The PREEMPT study - evaluating smartphone-assisted n-of-1 trials in patients with chronic pain: Study protocol for a randomized controlled trial

Colin Barr, Maria Marois, Ida Sim, Christopher H. Schmid, Barth Wilsey, Deborah Ward, Naihua Duan, Ron D. Hays, Joshua Selsky, Joseph Servadio, Marc Schwartz, Clyde Dsouza, Navjot Dhammi, Zachary B Holt, Victor Baquero, Scott MacDonald, Anthony F Jerant, Ron Sprinkle, Richard L Kravitz

Research output: Contribution to journalArticle

23 Scopus citations

Abstract

Background: Chronic pain is prevalent, costly, and clinically vexatious. Clinicians typically use a trial-and-error approach to treatment selection. Repeated crossover trials in a single patient (n-of-1 trials) may provide greater therapeutic precision. N-of-1 trials are the most direct way to estimate individual treatment effects and are useful in comparing the effectiveness and toxicity of different analgesic regimens. The goal of the PREEMPT study is to test the 'Trialist' mobile health smartphone app, which has been developed to make n-of-1 trials easier to accomplish, and to provide patients and clinicians with tools for individualizing treatments for chronic pain. Methods/design: A randomized controlled trial is being conducted to test the feasibility and effectiveness of the Trialist app. A total of 244 participants will be randomized to either the Trialist app intervention group (122 patients) or a usual care control group (122 patients). Patients assigned to the Trialist app will work with their clinicians to set up an n-of-1 trial comparing two pain regimens, selected from a menu of flexible options. The Trialist app provides treatment reminders and collects data entered daily by the patient on pain levels and treatment side effects. Upon completion of the n-of-1 trial, patients review results with their clinicians and develop a long-term treatment plan. The primary study outcome (comparing Trialist to usual care patients) is pain-related interference with daily functioning at 26 weeks. Discussion: Trialist will allow patients and clinicians to conduct personalized n-of-1 trials. In prior studies, n-of-1 trials have been shown to encourage greater patient involvement with care, which has in turn been associated with better health outcomes. mHealth technology implemented using smartphones may offer an efficient means of facilitating n-of-1 trials so that more patients can benefit from this approach.

Original languageEnglish (US)
Pages (from-to)1-11
Number of pages11
JournalTrials
DOIs
StateAccepted/In press - Feb 27 2015

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Keywords

  • Chronic pain
  • eHealth
  • mHealth
  • N-of-1
  • Randomized controlled trial
  • Smartphone

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Pharmacology (medical)

Cite this

Barr, C., Marois, M., Sim, I., Schmid, C. H., Wilsey, B., Ward, D., Duan, N., Hays, R. D., Selsky, J., Servadio, J., Schwartz, M., Dsouza, C., Dhammi, N., Holt, Z. B., Baquero, V., MacDonald, S., Jerant, A. F., Sprinkle, R., & Kravitz, R. L. (Accepted/In press). The PREEMPT study - evaluating smartphone-assisted n-of-1 trials in patients with chronic pain: Study protocol for a randomized controlled trial. Trials, 1-11. https://doi.org/10.1186/s13063-015-0590-8