CC BY-NC-ND 4.0 · Appl Clin Inform 2024; 15(01): 045-054
DOI: 10.1055/a-2214-8000
Research Article

An mHealth Design to Promote Medication Safety in Children with Medical Complexity

Anna Jolliff
1   Department of Health and Wellness Design, Indiana University at Bloomington, Bloomington, Indiana, United States
Ryan J. Coller
2   Department of Pediatrics, University of Wisconsin–Madison, Madison, Wisconsin, United States
Hannah Kearney
2   Department of Pediatrics, University of Wisconsin–Madison, Madison, Wisconsin, United States
Gemma Warner
2   Department of Pediatrics, University of Wisconsin–Madison, Madison, Wisconsin, United States
James A. Feinstein
3   Department of Pediatrics, University of Colorado School of Medicine, Aurora, Colorado, United States
Michelle A. Chui
2   Department of Pediatrics, University of Wisconsin–Madison, Madison, Wisconsin, United States
Steve O'Brien
4   Noble Applications, Madison, Wisconsin, United States
Misty Willey
4   Noble Applications, Madison, Wisconsin, United States
Barbara Katz
5   Family Voices of Wisconsin, Madison, Wisconsin, United States
Theodore D. Bach
2   Department of Pediatrics, University of Wisconsin–Madison, Madison, Wisconsin, United States
Nicole E. Werner
1   Department of Health and Wellness Design, Indiana University at Bloomington, Bloomington, Indiana, United States
› Author Affiliations
Funding We would like to thank the Agency for Healthcare Research and Quality (award number: R18HS028409) for their financial support of this work.


Background Children with medical complexity (CMC) are uniquely vulnerable to medication errors and preventable adverse drug events because of their extreme polypharmacy, medical fragility, and reliance on complicated medication schedules and routes managed by undersupported family caregivers. There is an opportunity to improve CMC outcomes by designing health information technologies that support medication administration accuracy, timeliness, and communication within CMC caregiving networks.

Objectives The present study engaged family caregivers, secondary caregivers, and clinicians who work with CMC in a codesign process to identify: (1) medication safety challenges experienced by CMC caregivers and (2) design requirements for a mobile health application to improve medication safety for CMC in the home.

Methods Study staff recruited family caregivers, secondary caregivers, and clinicians from a children's hospital-based pediatric complex care program to participate in virtual codesign sessions. During sessions, the facilitator-guided codesigners in generating and converging upon medication safety challenges and design requirements. Between sessions, the research team reviewed notes from the session to identify design specifications and modify the prototype. After design sessions concluded, each session recording was reviewed to confirm that all designer comments had been captured.

Results A total of N = 16 codesigners participated. Analyses yielded 11 challenges to medication safety and 11 corresponding design requirements that fit into three broader challenges: giving the right medication at the right time; communicating with others about medications; and accommodating complex medical routines. Supporting quotations from codesigners and prototype features associated with each design requirement are presented.

Conclusion This study generated design requirements for a tool that may improve medication safety by creating distributed situation awareness within the caregiving network. The next steps are to pilot test tools that integrate these design requirements for usability and feasibility, and to conduct a randomized control trial to determine if use of these tools reduces medication errors.

Protection of Human and Animal Subjects

This minimal risk study was reviewed and approved by the University of Wisconsin–Madison and Indiana University–Bloomington Institutional Review Boards.

