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 Holt, Victor Baquero, Scott MacDonald, Anthony Jerant, Ron Sprinkle, Richard L Kravitz, 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 Holt, Victor Baquero, Scott MacDonald, Anthony Jerant, Ron Sprinkle, Richard L Kravitz

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.

Figures

Figure 1
Figure 1
Participant flow through recruitment process.
Figure 2
Figure 2
Screenshot of the Trialist app showing a graph of a user’s responses to the daily questionnaire.
Figure 3
Figure 3
Screenshots of the Trialist app showing a question from the daily questionnaire and the ‘Reminders’ screen.

References

    1. Kröner-Herwig B. Chronic pain syndromes and their treatment by psychological interventions. Curr Opin Psychiatry. 2009;22(2):200–4. doi: 10.1097/YCO.0b013e3283252d5a.
    1. IOM (Institute of Medicine) Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research. Washington, DC: National Academies Press; 2011.
    1. Dobscha SK, Corson K, Flores JA, Tansill EC, Gerrity MS. Veterans Affairs primary care clinicians’ attitudes toward chronic pain and correlates of opioid prescribing rates. Pain Med. 2008;9(5):564–71. doi: 10.1111/j.1526-4637.2007.00330.x.
    1. Gureje O, Von Korff M, Simon GE, Gater R. Persistent pain and well-being: a World Health Organization Study in Primary Care. JAMA. 1998;280(2):147–51. doi: 10.1001/jama.280.2.147.
    1. Tsang A, Von Korff M, Lee S, Alonso J, Karam E, Angermeyer MC, et al. Common chronic pain conditions in developed and developing countries: gender and age differences and comorbidity with depression-anxiety disorders. J Pain. 2008;9(10):883–91. doi: 10.1016/j.jpain.2008.05.005.
    1. Leyshon RT. Coping with chronic pain: current advances and practical information for clinicians. Work. 2009;33(3):369–72.
    1. Sheather-Reid RB, Cohen ML. Efficacy of analgesics in chronic pain: a series of N-of-l studies. J Pain Symptom Manage. 1998;15(4):244–52. doi: 10.1016/S0885-3924(98)00369-8.
    1. Corson K, Doak MN, Denneson L, Crutchfield M, Soleck G, Dickinson KC, et al. Primary care clinician adherence to guidelines for the management of chronic musculoskeletal pain: results from the study of the effectiveness of a collaborative approach to pain. Pain Med. 2011;12(10):1490–501. doi: 10.1111/j.1526-4637.2011.01231.x.
    1. Warner M, Chen LH, Makuc DM. Increase in fatal poisonings involving opioid analgesics in the United States, 1999-2006. NCHS Data Brief. 2009;22:1–8.
    1. Dobscha SK, Corson K, Perrin NA, Hanson GC, Leibowitz RQ, Doak MN, et al. Collaborative care for chronic pain in primary care: a cluster randomized trial. JAMA. 2009;301(12):1242–52. doi: 10.1001/jama.2009.377.
    1. Turk DC. The potential of treatment matching for subgroups of patients with chronic pain: lumping versus splitting. Clin J Pain. 2005;21(1):44–55. doi: 10.1097/00002508-200501000-00006.
    1. Guyatt G, Sackett D, Taylor DW, Chong J, Roberts R, Pugsley S. Determining optimal therapy-randomized trials in individual patients. N Engl J Med. 1986;314(14):889–92. doi: 10.1056/NEJM198604033141406.
    1. Kravitz RL, Duan N, NiedzinskiI EJ, Hay MC, Subramanian SK, Weisner TS. What ever happened to N-of-1 trials? Insiders’ perspectives and a look to the future. Milbank Q. 2008;86(4):533–55. doi: 10.1111/j.1468-0009.2008.00533.x.
    1. Duan N, Kravitz RL, Schmid CH. Single-patient (n-of-1) trials: a pragmatic clinical decision methodology for patient-centered comparative effectiveness research. J Clin Epidemiol. 2013;66(8 Suppl):21–8. doi: 10.1016/j.jclinepi.2013.04.006.
    1. Cook DJ. Randomized trials in single subjects: the N of 1 study. Psychopharmacol Bull. 1996;32(3):363–7.
