Challenges in assessing population reach in a pragmatic trial

Beverly B Green, William M Vollmer, Erin Keast, Amanda F Petrik, Gloria D Coronado, Beverly B Green, William M Vollmer, Erin Keast, Amanda F Petrik, Gloria D Coronado

Abstract

Strategies and Opportunities to STOP Colon Cancer in Priority Populations (STOP CRC) was a pragmatic cluster-randomized trial conducted at federally qualified health centers and designed to "Reach" as many unscreened patients as possible by directly mailing them fecal screening tests. STOP CRC used an electronic health record registry to identify individuals' needing CRC screening and mail interventions to them. The registry was updated daily removing individuals completing CRC screening or those who no longer were clinic patients. Reach, a component RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance), is defined as the absolute number, percent, and representativeness of individuals "willing to participate in" or "exposed to" an initiative. We describe the complexities of measuring Reach in a pragmatic trial. Overall 21,134 patients were on the registry list for at least one day, with 18,226 remaining after removing patients completing screening before any mailings. Observed Reached (the percent of individuals exposed to the intervention) using each denominator was 30.7% and 35.6% respectively. Reach improved only modestly after accounting for factors that made it impossible for clinics to send mailings. Few differences were observed in demographic and health care utilization factors among individuals Reached versus not Reached, suggesting that health center Implementation was more influential than patients' willingness or ability to participate. A pragmatic definition of Reach that accounted for dynamic changes the absolute number eligible and the proportion exposed was more useful than traditional definitions of Reach. Actual Reach was dependent on Implementation and not patient level characteristics. Clinical Trials Registration Number: ClincalTrials.gov (NCT01742065).

Figures

Fig. 1
Fig. 1
Strategies and opportunities to STOP colon cancer study flow for the reach analysis.