Publication History

Received: 11 August 2023

Accepted: 09 November 2023

Accepted Manuscript online:
21 November 2023

Article published online:
17 January 2024

© 2024. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (

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  • References

  • 1 Smith MD, Spiller HA, Casavant MJ, Chounthirath T, Brophy TJ, Xiang H. Out-of-hospital medication errors among young children in the United States, 2002-2012. Pediatrics 2014; 134 (05) 867-876
  • 2 Berry JG, Hall M, Neff J. et al. Children with medical complexity and Medicaid: spending and cost savings. Health Aff (Millwood) 2014; 33 (12) 2199-2206
  • 3 Cohen E, Berry JG, Camacho X, Anderson G, Wodchis W, Guttmann A. Patterns and costs of health care use of children with medical complexity. Pediatrics 2012; 130 (06) e1463-e1470
  • 4 Walsh KE, Mazor KM, Stille CJ. et al. Medication errors in the homes of children with chronic conditions. Arch Dis Child 2011; 96 (06) 581-586
  • 5 Lokker N, Sanders L, Perrin EM. et al. Parental misinterpretations of over-the-counter pediatric cough and cold medication labels. Pediatrics 2009; 123 (06) 1464-1471
  • 6 Cárdenas-Valladolid J, Martín-Madrazo C, Salinero-Fort MA, Carrillo de-Santa Pau E, Abánades-Herranz JC, de Burgos-Lunar C. PATER Group. Prevalence of adherence to treatment in homebound elderly people in primary health care: a descriptive, cross-sectional, multicentre study. Drugs Aging 2010; 27 (08) 641-651
  • 7 Tulner LR, Kuper IM, Frankfort SV. et al. Discrepancies in reported drug use in geriatric outpatients: relevance to adverse events and drug-drug interactions. Am J Geriatr Pharmacother 2009; 7 (02) 93-104
  • 8 Edelstein H, Schippke J, Sheffe S, Kingsnorth S. Children with medical complexity: a scoping review of interventions to support caregiver stress. Child Care Health Dev 2017; 43 (03) 323-333
  • 9 Philips K, Zhou R, Lee DS. et al. Caregiver medication management and understanding after pediatric hospital discharge. Hosp Pediatr 2019; 9 (11) 844-850
  • 10 Yin HS, Mendelsohn AL, Wolf MS. et al. Parents' medication administration errors: role of dosing instruments and health literacy. Arch Pediatr Adolesc Med 2010; 164 (02) 181-186
  • 11 Zandieh SO, Goldmann DA, Keohane CA, Yoon C, Bates DW, Kaushal R. Risk factors in preventable adverse drug events in pediatric outpatients. J Pediatr 2008; 152 (02) 225-231
  • 12 Blackmer AB, Fox D, Arendt D, Phillips K, Feinstein JA. Perceived versus demonstrated understanding of the complex medications of medically complex children. J Pediatr Pharmacol Ther 2021; 26 (01) 62-72
  • 13 Feinstein JA, Friedman H, Orth LE. et al. Complexity of medication regimens for children with neurological impairment. JAMA Netw Open 2021; 4 (08) e2122818-e2122818
  • 14 Walsh KE, Roblin DW, Weingart SN. et al. Medication errors in the home: a multisite study of children with cancer. Pediatrics 2013; 131 (05) e1405-e1414
  • 15 Walsh KE, Dodd KS, Seetharaman K. et al. Medication errors among adults and children with cancer in the outpatient setting. J Clin Oncol 2009; 27 (06) 891-896
  • 16 Adams S, Nicholas D, Mahant S. et al. Care maps for children with medical complexity. Dev Med Child Neurol 2017; 59 (12) 1299-1306
  • 17 Adams S, Nicholas D, Weiser N. et al. An exploration of care mapping among families of children with medical complexity (CMC). Paediatr Child Health 2016; 21 (05) e63d-e63d
  • 18 Baker C, Loresto Jr F, Pickett K, Samay SS, Gance-Cleveland B. Facilitating health information exchange to improve health outcomes for school-aged children: school nurse electronic health record access. Appl Clin Inform 2022; 13 (04) 803-810
  • 19 Steitz B, Cronin RM, Davis SE, Yan E, Jackson GP. Long-term patterns of patient portal use for pediatric patients at an academic medical center. Appl Clin Inform 2017; 8 (03) 779-793
  • 20 Kelly MM, Dean SM, Carayon P, Wetterneck TB, Hoonakker PL. Healthcare team perceptions of a portal for parents of hospitalized children before and after implementation. Appl Clin Inform 2017; 8 (01) 265-278
  • 21 Werner NE, Fleischman A, Warner G. et al. Feasibility testing of Tubes@HOME: a mobile application to support family-delivered enteral care. Hosp Pediatr 2022; 12 (07) 663-673
  • 22 Chung SL. Pediatric health information technology—what we need for optimal care of children. Appl Clin Inform 2021; 12 (03) 708-709
  • 23 Simonsen J, Robertson T. Routledge International Handbook of Participatory Design. Vol. 711. New York: Routledge; 2012: 37-63
  • 24 Werner NE, Campbell NL, Boustani M, Ganci A, Holden RJ. Helping the helpers - a research protocol for user-centered technology to aid caregiver management of medications for people with Alzheimer's disease and related dementias. Res Social Adm Pharm 2022; 18 (09) 3680-3686
  • 25 Jolliff A, Dudek A, Zuraw M. et al. Co-design of a financial and legal planning tool for care partners of people living with Alzheimer's disease and related dementias. Innov Aging 2023; 7 (05) igad046
  • 26 Reddy A, Lester CA, Stone JA, Holden RJ, Phelan CH, Chui MA. Applying participatory design to a pharmacy system intervention. Res Social Adm Pharm 2019; 15 (11) 1358-1367
  • 27 Bratteteig T, Wagner I. Disentangling power and decision-making in participatory design. Proceedings of the 12th Participatory Design Conference 2012;1:41–50
  • 28 Burningham Z, Jackson GL, Kelleher JL. et al. Use of a medication safety audit and feedback tool in the emergency department is affected by prescribing characteristics. Appl Clin Inform 2023; 14 (04) 684-692
  • 29 Harrington L, Parker C, Ulanday K, Harrington C. Heuristic evaluation of a top-rated diabetes self-management app. Appl Clin Inform 2021; 12 (05) 1014-1020
  • 30 Miro. 2023 Accessed October 31, 2023 at
  • 31 Staiano F. Designing and Prototyping Interfaces with Figma: Learn Essential UX/UI Design Principles by Creating Interactive Prototypes for Mobile, Tablet, and Desktop. Packt Publishing Ltd; 2022
  • 32 Nageswaran S, Golden SL. Home health nurse collaboration in the medical neighborhood of children with medical complexity. Home Healthc Now 2016; 34 (09) 507-518
  • 33 Stanton NA. Distributed situation awareness. Theor Issues Ergon Sci 2016; 17 (01) 1-7
  • 34 Mitchell HK, Reddy A, Perry MA, Gathers CA, Fowler JC, Yehya N. Racial, ethnic, and socioeconomic disparities in paediatric critical care in the USA. Lancet Child Adolesc Health 2021; 5 (10) 739-750
  • 35 Smealie E, Rosenthal L, Johnson A, Roslin C, Hassett AL, Choi SW. Enhancing resilience in family caregivers using an mHealth app. Appl Clin Inform 2022; 13 (05) 1194-1206
  • 36 Measuring What Matters for Advancing the Science and Practice of Engagement. Patient-Centered Outcomes Research Institute 2023 Accessed October 31, 2023 at