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  1. Advancing Regulatory Science

​A Mixed Methods Research Design to Identify Factors Influencing Prescriber Decision-Making about Pain Management and Opioid Prescribing

CERSI Collaborators: Yale: Joe Ross, Ph.D.; Jessica Ritchie Yale-Site PM Mayo: Michael Hooten, M.D.; Molly Jeffery, Ph.D.; Kathleen Yost, Ph.D.; Jennifer Ridgeway, Ph.D.; Jessica McCoy Mayo Site and Project PM

FDA Collaborators: Blair Coleman, PhD, MPH; Sara Eggers, PhD; Katherine Hyatt Hawkins Shaw, PhD; Megan Moncur, MS; Reza Kazemi-Tabriz, PhD

Project Start: November 9, 2021

Regulatory Science Challenge

Information is currently limited on how healthcare providers make decisions regarding pain management, including what factors they consider when treating patients with pain. For example, appropriate use of opioids on a short-term basis to treat pain due to an injury or pain after an operation is often needed and clinically indicated. However, there is little information on why some patients who are prescribed opioid pain medications for short-term use will continue to receive prescriptions longer than anticipated. This research project will focus on learning more about how medical doctors and other health care providers make decisions about how they prescribe opioid pain medications.

The findings from this research project will strengthen FDA and other stakeholders’ understanding of healthcare provider decision-making for opioid prescribing, which in turn can inform other on-going research, such as FDA’s Opioids Systems Model, and strengthen communications used to support opioid use disorder prevention efforts.

Project Description and Goals

This research project has two primary Aims:

Aim 1: Interview individual physicians and other healthcare providers to understand their decision-making process around prescribing opioid pain medications. Responses from individual interviews will be combined and reviewed during focus groups with physicians and other health care providers to ensure accuracy and completeness.

Aim 2: Develop a survey (using responses from individual interviews and focus groups) to measure how physicians and other healthcare providers make decisions about prescribing opioid pain medications.

 
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