Evaluating a knowledge translation tool for parents about pediatric acute gastroenteritis: a pilot randomized trial

Lauren Albrecht, Shannon D Scott, Lisa Hartling, Lauren Albrecht, Shannon D Scott, Lisa Hartling

Abstract

Background: Pediatric acute gastroenteritis (AGE) is a common childhood illness with substantial health, family, and system impacts. Connecting parents to evidence-based patient education is key to effective decision-making and therapeutic management of AGE. Digital knowledge translation (KT) tools offer a promising approach to communicate complex health information to parents; therefore, we developed a whiteboard animation video for parents about AGE. To optimize future effectiveness evaluation of this video, the purpose of this pilot study is to assess feasibility of effectiveness outcomes and specific trial methods in four key trial domains.

Methods: A single-site, parallel-arm, pilot randomized trial will be conducted. The trial will employ quantitative and qualitative methods to evaluate feasibility objectives in key scientific, process, management, and resource domains. Parents seeking care for a child with AGE in the emergency department (ED) over a 6-month period will be randomized to receive the whiteboard animation video or a sham control video. Quantitative data will be collected electronically in the ED and at home (4-10 days post-ED visit). Qualitative data will be collected via semi-structured interviews with experimental condition participants after quantitative data collection. Data will be collected to perform a sample size calculation for a full-scale trial. Scientific outcomes will include parental knowledge, decision regret, and health utilization, and estimation for these outcomes will use confidence intervals (CI) of different widths to illustrate strength of preliminary evidence. CIs will be presented alongside minimum clinically important differences (MCIDs) calculated using two methods: (1) data driven and (2) patient perspective. Descriptive statistics will be calculated to describe process, management, and resource domain outcomes. Qualitative thematic analysis will be conducted to describe additional process, management, and resource outcomes in the experimental group. Analyses will be performed using intention-to-treat.

Discussion: This pilot randomized trial will inform the design and conduct of a full-scale, effectiveness trial by gathering key data in four domains: scientific, process, management, and resource. These results will impact the emerging field of KT efforts targeting health consumers and advance the science on the best mode of patient education for acute childhood illnesses.

Trial registration: clinicaltrails.gov registration number NCT03234777. Registered 31 July 2017.

Keywords: Caregivers; Health consumers; Knowledge translation; Parents; Pediatric emergency care; Pilot trial.

Conflict of interest statement

Ethics approval was obtained from the University of Alberta Health Research Ethics Board. Informed consent will be obtained from all study participants. Not applicable. The authors declare that they have no competing interests. Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Trial flow and timing of data collection

