Opt-out Approach Ups Trial Participation Among Patients Post-MI

Research on health interventions like remote monitoring for medical adherence may be furthered by an “opt-out” approach to enrollment. In a new analysis, potential trial participants who received all that they needed to enroll then were given the chance to opt out, were more likely to take part in the study than if they had to choose to “opt in.”

The opt-out approach may help give a much-needed boost to flagging rates of clinical trial enrollment, researchers say.

“There’s a lot of interest out there, from a clinical standpoint, in terms of how to engage patients when they’re not seeing us,” Shivan J. Mehta, MD (University of Pennsylvania, Philadelphia), told TCTMD. This is becoming ever more important, he said, in an era when patient outcomes and their role in value-based care are receiving greater emphasis.

For their study published online September 7, 2016, in JAMA Cardiology, Mehta and colleagues compared two groups:

  • an opt-in cohort (n = 235) derived from a larger study looking at how to encourage medication adherence among patients with fee-for-service Medicare coverage who were discharged from the University of Pennsylvania Health System after an MI
  • an opt-out cohort (n = 52) who had other insurance types (making them ineligible to participate in the Medicare-focused study) but were otherwise similar

The opt-out group were mailed pill bottles equipped for remote monitoring after hospital discharge, whereas the controls only received the supplies after agreeing to participate. No other aspects of the recruitment process, including the need to give verbal consent, differed between the two.

Even with the opt-out method, patients still had autonomy, Mehta stressed. “But they actually had the kit there, so it was much more tangible. They can see what it is, they can see what it’s like—as opposed to getting a random phone call from a person they don’t know, where typically most of us, our default is to say no.”

In this analysis, the proportion who said yes to using the special bottles was higher with the opt-out strategy than with the opt-in approach (38.5% vs 15.7%; P < 0.001). Among those who agreed to take part in the remote-monitoring study, there were no differences in the number of days patients’ opened their bottles over the first 3 months based on their enrollment method.

However, perhaps not surprisingly, there was a greater loss of equipment in the opt-out group: 38.5% of people sent bottles by default actually used them, compared with 56.8% of those in the opt-in group who elected to participate (P = 0.09). Were this to be implemented on a larger scale, Mehta said, this aspect would need to be addressed, possibly by requiring nonparticipants to mail back their kits, “because there are cost implications and you wouldn’t want to necessarily waste these devices.”


  • Mehta SJ, Troxel AB, Marcus N, et al. Participation rates with opt-out enrollment in a remote monitoring intervention for patients with myocardial infarction. JAMA Cardiol. 2016;Epub ahead of print.

  • Mehta reports no relevant conflicts of interest.

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