The Impact of Co-Dispensing Naloxone to Patients Prescribed Chronic Opioid Therapy

Risk Behavior Clinical Trial

Official title:

The Impact of Co-Dispensing Naloxone to Patients Prescribed Chronic Opioid Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03337100
• Other study ID #: CO-16-2405-02
• Secondary ID: 1R01DA042059
• Status: Completed
• Phase: N/A
• Start date: November 27, 2017
• Est. completion date: September 30, 2022

Study information

• Verified date: March 2023
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In the setting of naloxone standing orders, this study will assess if co-dispensing naloxone with opioids to patients prescribed chronic opioid therapy changes opioid risk behaviors, increases naloxone uptake, and increases knowledge about overdose and naloxone.

Description:

This is a pragmatic, pharmacy-based, cluster randomized controlled trial of a naloxone co-dispensing program for adults prescribed chronic opioid therapy. Pharmacies (target N=6) will be randomized to the order in which they are encouraged to implement a naloxone co-dispensing program for patients prescribed chronic opioid therapy. The intent of this program is to provide patients prescribed chronic opioid therapy naloxone for potential opioid overdose reversal under the terms of a standing order. Participants prescribed chronic opioid therapy who use randomized pharmacies will be recruited to receive knowledge and risk surveys at baseline and over the follow-up. The primary outcome is opioid risk behaviors (target enrollment is 200 patients). Secondary outcomes include knowledge about overdose and naloxone, substance use, and pain intensity. Patients who use randomized pharmacies (anticipated n=550 patients) will also be followed in the electronic health record for secondary outcomes: naloxone dispensings, changes in opioid dose, aberrant urine toxicology results, and overdose events.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: September 30, 2022
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Study Population:

• Eligible pharmacies
• Patients prescribed chronic opioid therapy

Inclusion Criteria for pharmacies:

• Stock naloxone for outpatient dispensing.
• Pharmacy leadership willing to provide naloxone under a co-dispensing protocol.
• Pharmacy leadership willing to be randomized to order of implementation.
• Have or can implement a naloxone standing order.

Exclusion Criteria for pharmacies:

• None

Inclusion Criteria for patients:

• Prescribed chronic opioid therapy and meet criteria for the pharmacy co-dispensing protocol
• Receive medications at participating pharmacies
• Have a health plan which covers the formulation of naloxone available at the pharmacy they received their opioid prescriptions from.
• (for surveys)18 years of age or greater

Exclusion Criteria:

• (for surveys) Non-English speaking, hospice enrollment, do-not-resuscitate order

Related Conditions & MeSH terms

• Drug Overdose
• Overdose
• Risk Behavior

Intervention

Behavioral:
• Co-Dispensing
Implementation of a naloxone co-dispensing pharmacy program. The intent of this program is to provide patients prescribed chronic opioid therapy naloxone under the terms of a standing order for potential opioid overdose reversal. Prior to implementing the program, a naloxone standing order will be implemented and pharmacy operational staff will provide training to pharmacy staff about the standing order and a naloxone co-dispensing protocol. Under a co-dispensing protocol, pharmacy staff members will identify opioid prescriptions meeting criteria for co-dispensing, prepare naloxone fills, offer patients naloxone, and provide counseling on its use.

Locations

Country	Name	City	State
United States	Denver Health	Denver	Colorado

Sponsors (3)

Lead Sponsor	Collaborator
Kaiser Permanente	Denver Health and Hospital Authority, National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Pain Intensity	Among survey participants, pain intensity will be assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS). PROMIS Scale v1.0 - Pain Intensity 3a. The PROMIS Pain Intensity instrument is scored on a scale of 3-15. A higher score represents greater pain intensity.	Change from baseline to 4-6 months and 8-10 months
Other	Rate of Opioid Overdose	Among survey participants and participants followed using automated data only, overdoses will be assessed using electronic health record and insurance claims data and death records. Survey participants will be asked about non-fatal overdose events.	Baseline up to 2.5 years
Other	Rate of Aberrant Urine Toxicology Screens	Among survey participants and participants followed using automated data only, urine toxicology screen results found in laboratory databases will be used to measure opioid medication diversion and drug use.	Baseline up to 2.5 years
Primary	Change in Opioid-Related Risk Behavior	Among survey participants, risk behavior will be assessed using the Opioid-Related Behaviors in Treatment (ORBIT) scale. The ORBIT is a scale used to identify recent risk behavior among patients receiving chronic opioid therapy. Scores on the single scale range from 0-40, with lower values representing less risk behavior.	Change from baseline to 4-6 months and 8-10 months
Secondary	Overdose and Naloxone Knowledge	Among survey participants, 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. The investigators have adapted it to be specific to prescription opioids. The modified-OOKS is scored on a scale of 0-28, with higher values representing greater knowledge about overdose and naloxone.	Change from baseline to 4-6 months, and 8-10 months
Secondary	Rate of Naloxone Dispensings	Among survey participants and participants followed using automated data only, pharmacy and insurance claims databases will be used to identify naloxone dispensings.	Baseline up to 2.5 years
Secondary	Patient reported naloxone pick-up	Among survey participants, surveys will be used to identify naloxone dispensings in the outpatient setting.	Baseline up to 10 months
Secondary	Changes in opioid dose	Among survey participants and participants followed using automated data only, changes in the milligrams morphine equivalent dose will be calculated from pharmacy and insurance claims databases.	Baseline up to 2.5 years
Secondary	Change in Drug Use Risk Behavior	Among survey participants, drug use risk behavior will be assessed using question 2 of the validated National Institutes on Drug Abuse-Modified Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) scale version 2.0. The investigators added an item about tobacco use from the WHO ASSIST V3.0 to the NIDA-modified ASSIST V2.0 instrument, resulting in a scale of 0-66, with lower values representing less drug use risk behavior.	Change from baseline to 4-6 months and 8-10 months
Secondary	Change in Hazardous Drinking or Alcohol Use Disorders	Among survey participants, alcohol use risk behavior will be assessed using the validated Alcohol Use Disorders Identification Test--Consumption (AUDIT-C) scale. The AUDIT-C is a screener used to identify patients with alcohol use disorders or hazardous drinking behavior. The AUDIT-C is scored on a scale of 0-12. The higher the score, the more likely it is that the patient's drinking is affecting his or her safety.	Change from baseline to 4-6 months and 8-10 months