Feasibility Testing of Tubes@HOME: A Mobile Application to Support Family-Delivered Enteral Care

Abstract

Background:

Assistance from medical devices is common for children with medical complexity (CMC) but introduces caregiving challenges. We tested the feasibility of “Tubes@HOME” a mobile application supporting CMC family-delivered care using enteral care as a model.

Methods:

Caregivers of CMC with enteral tubes participated in a 30-day feasibility study of Tubes@HOME November 2020 through January 2021. Tubes@HOME was available on mobile devices and designed to support collaborative care and tracking over time. Key features include child profile, caregiving network management, care routines, feedback loop, and action plans. Care routines delineated nutrition, medication and procedural tasks needed for the child – frequencies, completions, and reminders. Metadata summarized feature use among users. Feasibility was evaluated with post-use questionnaires and interviews. Measures of Tubes@HOME’s usability and usefulness included the NASA Task Load Index (TLX), System Usability Scale (SUS), and Acceptability and Use of Technology Questionnaire (AUTQ).

Results:

Among n=30 children, there were 30 primary (e.g., parent) and n=22 non-primary caregivers using Tubes@HOME. Children had a median (IQR) 10 (5.5–13) care routines created. For care routines created, 93% were marked complete at least once during the study period, with participants engaging with routines throughout study weeks 2–4. Results (Mean (SD)) indicated low mental workload (TLX) 30.9 (12.2), good usability (SUS) 75.4 (14.7), and above-average usefulness (AUTQ) 4.0 (0.7) associated with Tubes@HOME, respectively. Interviews contextualized usefulness and suggested improvements.

Conclusions:

Longitudinal use of Tubes@HOME among caregiving networks appeared feasible. Efficacy testing is needed, and outcomes could include reliability of care delivered in home and community.

INTRODUCTION

The imbalance between caregiving demands and supports for children with medical complexity (CMC) has direct health consequences, including avoidable hospitalization, missed school, and lost parent employment.^1–6 Managing sophisticated medical devices (e.g., tracheostomies, enteral tubes) is one unique source of such demands experienced by CMC caregivers. Despite supporting vital body functions, device complications are common and result in emergency department (ED) or hospital use.^{3, 7, 8} Several studies illustrate how enteral tube care challenges drive caregiver strain and isolation,^9–12 and strain or isolation during CMC caregiving is associated with lower perceived self-efficacy.^{13, 14}

Because enteral tubes are common among CMC,^{15, 16} they may be a valuable model for studying caregiver management of medical devices. When supported, enteral tube care can decrease CMC hospitalizations and antibiotics prescribed for respiratory infections.¹⁷ Supported enteral care can also improve nutritional status, meal duration, medication administration, and caregiver stress.¹⁷ Although complex care program enrollment may be associated with reductions in enteral tube complications,¹⁸ the best methods to support families of CMC in enteral tube care at home remains unknown.

Mobile health applications (or mHealth “apps”) have the potential to improve device care outcomes by improving collaborative symptom tracking, monitoring and management of chronic conditions, and caregiver communication.^19–21 In a prior study, we used a human-centered, iterative co-design process with family caregivers to create a highly usable mHealth solution to support enteral tube caregiving at home (“Tubes@HOME”).²² In this study, our objective was to test the feasibility of Tubes@HOME in terms of acceptability and use.

METHODS

Design

We conducted a 30-day feasibility study from November 2020 through January 2021. We used a mixed method approach to assess feasibility in terms of use (i.e., engagement with Tubes@HOME) and acceptability (i.e., ease of use and perceived usefulness).²³ The University’s Institutional Review Board approved this study.

Setting and Sample

We recruited family caregivers of CMC who use enteral tubes enrolled in the Pediatric Complex Care Program (PCCP) at a tertiary academic children’s hospital in the Midwest. The PCCP team includes general pediatricians, advanced practice providers, registered nurses, care coordinators, nutritionists, and a social worker; and provides outpatient and inpatient medical management and care coordination for CMC. PCCP criteria include CMC having chronic conditions affecting three or more organ systems, experiencing either five or more days of hospitalization or ten or more specialty clinic visits in the year prior to referral, and ongoing care from three or more medical or surgical specialists.

Participants were English-speaking family caregivers of CMC enrolled in PCCP who were at least 18 years of age, cared for a child with an enteral tube (gastro or gastro-jejunostomy), had an iOS mobile device (smartphone or tablet) on which they could install Tubes@HOME, and did not participate in the co-design study. We defined these participants as the primary caregiver. We used purposive recruitment to enroll primary caregiver participants with varying education levels and rurality. We used this approach because we anticipated participants with varying levels of formal education may have different needs and experiences using mHealth, and that those living rural environments have unique caregiving needs. Virtual enrollments were performed using video conferencing software. At enrollment, we asked primary caregiver participants to invite up to three secondary caregivers, defined as other caregivers providing direct care to the child in the home and community (e.g., other family members, friends, in-home nurses, respite caregivers, etc.).

