter | 0 health care encounter |
| Race (NIH/OMB) Unknown or Not Reported | 8098 health care encounter | 2125 health care encounter | 1976 health care encounter | 2397 health care encounter | 1600 health care encounter |
| Race (NIH/OMB) White | 71832 health care encounter | 22859 health care encounter | 18225 health care encounter | 13362 health care encounter | 17386 health care encounter |
| Region of Enrollment United States | 88047 health care encounter | 27177 health care encounter | 22226 health care encounter | 17804 health care encounter | 20840 health care encounter |
| Sex: Female, Male Female | 54590 health care encounter | 17166 health care encounter | 14392 health care encounter | 9739 health care encounter | 13293 health care encounter |
| Sex: Female, Male Male | 33457 health care encounter | 10011 health care encounter | 7834 health care encounter | 8065 health care encounter | 7547 health care encounter |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 22,226 | 0 / 17,804 | 0 / 20,840 | 0 / 27,177 |
| other Total, other adverse events | 0 / 22,226 | 0 / 17,804 | 0 / 20,840 | 0 / 27,177 |
| serious Total, serious adverse events | 0 / 22,226 | 0 / 17,804 | 0 / 20,840 | 0 / 27,177 |
Outcome results
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.
Time frame: Total over the course of one year
Population: Health encounter with a high-risk prescription written
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Provider Group 1: no Alert | Percentage of PDMP Checks Conducted During High-risk Prescriptions | 8187 health care encounters |
| Provider Group 2: Mandated Alert | Percentage of PDMP Checks Conducted During High-risk Prescriptions | 6322 health care encounters |
| Provider Group 3: PDMP Alert | Percentage of PDMP Checks Conducted During High-risk Prescriptions | 13360 health care encounters |
| Provider Group 4: PDMP + EHR Alert | Percentage of PDMP Checks Conducted During High-risk Prescriptions | 23328 health care encounters |
Secondary
Long Term Opioid Use
Number of encounters where the patient experiences long term or aberrant opioid use (combined metric).
Time frame: Total over the course of one year
Population: high risk opioid prescription medical visits for patients seen again in the hospital system
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Provider Group 1: no Alert | Long Term Opioid Use | aberrant opioid use | 503 health care encounters |
| Provider Group 1: no Alert | Long Term Opioid Use | chronic opioid use | 3,233 health care encounters |
| Provider Group 2: Mandated Alert | Long Term Opioid Use | chronic opioid use | 5,565 health care encounters |
| Provider Group 2: Mandated Alert | Long Term Opioid Use | aberrant opioid use | 731 health care encounters |
| Provider Group 3: PDMP Alert | Long Term Opioid Use | aberrant opioid use | 310 health care encounters |
| Provider Group 3: PDMP Alert | Long Term Opioid Use | chronic opioid use | 573 health care encounters |
| Provider Group 4: PDMP + EHR Alert | Long Term Opioid Use | aberrant opioid use | 433 health care encounters |
| Provider Group 4: PDMP + EHR Alert | Long Term Opioid Use | chronic opioid use | 2,414 health care encounters |
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).
Time frame: Total over the course of one year
Population: Health care encounters with a high risk prescribed medication that triggered clinical decision support alert.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Provider Group 1: no Alert | Percentage of High-risk Controlled Medication Prescriptions Abandoned | 538 health care encounters |
| Provider Group 2: Mandated Alert | Percentage of High-risk Controlled Medication Prescriptions Abandoned | 605 health care encounters |
| Provider Group 3: PDMP Alert | Percentage of High-risk Controlled Medication Prescriptions Abandoned | 768 health care encounters |
| Provider Group 4: PDMP + EHR Alert | Percentage of High-risk Controlled Medication Prescriptions Abandoned | 1314 health care encounters |