Pain ManagementNCT07011472
ACE Pilot 3: Decision Aid 2 Options vs 3 Options
A study testing Decision-Aid with 2-options and Decision aid with 3 options in people with Pain Management and Shared Decision Making, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
This research protocol is exploring a behavioral intervention: shared decision making with the use of a decision aid to select a post-operative analgesic. Specifically, the investigators will examine the impact of shared decision making on analgesic selection for acute pain management when 2 options are presented to… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pain Management, Shared Decision Making
- What is being tested?
- Decision-Aid with 2-options and Decision aid with 3 options
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jun 2025to 10 Aug 2026
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be able to understand the informed consent.
- Provide signed and dated informed consent form
- Be able to understand all directions for data gathering instruments in English
- Be willing and able to comply with all study procedures
- Planning to undergo extraction of one or more 3rd molars
- Be 18 years or older
Who cannot join
- While the actual analgesic prescribed to the patient may be different then the analgesic selected by the participant (their actual analgesic is NOT part of the research protocol) participants who self-report inability to take ibuprofen, acetaminophen or an opioid are not eligible since the decision aid is designed to help a patient select between a combination of ibuprofen/acetaminophen and an opioid containing analgesic.
- Participants would also be excluded due to any additional criteria that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study which includes:
- Prior participation in this study
- Inability or refusal to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Rutgers School of Dental Medicine
Newark, New Jersey, 07103
About this study
Official title: Post-Operative Analgesic Selection in Patients Planned for Third Molar Extraction After Undergoing Shared Decision Making Using 2- Versus 3-Option Decision-Aids
This research protocol is exploring a behavioral intervention: shared decision making with the use of a decision aid to select a post-operative analgesic. Specifically, the investigators will examine the impact of shared decision making on analgesic selection for acute pain management when 2 options are presented to the patient as compared to 3 options which includes an opioid prescription for "just-in-case" pain management. The investigators hypothesize that significantly more patients will choice an opioid option when the "just-in-case option is included.
Read the detailed description
Dentists often prescribe opioids to their patients to manage acute post-surgical pain, with hydrocodone/acetaminophen being the most commonly prescribed opioid combination. With an estimated 56 million tablets of hydrocodone prescribed to 3.5 million high school and young adults each year after third molar extractions, it is vitally important to develop the best evidence for acute pain management following dental procedures.
Dentists are among the leading prescribers of opioid analgesics, writing up to 12% of all opioid prescriptions and 31% of opioid prescriptions for young patients. Shared decision making is an integral component of patient-centered clinical care. Decision aids have been shown to be effective in improving patient satisfaction, and one study suggests shared decisions have the potential to decrease the number of opioids tablets prescribed. Shared decision making studies on analgesics selection for out-patient surgery, however, are limited and no studies have investigated the "just in case" phenomenon which send a message that the opioid options are better than the non-opioid options.
- Conditions
- Pain Management, Shared Decision Making
- Being tested
- Decision-Aid with 2-options, Decision aid with 3 options
- Keywords
- Analgesic selection, shared decision making, decision aid, non-opioid analgesic
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision-Aid with 2-optionsOther
This decision aid offers 2 options for post-operative analgesic: a non-opioid combination (ibuprofen/acetaminophen) or an opioid (hydrocodone).
Decision aid with 3 optionsOther
This decision aid offers 3 options for post-operative analgesic: a non-opioid combination (ibuprofen/acetaminophen), an opioid (hydrocodone), or a non-opioid combination with a "just-in-case" opioid prescription.
| Study group | Role | What they receive |
|---|---|---|
| Decision-Aid with 2-options | Active comparator | Participants in this arm will undergo a shared decision making process using a decision aid that offers 2 options for post-operative analgesic: a non-opioid combination (ibuprofen/acetaminophen) or an opioid (hydrocodone). Subsequently, their choice for post-operative analgesic will be recorded. Receives: Other: Decision-Aid with 2-options |
| Decision-Aid with 3-options | Active comparator | Participants in this arm will undergo a shared decision making process using a decision aid that offers 3 options for post-operative analgesic: [1] a non-opioid combination (ibuprofen/acetaminophen), [2] an opioid (hydrocodone), or [3] a non-opioid combination plus an opioid prescription for "just-in-case" pain management. Subsequently, their choice for post-operative analgesic will be recorded. Receives: Other: Decision aid with 3 options |
What is being measured
The primary outcome is the main question the study is designed to answer.