References

    1. Collaboratory N. Rethinking Clinical Trials: A Living Textboox of Prgamatic Clinical Trials. 2017. cited November 7. Available from.
    1. Coronado G.D., Golovaty I., Longton G., Levy L., Jimenez R. Effectiveness of a clinic-based colorectal cancer screening promotion program for underserved Hispanics. Cancer. 2011;117:1745–1754.
    1. Coronado G.D., Vollmer W.M., Petrik A., Aguirre J., Kapka T., DeVoe J., Puro J., Miers T., Turner A., Sanchez J., Retecki S., Nelson C., Green B.B. Strategies and opportunities to STOP colon cancer in priority populations: pragmatic pilot study design and outcomes. Biomed. Central Cancer. 2014;14 (PMCID: 3936821)
    1. Coronado G., Sanchez J., Devoe J., Green B. Advantages of wordless instructions on how to complete a fecal immunochemical test: lessons from patient advisory council members of a federally qualified health center. J. Cancer Educ. 2014;29:86–90. (PMCID: 3946071)
    1. Coronado G.D., Retecki S., Schneider J., Taplin S.H., Burdick T., Green B.B. Recruiting community health centers into pragmatic research: findings from STOP CRC. Clin. Trials. 2016;13:214–222. (PMCID: 4785071)
    1. Coronado G.D., Schneider J.L., Petrik A., Rivelli J., Taplin S., Green B.B. Implementation successes and challenges in participating in a pragmatic study to improve colon cancer screening: perspectives of health center leaders. Transl. Behav. Med. 2017;7:557–566.
    1. Coronado G.D., Petrik A.F., Vollmer W.M., Taplin S.H., Keast E.M., Fields S., Green B.B. Effectiveness of a mailed colorectal cancer screening outreach program in community health clinics: the STOP CRC cluster randomized clinical trial. JAMA Intern. Med. 2018;178:1174–1181.
    1. Dougherty M.K., Brenner A.T., Crockett S.D., Gupta S., Wheeler S.B., Coker-Schwimmer M., Cubillos L., Malo T., Reuland D.S. Evaluation of interventions intended to increase colorectal cancer screening rates in the United States: a systematic review and meta-analysis. JAMA Intern. Med. 2018;178(12):1645–1658.
    1. Finlayson M., Cattaneo D., Cameron M., Coote S., Matsuda P.N., Peterson E., Sosnoff J.J. Applying the RE-AIM framework to inform the development of a multiple sclerosis falls-prevention intervention. Int. J. MS Care. 2014;16:192–197. (PMCID: PMC4321458)
    1. Glasgow R.E., Estabrooks P.E. Pragmatic applications of RE-AIM for health care initiatives in community and clinical settings. Prev. Chronic Dis. 2018;15:E02. (PMCID: PMC5757385)
    1. Glasgow R.E., Vogt T.M., Boles S.M. Evaluating the public health impact of health promotion interventions: the RE-AIM framework. Am. J. Public Health. 1999;89:1322–1327.
    1. Glasgow R.E., Klesges L.M., Dzewaltowski D.A., Estabrooks P.A., Vogt T.M. Evaluating the impact of health promotion programs: using the RE-AIM framework to form summary measures for decision making involving complex issues. Health Educ. Res. 2006;21:688–694.
    1. Green B.B., Anderson M.L., Ralston J.D., Catz S., Fishman P.A., Cook A.J. Patient ability and willingness to participate in a web-based intervention to improve hypertension control. J. Med. Internet Res. 2011;13:e1. (PMCID: PMC3217242)
    1. Green B.B., Bogart A., Chubak J., Vernon S.W., Morales L.S., Meenan R.T., Laing S.S., Fuller S., Ko C., Wang C.Y. Nonparticipation in population-based trial to increase colorectal cancer screening. Am. J. Prev. Med. 2012;42:390–397. (PMCID: 3549634)
    1. Green B.B., Wang C.Y., Anderson M.L., Chubak J., Meenan R.T., Vernon S.W., Fuller S. An automated intervention with stepped increases in support to increase uptake of colorectal cancer screening: a randomized trial. Ann. Intern. Med. 2013;158:301–311. (PMCID: 3953144)
    1. Hall I.J., Tangka F.K.L., Sabatino S.A., Thompson T.D., Graubard B.I., Breen N. Patterns and trends in cancer screening in the United States. Prev. Chronic Dis. 2018;15:E97. (PMCID: 6093265)
    1. Jean-Jacques M., Kaleba E.O., Gatta J.L., Gracia G., Ryan E.R., Choucair B.N. Program to improve colorectal cancer screening in a low-income, racially diverse population: a randomized controlled trial. Ann. Fam. Med. 2012;10:412–417. (PMCID: 3438208)
    1. Lee RE, Reese-Smith JY, Mama SK, Medina AV, Wolfe KL, Estabrookes PA. Reach and representativeness of ethnic minority women in the health is power study: a longitudinal analysis. Transl. Behav. Med.. 2017;7:106–14. (PMCID: 5352633).
    1. Myers R., Sifri R., Hyslop T., Rosenthal M., Vernon S., Cocroft J., Wolf T., Andrel J., Wender R. A randomized controlled trial of the impact of targeted and tailored interventions on colorectal cancer screening. Cancer. 2007;110:2083–2091.
    1. RE-AIM REACH of health behavior interventions. [cited August 14, 2018]. Available from:
    1. RE-AIM Homepage [cited February 4, 2019]. Available from:
    1. Riley W.T., Glasgow R.E., Etheredge L., Abernethy A.P. Rapid, responsive, relevant (R3) research: a call for a rapid learning health research enterprise. Clin. Transl. Med. 2013;2:10. (PMCID: 3658895)
    1. Sabatino S.A., White M.C., Thompson T.D., Klabunde C.N., Centers for Disease Control and Prevention Cancer screening test use - United States, 2013. MMWR Morb. Mortal. Wkly Rep. 2015;64:464–468.
    1. Sequist T.D., Zaslavsky A.M., Marshall R., Fletcher R.H., Ayanian J.Z. Patient and physician reminders to promote colorectal cancer screening: a randomized controlled trial. Arch. Intern. Med. 2009;169:364–371. (PMCID: 2683730)
    1. Sweet S.N., Ginis K.A., Estabrooks P.A., Latimer-Cheung A.E. Operationalizing the RE-AIM framework to evaluate the impact of multi-sector partnerships. Implement. Sci. 2014;74 (PMCID: 4072487)
    1. Walsh J.M., Salazar R., Kaplan C., Nguyen L., Hwang J., Pasick R.J. Healthy colon, healthy life (colon sano, vida sana): colorectal cancer screening among Latinos in Santa Clara, California. J. Cancer Educ. 2010;25:36–42. (PMCID: 2848346)
    1. Yeary K.H.K., Moore P.C., Gauss C.H., Cornell C., Prewitt T.E., Shakya S., Turner J., Scarbrough C., Porter G., Estabrooks P.A. Reach and adoption of a randomized weight loss maintenance trial in rural African Americans of faith: the WORD (wholeness, oneness, righteousness, deliverance) Am. J. Health Promot. 2019;33(4):549–557. (890117118805065)

Source: PubMed

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