Enhancing Patient Understanding of Medication Risks and Benefits

Susan J Blalock, Elizabeth B Solow, Valerie F Reyna, Molly Keebler, Delesha Carpenter, Caprice Hunt, Genevieve Hickey, Jeffrey R Curtis, Kimberlee O'Neill, Sandra Bond Chapman, Susan J Blalock, Elizabeth B Solow, Valerie F Reyna, Molly Keebler, Delesha Carpenter, Caprice Hunt, Genevieve Hickey, Jeffrey R Curtis, Kimberlee O'Neill, Sandra Bond Chapman

Abstract

Objective: To evaluate the effectiveness of 2 interventions, including the DrugFactsBox format for presenting written medication information and the SMART (Strategic Memory Advanced Reasoning Training) program designed to enhance gist (i.e., "bottom-line" meaning) reasoning ability.

Methods: We used a 2 × 2 factorial research design. A total of 286 patients with rheumatoid arthritis were randomly assigned to 1 of 4 groups, including DrugFactsBox with the SMART program, DrugFactsBox without the SMART program, other consumer medication information (CMI) with the SMART program, and other CMI without the SMART program. Data were collected via telephone interviews and online questionnaires at 4 time points, including baseline and 6-week, 3-month, and 6-month time points following baseline. The primary outcome variable was informed decision-making, which was defined as making a value-consistent decision concerning use of disease-modifying antirheumatic drugs based on adequate knowledge.

Results: We found no main effects for the 2 interventions, either alone or in combination. However, there was a significant interaction between assignment to the SMART/no SMART groups and informed decision-making at baseline. Among participants in the SMART groups who did not meet the criteria for informed decision-making at baseline, 42.5% met the criteria at the 6-month follow-up, compared to 23.6% of participants in the no SMART groups (mean difference 18.9 [95% confidence interval 5.6, 32.2]; P = 0.007). This difference was driven by increased knowledge in the SMART groups. Among participants who met the criteria for informed decision-making at baseline, the difference between the SMART and no SMART groups was not statistically significant.

Conclusion: Participation in a theory-driven program to enhance gist reasoning may have a beneficial effect on informed decision-making among patients with inadequate knowledge concerning therapeutic options.

Trial registration: ClinicalTrials.gov NCT02820038.

© 2020 The Authors. Arthritis Care & Research published by Wiley Periodicals LLC on behalf of American College of Rheumatology.

Figures

Figure 1
Figure 1
Conceptual framework for gist reasoning training and written medication information.

