Clinical trial NCT04129138: Patient and Caregiver Attitudes and Beliefs Regarding Prescription of Intranasal Naloxone Spray for Opioid Overdose
Official title: A Survey of High Risk Patient and Caregiver Attitudes and Beliefs Regarding the Prescription of Intranasal Naloxone Spray for Opioid Overdose
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Caregiver
Patient
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-10-16
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients prescribed naloxone in the last year and their caregivers.

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.

Eligibility criteria: 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

Primary outcomes:
measure: To determine the proportion of high risk patients who perceive receiving a prescription of intranasal naloxone to be beneficial for them
timeFrame: Up to 1 year
Secondary outcomes:
measure: To determine the proportion of caregivers who perceive receiving a prescription of intranasal naloxone to be beneficial for the patient.
timeFrame: Up to 1 year
measure: To determine the association between high risk patients' and their caregivers' characteristics
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Jaya S Amaram-Davila, MD
role: PRINCIPAL_INVESTIGATOR
References: