Adverse Drug Effect of OpioidsNCT03887247
Reducing Concurrent Opioid-Benzodiazepine Prescriptions
A study testing E-mail Alert in people with Adverse Drug Effect of Opioids and Adverse Drug Effect of Benzodiazepines, run by Walter Reed National Military Medical Center at 1 site in United States.
Trial summary
The purpose of this effort is to use informative e-mails to improve the process of prescribing of opioids and benzodiazepines within the National Capital Region/Military Health System (NCR/MHS), with the aim of decreasing concurrent opioid and benzodiazepine prescribing. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Adverse Drug Effect of Opioids, Adverse Drug Effect of Benzodiazepines
- What is being tested?
- E-mail Alert
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,234 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2019to 1 Jun 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient had an overlapping opioid-benzodiazepine prescription
- At least one of the patient's providers (opioid prescribers, benzodiazepine prescribers, and/or PCM) is in the NCR
Who cannot join
- Patient has a cancer diagnosis
- Patient is receiving palliative care
- Patient is under 18
- Patient was previously allocated to a study condition
Trial locations and contacts
1 site in 1 country.
United States1 site
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
About this study
Official title: Reducing Concurrent Opioid-Benzodiazepine Prescriptions Through Provider Intervention
The purpose of this effort is to use informative e-mails to improve the process of prescribing of opioids and benzodiazepines within the National Capital Region/Military Health System (NCR/MHS), with the aim of decreasing concurrent opioid and benzodiazepine prescribing.
Read the detailed description
The purpose of this effort is to use low-cost informative e-mails to improve the process of prescribing of opioids and benzodiazepines within the National Capital Region/Military Health System (NCR/MHS), with the aim of decreasing concurrent opioid and benzodiazepine prescribing. Both the VA/DoD Clinical Practice Guideline for Opioid Therapy for Chronic Pain (2017) and the CDC Guideline for Prescribing Opioids for Chronic Pain (2016) strongly recommend against the concurrent use of opioids and benzodiazepines. Taken together, these drugs could cause respiratory depression, enhanced sedation, and death. The intervention population will be prescribers and primary care managers associated with patients who have recently received concurrent prescriptions of opioids and benzodiazepines. Using a randomized approach, we will allocate the NCR/MHS providers associated with patients with concurrent prescriptions for opioids and benzodiazepines to one of two conditions:
- E-mail alert - A messaging approach, in which we will send encrypted emails to the patient's opioid and benzodiazepine prescriber(s) and primary care manager that identify the concurrent prescriptions and detail the patient's prescription history, inform them of the VA/DoD guideline and risk to patient, and provide action steps and relevant resources. When multiple providers are involved, the email message will also encourage coordination across providers and provide relevant contact information
- As-Usual - An as-usual approach, in which providers are not sent messages. These providers can access patient information through the MHS Opioid Registry as before.
- Being tested
- E-mail Alert
- Keywords
- Care coordination, Opioid, Benzodiazepine, Behavioral science, Behavioral economics, Nudge, Fragmentation of care, Concurrent prescribing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-mail AlertBehavioural
Encrypted email to the following providers: the patient's opioid prescriber(s), benzodiazepine prescriber(s), and/or primary care manager. If there is more than one provider, they are copied together on the same message. The email identifies the concurrent prescriptions, details the patient's prescription history, includes relevant VA/DoD guidelines, states the risk of concurrent prescribing to patient, and provides action steps and relevant resources. When multiple providers are involved, the message encourages the providers to coordinate with each other and provides provider contact information to facilitate this communication.
| Study group | Role | What they receive |
|---|---|---|
| E-Mail Alert | Active comparator | Send email to the patient's opioid prescriber(s), benzodiazepine prescriber(s), and/or primary care manager. Receives: Behavioral: E-mail Alert |
| As-Usual | No intervention | As-usual (no email) approach. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overlapping Days
Overlapping days of opioids and benzodiazepines, determined using the dates of service and days supply of the prescription drug fills
Measured: 90 days
Opioid Days
Days of opioids received
Measured: 90 days
Benzodiazepine Days
Days of benzodiazepines received
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2019
- Study start6 Jun 2019
- Primary completion29 Jul 2021 (estimated)
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adverse Drug Effect of OpioidsStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,234 participants (actual)
Sponsor and investigators
- Lead sponsor
- Walter Reed National Military Medical Center
- Sponsor type
- US federal agency
- Collaborators
- United States Department of Defense, General Services Administration (GSA)
- Responsible party
- Sponsor
- Investigators
- Robert E Brutcher, PharmD,PhD, Principal investigator, Walter Reed National Military Medical Center and Uniformed Services University of the Health SciencesAlan Sim, PhD, Principal investigator, Defense Health AgencyElana Safran, MPP, Principal investigator, General Services Administration (GSA)Adam Sacarny, PhD, Principal investigator, General Services Administration and Columbia UniversityMary Steffel, PhD, Principal investigator, General Services Administration and Northeastern UniversityChristopher J Spevak, MD, MPH, JD, Principal investigator, Walter Reed National Medical Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03887247
- Sponsor's protocol ID
- REDUCE-CONCURRENT
- Status last verified
- Apr 2021
- First submitted
- 19 Mar 2019
- Last updated
- 19 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sacarny A, Safran E, Steffel M, Dunham JR, Abili OD, Mohajeri L, Oh PT, Sim A, Brutcher RE, Spevak C. Effect of Pharmacist Email Alerts on Concurrent Prescribing of Opioids and Benzodiazepines by Prescribers and Primary Care Managers: A Randomized Clinical Trial. JAMA Health Forum. 2022 Sep 2;3(9):e223378. doi: 10.1001/jamahealthforum.2022.3378.