    1. Dallery J, Cassidy RN, Raiff BR. Single-case experimental designs to evaluate novel technology-based health interventions. J Med Internet Res. 2013;15(2):268–84. doi: 10.2196/jmir.2227.
    1. Kravitz RL, Duan N, Braslow J. Evidence-based medicine, heterogeneity of treatment effects, and the trouble with averages. Milbank Q. 2004;82(4):661–87. doi: 10.1111/j.0887-378X.2004.00327.x.
    1. Kravitz RL, Paterniti DA, Hay MC, Subramanian S, Dean DE, Weisner T, et al. Marketing therapeutic precision: potential facilitators and barriers to adoption of n-of-1 trials. Contemp Clin Trials. 2009;30(5):436–45. doi: 10.1016/j.cct.2009.04.001.
    1. Folaranmi T. mHealth in Africa: challenges and opportunities. Perspect Publ Health. 2014;134(1):14–5. doi: 10.1177/1757913913514703.
    1. Kay M, Santos J, Takane M, WHO Global Observatory for eHealth. mHealth: new horizons for health through mobile technologies: second global survey on eHealth. 2011;3.
    1. Pellegrini CA, Duncan JM, Moller AC, Buscemi J, Sularz A, DeMott A, et al. A smartphone-supported weight loss program: design of the ENGAGED randomized controlled trial. BMC Public Health. 2012;12:1041. doi: 10.1186/1471-2458-12-1041.
    1. Luxton DD, McCann RA, Bush NE, Mishkind MC, Reger GM. mHealth for mental health: integrating smartphone technology in behavioral healthcare. Prof Psychol-Rer Pr. 2011;42(6):505–12. doi: 10.1037/a0024485.
    1. Schnall R, Okoniewski A, Tiase V, Low A, Rodriguez M, Kaplan S. Using text messaging to assess adolescents’ health information needs: an ecological momentary assessment. J Med Internet Res. 2013;15(3):101–9. doi: 10.2196/jmir.2395.
    1. Stinson JN, Petroz GC, Tait G, Feldman BM, Streiner D, McGrath PJ, et al. e-Ouch: usability testing of an electronic chronic pain diary for adolescents with arthritis. Clin J Pain. 2006;22(3):295–305. doi: 10.1097/01.ajp.0000173371.54579.31.
    1. Stinson JN, Stevens BJ, Feldman BM, Streiner D, McGrath PJ, Dupuis A, et al. Construct validity of a multidimensional electronic pain diary for adolescents with arthritis. Pain. 2008;136(3):281–92. doi: 10.1016/j.pain.2007.07.002.
    1. Kristjansdottir OB, Fors EA, Eide E, Finset A, Stensrud TL, van Dulmen S, et al. A smartphone-based intervention with diaries and therapist-feedback to reduce catastrophizing and increase functioning in women with chronic widespread pain: randomized controlled trial. J Med Internet Res. 2013;15(1):41–62. doi: 10.2196/jmir.2249.
    1. Glynn LG, Hayes PS, Casey M, Glynn F, Alvarez-Iglesias A, Newell J, et al. SMART MOVE-a smartphone-based intervention to promote physical activity in primary care: study protocol for a randomized controlled trial. Trials. 2013;14:157. doi: 10.1186/1745-6215-14-157.
    1. Duncan MJ, Vandelanotte C, Rosenkranz RR, Caperchione CM, Ding H, Ellison M, et al. Effectiveness of a website and mobile phone based physical activity and nutrition intervention for middle-aged males: trial protocol and baseline findings of the ManUp Study. BMC Public Health. 2012;12:656. doi: 10.1186/1471-2458-12-656.
    1. Mobile future in focus 2013. comScore: . Accessed 14 February 2014.
    1. Krebs EE, Bair MJ, Damush TM, Tu WZ, Wu JW, Kroenke K. Comparative responsiveness of pain outcome measures among primary care patients with musculoskeletal pain. Med Care. 2010;48(11):1007–14. doi: 10.1097/MLR.0b013e3181eaf835.
    1. Krebs EE, Lorenz KA, Bair MJ, Damush TM, Wu JW, Sutherland JM, et al. Development and initial validation of the PEG, a three-item scale assessing pain intensity and interference. J Gen Intern Med. 2009;24(6):733–8. doi: 10.1007/s11606-009-0981-1.
    1. Ward D, Wanlass R, Fishman D, Myers S. Pain self-management strategies. . Accessed 18 February 2014.
