Children with medical complexity (CMC) are commonly assisted by medical devices, which family caregivers are responsible for managing and troubleshooting in the home. Optimizing device use by maximizing the benefits and minimizing the complications is a critical goal for CMC but is relatively unexplored. In this study, we sought to identify and describe workarounds families have developed to optimize medical device use for their needs.
We conducted 30 contextual inquiry interviews with families of CMC in homes. Interviews were recorded, transcribed, and analyzed for barriers and workarounds specific to medical device usage through a directed content analysis. We used observation notes and photographs to confirm and elaborate on interview findings.
We identified 4 barriers to using medical devices in the home: (1) the quantity and type of devices allotted do not meet family needs, (2) the device is not designed to be used in locations families require, (3) device use is physically or organizationally disruptive to the home, and (4) the device is not designed to fit the user. We also identified 11 categories of workarounds to the barriers.
Families face many barriers in using medical devices to care for CMC. Our findings offer rich narrative and photographic data revealing the ways in which caregivers work around these barriers. Future researchers should explore the downstream effects of these ubiquitous, necessary workarounds on CMC outcomes toward developing interventions that optimize device use for families.
Children with medical complexity are commonly assisted by medical devices operated by family caregivers in the home. However, little is known about how families interact with these devices and how they optimize their use.
In this study, we identify and describe the workarounds that family caregivers make to overcome barriers to using the medical devices on which their children depend. These workarounds showcase family adaptability and reveal the need for context-sensitive device design.
Children with medical complexity (CMC) often rely on sophisticated medical devices to support or replace essential body functions.1,2 Examples of commonly used devices include gastrostomy tubes and pumps, tracheostomy tubes and ventilators, oxygen, and other breathing equipment, among others. These devices provide life-sustaining treatment, but their complications (eg, malfunctions, infections, etc) can lead to potentially preventable hospitalizations and emergency department visits for CMC.3 Optimizing device use by maximizing the benefits and minimizing the complications is a critical goal for CMC but is relatively unexplored.
Although we know that families are tasked with operating and troubleshooting their child’s medical devices day to day,1,4–6 important knowledge gaps exist about how families interact with these complex devices in the dynamic, uncontrolled home environment. As a result, clinicians have varying, often limited, expertise to guide a systematic clinical evaluation or guide practical counseling for families’ routine caregiving with these devices. Filling this critical gap would inform the content of clinicians’ anticipatory guidance to families about routine care. To determine how to comprehensively identify and then mitigate device-related consequences, we need a deeper understanding of real-world family experience of managing the child’s medical devices at home. This in-depth understanding would provide necessary insights into the challenges and strategies families use to optimize devices and their use to fit into everyday routines and environments. This could also plausibly guide device redesigns to improve health, safety, and satisfaction outcomes tied to medical devices.7,8
Workarounds are defined as deliberate, goal-oriented strategies or adaptations that workers (ie, family caregivers) develop to address barriers to achieving their goals; in addition, they imply that family caregivers’ work is not adequately supported in their current environment.9–11 With the overall goal of informing the design of interventions to support family caregivers’ medical device procurement and use, the objective of this study was to identify and describe the barriers that family caregivers experience in using medical devices in the home to provide care for CMC and the workarounds they make to address those barriers.
Setting and Sample
Participants were enrolled in and recruited from a pediatric complex care program (PCCP) at a midwestern tertiary care academic medical center. Criteria for enrollment in the PCCP include age <18 years at time of enrollment, ≥3 organ systems affected by chronic conditions, ≥3 medical or surgical specialists involved in ongoing care, and either ≥1 outpatient clinic visits or ≥5 hospital days in the previous year.
Participants in this study were English-speaking family caregivers of at least 1 CMC enrolled in the PCCP who were at least 18 years of age and lived within a 1.5 hour drive of the children’s hospital. Purposive recruitment was used to enroll participants with varying education levels, urban and rural households, and duration of experience caring for a CMC. Additionally, no one actively declined participation. On the basis of previous research using contextual inquiry in health care (and other) settings, a sample size of 20 is considered adequate.12–23
Design and Procedure
The field of human factors engineering (HFE), which takes a systems-approach to understanding the interactions between people and technologies,24 provides a framework for analyzing these interactions through an examination of workarounds.9,10,25 We used a descriptive qualitative design26 using the HFE-based contextual inquiry method to collect data,14 which we adapted for use in the home. Contextual inquiry combines semistructured interviews with observations to collect data by observing people while they perform tasks in their own environment and by including interview probes during and after observation.14,27 The interview guide was developed by 2 authors (N.E.W. and R.J.C.) with training in qualitative research, HFE, and pediatric complex care and was reviewed by our research team (Supplemental Information). The HFE-based Systems Engineering Initiative for Patient Safety 2.0 model28 was used to develop the interview guide, ensuring all levels of the system were discussed. The guide was iteratively edited throughout interviews with feedback from research participants (family caregivers of CMC) and our multidisciplinary research team, which included 2 family advisors. Our study was approved by the institutional review board. Verbal consent was obtained from each participant.