References

    1. Freedman SB, Ali S, Oleszczuk M, Gouin S, Hartling L. Treatment of acute gastroenteritis in children: an overview of systematic reviews of interventions commonly used in developed countries. Evidence-Based Child Health. 2013;8:1123–1137. doi: 10.1002/ebch.1932.
    1. Freedman SB, Sivabalasundaram V, Bohn V, Powell EC, Johnson DW, Boutis K. The treatment of pediatrics gastroenteritis: a comparative analysis of pediatric emergency physicians’ practice patterns. Acad Emerg Med. 2011;18:38–45. doi: 10.1111/j.1553-2712.2010.00960.x.
    1. Freedman SB, Etorky M, Gorelick M, the Pediatric Emergency Research Canada Gastroenteritis Study Group Evaluation of a gastroenteritis severity score for use in outpatient settings. Pediatrics. 2010;125:e1278–e1285. doi: 10.1542/peds.2009-3270.
    1. Kinlin LM, Bahm A, Guttmann A, Freedman SB. A survey of emergency department resources and strategies employed in the treatment of pediatric gastroenteritis. Acad Emerg Med. 2013;20(4):361–366. doi: 10.1111/acem.12108.
    1. Freedman S, Lowerison K. Alberta Provincial Pediatric EnTeric Infection Team (APPETITE) seminar series. 2015.
    1. Mast TC, DeMuro-Mercon C, Kelly CM, Floyd LE, Walter EB. The impact of rotovirus gastroenteritis on the family. BMC Pediatr. 2009;9:11. doi: 10.1186/1471-2431-9-11.
    1. Senecal M, Brisson M, Lebel MH, Yaremko J, Wong R, Gallant LA, Garfield HA, Ableman DJ, Ward RL, Sampalis JS, Mansi JA. Measuring the impact of rotavirus acute gastroenteritis episodes (MIRAGE): a prospective community-based study. Can J Infect Dis Med Microbiol. 2008;19(6):397–404.
    1. Albrecht L, Hartling L, Scott SD. Pediatric acute gastroenteritis: understanding caregivers’ experiences and information needs. Can J Emerg Med. 2016:1–9. 10.1017/cem.2016.363.
    1. Anidi I, Bazargan M, James FW. Knowledge and management of diarrhea among underserved minority parents/caregivers. Ambul Pediatr. 2002;2:20l–206. doi: 10.1367/1539-4409(2002)002<0201:KAMODA>;2.
    1. Freedman SS, Couto M, Spooner L, Haladyn K. The implementation of a gastroenteritis education program. Am J Emerg Med. 2011;29:271–277. doi: 10.1016/j.ajem.2009.09.032.
    1. Sustersic M, Jeannet E, Cozon-Rein L, Marechaus F, Genty C, Foote A, David-Tchouda S, Martinez L, Bosson JL. Impact of information leaflets on behavior of patients with gastroenteritis or tonsillitis: a cluster randomized trial in French primary care. J Gen Intern Med. 2012;28(1):25–31. doi: 10.1007/s11606-012-2164-8.
    1. Canadian Institutes of Health Research. Knowledge translation definition. 2015. . Accessed 18 Mar 2015.
    1. Grimshaw JM, Eccles MP, Lavis JN, Hill SJ, Squires JE. Knowledge translation of research findings. Implement Sci. 2012;7:50. doi: 10.1186/1748-5908-7-50.
    1. Wilson EAH, Makoul G, Bojarski EA, Cooper Bailey S, Waite KR, Rapp DN, Baker DW, et al. Comparative analysis of print and multimedial health materials: a review of the literature. Patient Educ Couns. 2012;89:7–14. doi: 10.1016/j.pec.2012.06.007.
    1. Jusko Friedman A, Cosby R, Boyko S, Hatton-Bauer J, Turnbull G. Effective teaching strategies and methods of delivery for patient education: a systematic review and practice guideline recommendations. J Cancer Educ. 2011;26:12–21. doi: 10.1007/s13187-010-0183-x.
    1. Boyd M, Lasserson TJ, McKean MC, Gibson PG, Ducharme FM, Haby M. Interventions for educating children who are at risk of asthma-related emergency department attendance. Cochrane Database of Systematic Reviews. 2009;(2):CD001290. 10.1002/14651858.CD001290.pub2.
