NCT07217548

Brief 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 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. 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. 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. 2.Survey Participants: Before and after the simulation, participants will take a survey to measure their misconceptions about opioid use.
  3. 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
3mo left

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress42%
Feb 2026Jul 2026

First Submitted

Initial submission to the registry

October 3, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 16, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

6 months

First QC Date

October 3, 2025

Last Update Submit

January 15, 2026

Conditions

Keywords

pharmacistsPharmD students

Outcome Measures

Primary Outcomes (2)

  • 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.

    Baseline and 10 days post-treatment

  • 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.

    3 months post-treatment

Study Arms (2)

POV simulation

EXPERIMENTAL

Participating 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.

Behavioral: point of view simulation

Control

SHAM COMPARATOR

Participating 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.

Behavioral: Control

Interventions

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.

POV simulation
ControlBEHAVIORAL

Participants will watch a hematology educational video unrelated to pain management

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ohio State University College of Pharmacy

Columbus, Ohio, 43210, United States

Location

Related Publications (4)

  • 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.

    PMID: 31125105BACKGROUND
  • 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.

    PMID: 31593753BACKGROUND
  • 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.

    PMID: 29682130BACKGROUND
  • 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.

    PMID: 34285152BACKGROUND

MeSH Terms

Conditions

Social Stigma

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Study Officials

  • Nicholas L Denton, PhD

    Ohio State University College of Pharmacy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants will be unaware of the other arm (POV simulation vs control intervention) and outcome assessors of empathy-based practice will be unaware of which arm participants belong to.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Model Details: Participants will be invited to complete the intervention arm or control arm, followed by assessment.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer

Study Record Dates

First Submitted

October 3, 2025

First Posted

October 16, 2025

Study Start

February 1, 2026

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

July 31, 2026

Last Updated

January 20, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

As part of the informed consent process, the research team promises participants that their individual deidentified data will not be shared with other researchers.

Locations