Data were collected during home visits with family caregivers lasting up to 2 hours. Two researchers attended each home visit; one led the semistructured interview, and the other made observation notes and took photographs of spaces and artifacts. Participants were asked to physically walk the researchers through a typical day of providing care for their CMC, demonstrating the actions used to provide care. The interviews were audio recorded and transcribed verbatim. Data collection took place from October 2017 to January 2019. Additional data, collected after the child’s enrollment in the PCCP (eg, organ systems involved, technologies used), were used to supplement our study data.
Interview transcripts were analyzed by using NVivo 12 qualitative analysis software (QSR International, Doncaster, Australia). Our cross-disciplinary data analysis team, which included experts in qualitative research methods, human factors and biomedical engineering, the clinical care of CMC, and advocacy for families of CMC, conducted a qualitative content analysis.29,30 We used team-based discussion to identify our specific research questions, guided by the study objective, a review of the current literature on concepts related to medical device workarounds,9,25,28,31,32 and our HFE expertise.30 We defined a workaround as “a change to one or more aspects of an existing work system in order to overcome, bypass, or minimize the impact of obstacles, mishaps, established practices, or structural constraints that are perceived as preventing that work system or its participants from achieving a desired level of efficiency, effectiveness, wellness or other personal goals.” We focused our analysis on identifying (1) the barriers participants described with using medical devices in the home to provide care to their child and (2) the associated workarounds they made to try and address those barriers. We defined medical device based on the US Food and Drug Administration classification.33
Two researchers (H.J.B. and N.S.) began by independently and broadly identifying passages that described workarounds to medical device use in 2 transcripts. Through a series of discussions with a third researcher (N.E.W.), a codebook was iteratively developed. The converged-on codebook was independently applied to each of the remaining 30 transcripts by 2 researchers. Any discrepancies were resolved in regular meetings between coders (H.J.B. and S.L.) and the full research team, as necessary.34,35 Codes related to medical device workarounds were then extracted from NVivo 12 for further categorization by 2 researchers (H.J.B. and N.E.W.). Observation notes and photographs from the home visits were used to confirm and elaborate on the categories identified in the interview transcripts. Categories identified during coding were then iteratively refined by the research team.30
Data were collected from N = 30 family caregivers in a state in the Midwest. Caregivers were between the ages of 20 and 78 years, with an average age of 38; caregivers were mostly female (80%) and white (77%), and 23% lived in a rural area. The average age of their child was 7 years old (range 1–19). In all, 90% of caregivers were caring for a child who used an enteral tube and 27% a tracheostomy. Table 1 provides additional characteristic details.
Medical Device Use Barriers and Associated Workarounds
We identified 4 categories of medical device use barriers: (1) quantity and type of devices allotted do not meet family needs, (2) device is not designed to be used in the locations families require, (3) device use is physically or organizationally disruptive to the home, and (4) device is not designed to fit the user. For each of the barriers, we also identified 2 to 3 categories of associated workarounds for a total of 11 workaround categories. Table 2 provides a detailed description of each barrier, the associated workarounds, and illustrative quotations.
Barrier 1: Quantity and Type of Devices Allotted Do Not Meet Needs
One barrier families encountered was a mismatch between the allotted number of medical devices provided and the frequency of their CMC’s need for the device. Families noted having too few supplies (eg, suction catheters for use with a suction machine). Similarly, families explained a need for back-up devices or components critical to their child’s survival (eg, biphasic positive airway pressure [BiPAP] water chambers, feeding pumps), but these were not routinely supplied.
To address this barrier, families described washing and reusing single-use supplies (eg, suction catheters) until they failed. Other families explained that they determined a set amount of time for reuse of certain supplies (eg, 1 week, 1 month, etc). One family described collecting their used syringes during a hospital stay to wash and reuse at home (Table 2, quote 1A).
Families also worked around this barrier by stockpiling equipment (eg, used BiPAP tubing and water chambers, syringes). One family described keeping an outdated but functional feeding pump as a backup in the event that the primary feeding pump required servicing and the temporary replacement pump supplied by the durable medical equipment provider was inadequate (Table 2, quote 1B).
Finally, families described working around this barrier by repurposing devices or supplies that are not traditionally designed for medical use, such as using infant bottle sterilizers to clean medical devices (Table 2, quote 1C) and modifying insulated lunchboxes to keep feeding bags with formula cool.
