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

Caregiver Clinical Trial

Official title:

A Survey of High Risk Patient and Caregiver Attitudes and Beliefs Regarding the Prescription of Intranasal Naloxone Spray for Opioid Overdose

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04129138
• Other study ID #: 2019-0330
• Secondary ID: NCI-2019-0674020
• Status: Recruiting
• Start date: July 18, 2020
• Est. completion date: June 30, 2024

Study information

• Verified date: March 2024
• Source: M.D. Anderson Cancer Center
• Contact: Jaya S. Amaram-Davila, MD
• Phone: (713) 792-6085
• Email: jsamaram[@]mdanderson.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Caregiver
• Opiate Overdose
• Patient

Intervention

Other:
• Survey Administration
Complete survey

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To determine the proportion of caregivers who perceive receiving a prescription of intranasal naloxone to be beneficial for the patient.		Up to 1 year
Secondary	To determine the association between high risk patients' and their caregivers' characteristics		Up to 1 year

External Links

•   MD Anderson Cancer Center Website