References

    1. Singh JA, Furst DE, Bharat A, Curtis JR, Kavanaugh AF, Kremer JM, et al. 2012 update of the 2008 American College of Rheumatology recommendations for the use of disease‐modifying antirheumatic drugs and biologic agents in the treatment of rheumatoid arthritis. Arthritis Care Res (Hoboken) 2012;64:625–39.
    1. Solomon DH, Bitton A, Katz JN, Radner H, Brown EM, Fraenkel L. Review: treat to target in rheumatoid arthritis: fact, fiction, or hypothesis? Arthritis Rheumatol 2014;66:775–82.
    1. Fraenkel L, Cunningham M. High disease activity may not be sufficient to escalate care. Arthritis Care Res (Hoboken) 2014;66:197–203.
    1. Van Hulst LT, Kievit W, van Bommel R, van Riel PL, Fraenkel L. Rheumatoid arthritis patients and rheumatologists approach the decision to escalate care differently: results of a maximum difference scaling experiment. Arthritis Care Res (Hoboken) 2011;63:1407–14.
    1. Donahue KE, Gartlehner G, Jonas DE, Lux LJ, Thieda P, Jonas BL, et al. Systematic review: comparative effectiveness and harms of disease‐modifying medications for rheumatoid arthritis. Ann Intern Med 2008;148:124–34.
    1. Le Blay P, Mouterde G, Barnetche T, Morel J, Combe B. Risk of malignancy including non‐melanoma skin cancers with anti‐tumor necrosis factor therapy in patients with rheumatoid arthritis: meta‐analysis of registries and systematic review of long‐term extension studies. Clin Exp Rheumatol 2012;30:756–64.
    1. Kourbeti IS, Ziakas PD, Mylonakis E. Biologic therapies in rheumatoid arthritis and the risk of opportunistic infections: a meta‐analysis. Clin Infect Dis 2014;58:1649–57.
    1. Williams M, Chakravarty EF. Rheumatoid arthritis and pregnancy: impediments to optimal management of both biologic use before, during and after pregnancy. Curr Opin Rheumatol 2014;26:341–6.
    1. Wolf MS, King J, Wilson EA, Curtis LM, Bailey SC, Duhig J, et al. Usability of FDA‐approved medication guides. J Gen Intern Med 2012;27:1714–20.
    1. Wolf MS, Davis TC, Shrank WH, Neuberger M, Parker RM. A critical review of FDA‐approved medication guides. Patient education and counseling 2006;62:316–22.
    1. Shiffman S, Gerlach KK, Sembower MA, Rohay JM. Consumer understanding of prescription drug information: an illustration using an antidepressant medication. Ann Pharmacother 2011;45:452–8.
    1. Schwartz L, Mazzola N, Hoffman RS, Howland MA, Mercurio‐Zappala M, Nelson LS. Evaluating patients' understanding of printed warfarin medication information. J Pharm Pract 2015;28:518–22.
    1. Wolf MS, Bailey SC, Serper M, Smith M, Davis TC, Russell AL, et al. Comparative effectiveness of patient‐centered strategies to improve FDA medication guides. Med Care 2014;52:781–9.
    1. Bailey SC, Navaratnam P, Black H, Russell AL, Wolf MS. Advancing best practices for prescription drug labeling. Ann Pharmacother 2015;49:1222–36.
    1. Berkman ND, Sheridan SL, Donahue KE, Halpern DJ, Crotty K. Low health literacy and health outcomes: an updated systematic review. Ann Intern Med 2011;155:97–107.
    1. Reyna VF. A new intuitionism: meaning, memory, and development in fuzzy‐trace theory. Judgm Decis Mak 2012;7:332–59.
    1. Reyna VF, Brainerd CJ. Dual processes in decision making and developmental neuroscience: a fuzzy‐trace model. Dev Rev 2011;31:180–206.
    1. Schwartz LM, Woloshin S, Welch HG. Using a drug facts box to communicate drug benefits and harms: two randomized trials. Ann Intern Med 2009;150:516–27.
    1. Schwartz LM, Woloshin S. The Drug Facts Box: improving the communication of prescription drug information. Proc Natl Acad Sci U S A 2013;110 Suppl 3:14069–74.
    1. Schwartz LM, Woloshin S, Welch HG. The drug facts box: providing consumers with simple tabular data on drug benefit and harm. Med Decis Making 2007;27:655–62.
    1. Vas AK, Spence J, Chapman SB. Abstracting meaning from complex information (gist reasoning) in adult traumatic brain injury. J Clin Exp Neuropsychol 2015;37:152–61.
    1. Motes MA, Gamino JF, Chapman SB, Rao NK, Maguire MJ, Brier MR, et al. Inhibitory control gains from higher‐order cognitive strategy training. Brain Cogn 2014;84:44–62.
    1. Gamino JF, Motes MM, Riddle R, Lyon GR, Spence JS, Chapman SB. Enhancing inferential abilities in adolescence: new hope for students in poverty. Front Hum Neurosci 2014;8:924.
