Patient Knowledge on Pain Management and Safe Opioid Use

Opioid Use Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04498559
• Other study ID #: 2019-2246
• Status: Completed
• Start date: July 24, 2020
• Est. completion date: December 12, 2020

Study information

• Verified date: April 2024
• Source: Hospital for Special Surgery, New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: December 12, 2020
• Est. primary completion date: December 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Opioid Use

Locations

Country	Name	City	State
United States	Hospital for Special Surgery	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York

Country where clinical trial is conducted

United States, 

Outcome

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