Randomized prospective trial to detect and distinguish between medication nonadherence, drug-drug interactions, and disease progression in chronic cardiometabolic disease

Abstract

Background: Disentangling nonadherence (NA), drug-drug interactions (DDIs), and disease progression from each other is an important clinical challenge for providers caring for patients with cardiometabolic diseases. NAs and DDIs are both ubiquitous and often overlooked. We studied a novel chronic disease management (CDM) test to detect medication adherence and the presence and severity of DDIs.

Materials and methods: We conducted a prospective, randomized controlled trial of 236 primary care physicians using computer-based, simulated patients, measuring clinical care with and without access to the CDM test. The primary outcomes were whether use of the CDM test increased the accuracy of diagnoses and ordering better treatments and how effective the intervention materials were in getting participants to order the CDM test.

Results: Physicians given the CDM test results showed a + 13.2% improvement in their diagnosis and treatment quality-of-care scores (p < 0.001) in the NA patient cases and a + 13.6% improvement in the DDI cases (p < 0.001). The difference-in-difference calculations between the intervention and control groups were + 10.4% for NA and + 10.8% for DDI (p < 0.01 for both). After controlling for physician and practice co-factors, intervention, compared to control, was 50.4x more likely to recognize medication NA and 3.3x more likely to correctly treat it. Intervention was 26.9x more likely to identify the DDI and 15.7x more likely to stop/switch the interacting medication compared to control. We found no significant improvements for the disease progression patient cases.

Conclusion: Distinguishing between nonadherence, drug-drug interactions, and disease progression is greatly improved using a reliable test, like the CDM test; improved diagnostic accuracy and treatment has the potential to improve patient quality of life, medication safety, clinical outcomes, and efficiency of health delivery.

Trial registration: clinicaltrials.gov (NCT05192590).

Keywords: Adverse drug reactions; Cardiometabolic diseases; Disease progression; Drug-drug interactions; Medication nonadherence; Polypharmacy.