Patient and Caregiver Attitudes and Beliefs Regarding Prescription of Intranasal Naloxone Spray for Opioid Overdose

Recruiting

• Conditions: Patient; Caregiver
• Interventions: Other: Survey Administration

• Registration Number: NCT04129138
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

This trial studies the attitudes and beliefs of high risk patients and caregivers regarding the prescription of intranasal naloxone spray for opioid overdose. Knowledge regarding high risk patients' and caregivers' beliefs and attitudes regarding co-prescription of naloxone spray with opioids may help to identify barriers to prescribing and helping tailor the education to better meet the needs of patients and caregivers.

Detailed Description

PRIMARY OBJECTIVE:

I. To determine the proportion of high risk patients who perceive receiving a prescription of intranasal naloxone to be beneficial for them.

SECONDARY OBJECTIVES:

I. To determine the proportion of caregivers who perceive receiving a prescription of intranasal naloxone to be beneficial for the patient.

II. To determine the association between high risk patients' and their caregivers' characteristics (this includes cut-annoyed-guilty-eye \[CAGE\], screener and opioid assessment for patients with pain \[SOAPP\], age, gender, ethnicity, education, employment status, presence of caregiver, cancer type, cancer stage, reason for Narcan prescription, health insurance, and setting of Narcan prescription) and their perception that a prescription for intranasal naloxone is beneficial for patients.

EXPLORATORY OBJECTIVE:

I. To conduct an exploratory analysis of high risk patients' and caregivers' attitudes and beliefs regarding prescription of intranasal naloxone spray.

OUTLINE:

Participants complete a survey over 30 minutes.

Study Timeline

• Study First Submitted: 2019-10-14
• Study First Submitted QC: 2019-10-14
• Study First Posted: 2019-10-16
• Study Start: 2020-07-18
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-26
• Last Update Posted: 2024-03-27
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Patients must have been prescribed intranasal naloxone in the past 1 year
• Patients and caregivers must be able to understand, read, write, and speak English
• Patients must have no clinical evidence of cognitive impairment, as determined by the palliative care provider (Memorial Delirium Assessment Scale score of >= 7)
• Patients must sign an informed consent
• Caregivers may sign an informed consent if available during the visit
• Caregivers may verbally consent over the phone if not present during the visit
• Caregiver must be a friend, significant other or family member
• Caregivers must have no evidence of cognitive impairment, as determined based on orientation questions pertaining to the date, day of the week, time, and place

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Exclusion Criteria

• PATIENT: Emotional or psychosocial distress as identified by the patient's palliative care
• PATIENT: Participants with Edmonton Symptom Assessment System (ESAS) anxiety score of > 6

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational (survey)	Survey Administration	Participants complete a survey over 30 minutes.

Primary Outcome Measures

Name	Time	Method
To determine the proportion of high risk patients who perceive receiving a prescription of intranasal naloxone to be beneficial for them	Up to 1 year

Secondary Outcome Measures

Name	Time	Method
To determine the proportion of caregivers who perceive receiving a prescription of intranasal naloxone to be beneficial for the patient.	Up to 1 year
To determine the association between high risk patients' and their caregivers' characteristics	Up to 1 year

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States