Participatory Research to Advance Colon Cancer Prevention (PROMPT): Study protocol for a pragmatic trial

Jamie H Thompson, Melinda M Davis, Michael C Leo, Jennifer L Schneider, David H Smith, Amanda F Petrik, Melissa Castillo, Brittany Younger, Gloria D Coronado, Jamie H Thompson, Melinda M Davis, Michael C Leo, Jennifer L Schneider, David H Smith, Amanda F Petrik, Melissa Castillo, Brittany Younger, Gloria D Coronado

Abstract

Background: Colon cancer is the second leading cause of cancer deaths in the United States. The Participatory Research to Advance Colon Cancer Prevention (PROMPT) study is a collaboration between two research institutions and a federally qualified health center (FQHC). The study seeks to raise colon cancer screening rates using a direct-mail fecal immunochemical testing (FIT) and reminder program in an FQHC serving a predominantly Latino population in California.

Methods: PROMPT is a pragmatic trial enrolling 16 clinics. The study will test automated and live prompts (i.e., alerts, reminders) to a direct-mail FIT program in two phases. In Phase I, we tailored and defined intervention components for the pilot using a community-based participatory research approach called boot camp translation. We then plan to conduct a three-arm patient-randomized comparative effectiveness trial in two pilot clinics to compare 1) automated prompts, 2) live prompts, and 3) a combination of automated plus live prompts to alert and remind patients to complete screening. In Phase II, the adapted best practice intervention will be spread to additional clinics within the FQHC (estimated population 27,000) and assessed for effectiveness. Patient and staff interviews will be conducted to explore receptivity to the program and identify barriers to implementation.

Discussion: This pragmatic trial applies innovative approaches to engage diverse stakeholders and will test the effectiveness and spread of a direct-mail plus reminder program. If successful, the program will provide a model for a cost-effective method to raise colon cancer screening rates among Latino patients receiving care in FQHCs.

Trial registration: National Clinical Trial (NCT) Identifier NCT03167125.

Keywords: Boot camp translation; Colon cancer screening; Community-based participatory research; Fecal immunochemical test; Pragmatic study.

Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

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References

    1. Siegel RL, Miller KD, Jemal A. Cancer statistics, 2016. CA Cancer J Clin. 2016;66(1):7–30.
    1. American Cancer Society. [Accessed October 11, 2017];Key Statistics for Colorectal Cancer. 2016 .
    1. Bibbins-Domingo K, Grossman DC, Curry SJ, Davidson KW, Epling JW, Jr, Garcia FAR, Gillman MW, Harper DM, Kemper AR, Krist AH, Kurth AE, Landefeld CS, Mangione CM, Owens DK, Phillips WR, Phipps MG, Pignone MP, Siu AL. Screening for Colorectal Cancer: US Preventive Services Task Force Recommendation Statement. JAMA. 2016;315(23):2564–2575.
    1. American Cancer Society. Cancer Facts & Figures for Hispanics/Latinos 2015–2017. Atlanta: American Cancer Society; 2015.
    1. American Cancer Society. Colorectal Cancer Facts & Figures 2017–2019. Atlanta: 2017.
    1. Nath JB, Costigan S, Lin F, Vittinghoff E, Hsia RY. Federally Qualified Health Center Access and Emergency Department Use Among Children. Pediatrics. 2016;138(4)
    1. Coronado GD, Golovaty I, Longton G, Levy L, Jimenez R. Effectiveness of a clinic-based colorectal cancer screening promotion program for underserved Hispanics. Cancer. 2011;117(8):1745–1754.
    1. Baker DW, Brown T, Buchanan DR, Weil J, Balsley K, Ranalli L, Lee JY, Cameron KA, Ferreira MR, Stephens Q, Goldman SN, Rademaker A, Wolf MS. Comparative effectiveness of a multifaceted intervention to improve adherence to annual colorectal cancer screening in community health centers: a randomized clinical trial. JAMA Intern Med. 2014;174(8):1235–1241.
    1. Goldberg D, Schiff GD, McNutt R, Furumoto-Dawson A, Hammerman M, Hoffman A. Mailings timed to patients' appointments: a controlled trial of fecal occult blood test cards. Am J Prev Med. 2004;26(5):431–435.
    1. Goldman SN, Liss DT, Brown T, Lee JY, Buchanan DR, Balsley K, Cesan A, Weil J, Garrity BH, Baker DW. Comparative Effectiveness of Multifaceted Outreach to Initiate Colorectal Cancer Screening in Community Health Centers: A Randomized Controlled Trial. J Gen Intern Med. 2015;30(8):1178–1184.
    1. Gupta S, Halm EA, Rockey DC, Hammons M, Koch M, Carter E, Valdez L, Tong L, Ahn C, Kashner M, Argenbright K, Tiro J, Geng Z, Pruitt S, Skinner CS. Comparative effectiveness of fecal immunochemical test outreach, colonoscopy outreach, and usual care for boosting colorectal cancer screening among the underserved: a randomized clinical trial. JAMA Intern Med. 2013;173(18):1725–1732.
    1. Davis MM FM, Shannon J, Coronado G, Stange K, Guise JM, Wheeler S, Buckley DI. A Systematic Review of Clinic and Community Intervention to Increase Fecal Testing for Colorectal Cancer in Rural and Low-Income Populations in the United States – How, What and When? 2017 [In Press]
    1. Goodman MJ, Ogdie A, Kanamori MJ, Canar J, O'Malley AS. Barriers and facilitators of colorectal cancer screening among Mid-Atlantic Latinos: focus group findings. Ethnicity & disease. 2006;16(1):255–261.
    1. Robinson CM, Cassells AN, Greene MA, Beach ML, Tobin JN, Dietrich AJ. Barriers to colorectal cancer screening among publicly insured urban women: no knowledge of tests and no clinician recommendation. Journal of the National Medical Association. 2011;103(8):746–753.
    1. Norman N, Bennett C, Cowart S, Felzien M, Flores M, Flores R, Haynes C, Hernandez M, Rodriquez MP, Sanchez N, Sanchez S, Winkelman K, Winkelman S, Zittleman L, Westfall JM. Boot camp translation: a method for building a community of solution. J Am Board Fam Med. 2013;26(3):254–263.
    1. Coronado GD, Rivelli JS, Fuoco MJ, Vollmer WM, Petrik AF, Keast E, Barker S, Topalanchik E, Jimenez R. Effect of Reminding Patients to Complete Fecal Immunochemical Testing: A Comparative Effectiveness Study of Automated and Live Approaches. J Gen Intern Med. 2017
    1. Glasgow RE. RE-AIMing research for application: ways to improve evidence for family medicine. J Am Board Fam Med. 2006;19(1):11–19.
    1. Glasgow RE, Klesges LM, Dzewaltowski DA, Bull SS, Estabrooks P. The future of health behavior change research: what is needed to improve translation of research into health promotion practice? Annals of behavioral medicine : a publication of the Society of Behavioral Medicine. 2004;27(1):3–12.
    1. Glasgow RE, Klesges LM, Dzewaltowski DA, Estabrooks PA, Vogt TM. Evaluating the impact of health promotion programs: using the RE-AIM framework to form summary measures for decision making involving complex issues. Health education research. 2006;21(5):688–694.
