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Pain Management and Safe Opioid Use

Sponsor
Hospital for Special Surgery, New York (Other)
Overall Status
Completed
CT.gov ID
NCT04498559
Collaborator
(none)
128
Enrollment
1
Location
4.6
Actual Duration (Months)
27.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    128 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Evaluating Patient Knowledge of Pain Management and Safe Opioid Use Before Surgery
    Actual Study Start Date :
    Jul 24, 2020
    Actual Primary Completion Date :
    Dec 12, 2020
    Actual Study Completion Date :
    Dec 12, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. Patient's knowledge about opioids based on a qualitative assessment [Prior to surgery]

      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

    Secondary Outcome Measures

    1. Age [Prior to surgery]

      Is the age the of patient associated with patients' knowledge of opioids

    2. Sex [Prior to surgery]

      Is the sex of the patient associated with patients' knowledge of opioids

    3. Race [Prior to surgery]

      Is the race of the patient associated with patients' knowledge of opioids

    4. Ethnicity [Prior to surgery]

      Is the ethnicity of the patient associated with patients' knowledge of opioids

    5. Previous surgeries [Prior to surgery]

      Are previous surgeries of the patient associated with patients' knowledge of opioids

    6. Previous opioid usage [Prior to surgery]

      Is the previous opioid usage of patient associated with patients' knowledge of opioids

    7. Education level [Prior to surgery]

      Is the education level of the patient associated with patients' knowledge of opioids

    8. Occupation [Prior to surgery]

      Is the occupation of the patient associated with patients' knowledge of opioids

    9. Alcohol and tobacco use [Prior to surgery]

      Is the alcohol and tobacco use of the patient associated with patients' knowledge of opioids

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital for Special Surgery New York New York United States 10021

    Sponsors and Collaborators

    • Hospital for Special Surgery, New York

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hospital for Special Surgery, New York
    ClinicalTrials.gov Identifier:
    NCT04498559
    Other Study ID Numbers:
    • 2019-2246
    First Posted:
    Aug 4, 2020
    Last Update Posted:
    Jan 14, 2021
    Last Verified:
    Jan 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Jan 14, 2021