Casting doubt: Are compound interventions effective for improving medication adherence and clinical outcomes?
Thursday, July 6, 2017
Alan Menius, Chief Data Scientist, spencer Health Solutions, LLC
An article in MobiHealthNews provides perspective on HeartStrong, a randomized study of 1500+ patients, published in JAMA Internal Medicine. HeartStrong studied the effectiveness of wireless technology, such as electronic medication reminders, and behavioral economic approaches, including financial incentives and social support, on delaying subsequent vascular events in patients following acute myocardial infarction (AMI) compared with usual care.
Patients aged 18 to 80 years were eligible if currently prescribed at least 2 of 4 study medications (statin, aspirin, ?-blocker, antiplatelet agent), and were hospital inpatients for 1 to 180 days and discharged home with a principal diagnosis of AMI. Patients were randomized 2:1 to a 12-month health plan-intermediated intervention using electronic pill bottles (Vitality Glowcap) combined with lottery incentives and social support for medication adherence (1000+ patients), or to usual care (500+ patients.) 35.5% of participants were female (n=536); mean (SD) age was 61.0 (10.3) years.
The study casts doubt on the effectiveness of compound interventions on the improvement of medication adherence or clinical outcomes. There were no statistically significant differences between study arms in time-to-first re-hospitalization for a vascular event or death, medication adherence, or total medical cost.
After reviewing the full text of the study, I have several observations.
How can we better engage patients for greater adherence rates?
Primary analyses were conducted as intention-to-treat; that is, all patients were analyzed regardless of whether they used the technology. While no statistically-significant differences were determined for any of the primary endpoints, it was noted that 12.5% of the intervention group did not activate their pill bottles. This begs the question of how would adherence and the other primary endpoints have been impacted if more than the intervention group had utilized the technology.
While study results are approaching statistical significance, why isn’t technology making a larger impact on adherence?
The secondary analyses included only those patients in the intervention group that followed the protocol by activating their pill bottles and enrolling a feedback partner. The intervention group had statistically-significantly lower readmission rates, including all-cause inpatient hospitalization HR, 0.79; 95% CI, 0.63-0.99, P = .03, higher mean adherence (0.48 [0.40] vs 0.42 [0.39]; P = .06). The study also shows lower mean annual medical spending ($21239 [$57611] vs $29810 [$74842], difference = -$8571; 95% CI, -$16542 to -$601; P = .04).
The MobiHealthNews article quotes Justin Wright, Eli Lilly Vice President of Drug Delivery Innovation, as saying that pharma thinking has already moved on from these sorts of technology-driven adherence initiatives. “We don’t talk about adherence anymore, it’s about patient engagement,” Wright said.
Wright’s comments seem to make the claim that adherence isn’t important anymore. However, this study wasn’t designed to measure the impact of adherence on the other endpoints, just the technology. Especially if that technology made a greater impact on adherence levels.
How do we engage the most difficult-to-engage patients?
After reviewing the full study results, I conclude that when patients are using the technology, their outcomes are better, and based on the secondary analysis of this study, statistically significant. Perhaps the question isn’t whether the technology works, but how to engage the most difficult-to-engage patients (e.g., the 12.5% that did not activate their pill bottles.) We should also consider whether ease-of-use might have a larger impact on behavior and adherence.
A technology that is easier and simpler to use might help reach non-adopters.
I noted that the Vitality Glowcap requires a different pill bottle for each medication, so study patients could have up to four Glowcap pill bottles to use, resulting in four different electronic notifications. In comparison, spencer, our in-home medication dispenser and seriously connected health partner, dispenses all pills in one package, making it simpler to use. Additionally, Vitality Glowcap has a browser-based interface for reminders and motivating messages, but is accessed separately from the pill bottles. spencer’s interface is on the device dispensing the pills, so you can see your status and progress on the same device.
My conclusion is that a technology easier and simpler to use might help reach the non-adopters, and may also further increase adherence levels of those who are adopters. spencer is a different kind of solution, built from the ground up, using key learnings from the failures of the past to create a new breed of pharmacy technology that addresses the underlying behavior around non-adherence, instead of non-adherence itself.
To learn more about spencer and how it addresses the underlying behavior around non-adherence, contact us today.