REDONNA was a single-blinded, two-arm clinical trial of a prescribing Portrait for eligible family physicians in British Columbia, Canada. It examined the effectiveness of mailed prescribing Portraits to Reduce Initiation of Opioid Analgesics among Opioid-Naïve People Experiencing Pain.
Exposure to opioid analgesics has historically raised concern for a potential risk of developing prescription-type opioid use disorder. Prescriber audit-and-feedback interventions may impact opioid prescribing, but some studies have shown detrimental effects for people who use opioids.
This blog summarises a recent paper published by the study team in the Contemporary Clinical Trials journal.
How was the REDONNA study done?
The primary outcome was the change in the number of initiations of opioid analgesic prescriptions written by family physicians for acute/chronic pain management.
We compared outcomes for a 6-month window before vs. after each mailed Portrait, using differences in percent differences (DPD) with 95% confidence intervals (CI), and odds ratios (OR) from logistic regressions adjusted for clustering of patients by family physicians (Early vs Delayed mailing).
What did the study find?
In the Early (n = 2,260) and Delayed (n = 2,156) groups, opioid initiations per month were the same in the Before (2.10 Early; 2.06 Delayed) and After (1.94 Early; 1.95 Delayed) windows.
The DPD was -2.1% (CI: -4.4% to 0.3%), and ORs were: 0.98 (CI: 0.96 to 1.01) for any opioid, 0.97 (CI: 0.94 to 1.01) for codeine (62% of initiations), and 1.0 (CI: 0.97 to 1.07) for tramadol (25% of initiations).
There were no differences in mean quantity of tablets, mean milligrams of morphine equivalents (MME), or mean number of days.
Why is the study important even if Portraits had no impact?
In sum, the Portrait had no impact on family physicians’ rates of initiating opioid analgesics to opioid-naïve patients experiencing pain. It is worth thinking about the context of the Portraits’ implementation.
First, the COVID-19 pandemic started with unprecedented disruptions in March 2020 between the Early and the Delayed mailings.
Second, the provincial health authorities scaled up their efforts to reduce fatal and non-fatal drug poisonings by increasing the availability of not only harm reduction services. Such as overdose prevention sites, but also of prescribed safer supply and evidence based treatments for OUD (slow-release oral morphine, hydromorphone, and most recently fentanyl).
Third, data from previous years reflected REDONNA’s baseline rates of initiations among opioid-naïve persons. These data suggested a very low starting point (mean monthly initiation rate of 2.05 opioid prescriptions per physician) which might be challenging to reduce even further.
Fourth, the emerging surveillance data also suggested a low prevalence of pharmaceutical opioids detected on toxicology in people who died from illicit drug poisoning. Surveillance also suggested associations between inconsistent de-prescribing, rapid discontinuations, and mortality rates.
Finally, these various potential confounders likely limited the actual power of Portrait interventions to decrease the initiations and clearly suggest a need for ongoing efforts to discourage rapid discontinuation. Sending prescribing feedback won’t fix the drug toxicity crisis.
If you liked this post, you might also want to read a post about the study written by Dr Rita McCracken:
REDONNA – last quantitative paper – our intervention did not change prescribing behaviour and other reflections from October 11, 2023. You can read about it on X, or visit the REDONNA study at Dr Rita McCracken’s home page here.
When you do a randomized trial and do not find a statistically significant effect for your intervention… there are still lessons learned. #silverlinings #AcademicTwitter https://t.co/HqiHeLqaYQ
— Dr. Rita McCracken, MD, PhD (she/her) (@DrRitaMc) October 11, 2023
Cited study: McCracken, R., Narayan, S., Maclure, M., Cooper, I., Cui, Z., Cullen, W., Dormuth, C., Hamilton, M.A., Nolan, S., Singer, J., Socías, M.E., Wong, S., Klimas, J. (2023) Evaluation of audit and feedback to family physicians on prescribing of opioid analgesics to opioid-naïve patients: A pragmatic randomized delay trial. Contemporary Clin Trials, (134):107354 Epub 2023 Oct 5.
Link to cited study: https://pubmed.ncbi.nlm.nih.gov/37802223/
Trial registration: The study was registered prospectively on 30 March 2020 at the ISRCTN Register (https://www.isrctn.com/ISRCTN34246811).
Further information on the data sets used for this project is at: https://my.popdata.bc.ca/project_listings/21-090/collection_approval_dates. All inferences, opinions, and conclusions drawn in this material are those of the author(s), and do not reflect the opinions or policies of the Data Steward(s).