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Stigmapoint of viewNCT07217548

Solving Stigma Through POV Simulation: Enhancing Pharmacist Empathy-based Practices With Sickle Cell Disease Patients

A study testing point of view simulation in people with Stigma, run by Ohio State University at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Why This Research Matters (Significance) 1 in 5 of the 50+ million people with chronic pain in the U.S. face stigma when using opioids, especially women and racial minorities. This stigma often comes from pharmacy staff treating chronic pain patients as drug seekers, who then refuse to fill the patient's script, and… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Stigma
What is being tested?
point of view simulation
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
200 participants
Where
1 siteUnited States
Study dates
1 Sep 2026to 31 Jul 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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

  • Practicing healthcare professional OR student in a healthcare professional program
  • Ability to fill opioid prescriptions

Who cannot join

  • Not currently practicing or rotating in a clinical setting that fills opioid prescriptions

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Nicholas L Denton, PhD contact

6142929917

denton.58@osu.edu

United States1 site
  • Ohio State University College of Pharmacy

    Columbus, Ohio, 43210

    Nicholas Denton, PhD, 6142929917, denton.58@osu.edu

Other trials in United States

About this study

Why This Research Matters (Significance)

1 in 5 of the 50+ million people with chronic pain in the U.S. face stigma when using opioids, especially women and racial minorities. This stigma often comes from pharmacy staff treating chronic pain patients as drug seekers, who then refuse to fill the patient's script, and leave the patient in severe pain. The team has found that having pharmacists watch testimonial videos of sickle cell patients sharing their pain management struggles can help reduce these misconceptions. However, using point of view simulations could be even more effective in fostering empathy among pharmacists. The goal is to create an educational simulation that helps pharmacists better understand and manage pain in sickle cell patients, ultimately improving their care.

Read more

What Makes This Research Unique (Innovation) Traditional methods to address biases in healthcare include watching patient testimonials or using expensive actors to play a standardized patient interaction to health professionals. This innovative point of view simulations engage participants' empathy more effectively by playing back what participants told the patient from the patient's point of view and are more accessible by having participants interact with the simulation on the computer any time and any place, rather than organizing a paid actor to visit the hospital. With advancements in artificial intelligence, we can create interactive simulations where virtual patients respond dynamically to questions, making the experience more realistic and impactful.

How Will the Researchers Conduct the Research (Approach)

The researchers will test if point of view simulations can reduce misconceptions among healthcare professionals and improve pain management for sickle cell patients. Here's the plan:

  1. Create and Implement the Simulation: Use it as part of the training for pharmacy and hospital staff, as well as nursing and pharmacy students.
  2. Survey Participants: Before and after the simulation, participants will take a survey to measure their misconceptions about opioid use.
  3. Follow-Up: Six months later, researchers will survey the participants' patients and their managers to see if there's been an improvement in the empathetic care the participants provided.
Read the detailed description
  1. SIGNIFICANCE An unintended translational science challenge of the opioid epidemic is that >20% of the 50+ million chronic pain patients in the US alone face opioid use stigma from pharmacy staff that has left them in debilitating pain.1 Within this cohort of stigmatized patients there's a higher portion of women and girls that have been harmed by misogynistic stereotypes of "hysteric" and "oversensitive" women exaggerating their pain, resulting in pharmacists questioning the legitimacy of their pain more than male chronic pain patients.2,3 Likewise, there's also a higher portion of Black chronic patients undertreated in their pain as racial stereotypes of Black Americans as "criminals" and "drug addicts" due to racial trauma inflected during the US War on Drugs result in Black patients being disproportionately mislabeled as drug-seeking.4 Health professional training often perpetuates misconceptions like "melanin makes skin thicker" and "white skin has more free nerve endings" that also contribute to implicit bias against giving Black patients the same level of pain management as their white counterparts.5 Woman sickle cell disease (SCD) patients are particularly vulnerable to being mislabeled as drug-seeking due to misogynistic and racist stereotyping intersectionality while managing debilitating pain from relatively invisible vaso-occlusion crisis that necessitates chronic opioid use and eventual breakthrough pain as opioid tolerance develops.6,7 While the project team has previously demonstrated that SCD patient testimonial videos partially alleviates common opioid misconceptions shared by pharmacists, the limited translation of knowledge from educational interventions to noticeable change in pharmacists' practice remains a critical knowledge gap. While tasking pharmacists to passively watch patient testimonials sharing their struggles in pain management did result in significant decreases in agreement scores to misconceptions like "opioids are always dangerous when used long term" or "a patient can receive great care without being treated for pain", baseline agreement was already very low to discriminatory statements like "race has a negligible impact on the perception of a patient's drug habits" despite continued discrimination in pharmacy practice. This disconnect between learners' knowledge of health disparities and self-awareness of deficiencies in their practice is likely due to the implicit nature of bias where microaggressions against patients persist unnoticed by the healthcare professional.8 The proposed research aligns with the translational science definition through practical application of our previous research and others' scientific discoveries toward creating innovative point-of-view (POV) simulations through a collaborative approach including an interdisciplinary research team alongside SCD community partners, with broad applicability across not just SCD patient biases but other patient-healthcare professional interactions where microaggressions negatively impact health outcomes. The central theme is to create a freely distributed and empathetically impactful educational simulation that results in better health outcomes for SCD patients. Primary goals are to recruit SCD community partners in the quick and efficient production of the POV simulation, to broadly implement the simulation into continuing education workshops and courses throughout our collaborative network, and to rigorously and ethically assess whether the POV simulation decreases pharmacists' agreement toward opioid use misconceptions and whether SCD patients observe quality improvements in their pharmacy's empathy-based care practices.
  2. INNOVATION The predominate clinical education practices to address implicit basis include participant's passively watching patient testimonials or hiring cost-prohibitory standardized patients; our research team includes pioneers in POV simulation technologies that have the potential to drive engaging and accessible educational interventions against healthcare professional biases against SCD patients. In POV simulations, participants actively engage with a patient looking to fill an opioid script at a community pharmacy setting through the point of view of the pharmacist. Using a "choose your own adventure" branch chain format, the research team has already drafted interaction pathways where participants can respond to the patient with empathy-based practice, act on a common misconception around chronic opioid use, or mislabel the patient as drug seeking. After 3-4 interaction branches, the participants reach a decision to fill the opioid script, deny it, or some variation of delaying the script being filled. The POV simulation then replays the participant's choices back to them from the patient's point of view, revealing that the SCD patient was in genuine pain and engaging participant's empathy as they rewatch their microaggressive and mislabeled drug seeker choices through the patient's POV. In addition to leveraging empathy-based learning, POV simulations can be engaged asynchronously online and repeated as many times as participants want, making POV simulations much more accessible to health professionals than training and scheduling a standardized patient actor to roleplay the simulation.9 With advancements in AI technology, there's also potential to enhance the authenticity and therefore impact of the interaction by incorporating chatbot-like AI patients that dynamically respond to participants interview questions rather than following a set script for a case study.
  3. APPROACH To test the hypothesis that POV simulations can alleviate misconceptions in health professionals and improve pain management outcomes in SCD patients, the research team first aims to create a POV SCD patient simulation that is engages empathy in participants and is authentic to the SCD patient experience. The research team of SCD hematology, palliative care, health disparity, and education technology experts have already drafted branching interaction scripts that include authentic misconceptions, microaggressions, and empathy-based care responses observed in pharmacy practices. SCD patient and advocates from community partners at the Faith Thomas Foundation engage in the translational science process by consulting on the authenticity of the simulation. The next aim is to assess whether the POV simulation alleviates the misconceptions around opioid use that are most detrimental toward chronic pain patients by implementing the learning intervention within the research team's various institutions that include pharmacy/ER staff and nursing/PharmD students who serve >2,000 SCD patients. Staff participants will be incentivized with continuing education credit while student participants will receive a course assessment grade to take our experimentally validated, 16-item opioid stigma misconceptions Likert survey right before completing the POV simulation and again 10 days afterwards along with a reflection on any specific microaggressions or misconceptions that participants realized they had around chronic opioid use. Community partners will likewise consult on the survey design to validate the impact of the survey questions on SCD opioid use stigma. The final aim will be to determine whether the POV simulation caused noticeable change in healthcare participants' empathy-based care practices and SCD patient health outcomes by surveying SCD patient simulated patients. Six months after completing the POV simulation, participants' and non-participant controls' SCD patients will also be invited to complete a 12-item expert-validated Likert survey on their healthcare professional's empathetic care practices and microaggressions along with a free response question on their overall satisfaction in their pain management outcomes to assess for impactful changes in SCD patient care (Fig. 3). Survey data will be collected via Qualtrics and stored on a secure drive in compliance with OSU's data storage and sharing policies. Multivariate analysis of survey participants' agreement scores will control for differences in their practice site, demographics (gender, race/ethnicity, age, etc.), and any close relationships they have with SCD or opioid use disorder when determining whether POV simulations alleviated health professional participants' misconceptions and improved SCD patient outcomes.
  4. HEALTH EQUITY The community partner, the Faith Thomas Foundation, has agreed to recruit SCD patients and advocates that will be engaged in every phase of the translational process in the project design. To reduce any potential biases or misconceptions the POV simulation producers and actors might have about SCD patients, reviewing the simulation scripts and guiding the actors to make sure the SCD patient experience is authentically represented in the simulation. Likewise, SCD consultants would be able to assist in ethically recruiting a representative population of SCD patients from the research team's combined network of >2,000 patients to provide authentic assessment of their health outcomes rather than relying solely on self-reported observations from the health professionals. By creating an engaging, empathetic, and accessible educational intervention, this project has the potential to expand beyond the >2,000 SCD patients within the research team's network toward reducing health disparities and debilitating pain for the 10+ million chronic pain patients that encounter stigma for their opioid use.
Conditions
Stigma
Being tested
point of view simulation, Control
Keywords
pharmacists, PharmD students
Medical subject headings
Social Stigma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • point of view simulationBehavioural

    In POV simulations, participants actively engage with a patient looking to fill an opioid script at a community pharmacy setting through the point of view of the pharmacist. Using a "choose your own adventure" branch chain format, our research team has already drafted interaction pathways where participants can respond to the patient with empathy-based practice, act on a common misconception around chronic opioid use, or mislabel the patient as drug seeking. After 3-4 interaction branches, the participants reach a decision to fill the opioid script, deny it, or some variation of delaying the script being filled. The POV simulation then replays the participant's choices back to them from the patient's point of view, revealing that the SCD patient was in genuine pain and engaging participant's empathy as they rewatch their microaggressive and mislabeled drug seeker choices through the patient's POV.