    1. Chapman SB, Mudar RA. Enhancement of cognitive and neural functions through complex reasoning training: evidence from normal and clinical populations. Front Syst Neurosci 2014;8:69.
    1. Cook LG, Chapman SB, Elliott AC, Evenson NN, Vinton K. Cognitive gains from gist reasoning training in adolescents with chronic‐stage traumatic brain injury. Front Neurol 2014;5:87.
    1. Anand R, Chapman SB, Rackley A, Keebler M, Zientz J, Hart J Jr. Gist reasoning training in cognitively normal seniors. Int J Geriatr Psychiatry 2011;26:961–8.
    1. Chapman SB, Aslan S, Spence JS, Hart JJ Jr, Bartz EK, Didehbani N, et al. Neural mechanisms of brain plasticity with complex cognitive training in healthy seniors. Cereb Cortex 2015;25:396–405.
    1. Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. Int J Surg 2012;10:28–55.
    1. Pincus T, Swearingen CJ, Bergman M, Yazici Y. RAPID3 (Routine Assessment of Patient Index Data 3), a rheumatoid arthritis index without formal joint counts for routine care: proposed severity categories compared to disease activity score and clinical disease activity index categories. J Rheumatol 2008;35:2136–47.
    1. Pincus T, Yazici Y, Bergman MJ. RAPID3, an index to assess and monitor patients with rheumatoid arthritis, without formal joint counts: similar results to DAS28 and CDAI in clinical trials and clinical care. Rheum Dis Clin North Am 2009;35:773–8.
    1. Reyna VF. A theory of medical decision making and health: fuzzy trace theory. Med Decis Making 2008;28:850–65.
    1. Marteau TM, Dormandy E, Michie S. A measure of informed choice. Health Expect 2001;4:99–108.33.
    1. Dormandy E, Tsui EY, Marteau TM. Development of a measure of informed choice suitable for use in low literacy populations. Patient Educ Couns 2007;66:278–95.
    1. Sepucha K, Ozanne E, Silvia K, Partridge A, Mulley AG Jr. An approach to measuring the quality of breast cancer decisions. Patient Educ Couns 2007;65:261–9.
    1. Fraenkel L, Peters E, Charpentier P, Olsen B, Errante L, Schoen RT, et al. Decision tool to improve the quality of care in rheumatoid arthritis. Arthritis Care Res (Hoboken) 2012;64:977–85.
    1. Fayet F, Savel C, Rodere M, Pereira B, Abdi D, Mathieu S, et al. The development of a questionnaire to evaluate rheumatoid arthritis patient's knowledge about methotrexate. J Clin Nurs 2016;25:682–9.
    1. Barton JL, Trupin L, Schillinger D, Evans‐Young G, Imboden J, Montori VM, et al. Use of low‐literacy decision aid to enhance knowledge and reduce decisional conflict among a diverse population of adults with rheumatoid arthritis: results of a pilot study. Arthritis Care Res (Hoboken) 2016;68:889–98.
    1. Vas AK, Chapman SB, Cook LG, Elliott AC, Keebler M. Higher‐order reasoning training years after traumatic brain injury in adults. J Head Trauma Rehabil 2011;26:224–39.
    1. Sullivan TR, White IR, Salter AB, Ryan P, Lee KJ. Should multiple imputation be the method of choice for handling missing data in randomized trials? Stat Methods Med Res 2018;27:2610–26.
    1. Cohen J. Statistical power analysis for the behavioral sciences, 2nd ed. Hillsdale, NJ: Erlbaum;1988.
    1. Mudar RA, Chapman SB, Rackley A, Eroh J, Hsueh‐Sheng C, Perez A, et al. Enhancing latent cognitive capacity in mild cognitive impairment with gist reasoning training: a pilot study. Int J Geriatr Psychiatry 2017;32:548–55.
    1. Motes MA, Yezhuvath US, Aslan S, Spence JS, Rypma B, Chapman SB. Higher‐order cognitive training effects on processing speed‐related neural activity: a randomized trial. Neurobiol Aging 2018;62:72–81.
    1. Chapman SB, Spence JS, Aslan S, Keebler MW. Enhancing innovation and underlying neural mechanisms via cognitive training in healthy older adults. Front Aging Neurosci 2017;9:314.
    1. Woloshin S, Schwartz LM. Communicating data about the benefits and harms of treatment: a randomized trial. Ann Intern Med 2011;155:87–96.
    1. Ackerman IN, Bucknill A, Page RS, Broughton NS, Roberts C, Cavka B, et al. Preferences for disease‐related education and support among younger people with hip or knee osteoarthritis. Arthritis Care Res (Hoboken) 2017;69:499–508.
    1. Wolfe CR, Reyna VF, Widmer CL, Cedillos‐Whynott EM, Brust‐Renck PG, Weil AM, et al. Understanding genetic breast cancer risk: processing loci of the BRCA gist intelligent tutoring system. Learn Individ Differ 2016;49:178–89.

Source: PubMed

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