Key result
Telehealth medication optimization achieves ~96% adherence across both PCI and placebo groups.
Why the study?
Detailed assessment of medication adherence was conducted to measure the efficacy of implementing a telehealth medication optimization protocol and assist interpretation of the main trial endpoints.
Does a telehealth-based medication optimization protocol achieve high medication adherence in patients with stable angina undergoing PCI or a placebo procedure?
RCT
Placebo-controlled
Randomized
Yes
Does a telehealth-based medication optimization protocol achieve high medication adherence in patients with stable angina undergoing PCI or a placebo procedure?
A telehealth-based medication optimization protocol achieved very high adherence rates in patients with stable angina, validating the medical therapy implementation in the ORBITA trial.
Supports ORBITA medical therapy implementation; leaves open whether telehealth optimization improves outcomes in routine practice.
INTRODUCTION: The ORBITA trial of percutaneous coronary intervention (PCI) versus a placebo procedure for patients with stable angina was conducted across six sites in the United Kingdom via home monitoring and telephone consultations. Patients underwent detailed assessment of medication adherence which allowed us to measure the efficacy of the implementation of the optimization protocol and interpretation of the main trial endpoints. METHODS: Prescribing data were collected throughout the trial. Self-reported adherence was assessed, and urine samples collected at pre-randomization and at follow-up for direct assessment of adherence using high-performance liquid chromatography with tandem mass spectrometry (HPLC MS/MS). RESULTS: Self-reported adherence was >96% for all drugs in both treatment groups at both stages. The percentage of samples in which drug was detected at pre-randomization and at follow-up in the PCI versus placebo groups respectively was: clopidogrel, 96% versus 90% and 98% versus 94%; atorvastatin, 95% versus 92% and 92% versus 91%; perindopril, 95% versus 97% and 85% versus 100%; bisoprolol, 98% versus 99% and 96% versus 97%; amlodipine, 99% versus 99% and 94% versus 96%; nicorandil, 98% versus 96% and 94% versus 92%; ivabradine, 100% versus 100% and 100% versus 100%; and ranolazine, 100% versus 100% and 100% versus 100%. CONCLUSIONS: Adherence levels were high throughout the study when quantified by self-reporting methods and similarly high proportions of drug were detected by urinary assay. The results indicate successful implementation of the optimization protocol delivered by telephone, an approach that could serve as a model for treatment of chronic conditions, particularly as consultations are increasingly conducted online.
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Thompson et al. (2021) conducted an RCT in Stable angina. Percutaneous coronary intervention (PCI) vs. Placebo procedure was evaluated on Medication adherence (self-reported and urinary assay). A telehealth medication optimization protocol achieved >96% self-reported adherence and high urinary assay detection rates in both PCI and placebo groups.
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