- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02665429
A Quality Improvement Project to Investigate Individual Provider Variation in Opioid Prescribing From the Emergency Department
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Opioid misuse is a known public safety threat and public health problem, both nationwide and in the Commonwealth of Massachusetts. As a part of these efforts, Emergency Department (ED) outpatient prescriptions have been identified as a potential area for improvement. The Massachusetts Hospital Association (MHA), in conjunction with other stakeholders, developed a set of recommendations to address opioid management and prescribing within the ED setting.
This study is timed to coincide with the rollout by UMassMemorial Health Care of a system-wide opioid prescribing practice guideline/policy which mirrors the Massachusetts Hospital Association's guideline. This rollout provides a unique opportunity for a natural experiment related to provider prescribing practices.
This is a quality improvement project with two primary objectives:
- Improve understanding of physician practice patterns related to emergency department (ED) opioid prescribing
- Evaluate the effectiveness of providing individual clinician profile data in influencing behavior change among ED providers, as it relates to their opioid prescribing patterns
There are two corresponding specific aims:
- Quantitatively describe the current state of opioid prescribing by ED clinicians at four UMass Memorial EDs (using prescriptions generated within the ED electronic health information system between February 2014 and the study implementation date). Descriptive statistics being considered for feasibility of study include:
- Number of opioid prescriptions per hundred patients seen
- Percentage of total prescriptions written that are opioids
- Mean or median quantity of pills dispensed per opioid prescription
- Number of prescriptions for long-acting opioid formulations
- Evaluate the effect on prescribing practices of providing individual clinicians with their profile data to illustrate their personal opioid prescribing patterns, relative to the de-identified distribution for all other clinicians in the ED group
This project is timed to coincide with the separately planned implementation of a system-wide opioid prescribing guideline. The guideline implementation is an independent event, but we feel that it presents a unique opportunity for a simultaneous experimental intervention to assess whether providing clinicians with their individual data alters their prescribing practices beyond any effect achieved simply by being subject to the new guideline. Data collected from the electronic medical record and clinician self-reported data about their perceptions of their prescribing practices will be used to evaluate both the effect of the guideline implementation (i.e. comparison of prescribing patterns for all clinicians before and after guideline implementation) and the combined effect of guideline implementation plus individual profile intervention (i.e. comparisons across intervention versus control groups).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Clinton, Massachusetts, United States
- UMass Clinton Hospital
-
Marlborough, Massachusetts, United States
- UMass Memorial Marlborough Hospital
-
Worcester, Massachusetts, United States
- UMass Memorial Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Provider who practices Emergency Medicine in one or more of four UMass-affiliated EDs (UMassMemorial Medical Center, Marlborough Hospital, and Clinton Hospital), including attending physicians, resident physicians, and advanced practice providers (PAs and NPs).
- Have placed at least one electronic prescription for a medication of interest (namely opioids) in the PulseCheck electronic medical record system during the 12 months prior to the implementation of the opioid guidelines
- Be actively practicing in a UMass-affiliated ED at time of implementation of the guidelines
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
Providers who are subject only to the routine implementation of clinical practice guidelines without additional experimental intervention
|
|
|
Experimental: Intervention
Providers who are subject to routine clinical practice guideline implementation AND receive provider's own individual prescribing data profile intervention ("Individual prescribing data profile and self-assessment")
|
Prior to receiving his or her individual data profile, each provider in the intervention group will be asked to identify his or her self-assessment of his or her own opioid prescribing practices.
Immediately after providing self-perception data, providers will be provided with their true profile data with a visual display of where they fall within the distribution of their peers.
All peer data are de-identified.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in number of opioid prescriptions per hundred patients seen
Time Frame: Pre-intervention baseline compared to 1, 2, 3, 6, 9, 12 months post-intervention
|
Pre-intervention baseline compared to 1, 2, 3, 6, 9, 12 months post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in percentage of total prescriptions written that are opioids
Time Frame: Pre-intervention baseline compared to 1, 2, 3, 6, 9, 12 months post-intervention
|
Pre-intervention baseline compared to 1, 2, 3, 6, 9, 12 months post-intervention
|
|
Change in median quantity of pills dispensed per opioid prescription
Time Frame: Pre-intervention baseline compared to 1, 2, 3, 6, 9, 12 months post-intervention
|
Pre-intervention baseline compared to 1, 2, 3, 6, 9, 12 months post-intervention
|
|
Change in number of prescriptions for long-acting opioid formulations
Time Frame: Pre-intervention baseline compared to 1, 2, 3, 6, 9, 12 months post-intervention
|
Pre-intervention baseline compared to 1, 2, 3, 6, 9, 12 months post-intervention
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-assessment of decile for number of opioid prescriptions per hundred patients seen
Time Frame: Once, at time of enrollment
|
The provider's self-assessment of their decile of number of opioid prescriptions per hundred patients seen, compared to their peers
|
Once, at time of enrollment
|
|
Self-assessment of decile for percentage of total prescriptions written that are opioids
Time Frame: Once, at time of enrollment
|
The provider's self-assessment of their decile of their percentage of total prescriptions written that are opioids, compared to their peers
|
Once, at time of enrollment
|
|
Self-assessment of decile for median quantity of pills dispensed per opioid prescription
Time Frame: Once, at time of enrollment
|
The provider's self-assessment of their decile of their median quantity of pills dispensed per opioid prescription, compared to their peers
|
Once, at time of enrollment
|
|
Self-assessment of decile for number of prescriptions for long-acting opioid formulations
Time Frame: Once, at time of enrollment
|
The provider's self-assessment of their decile of their number of prescriptions for long-acting opioid formulations, compared to their peers
|
Once, at time of enrollment
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Sean Michael, MD, UMass Memorial Health Care
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H00009241
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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