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Contemp Clin Trials. 2018 Nov 8;76:1-8. doi: 10.1016/j.cct.2018.11.007. [Epub ahead of print]

Randomized evaluation of trial acceptability by INcentive (RETAIN): Study protocol for two embedded randomized controlled trials.

Author information

1
Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA; Palliative and Advanced Illness Research Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA; Center for Health Incentives and Behavioral Economics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA; Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA, USA. Electronic address: Dustin.Krutsinger@uphs.upenn.edu.
2
Palliative and Advanced Illness Research Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
3
Palliative and Advanced Illness Research Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA; Department of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
4
Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
5
Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
6
Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA; Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
7
Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
8
Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA; Center for Health Incentives and Behavioral Economics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA; Department of Health Care Management, The Wharton School, University of Pennsylvania, Philadelphia, PA, USA; Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA, USA.
9
Department of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA; Department of Health Care Management, The Wharton School, University of Pennsylvania, Philadelphia, PA, USA; Family Medicine and Community Health, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States; Department of Anthropology, University of Pennsylvania School of Arts and Sciences, Philadelphia, PA, United States.
10
Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA; Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA; Penn Memory Center at the Penn Neuroscience Center, Philadelphia, PA, USA; Department of Neurology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
11
Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA; Center for Health Incentives and Behavioral Economics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA; Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA, USA; Department of Health Care Management, The Wharton School, University of Pennsylvania, Philadelphia, PA, USA.
12
Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA; Center for Health Incentives and Behavioral Economics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA; Department of Health Care Management, The Wharton School, University of Pennsylvania, Philadelphia, PA, USA; Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA, USA; Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
13
Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA; Palliative and Advanced Illness Research Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA; Center for Health Incentives and Behavioral Economics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA; Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA, USA; Department of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA; Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.

Abstract

INTRODUCTION:

The most common and conceptually sound ethical concerns with financial incentives for research participation are that they may (1) represent undue inducements by blunting peoples' perceptions of research risks, thereby preventing fully informed consent; or (2) represent unjust inducements by encouraging enrollment preferentially among the poor. Neither of these concerns has been shown to manifest in studies testing the effects of incentives on decisions to participate in hypothetical randomized clinical trials (RCTs), but neither has been assessed in real RCTs.

METHODS AND ANALYSES:

We are conducting randomized trials of real incentives embedded within two parent RCTs. In each of two trials conducted in parallel, we are randomizing 576 participants to one of three incentive groups. Following preliminary determination of patients' eligibility in the parent RCT, we assess patients' research attitudes, demographic characteristics, perceived research risks, time spent reviewing consent documents, ability to distinguish research from patient care, and comprehension of key trial features. These quantitative assessments will be supplemented by semi-structured interviews for a selected group of participants that more deeply explore patients' motivations for trial participation. The trials are each designed to have adequate power to rule out undue and unjust inducement. We are also exploring potential benefits of incentives, including possible increased attention to research risks and cost-effectiveness.

KEYWORDS:

Behavioral economics; Ethics; Incentives; Nudge; Randomized controlled trials

PMID:
30414865
DOI:
10.1016/j.cct.2018.11.007

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