Barrier 2: Device Not Designed to Be Used in the Locations Families Require
Another barrier identified was that medical devices were not designed to be used in the locations where families needed to use them. Families described needing to use equipment (eg, feeding pumps, suction machines, and oxygen) when on the go, both within and beyond their home. Families also explained that device size was often a barrier to use, noting that wheelchairs and gait trainers could be difficult to transport to the necessary locations, such as the home, school, and summer camp, and even within the home itself.
Families worked around this barrier by modifying medical devices for use while in motion, such as hanging oxygen tubing throughout their home so their child could move around and making modifications to the child’s car seat to be able to take them in the car, including using Velcro, bungee cords, and carabiners to strategically place medical devices. One family described modifying a rolling cart to house their child’s medical devices so they could more easily move them around the home (Fig 1, Table 2, quote 2A).
To work around the barrier of transporting large devices, families developed strategies for how and when to use and move them, including designating spaces for their use. One family described leaving their child’s gait trainer at summer camp because it was not possible to fit it in the car along with the child and the wheelchair (Table 2, quote 2B).
Barrier 3: Device Use Is Physically or Organizationally Disruptive to the Home
Families described barriers related to device use being disruptive to the home environment. Families found devices to be noisy and physically disruptive.
To work around this barrier, families described modifying the devices physically. One family described wrapping pool noodles around their child’s gait trainer to decrease the damage it would cause to other items in the home when the child ran into things while using it (Table 2, quote 3A).
Families also noted that if a device was too disruptive, they stopped using it. One caregiver indicated that the noise emitted by the oxygen concentrator was so overwhelming that the inconvenience of storing and using multiple oxygen tanks (due to the rapid pace at which her child consumed oxygen) was still preferable to the use of the concentrator (Table 2, quote 3B).
Barrier 4: Device Not Designed to Fit the User
Families described barriers related to receiving medical equipment (eg, nebulizer masks, wheelchairs) that did not appropriately fit their child or was not conducive to optimal use by the caregiver (eg, bed height).
To address this barrier, families described modifying devices to better fit their CMC, such as resizing elastic on nebulizer masks or rolling up towels to better support the child in the wheelchair. One family recounted the process they went through to get a bath chair to fit their child, including adjusting the straps and tightening segments of the chair (Table 2, quote 4A).
Families also described modifying the manner in which they used devices, such as altering the timing of use (eg, modifying timing of feedings) or substituting contents of food blends used for enteral tube feeding (Table 2, quote 4B).
Relatively little is known about families’ interactions with medical devices and, by extension, how to optimize device use in the home. We used an HFE approach to identify and describe the workarounds that family caregivers make to overcome barriers to using the medical devices on which their children depend. Our data, which represent a diverse group of families with respect to rurality, income, and education, uncovered specific family-identified barriers and the extensive workarounds families use to optimize use of these medical devices in their homes. These results have broad implications for the design of medical devices and interventions used in the home and can inform how clinicians review device caregiving and anticipatory guidance during their CMC clinical encounters.
Our results reveal a critical issue: medical devices are not designed to universally fit the complex and dynamic home environment where family caregivers of CMC are required to use them. This may be due in part to the difference between the home environment and controlled clinical spaces for which some of these devices were originally designed in addition to the lack of an empirical record about in-home needs for use that could guide device design.36 Our study provides the first step toward filling that critical gap and also contributes to the growing body of literature acknowledging that family caregivers require devices and technologies that are designed to fit the context in which they are using them.37–40
Additionally, in this study, we describe workarounds to barriers identified by families, which point toward 2 potential solutions: (1) the design of interventions and processes that can be used to assess risk and address the potential implications of family adaptations of medical devices and (2) the redesign of medical devices for optimal home use. For example, the workarounds identified in our study could be used to develop design principles to guide device redesign.41 In addition, although our results can be used to appreciate the capacity of families to adapt medical devices for their needs; the necessity of these adaptations speaks to the suboptimal design of the medical devices to account for those needs. The range of adaptability found in our study (some families described working around many barriers, whereas others had not modified anything despite facing similar barriers) suggests that targeted interventions are needed to assess family risk tolerance and support appropriate adaptability. One such intervention could be the delivery of anticipatory guidance by clinicians to support families in safely adapting devices or device use to overcome the unique barriers they face in their home environments, an intervention that has proven effective in increasing consistency of hearing aid use.42
Some of the identified workarounds are likely more consequential than others. For example, it is concerning that certain barriers, such as devices that disrupt the home environment, at times lead families to stop using the device. Turning off disruptive machines may be unintentionally associated with worse outcomes due to less consistent monitoring or management of certain disease states (eg, cardiovascular effects of chronic hypoxia from an unused disruptive oxygen concentrator). We speculate that there is a wide range of inherent risks and benefits among the workarounds we have identified, consistent with previous findings that workarounds can both widen and close gaps.9 In this case, we do not yet know the downstream effects of these family-initiated workarounds.