% participants selecting opioid analgesics versus non-opioid analgesics
•To determine difference in proportion of patients who choose an opioid option for analgesics after participation in a shared decision making process using a decision aid
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2025
- Study start16 Jun 2025
- Primary completion10 Aug 2026
- Study completion10 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cecile A. Feldman, DMD, Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07011472
- Sponsor's protocol ID
- Pro2025000930
- Status last verified
- Aug 2026
- First submitted
- 21 May 2025
- Last updated
- 12 Aug 2026
- 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 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Operative Analgesic Selection in Patients Planned for Third Molar Extraction After Undergoing Shared Decision Making Using 2- Versus 3-Option Decision-Aids
- ClinicalTrials.gov ID
- NCT07011472
- Acronym / sponsor ID
- Pro2025000930
- Conditions
- Pain Management, Shared Decision Making
- Keywords
- Analgesic selection, shared decision making, decision aid, non-opioid analgesic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 16 Jun 2025 (actual)
- Primary completion
- 10 Aug 2026 (actual)
- Study completion
- 10 Aug 2026 (actual)
- First posted
- 8 Jun 2025 (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 research protocol is exploring a behavioral intervention: shared decision making with the use of a decision aid to select a post-operative analgesic. Specifically, the investigators will examine the impact of shared decision making on analgesic selection for acute pain management when 2 options are presented to the patient as compared to 3 options which includes an opioid prescription for "just-in-case" pain management. The investigators hypothesize that significantly more patients will choice an opioid option when the "just-in-case option is included.
Detailed description
Dentists often prescribe opioids to their patients to manage acute post-surgical pain, with hydrocodone/acetaminophen being the most commonly prescribed opioid combination. With an estimated 56 million tablets of hydrocodone prescribed to 3.5 million high school and young adults each year after third molar extractions, it is vitally important to develop the best evidence for acute pain management following dental procedures.
Dentists are among the leading prescribers of opioid analgesics, writing up to 12% of all opioid prescriptions and 31% of opioid prescriptions for young patients. Shared decision making is an integral component of patient-centered clinical care. Decision aids have been shown to be effective in improving patient satisfaction, and one study suggests shared decisions have the potential to decrease the number of opioids tablets prescribed. Shared decision making studies on analgesics selection for out-patient surgery, however, are limited and no studies have investigated the "just in case" phenomenon which send a message that the opioid options are better than the non-opioid options.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Decision-Aid with 2-options | Active comparator | Other: Decision-Aid with 2-optionsParticipants in this arm will undergo a shared decision making process using a decision aid that offers 2 options for post-operative analgesic: a non-opioid combination (ibuprofen/acetaminophen) or an opioid (hydrocodone). Subsequently, their choice for post-operative analgesic will be recorded. |
| Decision-Aid with 3-options | Active comparator | Other: Decision aid with 3 optionsParticipants in this arm will undergo a shared decision making process using a decision aid that offers 3 options for post-operative analgesic: [1] a non-opioid combination (ibuprofen/acetaminophen), [2] an opioid (hydrocodone), or [3] a non-opioid combination plus an opioid prescription for "just-in-case" pain management. Subsequently, their choice for post-operative analgesic will be recorded. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Be able to understand the informed consent.
- Provide signed and dated informed consent form
- Be able to understand all directions for data gathering instruments in English
- Be willing and able to comply with all study procedures
- Planning to undergo extraction of one or more 3rd molars
Key exclusion criteria (4 listed)
- While the actual analgesic prescribed to the patient may be different then the analgesic selected by the participant (their actual analgesic is NOT part of the research protocol) participants who self-report inability to take ibuprofen, acetaminophen or an opioid are not eligible since the decision aid is designed to help a patient select between a combination of ibuprofen/acetaminophen and an opioid containing analgesic.
- Participants would also be excluded due to any additional criteria that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study which includes:
- Prior participation in this study
- Inability or refusal to provide informed consent
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 |
|---|---|---|
| Decision-Aid with 2-optionsThis decision aid offers 2 options for post-operative analgesic: a non-opioid combination (ibuprofen/acetaminophen) or an opioid (hydrocodone). | Other | Decision-Aid with 2-options |
| Decision aid with 3 optionsThis decision aid offers 3 options for post-operative analgesic: a non-opioid combination (ibuprofen/acetaminophen), an opioid (hydrocodone), or a non-opioid combination with a "just-in-case" opioid prescription. | Other | Decision-Aid with 3-options |
Primary outcome
% participants selecting opioid analgesics versus non-opioid analgesics
Time frame: Day 1
•To determine difference in proportion of patients who choose an opioid option for analgesics after participation in a shared decision making process using a decision aid
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 12 Aug 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decision-Aid with 2-options and Decision aid with 3 options in people with Pain Management and Shared Decision Making, run by Rutgers, The State University of New Jersey 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 6 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: finished, as of the sponsor's last update on 12 Aug 2026. 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?
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?
% participants selecting opioid analgesics versus non-opioid analgesics (time frame: Day 1). 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 12 Aug 2026; AzTrials last refreshed its copy on 31 Oct 2026.