    1. Bartholomew LK, Parcel GS, Kok G. Intervention mapping: a process for developing theory- and evidence-based health education programs. Health education & behavior : the official publication of the Society for Public Health Education. 1998;25(5):545–563.
    1. Fernandez ME, Gonzales A, Tortolero-Luna G, Partida S, Bartholomew LK. Using intervention mapping to develop a breast and cervical cancer screening program for Hispanic farmworkers: Cultivando La Salud. Health promotion practice. 2005;6(4):394–404.
    1. Byrd TL, Wilson KM, Smith JL, Heckert A, Orians CE, Vernon SW, Fernandez-Esquer ME, Fernandez ME. Using intervention mapping as a participatory strategy: development of a cervical cancer screening intervention for Hispanic women. Health education & behavior : the official publication of the Society for Public Health Education. 2012;39(5):603–611.
    1. Hou SI, Fernandez ME, Parcel GS. Development of a cervical cancer educational program for Chinese women using intervention mapping. Health promotion practice. 2004;5(1):80–87.
    1. Thompson JH, Davis MM, Michaels L, Rivelli J, Castillo M, Younger B, Castro M, Reich S GC. Using boot camp translation to design a system-based intervention to improve rates of colon cancer screening among Latino patients in community health centers [In Process] 2018
    1. Hintze J. PASS 13. 2014 .
    1. Hussey MA, Hughes JP. Design and analysis of stepped wedge cluster randomized trials. Contemporary clinical trials. 2007;28(2):182–191.
    1. Brown CA, Lilford RJ. The stepped wedge trial design: a systematic review. BMC medical research methodology. 2006;6:54.
    1. Mdege ND, Man MS, Taylor Nee Brown CA, Torgerson DJ. Systematic review of stepped wedge cluster randomized trials shows that design is particularly used to evaluate interventions during routine implementation. Journal of clinical epidemiology. 2011;64(9):936–948.
    1. Hemming K, Lilford R, Girling AJ. Stepped-wedge cluster randomised controlled trials: a generic framework including parallel and multiple-level designs. Statistics in medicine. 2015;34(2):181–196.
    1. Green BB, Wang CY, Anderson ML, Chubak J, Meenan RT, Vernon SW, Fuller S. An automated intervention with stepped increases in support to increase uptake of colorectal cancer screening: a randomized trial. Annals of internal medicine. 2013;158(5 Pt 1):301–311.
    1. Mauskopf JA, Sullivan SD, Annemans L, Caro J, Mullins CD, Nuijten M, Orlewska E, Watkins J, Trueman P. Principles of good practice for budget impact analysis: report of the ISPOR Task Force on good research practices--budget impact analysis. Value Health. 2007;10(5):336–347.
    1. Coronado GD, Vollmer WM, Petrik A, Aguirre J, Kapka T, Devoe J, Puro J, Miers T, Lembach J, Turner A, Sanchez J, Retecki S, Nelson C, Green B. Strategies and opportunities to STOP colon cancer in priority populations: pragmatic pilot study design and outcomes. BMC cancer. 2014;14:55.
    1. Nguyen BH, Stewart SL, Nguyen TT, Bui-Tong N, McPhee SJ. Effectiveness of Lay Health Worker Outreach in Reducing Disparities in Colorectal Cancer Screening in Vietnamese Americans. American journal of public health. 2015:e1–e7.
    1. Enard KR, Nevarez L, Hernandez M, Hovick SR, Moguel MR, Hajek RA, Blinka CE, Jones LA, Torres-Vigil I. Patient navigation to increase colorectal cancer screening among Latino Medicare enrollees: a randomized controlled trial. Cancer causes & control : CCC. 2015
    1. Steffen LE, Boucher KM, Damron BH, Pappas LM, Walters ST, Flores KG, Boonyasiriwat W, Vernon SW, Stroup AM, Schwartz MD, Edwards SL, Kohlmann WK, Lowery JT, Wiggins CL, Hill DA, Higginbotham JC, Burt R, Simmons RG, Kinney AY. Efficacy of a Telehealth Intervention on Colonoscopy Uptake When Cost Is a Barrier: The Family CARE Cluster Randomized Controlled Trial. Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology. 2015
    1. Krok-Schoen JL, Young GS, Pennell ML, Reiter PL, Katz ML, Post DM, Tatum CM, Paskett ED. Testing Interventions to Motivate and Educate (TIME): A multi-level intervention to improve colorectal cancer screening. Preventive medicine reports. 2015;2:306–313.
    1. Rawl SM, Christy SM, Monahan PO, Ding Y, Krier C, Champion VL, Rex D. Tailored telephone counseling increases colorectal cancer screening. Health education research. 2015;30(4):622–637.
    1. Rohan EA, Boehm JE, DeGroff A, Glover-Kudon R, Preissle J. Implementing the CDC's Colorectal Cancer Screening Demonstration Program: wisdom from the field. Cancer. 2013;(119 Suppl 15):2870–2883.

Source: PubMed

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