Using Clinical Trial Data to Estimate the Costs of Behavioral Interventions for Potential Adopters: A Guide for Trialists

Abstract

Behavioral interventions involving electronic devices, financial incentives, gamification, and specially trained staff to encourage healthy behaviors are becoming increasingly prevalent and important in health innovation and improvement efforts. Although considerations of cost are key to their wider adoption, cost information is lacking because the resources required cannot be costed using standard administrative billing data. Pragmatic clinical trials that test behavioral interventions are potentially the best and often only source of cost information but rarely incorporate costing studies. This article provides a guide for researchers to help them collect and analyze, during the trial and with little additional effort, the information needed to inform potential adopters of the costs of adopting a behavioral intervention. A key challenge in using trial data is the separation of implementation costs, the costs an adopter would incur, from research costs. Based on experience with 3 randomized clinical trials of behavioral interventions, this article explains how to frame the costing problem, including how to think about costs associated with the control group, and describes methods for collecting data on individual costs: specifications for costing a technology platform that supports the specialized functions required, how to set up a time log to collect data on the time staff spend on implementation, and issues in getting data on device, overhead, and financial incentive costs.

Trial registration: ClinicalTrials.gov NCT02708654 NCT01798784 NCT02246959.

Keywords: behavioral intervention; clinical trial; costing; medication adherence; outcomes research; pragmatic trial; preventive services; translating research into practice.

Conflict of interest statement

Conflicts of interest. Drs Asch and Volpp are partners at VAL Health, and Dr Troxel is on VAL Health’s Scientific Advisory Board. Dr. Volpp has served as a consultant for CVS Caremark and received research funding from CVS, Weight Watchers, Humana, Vitality/Discovery, Oscar, and Hawaii Medical Services Association. The other authors report no conflicts.

Figures

Figure 1

Flow chart of steps and methods.