  • ControlBehavioural

    Participants will watch a hematology educational video unrelated to pain management

Study groups in NCT07217548
Study groupRoleWhat they receive
POV simulationExperimentalParticipating pharmacists in the experimental arm will receive an email invitation to complete a 16-item pre-survey around opioid use misconceptions before completing the point of view simulation activity. 10 days after participants complete the simulation they will be invited to complete the opioid misconception survey again as a post-learning intervention assessment. 6 months after participants complete the simulation, their practice site will be visited by a sickle cell disease patient evaluator who will refill their opioid medication with the pharmacist and then complete an 11-item evaluation survey on the pharmacist's empathy-based pharmacy practices.
Receives: Behavioral: point of view simulation
ControlSham comparatorParticipating pharmacists in the sham arm will receive an email invitation to complete a 16-item pre-survey around opioid use misconceptions before completing an unrelated hematology educational activity. 10 days after participants complete the simulation they will be invited to complete the opioid misconception survey again as a post-learning intervention assessment. 6 months after participants complete the simulation, their practice site will be visited by a sickle cell disease patient evaluator who will refill their opioid medication with the pharmacist and then complete an 11-item evaluation survey on the pharmacist's empathy-based pharmacy practices.
Receives: Behavioral: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Agreement/disagreement toward opioid use misconceptions

    An experimentally validated, 16-item opioid stigma misconceptions survey right before starting the POV simulation and again 10 days afterwards with the aim to assess alleviation of misconceptions most impactful to chronic pain patients such as sickle cell disease patients.

    Measured: Baseline and 10 days post-treatment

  2. Frequency of empathy-based care practices when filling opioid prescriptions

    Three months after completing the POV simulation, sickle cell patients on the research team will also be invited to complete a 12-item expert-validated survey on the participants' empathetic care with the aim to assess impacts of the POV simulation on patient care.

    Measured: 3 months post-treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Oct 2025
  2. Study start1 Sep 2026 (estimated)
  3. Primary completion31 Jul 2027 (estimated)
  4. Study completion31 Jul 2027 (estimated)

Resources

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
Non-randomised
Intervention model
Crossover
Model description
Participants will be invited to complete the intervention arm or control arm, followed by assessment.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07217548
Sponsor's protocol ID
UM1TR004548
Other IDs
UM1TR004548
Acronym
point of view
Status last verified
Jun 2026
First submitted
3 Oct 2025
Last updated
1 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: As part of the informed consent process, the research team promises participants that their individual deidentified data will not be shared with other researchers.

Publications

  • Sinha CB, Bakshi N, Ross D, Krishnamurti L. Management of Chronic Pain in Adults Living With Sickle Cell Disease in the Era of the Opioid Epidemic: A Qualitative Study. JAMA Netw Open. 2019 May 3;2(5):e194410. doi: 10.1001/jamanetworkopen.2019.4410.

    PubMed 31125105
  • Carroll CP. Opioid treatment for acute and chronic pain in patients with sickle cell disease. Neurosci Lett. 2020 Jan 1;714:134534. doi: 10.1016/j.neulet.2019.134534. Epub 2019 Oct 5.

    PubMed 31593753
  • Samulowitz A, Gremyr I, Eriksson E, Hensing G. "Brave Men" and "Emotional Women": A Theory-Guided Literature Review on Gender Bias in Health Care and Gendered Norms towards Patients with Chronic Pain. Pain Res Manag. 2018 Feb 25;2018:6358624. doi: 10.1155/2018/6358624. eCollection 2018.

    PubMed 29682130
  • Grant AD, Miller MM, Anastas TM, Quinn P, Lok B, Hirsh AT. Opioid-related risk perceptions in chronic pain: influence of patient gender and previous misuse behaviors. Pain. 2022 Apr 1;163(4):711-718. doi: 10.1097/j.pain.0000000000002412.

    PubMed 34285152

Questions about this trial

What is this clinical trial studying?

A study testing point of view simulation in people with Stigma, run by Ohio State University 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 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: opening soon, as of the sponsor's last update on 1 Jul 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. Some participants in this study may receive a placebo. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Nicholas L Denton, PhD (6142929917, denton.58@osu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Agreement/disagreement toward opioid use misconceptions (time frame: Baseline and 10 days post-treatment). The study lists 2 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 NCT07217548, which also lists 4 linked publications.

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 1 Jul 2026.

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