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

NCT ID: NCT04918355

Last Updated: 2025-09-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 3635 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-02-16
• Study Completion Date: 2023-11-30

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.

Conditions

Medication Abuse

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Provider Group 1: no alert

Control group to enable tracking of temporal changes in prescribing. Providers will not see any alert.

No interventions assigned to this group

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.

Clinical Decision Support (CDS) alerts

Intervention Type: 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.

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.

Clinical Decision Support (CDS) alerts

Intervention Type: 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.

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.

Clinical Decision Support (CDS) alerts

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Licensed health care providers within the UCHealth system with a history (previous year) of prescribing opioids and/or benzodiazepines.

• Patient seen by a randomized provider within the UCHealth system who may receive an opioid prescription

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

• 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)

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jason A Hoppe, DO

Role: PRINCIPAL_INVESTIGATOR

University of Colorado School of Medicine

Locations

University of Colorado Hospital

Aurora, Colorado, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

20-0072

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

19-1130

Identifier Type: -

Identifier Source: org_study_id