    1. Taddio A, Shah V, Leung E, Wang J, Parikh C, Smart S, et al. Knowledge translation of the HELPinKIDS clinical practice guideline for managing childhood vaccination pain: usability and knowledge uptake of educational materials directed to new parents. BMC Pediatr. 2013;13:23. doi: 10.1186/1471-2431-13-23.
    1. Morrison AK, Myrvik MP, Brousseau DC, Hoffman RG, Stanley RM. The relationship between parent health literacy and pediatric emergency department utilization: a systematic review. Acad Pediatr. 2013;13(5):421–429. doi: 10.1016/j.acap.2013.03.001.
    1. Engel KG, Heisler M, Smith DM, Robinson CH, Forman JH, Ubel PA. Patient comprehension of emergency department care and instructions: are patients aware of when they do not understand? Ann Emerg Med. 2009;53(4):454–461. doi: 10.1016/j.annemergmed.2008.05.016.
    1. Vashi A, Rhodes KV. “Sign right here and you’re good to go”: a content analysis of audiotaped emergency department discharge instructions. Ann Emerg Med. 2011;57(4):315–322. doi: 10.1016/j.annemergmed.2010.08.024.
    1. Sanders LM, Federico S, Klass P, Abrams MA, Dreyer B. Literacy and child health: a systematic review. JAMA Pediatr. 2009;163(2):131–140.
    1. Spandorfer JM, Karras DJ, Hughes LA, Caputo C. Comprehension of discharge instructions by patients in an urban emergency department. Ann Emerg Med. 1995;25(1):71–74. doi: 10.1016/S0196-0644(95)70358-6.
    1. Lipstein EA, Brinkman WB, Britto MT. What is known about parents’ treatment decisions? A narrative review of pediatric decision making. Med Decis Mak. 2012;32(2):246–258. doi: 10.1177/0272989X11421528.
    1. Saidinejad M, Zorc J. Mobile and web-based education: delivering emergency department discharge and aftercare instructions. Pediatr Emerg Care. 2014;30:211–216. doi: 10.1097/PEC.0000000000000097.
    1. Sacristan JA. Patient-centred medicine and patient-oriented research: improving health outcomes for individual patients. BMC Med Inform Decis Mak. 2013;13:6. doi: 10.1186/1472-6947-13-6.
    1. Albrecht L, Scott SD, Hartling L. Knowledge translation tools for parents on child health topics: a scoping review. BMC Health Serv Res. 17:686. 10.1186/s12913-017-2632-2.
    1. Thabane L, Ma J, Chu R, Cheng J, Rios LP, Robson R, Thabane M, Giangregoria L, Goldsmith CH. A tutorial on pilot studies: the what, why and how. BMC Med Res Methodol. 2010;10:1. 10.1186/1471-2288-10-1.
    1. Arain M, Campbell MJ, Cooper CL, Lancaster GA. What is a pilot or feasibility study? A review of current practice and editorial policy. BMC Med Res Methodol. 2010;10:67. doi: 10.1186/1471-2288-10-67.
    1. Shanyinde M, Pickering RM, Weatherall M. Questions asked and answered in pilot and feasibility randomized controlled trials. BMC Med Res Methodol. 2011;11:117. doi: 10.1186/1471-2288-11-117.
    1. Centres for Disease Control and Prevention . Fight Germs. Wash Your Hands (3:00) 2016.
    1. Efird J. Blocked randomization with randomly selected block sizes. Int J Environ Res Public Health. 2011;8(1):15–20. doi: 10.3390/ijerph8010015.
    1. Teare MD, Dimairo M, Shephard N, Hayman A, Whitehead A, Walters SJ. Sample size requirements to estimate key design parameters from external pilot randomised controlled trials: a simulation study. Trials. 2014;15:264. doi: 10.1186/1745-6215-15-264.
    1. Billingham SAM, Whitehead AL, Julious SA. An audit of sample sizes for pilot and feasibility trials being undertaken in the United Kingdom registered in the United Kingdom Clinical Research Network Database. BMC Med Res Methodol. 2013;13:104. doi: 10.1186/1471-2288-13-104.
    1. Elliott EJ. Acute gastroenteritis in children. BMJ. 2007;334(7583):35–40. doi: 10.1136/bmj.39036.406169.80.
    1. Sandelowski M. Sample size in qualitative research. Res Nurs Health. 1995;18:179–183. doi: 10.1002/nur.4770180211.
