Risk Behavior Clinical Trial
Official title:
The Impact of Co-Dispensing Naloxone to Patients Prescribed Chronic Opioid Therapy
Verified date | March 2023 |
Source | Kaiser Permanente |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Denver Health | Denver | Colorado |
Lead Sponsor | Collaborator |
---|---|
Kaiser Permanente | Denver Health and Hospital Authority, National Institute on Drug Abuse (NIDA) |
United States,
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 |
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