Patient Knowledge on Pain Management and Safe Opioid Use

NCT04498559 | Completed

• 1 other identifier: 2019-2246
• Study Type: observational
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine what patients currently know about opioids, including their role in pain management, side effects, risks of abuse, and proper storage and disposal. It is critical for patients to be properly informed about opioid usage in treating postoperative pain, but current gaps in patient knowledge are not well understood. This study will help identify knowledge deficiencies and guide future patient education. Additionally, this study will examine possible patient factors that may be associated with these gaps. Evaluation of patient knowledge will be assessed through interviews conducted before patients' day of surgery.

Conditions

Opioid Use

Outcome Measures

Primary Outcomes (1)

• Patient's knowledge about opioids based on a qualitative assessment

  Patient's answers to opioid-related questions will be summarized using grounded theory, and a comparative analytic strategy to categories. A PI-provided scoring manual will also be used to quantify the accuracy and level of patients' knowledge about opioids. Reference: Berkwits M, Inui TS. Making use of qualitative research techniques. J Gen Intern Med. 1998;13(3):195-199. doi:10.1046/j.1525-1497.1998.00054.x

  Prior to surgery

Secondary Outcomes (9)

• Age

  Prior to surgery

• Sex

  Prior to surgery

• Race

  Prior to surgery

• Ethnicity

  Prior to surgery

• Previous surgeries

  Prior to surgery

Study Arms (1)

Patients undergoing total hip replacement

Patients at HSS Main Campus undergoing primary total hip replacement surgery, age range between 18 and 80 years old, and English speaking

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing primary total hip replacement surgery.

You may qualify if:

• Age range between 18 and 80 years old
• Undergoing primary total hip replacement surgery
• English speaking

You may not qualify if:

• Medical background (profession that involves the prescribing, dispensing, handling, or administering of opioids)
• History of chronic opioid use (continuous opioid use for 3 or more months)
• Opioid use within the past 3 months
• Non-English speakers

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Study Officials

• Bradley H Lee, MD

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2020
• First Posted: August 4, 2020
• Study Start: July 24, 2020
• Primary Completion: December 12, 2020
• Study Completion: December 12, 2020
• Last Updated: May 1, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 3 months and ending 36 months after publication
• Access Criteria: Researchers who provide methodologically sound proposal To achieve aims in the approved protocol Proposals should be directed to leeb@hss.edu. Proposals may be submitted up to 36 months after article publication. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)