Patient Knowledge on Pain Management and Safe Opioid Use

Evaluating Patient Knowledge of Pain Management and Safe Opioid Use Before Surgery

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.

Study Overview

• Status: Completed
• Conditions: Opioid Use

Detailed Description

Opioids are frequently prescribed to treat pain after surgery, and while these medications may be effective analgesics they are also susceptible to misuse and addiction. There are growing concerns that prescription opioids contribute to the existing opioid supply and become potential sources for abuse1,2. In fact, opioids are often abused by those using medications not prescribed to them but obtained from friends or relatives3,4.

Many patients who undergo surgery are not given adequate information about opioids and strategies for postoperative pain management. Studies find that inadequate knowledge and inability to recall postoperative pain regimens result in poor compliance5. Many patients are also unaware of how to properly store and dispose of prescription opioids1,6 and this predisposes them to opioid misuse and improper saving and sharing of pills6.

Little is known, however, about the specific gaps in knowledge and what patient demographics may be associated with lack of understanding. As an initial step toward addressing these issues, this study seeks to identify deficiencies in patient understanding of opioids and pain management.

• Study Type: Observational
• Enrollment (Actual): 128

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Hospital for Special Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing primary total hip replacement surgery.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age	Is the age the of patient associated with patients' knowledge of opioids	Prior to surgery
Sex	Is the sex of the patient associated with patients' knowledge of opioids	Prior to surgery
Race	Is the race of the patient associated with patients' knowledge of opioids	Prior to surgery
Ethnicity	Is the ethnicity of the patient associated with patients' knowledge of opioids	Prior to surgery
Previous surgeries	Are previous surgeries of the patient associated with patients' knowledge of opioids	Prior to surgery
Previous opioid usage	Is the previous opioid usage of patient associated with patients' knowledge of opioids	Prior to surgery
Education level	Is the education level of the patient associated with patients' knowledge of opioids	Prior to surgery
Occupation	Is the occupation of the patient associated with patients' knowledge of opioids	Prior to surgery
Alcohol and tobacco use	Is the alcohol and tobacco use of the patient associated with patients' knowledge of opioids	Prior to surgery

Collaborators and Investigators

• Sponsor: Hospital for Special Surgery, New York
• Investigators: Principal Investigator: Bradley H Lee, MD, Hospital for Special Surgery, New York

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2020
• Primary Completion (Actual): December 12, 2020
• Study Completion (Actual): December 12, 2020

Study Registration Dates

• First Submitted: July 27, 2020
• First Submitted That Met QC Criteria: August 3, 2020
• First Posted (Actual): August 4, 2020

Study Record Updates

• Last Update Posted (Actual): April 8, 2024
• Last Update Submitted That Met QC Criteria: April 4, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2019-2246

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification
• IPD Sharing Time Frame: Beginning 3 months and ending 36 months after publication

IPD Sharing 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.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No