Impact of Direct Outreach to Expand Access to Naloxone in the Context of Standing Orders
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03241771|
Recruitment Status : Recruiting
First Posted : August 7, 2017
Last Update Posted : October 18, 2017
|Condition or disease||Intervention/treatment||Phase|
|Opioid Abuse Overdose Risk Behavior||Behavioral: Naloxone Navigator 1.0||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Impact of Direct Outreach to Expand Access to Naloxone in the Context of Standing Orders|
|Actual Study Start Date :||August 14, 2017|
|Estimated Primary Completion Date :||July 31, 2018|
|Estimated Study Completion Date :||July 31, 2018|
Experimental: Naloxone Navigator 1.0
Participants randomized to the Naloxone Navigator 1.0 arm will receive a link to the web-based resource. They will also receive usual care from their health plan, pharmacy and physicians. As part of usual care, participants will have access to naloxone through standing orders (i.e., they can request it without a prescription under their usual pharmacy benefit).
Behavioral: Naloxone Navigator 1.0
Patients on chronic opioid therapy will be outreached via email, mail and phone. Within 1 month of enrollment into the trial, intervention participants will receive a link to the web-based resource to view. This is designed to provide overdose education, increase opioid risk awareness, and encourage patients to obtain naloxone.
Other Name: Naloxone Navigator (NN)
No Intervention: Usual Care
Participants in the usual care arm will receive usual care from their health plan, pharmacy and physicians. As part of usual care, participants will have access to naloxone through standing orders (i.e., they can request it without a prescription under their usual pharmacy benefit).
- Risk Behavior [ Time Frame: 4 months ]Risk behavior will be assessed using the Opioid-Related Behaviors in Treatment (ORBIT) scale. The ORBIT is a brief scale used to identify recent risk behavior among patients receiving chronic opioid therapy.
- Patient Knowledge [ Time Frame: Within 1 month of study enrollment ]Patient knowledge of overdose and naloxone will be measured using survey items adapted from the Opioid Overdose Knowledge Scale (OOKS). The OOKS is a scale measuring knowledge of overdose risks, warning signs, steps to address the overdose and appropriate use of naloxone.
- Naloxone Dispensings [ Time Frame: 4 months ]Electronic health records and pharmacy databases will be used to identify naloxone dispensings in the outpatient setting.
- Opioid dose [ Time Frame: 4 months ]We will calculate changes in the milligrams morphine equivalent dose
- Drug Use Risk Behavior [ Time Frame: 4 months ]Drug Use Risk Behavior will be assessed using the validated National Institutes on Drug Abuse-Modified (ASSIST) scale.
- Alcohol Use Risk Behavior [ Time Frame: 4 months ]Alcohol Use Risk Behavior will be assessed using the validated Alcohol Use Disorders Identification Test--Consumption (AUDIT-C Lite) scale. AUDIT-C Lite is a brief screener used to identify patients with alcohol use disorders or hazardous drinking behavior
- Pain Intensity [ Time Frame: 4 months ]Pain intensity will be assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS). PROMIS Pain Intensity - Short Form instrument measures pain intensity over time
- Overdose [ Time Frame: 4 months ]Fatal and nonfatal overdoses will be assessed using International Classification of Disease (ICD)-10 codes in the electronic health record data and death records.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03241771
|Contact: Nikki Wagner, MPHemail@example.com|
|Contact: Shane Mueller, MSWfirstname.lastname@example.org|
|United States, Colorado|
|Denver, Colorado, United States, 80204|
|Contact: Nikki Wagner, MPH 303-614-1223 email@example.com|
|Principal Investigator: Ingrid Binswanger, MD|
|Principal Investigator: Jason Glanz, PhD|
|Principal Investigator:||Ingrid Binswanger, MD||Kaiser Permanente|
|Principal Investigator:||Jason Glanz, PhD||Kaiser Permanente|