Although our study lays the foundation for critical future work in linking our understanding of family’s interactions with medical devices in the home to their influence on health outcomes, further research is needed to inform redesign of medical devices. Systematic studies that inventory family device use and workarounds could direct attention to those devices that may be candidates for redesign. As a population that is uniquely dependent on medical devices to sustain life, CMC families’ interactions with medical devices can provide a test case for identifying the need for redesign of devices that are used by other pediatric and adult populations with chronic disease.
In addition, the field of HFE is uniquely situated to address risk assessment, intervention development, and device design. For example, tools like prospective risk assessment of family caregivers’ workarounds could identify and prioritize workarounds that have the most positive and negative influences on patient outcomes.43,44 This, combined with a systematic approach for inventorying and quantifying workarounds, could yield insights that inform appropriate action. Other HFE methods, such as participatory design, have already been shown to be successful in engaging families in creating interventions that meet shared needs.45,46 Finally, the application of HFE expertise on design aids (eg, personas) could inform the development of tools that capture relevant contextual information about the home environment and display it to medical device designers.47,48
A number of limitations to our study should be considered. First, our analysis relied on families recounting barriers and the workarounds that they developed. It is possible that some workarounds are so routine that families would not think to articulate them. Therefore, there may be workarounds that were not captured. Future researchers could employ novel methods, such as ecological momentary assessment, to capture families’ workarounds more comprehensively.49
Second, all families participating in our study were located within a 1.5 hour drive radius and were recruited through a single institution’s PCCP. Thus, our findings may not be representative of all families in other geographic, socioeconomic, or cultural settings. In addition, although our racial distribution of caregivers mirrors that of the state within which our study occurred, it is not representative of the overall caregiver population. Future researchers should focus on expansion to additional settings and caregiving populations (eg, Black or non–English speaking) to explore workarounds of families who care for CMC in other geographic, socioeconomic, and cultural settings.
Third, the focus of this study was on medical device use in the home, and we did not look at families’ relationships with their providers, either during prescribing or counseling. In future studies, researchers should explore how families interact with professional health care providers regarding their at-home medical device use and how barriers they experience may propagate.
Finally, we focused only on medical device use, not on their access or procurement. Although families developed workarounds for a mismatch between supply allotment and need, it is likely that families have other strategies for obtaining equipment, such as using the person-to-person medical economy.50 For a variety of reasons, including insurance or access barriers, the devices families acquire for their CMC can represent a workaround compared with devices that would have been more convenient, preferable, or recommended by the health care team. As such, our findings may only scratch the surface of the barriers that families experience with their child’s medical devices.
Our findings highlight the many barriers families encounter when using medical devices to care for CMC in their homes and the unique workarounds they create to address these barriers. The workarounds generated by families provide important insights into the ways in which medical devices are not systematically designed to be used the way families need to use them. These workarounds also point to families’ adaptability in bridging this gap. In future work, researchers must take the next critical step to determining positive and negative consequences of the workarounds that families are forced to make and develop interventions that optimize device use for families.
We thank the families of CMC who welcomed us into their homes and shared about the realities of their lives with us. We also thank the research assistants on this project who supported data collection.
Drs Werner and Coller conceptualized and designed the study, coordinated and supervised data collection, and critically reviewed and revised the manuscript; Ms Barton lead the data analysis, drafted the initial manuscript, and revised the manuscript; Ms Loganathar and Mr Singhe contributed to data analysis and critically reviewed the manuscript; Ms Katz, Ms Warner, and Drs Kelly and Ehlenbach contributed to data collection and interpretation and critically reviewed the manuscript; and all authors approved the final manuscript as submitted and agree to be accountable for all aspects of the work.
FUNDING: Supported by the Health Resources and Services Administration of the US Department of Health and Human Services under UA6MC31101 (Children and Youth With Special Health Care Needs Research Network) and by KL2 grant KL2TR002374 from the Institute for Clinical and Translational Research through the National Institutes of Health National Center for Advancing Translational Sciences grant 1UL1TR002373. The information or content and conclusions are those of the authors and should not be construed as the official position or policy of, nor should any endorsements be inferred by, the Health Resources and Services Administration, the US Department of Health and Human Services, the National Institutes of Health, and the US Government. Funded by the National Institutes of Health (NIH).
POTENTIAL CONFLICT OF INTEREST: The authors have indicated they have no potential conflicts of interest to disclose.
FINANCIAL DISCLOSURE: The authors have indicated they have no financial relationships relevant to this article to disclose.