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Trials. 2015 Feb 27;16:67. doi: 10.1186/s13063-015-0590-8.

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

Author information

1
Center for Health Care Policy and Research, University of California Davis, 2103 Stockton Blvd, Suite 2224, Sacramento, CA, 95817, USA. colin.barr@ucdmc.ucdavis.edu.
2
Center for Health Care Policy and Research, University of California Davis, 2103 Stockton Blvd, Suite 2224, Sacramento, CA, 95817, USA. mtstoecklin@ucdavis.edu.
3
Department of General Internal Medicine, University of California San Francisco, 1545 Divisadero St, Suite 308, San Francisco, CA, 94118, USA. sim@medicine.ucsf.edu.
4
Open mHealth, 412 Broadway, Floor 2, New York, NY, 10013, USA. sim@medicine.ucsf.edu.
5
Department of Biostatistics and Center for Evidence Based Medicine, Brown University School of Public Health, 121 South Main Street, Providence, RI, 02912, USA. Christopher_Schmid@brown.edu.
6
Department of Physical Medicine & Rehabilitation, 4150 V Street, Suite 1200, Sacramento, CA, 95817, USA. barth.wilsey@ucdmc.ucdavis.edu.
7
VA Northern California Health Care System, 10535 Hospital Way, Mather, CA, 95655, USA. barth.wilsey@ucdmc.ucdavis.edu.
8
Betty Irene Moore School of Nursing, University of California Davis, 4610 X Street, Sacramento, CA, 95817, USA. deborah.ward@ucdmc.ucdavis.edu.
9
Department of Psychiatry, Columbia University, 1051 Riverside Drive, Unit 48, New York, NY, 10032, USA. Naihua.Duan@Columbia.edu.
10
Division of General Internal Medicine & Health Services Research, Department of Medicine, University of California Los Angeles, 911 Broxton Avenue, Los Angeles, CA, 90024, USA. drhays@ucla.edu.
11
Open mHealth, 412 Broadway, Floor 2, New York, NY, 10013, USA. joshua.selsky@gmail.com.
12
Cornell Tech, 111 8th Avenue, Number 302, New York, NY, 10011, USA. joshua.selsky@gmail.com.
13
Department of Biostatistics and Center for Evidence Based Medicine, Brown University School of Public Health, 121 South Main Street, Providence, RI, 02912, USA. joseph_servadio@brown.edu.
14
2Know, Inc, 257 Gold Street #1408, Brooklyn, NY, 11201, USA. marc@2know.com.
15
Center for Health Care Policy and Research, University of California Davis, 2103 Stockton Blvd, Suite 2224, Sacramento, CA, 95817, USA. cvdsouza@ucdavis.edu.
16
Center for Health Care Policy and Research, University of California Davis, 2103 Stockton Blvd, Suite 2224, Sacramento, CA, 95817, USA. nkdhammi@ucdavis.edu.
17
Department of Internal Medicine, University of California Davis, 4150 V Street, Suite 3100, Sacramento, CA, 95817, USA. zachary.holt@ucdmc.ucdavis.edu.
18
University of California Davis Medical Group - Folsom, 1370 Prairie City Road, Folsom, CA, 95630, USA. victor.baquero@ucdmc.ucdavis.edu.
19
University of California Davis Medical Group - Sacramento, 2825 J Street, Suite 300, Sacramento, CA, 95816, USA. scott.macdonald@ucdmc.ucdavis.edu.
20
Department of Family and Community Medicine, University of California Davis, 4860 Y Street, Suite 2300, Sacramento, CA, 95817, USA. anthony.jerant@ucdmc.ucdavis.edu.
21
University of California Davis Medical Group - Davis, 2660 West Covell Boulevard, Suites A, B and C, Davis, CA, 95616, USA. ron.sprinkle@ucdmc.ucdavis.edu.
22
Center for Health Care Policy and Research, University of California Davis, 2103 Stockton Blvd, Suite 2224, Sacramento, CA, 95817, USA. rlkravitz@ucdavis.edu.
23
Department of Internal Medicine, University of California Davis, 4150 V Street, Suite 3100, Sacramento, CA, 95817, USA. rlkravitz@ucdavis.edu.

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.

TRIAL REGISTRATION:

ClinicalTrials.gov: NCT02116621 , first registered 15 April 2014.

PMID:
25881274
PMCID:
PMC4367894
DOI:
10.1186/s13063-015-0590-8
[Indexed for MEDLINE]
Free PMC Article

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