    1. Morse J, Field P. Qualitative research methods for health professionals. 2. CA: Sage; 1995.
    1. Sandelowski M. Whatever happened to qualitative description? Res Nurs Health. 2000;23:334–340. doi: 10.1002/1098-240X(200008)23:4<334::AID-NUR9>;2-G.
    1. Sandelowski M. What’s in a name? Qualitative description revisited. Res Nurs Health. 2010;33:77–84.
    1. Yin R. Qualitative research from start to finish. New York: The Guilford Press; 2011.
    1. Jones TF, McMillian MB, Scallan E, Frenzen PS, Cronquist AB, Thomas S, Angulo FJ. A population-based estimate of the substantial burden of diarrhoeal disease in the United States; FoodNet, 1996-2003. Epidemiol Infect. 2007;135:293–301. doi: 10.1017/S0950268806006765.
    1. King CK, Glass R, Brese JS, Duggan C. Managing acute gastroenteritis among children: oral rehydration, maintenance, and nutritional therapy. MMWR Recomm Rep. 2003;52(RR16):1–16.
    1. IBM Corp . IBM SPSS statistics for windows, version 22. 2013.
    1. Lancaster GA, Dodd S, Williamson PR. Design and analysis of pilot studies: recommendations for good practice. J Eval Clin Pract. 2004;10(2):307–312. doi: 10.1111/j..2002.384.doc.x.
    1. Lee EC, Whitehead AL, Jacques RM, Julious SA. The statistical interpretation of pilot trials: should significance thresholds be reconsidered? BMC Med Res Methodol. 2014;14:41. doi: 10.1186/1471-2288-14-41.
    1. Gardner MJ, Altman DG. Confidence intervals rather than P values: estimation rather than hypothesis testing. Statistics in Medicine. BMJ. 1986;292:746–750.
    1. Cohen J. The earth is round (p < .05) Am Psychol. 1994;49(12):997–1003. doi: 10.1037/0003-066X.49.12.997.
    1. QSR International Pty Ltd . NVivo qualitative data analysis Software. version 11. 2015.
    1. Vaismoradi M, Turunen H, Bondas T. Content analysis and thematic analysis: implications for conducting a qualitative descriptive study. Nurs Health Sci. 2013;15:398–405. doi: 10.1111/nhs.12048.
    1. Sparker A. Narrative analysis: exploring the what’s and how’s of personal stories. In: Holloway I, editor. Qualitative research in health care. 1. Berkshire: Open University Press; 2005. pp. 191–208.
    1. Braun V, Clarke V. Using thematic analysis in psychology. Qual Res Psychol. 2006;3:77–101. doi: 10.1191/1478088706qp063oa.
    1. Fereday J, Muir-Cochrane E. Demonstrating rigor using thematic analysis: a hybrid approach of inductive and deductive coding and theme development. Int J Qual Methods. 2006;5(1):80-92.
    1. Ballinger C, Yardley L, Payne S. Observation and action research. In: Marks DF, Yardley L, editors. Research methods for clinical and health psychology (1st edition) London: Sage Publications Ltd; 2004. pp. 102–121.
    1. Rolfe G. Validity, trustworthiness and rigour: quality and the idea of qualitative research. J Adv Nurs. 2006;53:304–310. doi: 10.1111/j.1365-2648.2006.03727.x.
    1. SoftLayer . HIPPA & SoftLayer: protecting patient privacy. 2017.
    1. Freedman SB, Deiratany S, Goldman RD, Benseler S. Development of a caregiver gastroenteritis knowledge questionnaire. Ambul Pediatr. 2008;8:261–265. doi: 10.1016/j.ambp.2008.02.003.
    1. Brehaut JC, O’Connor AM, Wood TJ, Hack TF, Siminoff L, Gordon E, Feldman-Stewart D. Validation of a decision regret scale. Med Decis Mak. 2003;23(4):281–292. doi: 10.1177/0272989X03256005.
    1. O’Connor AM. User manual—decision regret scale. 2003. Retrieved from: .
    1. Wells G, Beaton D, Shea B, Boers M, Simon L, Strand V, Brooks P, Tugwell P. Minimal clinically important differences: review of methods. J Rheumatol. 2001;28(2):406–412.

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