    1. Rosser BA, McCracken LM, Velleman SC, Boichat C, Eccleston C. Concerns about medication and medication adherence in patients with chronic pain recruited from general practice. Pain. 2011;152(5):1201–5. doi: 10.1016/j.pain.2011.01.053.
    1. McCracken LM, Hoskins J, Eccleston C. Concerns about medication and medication use in chronic pain. J Pain. 2006;7(10):726–34. doi: 10.1016/j.jpain.2006.02.014.
    1. Consumer Assessment of Healthcare Providers and Systems (CAHPS) Program . CAHPS® Clinician & Group Surveys - Supplemental Items for the Adult Surveys 2.0. Rockville, MD: Agency for Healthcare Research and Quality (AHRQ); 2012.
    1. Hays RD, Berman LJ, Kanter MH, Hugh M, Oglesby RR, Kim CY, et al. Evaluating the psychometric properties of the CAHPS® Patient-centered Medical Home survey. Clin Ther. 2014;36(5):689–96. doi: 10.1016/j.clinthera.2014.04.004.
    1. Scholle SH, Vuong O, Ding L, Fry S, Gallagher P, Brown JA, et al. Development of and field test results for the CAHPS® PCMH Survey. Med Care. 2012;50(Suppl):2–10. doi: 10.1097/MLR.0b013e3182610aba.
    1. Evans CJ, Trudeau E, Mertzanis XXX, Marquis P, Pena BM, Wong J, et al. Development and validation of the pain treatment satisfaction scale (ptss): a patient satisfaction questionnaire for use in patients with chronic or acute pain. Pain. 2004;112(3):254–66. doi: 10.1016/j.pain.2004.09.005.
    1. Thom DH, Wong ST, Guzman D, Wu A, Penko J, Miaskowski C, et al. Physician trust in the patient: development and validation of a new measure. Ann Fam Med. 2011;9(2):148–54. doi: 10.1370/afm.1224.
    1. Hays RD, Bjorner JB, Revicki DA, Spritzer KL, Cella D. Development of physical and mental health summary scores from the patient-reported outcomes measurement information system (PROMIS) global items. Qual Life Res. 2009;18(7):873–80. doi: 10.1007/s11136-009-9496-9.
    1. Payne KFB, Wharrad H, Watts K. Smartphone and medical related App use among medical students and junior doctors in the United Kingdom (UK): a regional survey. BMC Med Inform Decis Mak. 2012;12:121. doi: 10.1186/1472-6947-12-121.
    1. Consumer Assessment of Healthcare Providers and Systems (CAHPS) Program . CAHPS® Clinician & Group Surveys - 12-Month Survey 2.0. Rockville, MD: Agency for Healthcare Research and Quality (AHRQ); 2011.
    1. Brooke J. SUS: A ‘quick and dirty’ usability scale. In: Jordan PW, Thomas BA, Weerdmeester I, McClelland IL, editors. Usability evaluation in industry. London: Taylor & Francis; 1996. pp. 189–94.
    1. Group Health Cooperative. Internet-based medication adherence program for nicotine dependence treatment. . Bethesda (MD): National Library of Medicine (US). .
    1. Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap) - a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009;42(2):377–81. doi: 10.1016/j.jbi.2008.08.010.
    1. Freier A, Karlton P, Kocher P. The Secure Sockets Layer (SSL) Protocol version 3.0. Internet Engineering Task Force (IETF). ; 2011.
    1. Dierks T, Rescorla E. The Transport Layer Security (TLS) Protocol version 1.2. Internet Engineering Task Force (IETF). .
    1. Sehgal N, Colson J, Smith HS. Chronic pain treatment with opioid analgesics: benefits versus harms of long-term therapy. Expert Rev Neurother. 2013;13(11):1201–20. doi: 10.1586/14737175.2013.846517.
    1. Greenfield S, Kaplan S, Ware JEJ. Expanding patient involvement in care effects on patient outcomes. Ann Intern Med. 1985;102(4):520–8. doi: 10.7326/0003-4819-102-4-520.
    1. Hay MC, Weisner TS, Subramanian S, Duan N, Niedzinski EJ, Kravitz RL. Harnessing experience: exploring the gap between evidence-based medicine and clinical practice. J Eval Clin Pract. 2008;14(5):707–13. doi: 10.1111/j.1365-2753.2008.01009.x.

Source: PubMed

Спонсоры и соавторы

Заболевания

Медикаментозные вмешательства

Подписаться