Tubes@HOME Intervention

We engaged CMC caregivers and multidisciplinary stakeholders (e.g., experts in family advocacy, clinical care, state policy, enteral tube supplies, informatics, software development) to design and develop Tubes@HOME using a human-centered design process.³⁵ Tubes@HOME is a mobile app designed for and by CMC caregivers. The present version of @HOME supports an iOS operating system, with plans to develop an Android version. The app is designed to promote communication and coordination among the network of caregivers to provide consistent, high-quality care to a child with medical complexity. Key features include 1) home page, 2) child profile, 3) caregiving network management, 4) care routines, 5) care feedback loop, and 6) action plans. Details of each feature are provided in Table 1.

Table 1.

Key features of the Tubes@HOME app

Key Feature	Description	Purpose	Functional Requirements
Home page	The main page where users can view the current care situation	Promote situation awareness around the child and their current care needs	•View and complete care routines that need to be done •Receive alerts when a care routine is completed or overdue •Write and view simple note hand-offs
Child Profile	Page with details about the child	Provide users with essential information to understand and support the child	•Record important information about the child (e.g. personality and unique characteristics, comfort measures, needs, likes) •Record tube details (e.g., size, length, frequency of changes, data of original placement) •Include image of the child
Caregiving Network Management	Feature that allows primary user to manage all of the child’s caregivers	Manage user information and access to app features	•Invite and remove users (or user permissions) within Tubes@HOME •View users and their contact details
Care Routines	App page to create and edit all care details and schedules	Facilitate continuity and accuracy of care, ensuring t child receives appropriate and timely nutrition and other care	•Create and maintain schedules for what care to do when, labeled and organized by caregiver (user) preference •Enter meal schedules throughout the day, including formulas, foods, water and supplements •View when foods, medications, or procedures are due and completed •Set reminders or alarms to distinguish when a care is due or overdue •Indicate child’s sick day nutrition and hydration plans
Care Feedback Loop	Push notifications for care routines with completion step	Ensure continuity and accuracy of care and provide peace of mind	•Receive notifications when foods, medications, or procedures are due •Log when foods, medications, or procedures are completed •Receive notification when care routines are completed
Action Plans	App page that has specific details for crisis situations	Ensure all caregivers have access to troubleshooting and emergency information	•Provide direction for common enteral tube-related emergencies •All users receive standard (though editable) plans for tube dislodgement or breaking, granulation tissue, skin redness, and tube site leaking or bleeding •Users can create additional custom plans for issues faced by their child

Procedures

Before enrollment, participants were mailed a packet of study materials including the consent form and a quick start guide for using Tubes@HOME. Participants were asked to bring a list of their child’s enteral feeding routines, medications, and secondary caregiver email addresses to the enrollment visit. During the 60-minute enrollment session, participants were consented and oriented to Tubes@HOME after downloading the app, set up an account, entered their care routines, accessed technical support, and invited secondary caregivers.

After enrollment, participants used Tubes@HOME for 30 days. They were asked to log in at least once daily since this was a new technology for them and may take some time to integrate into their routines. We let participants direct use and did not require a specific type or duration of use. We sent participants a daily email reminder to log in to prompt everyday use that included a caregiver or child wellness tip, information on healthcare navigation, or clinical tips related to CMC. The message also contained the contact information for technical support and the PCCP. At the end of week one, a study team member contacted the primary caregiver participant by phone to inquire whether they had any questions or concerns in using the app. On day 31, user accounts were deactivated, and a post-trial session was conducted for data collection.

Measures

Primary caregivers were the main focus of data collection, and they completed a pre-trial survey during enrollment visits as well as a post-trial survey and a recorded semi-structured interview during the post-trial visit. Other data sources included Tubes@HOME metadata and child electronic health records. From the health record (Epic Systems, Verona, Wisconsin), research staff used a structured data abstraction form to identify the type and duration of enteral tube use, numbers of emergency department, hospital and clinic visits, and whether visits were enteral-related.⁷ Primary caregiver participants received $25 upon completion of the enrollment visit and $100 upon completing their participation in the 30-day trial. Secondary caregivers did not receive an honorarium.

Participant characteristics

We collected caregiver demographics, including age, gender, and income, through the pre-trial survey. Child characteristics were extracted from the medical record, including gender, age, type of enteral device (e.g., gastrostomy, gastro-jejunostomy), enteral tube duration, involved organ systems, daily scheduled enteral medications, involved subspecialties, total encounters in the prior year, and enteral related encounters in the preceding year.⁷ We measured caregiver strain using the seven-item caregiver strain questionnaire (CGSQ7) with a response range from 1 (not a problem at all) to 5 (very much a problem). We also measured caregiver activation (i.e., confidence, skills, and attitudes to manage health) using the 10-item Family Caregiver Activation in Transition (FCAT) scale with a response range from 1–5, with higher scores indicating higher activation. Activation was measured in this study because we hypothesize that activation might influence how families use mHealth tools, and to establish a baseline for future evaluations to determine whether mHealth tools influence activation levels.

