SurgeryNORMSNCT04927351
Nudges for Opioid Reduction After Major Surgery Trial
A study testing Electronic Medical Record Based Discharge Medication Order Set in people with Surgery, run by University of Washington at 1 site in United States.
Trial summary
This is a prospective pilot trial to evaluate a new electronic medical record based intervention to improve discharges after surgery. The investigators hypothesize that standard discharge medications after surgery will help to optimize opioid prescribing and potentially decrease healthcare utilization in the first 30… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery
- What is being tested?
- Electronic Medical Record Based Discharge Medication Order Set
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 484 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2021to 1 Dec 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients
- Aged 18 and over
- Undergo selected general surgical procedures
Who cannot join
- Less than 18 years of age
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nudges for Opioid Reduction After Major Surgery
This is a prospective pilot trial to evaluate a new electronic medical record based intervention to improve discharges after surgery. The investigators hypothesize that standard discharge medications after surgery will help to optimize opioid prescribing and potentially decrease healthcare utilization in the first 30 days after surgery.
Read the detailed description
This is a 2-arm parallel randomized trial comparing a new electronic medical record (EMR)-based intervention to usual care after surgery. All patients will receive their usual peri- and intraoperative care. Then, upon discharge, their providers will see the new EMR-based discharge order set (intervention arm) or not (usual care). The investigators hypothesize that standard discharge medication order sets after surgery will help to optimize opioid prescribing and potentially decrease healthcare utilization in the first 30 days after surgery.
- Conditions
- Surgery
- Being tested
- Electronic Medical Record Based Discharge Medication Order Set
- Keywords
- Surgery, Discharge, Hospital Systems, Electronic Medical Record, Opioids, Prescription
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic Medical Record Based Discharge Medication Order SetBehavioural
New medication discharge order set including recommended opioid quantities, adjunct pain medication
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | New electronic medical record based discharge medication order set. Receives: Behavioral: Electronic Medical Record Based Discharge Medication Order Set |
| Control | No intervention | Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Discharge Opioid Burden
Morphine milligram equivalents in the initial discharge prescription after index surgery
Measured: Immediately after study intervention
Secondary outcomes (4)
Additional Opioid Burden within 30 days
Morphine milligram equivalents on any additional opioid prescription within 30 days of discharge
Measured: Within 30 Days
Proportion of cases with Phone Calls to Surgery Department
Phone calls to surgery department within 30 days of discharge
Measured: Within 30 Days
Proportion of Cases with Emergency Room Visits
ER visits within 30 days of discharge
Measured: Within 30 Days
Proportion of Cases with Hospital Readmissions to a Surgical Service
Readmissions to surgical service within 30 days of discharge
Measured: Within 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2021
- Study start17 Nov 2021
- Primary completion1 Dec 2022
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Model description
- 2 arm parallel, cluster-randomized trial
- Masking
- None (open label)
- Enrolment
- 484 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Flum, University of Washington
- Investigators
- David Flum, MD, MPH, Study director, University of WashingtonIrene Zhang, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04927351
- Sponsor's protocol ID
- STUDY00013382
- Other IDs
- 2T32DK070555-06
- Acronym
- NORMS
- Status last verified
- Jul 2024
- First submitted
- 4 Jun 2021
- Last updated
- 8 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nudges for Opioid Reduction After Major Surgery
- ClinicalTrials.gov ID
- NCT04927351
- Acronym / sponsor ID
- NORMS / STUDY00013382
- Conditions
- Surgery
- Keywords
- Surgery, Discharge, Hospital Systems, Electronic Medical Record, Opioids, Prescription
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 484 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 17 Nov 2021 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 16 Jun 2021 (actual)
- 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 prospective pilot trial to evaluate a new electronic medical record based intervention to improve discharges after surgery. The investigators hypothesize that standard discharge medications after surgery will help to optimize opioid prescribing and potentially decrease healthcare utilization in the first 30 days after surgery.
Detailed description
This is a 2-arm parallel randomized trial comparing a new electronic medical record (EMR)-based intervention to usual care after surgery. All patients will receive their usual peri- and intraoperative care. Then, upon discharge, their providers will see the new EMR-based discharge order set (intervention arm) or not (usual care). The investigators hypothesize that standard discharge medication order sets after surgery will help to optimize opioid prescribing and potentially decrease healthcare utilization in the first 30 days after surgery.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2 arm parallel, cluster-randomized trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Electronic Medical Record Based Discharge Medication Order SetNew electronic medical record based discharge medication order set. |
| Control | No intervention | –Usual Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients
- Aged 18 and over
- Undergo selected general surgical procedures
Key exclusion criteria (1 listed)
- Less than 18 years of age
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 |
|---|---|---|
| Electronic Medical Record Based Discharge Medication Order SetNew medication discharge order set including recommended opioid quantities, adjunct pain medication | Behavioural | Intervention |
Primary outcome
Total Discharge Opioid Burden
Time frame: Immediately after study intervention
Morphine milligram equivalents in the initial discharge prescription after index surgery
4 secondary outcomes
Additional Opioid Burden within 30 days
Time frame: Within 30 Days
Proportion of cases with Phone Calls to Surgery Department
Time frame: Within 30 Days
Proportion of Cases with Emergency Room Visits
Time frame: Within 30 Days
Proportion of Cases with Hospital Readmissions to a Surgical Service
Time frame: Within 30 Days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
- 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.
David Flum, MD, MPH study director
University of Washington
Irene Zhang, MD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic Medical Record Based Discharge Medication Order Set in people with Surgery, run by University of Washington at 1 site 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: status not confirmed, as of the sponsor's last update on 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
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?
Total Discharge Opioid Burden (time frame: Immediately after study 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 8 Jul 2024.