Intensive insulin-adherence interventions that target patients with type 2 diabetes who are most at risk for noncompliance show more benefit than blanket interventions for all patients regardless of risk, new research shows.
“If we have a set amount of resources that we could use to help patients, what is the best way to help them from a population health perspective — giving those in need more help or helping everyone to a smaller degree?” asked researchers, led by Julie C. Lauffenburger, PharmD, PhD.
“This study helps answer that question, and to our knowledge, no study had definitively evaluated this type of question in a randomized way before, especially using predictive algorithms to facilitate the targeting,” said Lauffenburger, of the Department of Medicine, Center for Healthcare Delivery Sciences, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts.
“This study suggests that with a given set of resources, healthcare organizations and clinicians should consider targeting more intensive interventions to those in greatest need, particularly based on both disease control and predicted risk of nonadherence, because that approach appears to be more effective than untargeted approaches,” she observed.
Three Levels of Intervention in the Study
Lauffenburger and colleagues note that patient adherence to type 2 diabetes medications, especially insulin, “remains poor.”
For the study, published online March 15 in JAMA Network Open, they embedded a clinical trial within a large health insurance system and limited the exclusion criteria. They assessed 6000 patients with type 2 diabetes who were receiving basal insulin over age 18 years enrolled with Horizon health insurance in New Jersey.
“Our goal was to mimic a real-world setting to compare three equivalent-priced strategies to aid the implementation and dissemination of the most effective strategy given a set amount of resources,” they observe.
In the first group, considered the low-intensity intervention, all patients had an individually tailored telephone consultation with a clinical pharmacist and two follow-up calls.
In the second group, a more moderate-intensity consultation was provided to only 60% of patients considered at higher risk for nonadherence to insulin based on an algorithm (from analytics firm RxAnte) of pharmacy and medical claims data, including demographic and clinical information.
Patients in this group received up to six follow-up calls, in addition to two calls with their primary care clinician and/or pharmacy to clarify any questions. They were also offered participation in a weekly text messaging program focused on medication-taking behaviors, lifestyle choices, and glycemic control.
In the third group, considered high-intensity, the intervention was targeted to just 40% of patients with HbA1c levels of 8% or more and considered at high risk of nonadherence. In addition to receiving all of the components of the other interventions, these people could receive up to 12 follow-up calls, and primary care clinicians or pharmacies could be called as often as necessary.
In the consultations, pharmacists had discussions with patients about issues including their individual beliefs and expectations of their diabetes treatments. They also discussed barriers to optimal treatment and provided counseling on strategies for achieving good control.
No Difference in Insulin Persistence but Glycemic Control Better
For the primary endpoint of insulin persistence, there was no significant difference for the moderate- or high-intensity groups compared with the low-intensity group.
Greater improvements in glycemic control, however, were seen in the high-intensity group (difference from baseline in absolute HbA1c, –0.25%) compared with the low- and moderate-intensity groups, which were similar (–0.15%).
Although glycemic control was a secondary outcome, the improvement is ultimately “a more meaningful outcome in diabetes care,” the authors stress.
“Compared with an untargeted low-intensity intervention, a highly targeted high-intensity intervention improved glycemic control by a statistically significant amount.”
“Although the levels of glycemic control achieved were modest, the improvements were roughly equivalent to those anticipated from the addition of an oral hypoglycemic medication,” they write.
There were no differences between the three groups in terms of total spending or number of office visits.
The moderate-intensity group did, however, have more hospitalizations (odds ratio, 1.22) and emergency department visits (odds ratio, 1.38) compared with the low-intensity group. Targeting interventions to those with good glycemic control, potentially leading to increased hypoglycemia, could explain the unexpected finding, the authors note.
“In other words, administering interventions to patients who were predicted to be nonpersistent without considering their actual glycemic control could have led to worsened outcomes requiring hospitalization,” they write.
Only a Third of Patients Stuck With Intervention
Compliance with the intervention was relatively low in all groups: only 24.7% of those in the low-intensity group, 30.7% in the medium-intensity group, and 34.3% in the high-intensity group completed the telephone consultation with a pharmacist.
Lauffenburger noted that the response rates are similar to those seen in other studies and that the low rates could reflect the fact that the patients who were targeted were more difficult to engage.
“While many healthcare organizations, particularly health insurers, use telephonic management programs to outreach to members, the telephone reach rates can be fairly low, especially in a commercially insured population such as this,” she observed.
The study was funded by Sanofi. Lauffenburger has reported receiving grants from Sanofi during the study and from AstraZeneca outside the submitted work.
JAMA Netw Open. Published March 15, 2019. Full text