Tubes@HOME Feasibility

Tubes@HOME Use

We captured use metadata through the Tubes@HOME app including user types, feature use, and use frequencies. Use data was collected for both primary and secondary caregivers.

Tubes@HOME Acceptability

We measured acceptability in terms of Tubes@HOME usability and usefulness. We measured usability with the System Usability Scale (SUS)²⁴ and the NASA Task Load Index (NASA TLX).^{25, 26} SUS contains ten statements (e.g., “Learning to use the IT intervention was quick for me”) and a five-point response scale (strongly disagree to strongly agree). NASA TLX assesses the mental workload associated with app use on six subscales with a 100-point range (very low to very high).

We measured usefulness with the Technology Acceptance Model perceived usefulness scale and the attitude toward the technology subscale from the Unified Theory on Acceptance and Use of Technology (UTAUT) Model.^{23, 27} Each subscale contains four statements (e.g., Using Tubes@HOME would make it easier to care for my child) and a five-point response scale (strongly disagree to strongly agree).

Protocol Feasibility

We measured recruitment, retention, fidelity, and data collection processes to assess protocol feasibility. We measured recruitment as the number attempted to reach, the number enrolled, and the number declined. We measured retention as a drop-out rate. We measured fidelity in terms of account creation, completion of the one-week check-in call, and the number opted out of the daily reminder email. We measured data collection processes in terms of enrollment and post-trial visit completion times and completeness of questionnaires.

Qualitative Interviews

We also conducted a semi-structured interview consisting of three questions and specific probes to identify factors influencing Tubes@HOME acceptability, which were audio-recorded and transcribed verbatim. The purpose of the interviews was to provide contextual information to support the interpretation of the quantitative findings. Overarching questions were: 1) What about Tubes@HOME was most/least useful; 2) How did Tubes@HOME help you and your family; and 3) What else should Tubes@HOME do – what other features are needed.

Data Analysis

We used SAS to compute descriptive statistics for each quantitative outcome measure. We analyzed interview data using general content analysis⁵³ to identify specific categories related to factors influencing usefulness. One research team member reviewed the data and identified initial categories, which were subsequently refined through team-based discussions with the senior members of the research team. Final categories were brought to the entire research team for discussion and refinement until consensus was reached.

RESULTS

Participants

We enrolled n=30 caregiver-child dyads. Participants were primarily female (90%), median (interquartile range, IQR) age 36 (31–41) years, and median (IQR) years of enteral tube caregiving experience of 6 (3–10) (Table 2). Approximately one-third of caregivers had high school or college education, half had associate’s or college degrees, and 20% had graduate degrees. Children were 50% female, n=26 (87%) had gastrostomy tubes, and 4 (13%) had gastrojejunostomy tubes. In the year before study enrollment, 33% of ED visits, 8% of hospitalizations, and 25% of clinic visits included an enteral tube-related focus (Table 2). Children received a median (IQR) 5.5 (2–10) daily enteral medications.

Table 2.

Participant Characteristics

	n (%)
Parent Characteristics
Sex – Primary Caregiver
Male	3 (10%)
Female	27 (90%)
Age
Median, (IQR)	36 (31 – 41)
Urban/ Rural Status
Urban	24 (80%)
Rural	6 (20%)
Highest Education
High school graduate or GED	3 (10%)
Some college	6 (20%)
Associate’s degree/ technical college	7 (23%)
College degree	8 (27%)
Higher than a college degree	6 (20%)
Income
Less than $40,000	7 (23%)
$40,000 - $79,999	9 (30%)
$80,000 - $99,999	5 (17%)
More than $100,000	6 (20%)
Not reported	3 (10%)
Family Caregiver Activation in Transitions Tool
Mean (Standard Deviation)	4.5 (0.3)
Caregiver Strain Questionnaire
Mean (Standard Deviation)*	5.2 (1.8)
Child Characteristics
Sex
Male	15 (50%)
Female	15 (50%)
Age
3 – 10	22 (73%)
11 – 13	2 (7%)
14 – 18	6 (20%)
Type of Enteral Device
G Tube	26 (87%)
GJ Tube	4 (13%)
Enteral Tube Duration
Median (IQR)	6.5 (3 – 10)
Involved Organ Systems
Median (IQR)	6 (5 – 7)
Involved Subspecialties
Median (IQR)	7 (6 – 8)
Daily Scheduled Enteral Medications
Median (IQR)	5.5 (2 – 10)
Total Encounters in the Prior Year
Emergency Department	6
Hospitalization	12
Clinic	24
Encounters: Enteral - Related
Emergency Department	2 (33%)
Hospitalization	1 (8%)

