The standardized signature informed consent (SIC) policy launched in 2014 by the Veterans Health Administration (VHA) associated with increased medical follow-up among patients receiving long-term opioid therapy (LTOT). These findings were published in the Journal of Pain Research.
Patients (N=409,895) receiving LTOT between 2013 and 2016 were identified using the VHA’s Corporate Data Warehouse. Prior to and after the standardization of SIC, the rate of medical follow-up within 30 days and primary care follow-up within 3 months after initiating LTOT were evaluated.
During 2013 (n=280,528), 2014 (n=259,061), and 2015 (n=218,827), patients were 92%-93% men and 86%-87% were receiving chronic short acting opioids.
From 2013 to 2015, any medical follow-up during the first 30 days increased from 75% to 78% and primary care visits within the first 3 months increased from 75% to 80%.
Any follow-up within 30 days increased in 2014 compared with 2013 (RR, 1.076; 95% CI, 1.067-1.085), in 2015 compared with 2013 (RR, 1.119; 95% CI, 1.104-1.33), and in 2015 compared with 2014 (RR, 1.040; 95% CI, 1.032-1.047). Similarly, primary care visits within 3 months increased in 2014 compared with 2013 (RR, 1.084; 95% CI, 1.076-1.093), in 2015 compared with 2013 (RR, 1.134; 95% CI, 1.118-1.50), and in 2015 compared with 2014 (RR, 1.046; 95% CI, 1.037-1.055).
After adjusting for potential cofounders, a 1% increase in SIC coverage among patients cared for at the same site, who were in the same opioid tier, and receiving care during the same month associated with a 4% increase in medical follow-up and 6% increase in primary care follow-up.
The major limitation of this study was that during the study period, the VHA was also employing other initiatives aimed at improving safe opioid prescribing, which may have confounded results.
The researchers concluded, “Our findings suggest that system-wide policies fostering shared decision-making and ethical healthcare practices, such as informed consent can improve patient engagement in a large, national healthcare system, which could improve patient safety. Further research is needed to focus on understanding the impact of the VHA’s SIC policy on other measures of guideline-concordant opioid therapy and on serious adverse events.”
Avoundjian T, Troszak L, Cohen J, Foglia MB, Trafton J, Midboe A. Impact of Informed Consent and Education on Care Engagement After Opioid Initiation in the Veterans Health Administration. J Pain Res. Published online May 25, 2022. doi:10.2147/JPR.S317183