NCT02790476

Behavioral Insights to Encourage Judicious Prescribing of Opioids

Completed NA Results posted Last updated 29 April 2024

What this trial tests

NA trial testing Letters in Substance-Related Disorders in 851 participants. Completed in 27 February 2018.

Timeline

27 January 2017

Primary endpoint
27 May 2017

27 February 2018

Quick facts

Lead sponsor	University of Southern California
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	851
Start date	27 January 2017
Primary completion	27 May 2017
Estimated completion	27 February 2018
Sites	1 location across United States

Drugs / interventions tested

• Letters

Conditions studied

• Substance-Related Disorders — all drugs for Substance-Related Disorders →

Sponsor

University of Southern California

Who can join

Eligibility, any sex, with Substance-Related Disorders. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Average Change Over Time in Dispensed Narcotics Primary · 12 months

The hypothesis is that the average change over time in dispensed narcotic represented as monthly morphine milligram equivalent (MME) dose will be larger for prescribers receiving the letter intervention, compared to the average change over time for the control prescribers not receiving the letter intervention.

Adjusted per-prescriber mean weekly morphine milligram equivalents (MMEs); Pre intervention

Group	Value	95% CI
Letter Intervention	347.65	339.27 – 356.03
Control	350.09	341.77 – 358.40

Adjusted per-prescriber mean weekly MMEs; 1-3 months Post intervention

Group	Value	95% CI
Letter Intervention	288.36	281.61 – 295.11
Control	318.60	311.03 – 326.17

Adjusted per-prescriber mean weekly MMEs; 4-12 months Post intervention

Group	Value	95% CI
Letter Intervention	167.83	163.91 – 171.74
Control	182.67	178.46 – 186.88

Number of Opioid Prescriptions for > 90 Morphine Milligram Equivalent (MME) and ≥ 50 MME Primary · 12 months

The hypothesis is that there will be fewer opioid prescriptions both at a dose \> 90 morphine milligram equivalent (MME) and at a dose ≥ 50 MME among prescribers receiving the letter intervention, compared to control prescribers not receiving the letter intervention.

Number of => 50 MME Prescriptions Pre intervention

Group	Value	95% CI
Letter Intervention	3.74	3.57 – 3.91
Control	4.59	4.41 – 4.76

Number of => 50 MME Prescriptions 1-3 months Post intervention

Group	Value	95% CI
Letter Intervention	3.45	3.08 – 3.82
Control	3.95	3.59 – 4.30

Number of => 50 MME Prescriptions 4-12 months Post-intervention

Group	Value	95% CI
Letter Intervention	3.00	2.79 – 3.21
Control	3.15	2.95 – 3.35

Number of > 90 MME Prescriptions Pre intervention

Group	Value	95% CI
Letter Intervention	2.14	2.02 – 2.27
Control	2.55	2.44 – 2.67

Number of > 90 MME Prescriptions 1-3 Post intervention

Group	Value	95% CI
Letter Intervention	2.00	1.76 – 2.25
Control	2.20	1.96 – 2.44

Number of > 90 MME Prescriptions 4-12 months Post intervention

Group	Value	95% CI
Letter Intervention	1.71	1.57 – 1.85
Control	1.74	1.61 – 1.87

Number of Opioid and Benzodiazepine Co-prescriptions Primary · 12 months

The hypothesis is that there will be fewer opioid and benzodiazepine co-prescriptions for prescribers receiving the letter intervention, compared to control prescribers not receiving the letter intervention.

Pre intervention

Group	Value	95% CI
Letter Intervention	12.2	9.8 – 14.6
Control	13.6	11.0 – 16.1

Post intervention

Group	Value	95% CI
Letter Intervention	13.4	12.3 – 14.4
Control	16.7	15.5 – 17.9

Number of "New Start" Prescriptions Secondary · 12 months

The hypothesis is that there will be fewer prescriptions for opioid naïve patients by prescribers receiving the letter intervention, compared to control prescribers not receiving the letter intervention.

Pre intervention

Group	Value	95% CI
Letter Intervention	3.72	3.64 – 3.80
Control	3.51	3.44 – 3.59

1-3 months post intervention

Group	Value	95% CI
Letter Intervention	2.44	2.27 – 2.61
Control	2.26	2.10 – 2.43

4-12 months post intervention

Group	Value	95% CI
Letter Intervention	2.08	1.99 – 2.18
Control	1.84	1.76 – 1.93

Sponsor's own description

In collaboration with the San Diego Medical Examiner's Office and the State of California's controlled Substance Utilization Review and Evaluation System (CURES), the investigators propose to review opioid poisonings over the past 12 months and will send letters to prescribers in California when at least one of the provider's prescription(s) was filled by a patient who died of an opioid poisoning in San Diego County. The letters will be non-judgmental and factual, explaining that a patient of the provider who was being treated with prescription narcotics died of an opioid poisoning. The letter will also encourage judicious prescribing including use of the CURES system before prescribing. The investigators will evaluate physician prescribing practices over 24 months 12 months pre- and 12 months post-letter using data from the CURES database. The investigators' hypothesis is that letters will make the risk of opioids more cognitively available and that physicians will respond by prescribing opioids more carefully. This will result in fewer deaths due to misuse and more frequent use of the CURES system.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Association of Fatal Overdose Notification Letters With Prescription of Benzodiazepines: Secondary Analysis of a Randomized Clinical Trial.
   Kelley MA, Lev R, Lucas J, Knight T, et al · · 2022 · cited 2× · PMID 35994260 · DOI 10.1001/jamainternmed.2022.3372
2. Effect of Prescriber Notifications of Patient's Fatal Overdose on Opioid Prescribing at 4 to 12 Months: A Randomized Clinical Trial.
   Doctor JN, Stewart E, Lev R, Lucas J, et al · · 2023 · cited 1× · PMID 36607639 · DOI 10.1001/jamanetworkopen.2022.49877