Analgesics, OpioidNCT02665429
A Quality Improvement Project to Investigate Individual Provider Variation in Opioid Prescribing From the Emergency Department
A study testing Individual prescribing data profile and self-assessment in people with Analgesics, Opioid and Delivery of Health Care, run by University of Massachusetts, Worcester at 3 sites in United States.
Trial summary
This is a study of emergency physicians' prescribing patterns related to opioid (narcotic) medications. We are trying to determine whether giving providers access to their own prescribing data influences their prescribing patterns. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Analgesics, Opioid, Delivery of Health Care, Drug Prescribing
- What is being tested?
- Individual prescribing data profile and self-assessment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Feb 2016to 1 Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
3 sites in 1 country.
United States3 sites
UMass Clinton Hospital
Clinton, Massachusetts
UMass Memorial Marlborough Hospital
Marlborough, Massachusetts
UMass Memorial Medical Center
Worcester, Massachusetts
About this study
This is a study of emergency physicians' prescribing patterns related to opioid (narcotic) medications. We are trying to determine whether giving providers access to their own prescribing data influences their prescribing patterns.
Read the 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).
- Conditions
- Analgesics, Opioid, Delivery of Health Care, Drug Prescribing, Over Prescribing, Prescribing Patterns, Physician, Practice Management, Medical
- Being tested
- Individual prescribing data profile and self-assessment
- Keywords
- Emergency Medicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual prescribing data profile and self-assessmentBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Providers who are subject only to the routine implementation of clinical practice guidelines without additional experimental intervention |
| Intervention | Experimental | 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") Receives: Behavioral: Individual prescribing data profile and self-assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in number of opioid prescriptions per hundred patients seen
Measured: Pre-intervention baseline compared to 1, 2, 3, 6, 9, 12 months post-intervention
Secondary outcomes (3)
Change in percentage of total prescriptions written that are opioids
Measured: Pre-intervention baseline compared to 1, 2, 3, 6, 9, 12 months post-intervention
Change in median quantity of pills dispensed per opioid prescription
Measured: Pre-intervention baseline compared to 1, 2, 3, 6, 9, 12 months post-intervention
Change in number of prescriptions for long-acting opioid formulations
Measured: Pre-intervention baseline compared to 1, 2, 3, 6, 9, 12 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2016 (estimated)
- Study start1 Feb 2016
- Primary completion1 Mar 2017
- Study completion1 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Analgesics, OpioidStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- UMass Memorial Health
- Responsible party
- Principal investigator, Sean Michael, University of Massachusetts, Worcester
- Investigators
- Sean Michael, MD, Principal investigator, UMass Memorial Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02665429
- Sponsor's protocol ID
- H00009241
- Status last verified
- Jun 2017
- First submitted
- 20 Jan 2016
- Last updated
- 27 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Quality Improvement Project to Investigate Individual Provider Variation in Opioid Prescribing From the Emergency Department
- ClinicalTrials.gov ID
- NCT02665429
- Acronym / sponsor ID
- H00009241
- Conditions
- Analgesics, Opioid, Delivery of Health Care, Drug Prescribing, Over Prescribing, Prescribing Patterns, Physician, Practice Management, Medical
- Keywords
- Emergency Medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- UMass Memorial Health
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 1 Mar 2017 (actual)
- Study completion
- 1 Mar 2017 (actual)
- First posted
- 27 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study of emergency physicians' prescribing patterns related to opioid (narcotic) medications. We are trying to determine whether giving providers access to their own prescribing data influences their prescribing patterns.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Providers who are subject only to the routine implementation of clinical practice guidelines without additional experimental intervention |
| Intervention | Experimental | Behavioral: Individual prescribing data profile and self-assessmentProviders 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") |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individual prescribing data profile and self-assessmentPrior 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. | Behavioural | Intervention |
Primary outcome
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
3 secondary outcomes
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sean Michael, MD principal investigator
UMass Memorial Health
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individual prescribing data profile and self-assessment in people with Analgesics, Opioid and Delivery of Health Care, run by University of Massachusetts, Worcester at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2017.