Patient and Caregiver Attitudes and Beliefs Regarding Prescription of Intranasal Naloxone Spray for Opioid Overdose
A Survey of High Risk Patient and Caregiver Attitudes and Beliefs Regarding the Prescription of Intranasal Naloxone Spray for Opioid Overdose
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Texas
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Houston, Texas, United States, 77030
- M D Anderson Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Observational (survey)
Participants complete a survey over 30 minutes.
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Complete survey
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To determine the proportion of high risk patients who perceive receiving a prescription of intranasal naloxone to be beneficial for them
Time Frame: Up to 1 year
|
Up to 1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To determine the proportion of caregivers who perceive receiving a prescription of intranasal naloxone to be beneficial for the patient.
Time Frame: Up to 1 year
|
Up to 1 year
|
|
To determine the association between high risk patients' and their caregivers' characteristics
Time Frame: Up to 1 year
|
Up to 1 year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jaya S Amaram-Davila, MD, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-0330 (Other Identifier: M D Anderson Cancer Center)
- NCI-2019-06740 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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