Huge grant fails to reduce ODs by 40%; does show a 9% drop over four states, saving an estimated 483 lives, but few in Ky.

The National Institues of Health’sNational Institute on Drug Abuse and the Substance Abuse and Mental Health Services Administration funded the study through the NIH HEAL Initiative.

By Melissa Patrick

Kentucky Health News

A four-state, $350 million research grant that included Kentucky fell far short of its goal of reducing opioid overdose deaths by 40% over four years, instead showing an estimated 9% drop in such deaths. 

"That translates into an estimated 483 opioid-overdose deaths that were averted in the communities that received the intervention," said Patricia Freeman, part of the HEALing Communities Study research team and an associate professor of pharmacy at the University of Kentucky.  

Another model, comparing those to communities to a control group of counties with similar charcteristics, showed a 15% average reduction in opioid-overdose deaths in the intervention communities, which Freeman said was "very close to reaching statistical significance."

"It's still consequential even though it didn't reach statistical significance," said Freeman. "An estimated 483 lives were saved. And just because it didn't reach statistical significance doesn't mean that it was not a meaningful public-health impact." 

In Kentucky, there was no real difference in the adjusted rate of opioid-related overdose deaths between the intervention counties and the control-group counties, with 59.8 deaths per 100,000 residents in the intervention communities and 59.3 per 100,000 in the control communities. 

The study compared the control and intervention communities for one year, July 2021 through June 2022. 

"In retrospect, I think people will say that the 40% was a very ambitious goal," said Freeman. The researchers in the paper said likewise, adding, "The trial may have been underpowered to detect substantially smaller yet clinically meaningful differences."

An underpowered study does not have a sufficiently large sample size to answer the research question of interest,"  says the National Library of Medicine. according to L.D. Case and W.T. Ambrosius in an article titled "Power and Sample Size," published in Topics in Biostatistics.

The study, published June 16 in The New England Journal of Medicine, found no differences in estimated opioid-overdose deaths among the four states, nor any statistical differences between urban and rural communities, by age, by sex or among racial and ethnic groups. 

The research paper identifies several unforeseen challenges that likely diminished the impact of the interventions. Those include the Covid-19 pandemic, which began just two months after the start of the study’s intervention, an increase in the prevalence of fentanyl in illicit drug markets, and a 10-month implementation period, which may have been too short for communities to fully implement and see the effects of their efforts, says a UK news release.  

The four-year study, launched in 2019, included 67 communities affected by opioid abuse, including 16 Kentucky counties. UK  received $87 million from the National institutes of Health for the study, the largest competitive award UK has ever received. 

The other participants were Boston Medical Center in Massachusetts, Columbia University in New York City and Ohio State University. 

The Kentucky counties where interventions were made were Boyd, Boyle, Clark, Fayette, Floyd, Franklin, Kenton and Madison. The control-group counties were Bourbon, Campbell, Carter, Greenup, Jefferson, Jessamine, Knox and Mason.

Freeman noted that the published study results don't reflect county-level data, but the impact of the interventions in all 67 communities.  

The interventions involved increasing education about overdoses; increasing overdose-prevention education and distribution of the anti-overdose drug naloxone; increasing access to and retention of medications to treat opioid-use disorder, including methadone and buprenorphine; safer opioid prescribing, dispensing and disposal practices; and reducing the stigma of addiction.

 

"Specific efforts in Kentucky included partnering with 145 organizations to distribute more than 40,000 naloxone units," the news release says. "Strategies to help people find and stay in treatment deployed 26 peer-recovery coaches and 16 care navigators and provided $411,848 in transportation support.

"Other activities included partnering with 35 pharmacies to install permanent medication-disposal drop boxes, which has resulted in the incineration of more than 6,500 pounds of leftover medication. Efforts to reduce stigma and increase awareness of treatment resources produced 64 communication campaigns, resulting in 73 million engagements."

The study's principal investigator, Sharon Walsh, a professor in the College of Medicine and College of Pharmacy and director of the UK Center on Drug and Alcohol Research, said in the release, “Our findings demonstrate that implementing these evidence-based practices through community-engaged strategies and partnerships can make a meaningful impact on combating overdoses, even amid the rapidly evolving opioid epidemic and unprecedented disruptions like the Covid-19 pandemic,”  

Freeman said researchers are continuing to analyze the data to look at the impact of each strategy used in the study, and have written a paper that is under peer review, looking at how naloxone distribution changed in the intervention and control communities.

She said they will also continue to analyze the impact of the interventions on non-fatal overdoses, the impact on overdoses that involved opioids and other substances, since this study was specific to opioids, among other things.

Also coming are results from the control communities, which received the interventions after the comparisons between the control communities and intervention communities were complete.

"We'll be trying to really understand what were the strategies that were the most impactful in our communities," Freeman said. 

Looking forward, Freeman said she thought Kentucky could see some long-term benefits from this study because of the infrastructure, technical assistance and training that was set up with the agencies and organizations to implement the study. "I'm interested to see what's going to be a longer term impact," she said. 

The good news is that Kentucky has experienced two years of declines in overdose deaths. In  2022, it was one of only eight states that saw a decrease in drug overdose deaths, and in 2023, it saw a 10% drop in such deaths, according to the state's Office of Drug Control Policy.

Updated 06/25/24: This article has been updated to reflect the correct attribution for the definition of an "underpowered study" to be  L.D. Case and W.T. Ambrosius in an article titled "Power and Sample Size," published in Topics in Biostatistics.