PubMed 36218952
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Concurrent Opioid-Benzodiazepine Prescriptions Through Provider Intervention
- ClinicalTrials.gov ID
- NCT03887247
- Acronym / sponsor ID
- REDUCE-CONCURRENT
- Keywords
- Care coordination, Opioid, Benzodiazepine, Behavioral science, Behavioral economics, Nudge, Fragmentation of care, Concurrent prescribing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,234 participants (actual)
- Lead sponsor
- Walter Reed National Military Medical CenterUS federal agency
- Collaborators
- United States Department of Defense, General Services Administration (GSA)
- Study start
- 6 Jun 2019 (actual)
- Primary completion
- 29 Jul 2021 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 22 Mar 2019 (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.
The purpose of this effort is to use informative e-mails to improve the process of prescribing of opioids and benzodiazepines within the National Capital Region/Military Health System (NCR/MHS), with the aim of decreasing concurrent opioid and benzodiazepine prescribing.
Detailed description
The purpose of this effort is to use low-cost informative e-mails to improve the process of prescribing of opioids and benzodiazepines within the National Capital Region/Military Health System (NCR/MHS), with the aim of decreasing concurrent opioid and benzodiazepine prescribing. Both the VA/DoD Clinical Practice Guideline for Opioid Therapy for Chronic Pain (2017) and the CDC Guideline for Prescribing Opioids for Chronic Pain (2016) strongly recommend against the concurrent use of opioids and benzodiazepines. Taken together, these drugs could cause respiratory depression, enhanced sedation, and death. The intervention population will be prescribers and primary care managers associated with patients who have recently received concurrent prescriptions of opioids and benzodiazepines. Using a randomized approach, we will allocate the NCR/MHS providers associated with patients with concurrent prescriptions for opioids and benzodiazepines to one of two conditions:
- E-mail alert - A messaging approach, in which we will send encrypted emails to the patient's opioid and benzodiazepine prescriber(s) and primary care manager that identify the concurrent prescriptions and detail the patient's prescription history, inform them of the VA/DoD guideline and risk to patient, and provide action steps and relevant resources. When multiple providers are involved, the email message will also encourage coordination across providers and provide relevant contact information
- As-Usual - An as-usual approach, in which providers are not sent messages. These providers can access patient information through the MHS Opioid Registry as before.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| E-Mail Alert | Active comparator | Behavioral: E-mail AlertSend email to the patient's opioid prescriber(s), benzodiazepine prescriber(s), and/or primary care manager. |
| As-Usual | No intervention | –As-usual (no email) approach. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient had an overlapping opioid-benzodiazepine prescription
- At least one of the patient's providers (opioid prescribers, benzodiazepine prescribers, and/or PCM) is in the NCR
Key exclusion criteria (4 listed)
- Patient has a cancer diagnosis
- Patient is receiving palliative care
- Patient is under 18
- Patient was previously allocated to a study condition
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 |
|---|---|---|
| E-mail AlertEncrypted email to the following providers: the patient's opioid prescriber(s), benzodiazepine prescriber(s), and/or primary care manager. If there is more than one provider, they are copied together on the same message. The email identifies the concurrent prescriptions, details the patient's prescription history, includes relevant VA/DoD guidelines, states the risk of concurrent prescribing to patient, and provides action steps and relevant resources. When multiple providers are involved, the message encourages the providers to coordinate with each other and provides provider contact information to facilitate this communication. | Behavioural | E-Mail Alert |
Primary outcome
Overlapping Days
Time frame: 90 days
Overlapping days of opioids and benzodiazepines, determined using the dates of service and days supply of the prescription drug fills
Opioid Days
Time frame: 90 days
Days of opioids received
Benzodiazepine Days
Time frame: 90 days
Days of benzodiazepines received
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2021.
- Derived from this study: PubMed 36218952Sacarny A, Safran E, Steffel M, Dunham JR, Abili OD, Mohajeri L, Oh PT, Sim A, Brutcher RE, Spevak C. Effect of Pharmacist Email Alerts on Concurrent Prescribing of Opioids and Benzodiazepines by Prescribers and Primary Care Managers: A Randomized Clinical Trial. JAMA Health Forum. 2022 Sep 2;3(9):e223378. doi: 10.1001/jamahealthforum.2022.3378.
- 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.
Robert E Brutcher, PharmD,PhD principal investigator
Walter Reed National Military Medical Center and Uniformed Services University of the Health Sciences
Alan Sim, PhD principal investigator
Defense Health Agency
Elana Safran, MPP principal investigator
General Services Administration (GSA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing E-mail Alert in people with Adverse Drug Effect of Opioids and Adverse Drug Effect of Benzodiazepines, run by Walter Reed National Military Medical Center 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 2 inclusion and 4 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 19 May 2021. 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?
Overlapping Days (time frame: 90 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03887247, which also lists 1 linked publication.
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 19 May 2021.