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

Completed

• Conditions: Medication Abuse
• Interventions: Other: Clinical Decision Support (CDS) alerts

• Registration Number: NCT04918355
• Lead Sponsor: University of Colorado, Denver

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, cluster-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 in the ambulatory setting will be randomized as "clinics" defined as groups of providers who prescribe at the same site or set of sites (such as a series of primary care clinics staffed by an identifiable set of providers). Approximately 4000 providers will be included, based on historical staffing of UCHealth facilities.

Patients will be identified on the basis of an encounter with an enrolled provider and will not be further randomized. 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 Timeline

• Study Start: 2021-02-16
• Study First Submitted: 2021-06-02
• Study First Submitted QC: 2021-06-02
• Study First Posted: 2021-06-08
• Primary Completion: 2023-05-30
• Study Completion: 2023-11-30
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-09
• Last Update Posted: 2024-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88047

Inclusion Criteria

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

Provider

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Provider Group 2: Mandated alert	Clinical Decision Support (CDS) alerts	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.
Provider Group 3: PDMP alert	Clinical Decision Support (CDS) alerts	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.
Provider Group 4: PDMP + EHR alert	Clinical Decision Support (CDS) alerts	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.

Primary Outcome Measures

Name	Time	Method
Percentage of PDMP checks for 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 criteria for whom the healthcare provider consults the Prescription Drug Monitoring Program (PDMP) prior to signing

Secondary Outcome Measures

Name	Time	Method
Percentage of high-risk controlled medication prescriptions	Total over the course of one year	Differences between groups in the percentage of patients with one or more high risk criteria who go on to receive an opioid or benzodiazepine prescription after the CDS alert fires.
Long term opioid use	Total over the course of one year	Differences in the percentage of patients seen by providers in each group who go on to long term or aberrant use (combined metric) of controlled medications.
Pre-prescription PDMP use	Total over the course of one year	Differences between groups in the frequency with which providers check the PDMP for high risk (by alert criteria) and low risk prescriptions respectively.

Trial Locations

Locations (1)

University of Colorado Hospital; 🇺🇸 Aurora, Colorado, United States