^*Global score is calculated as the sum of the two subscale scores

Tubes@HOME Feasibility (Use)

Among the enrolled children, a total of n=52 (30 primary and 22 secondary) used Tubes@HOME during the feasibility trial period (Table 2). The median (IQR) number of caregiver users per child was 2 (1–2). The use of specific features across the testing cohort is summarized in Table 3. Each child had a median (IQR) 10 (5.5–13) different care routines created. Nearly all (93%) of care routines were marked complete at least once during the trial period, with 90% of the daily care routines were marked complete by primary caregivers. The completion of care routines within Tubes@HOME peaked in week 1; and from week 1 to 2, about one-third of users had higher use, one-third had lower, and one-third had about the same. Use during testing weeks two through four appeared stable and sustained (Figure 1). Among the 52 caregivers using Tubes@HOME, n=15 (28%) used the communication feature to communicate across the network, with 73% of these communications created by primary caregivers. While all participants received a universal set of enteral tube action plans with Tubes@HOME (Table 1), 3 (10%) of primary caregivers created additional action plans, which focused on seizures, respiratory distress, hypothermia and diaper rash.

Table 3.

Tubes@HOME Feasibility – Use, Usability, and Usefulness

	n (%)
Tubes@HOME Users
Total Caregivers	52
Primary Caregivers	30
Additional Caregivers	22
Number of caregivers per child, Median (IQR)	2 (1 – 2)
Care Routines
Caregivers utilizing care routines	31 (60)
Care routine quantity by child, Median (IQR)	10 (5.5 – 13)
Care routines marked as complete	300 (93)
Completions of care routine, Median (IQR)	10 (4 – 22)
Care routine completions by primary caregiver	4213 (90)
Network Communications
Caregivers utilizing communications	15 (28)
Number of communications per child, Median (IQR)	2 (1 – 4)
Number of communications created by primary caregiver	30 (73)
Child Profile Elements Completed by Users
Preferred name	30 (100)
Allergies	23 (74)
Calmed by	17 (55)
Things to know	16 (52)
Assistance with	12 (39)
Upset by	10 (32)
Best communicative method	9 (29)
Technology	7 (23)
Comfort measures	5 (16)
Action Plan Creation
Caregivers using action plans	3 (10)
Total action plans created	4
Usability and Usefulness
Number of questions or concerns in using the app at 1 week	0
NASA Task Load Index, mean (standard deviation)	30.9 (12.2)
System Usability Scale, mean (standard deviation)	75.4 (14.7)
Perceived Usefulness, mean (standard deviation)	3.3 (0.8)
Attitudes toward using the technology, mean (standard deviation)	4.0 (0.7)

Figure 1.

Completion of care routines by week.

Tubes@HOME Acceptability (Usability and Usefulness)

The mean (SD) usability scores of 30.9 (12.2) for the NASA TLX and 75.4 (14.7) for the SUS indicated low mental workload to use Tubes@HOME and ‘good’ usability (comparable to Microsoft Word or Nintendo Wii) (Table 3).²⁸ The mean (SD) usefulness scores of 3.3 (0.8) for perceived usefulness and 4.0 (0.7) for attitudes towards use indicate average to above average perceptions of usefulness and an overall positive attitude towards Tubes@HOME.

Protocol Feasibility

All the primary caregivers approached for enrollment were enrolled in the study (n=30), and no participants dropped out of the study. All data elements were completed among survey respondents, and only one single item was missing across enrollment and post-trial surveys. All enrolled participants created a Tubes@HOME account, none opted out of the daily reminder email, and 28/30 (83%) completed the week one check-in call.

Qualitative Results

We identified five usefulness facilitators and seven opportunities to improve usefulness (Table 4). Participants reported that Tubes@HOME was useful for ensuring reliably delivered care, establishing new care routines, and identifying errors in real-time such as missed medications. Participants also described that Tubes@HOME was useful for tracking health indicators to share with the healthcare team and made care less overwhelming. Opportunities to improve usefulness included additional features such as photo and file uploads to provide more description within care routines, customizable and longitudinal tracking of clinical indicators of health (e.g., growth parameters, selected vital signs, unique and relevant lab values, urine output, seizure frequency and duration, etc), more flexibility in routine scheduling to accommodate atypical days, including all aspects of care (i.e., in addition to enteral care), and receiving alerts if routines are not completed by a secondary caregiver. Participants also described how different interfaces for primary and secondary caregivers and integration with the healthcare systems, such as the electronic health record, could reduce any Tubes@HOME data entry burdens for families.

Table 4.

Categories identified in the qualitative analysis of perceived usefulness with descriptions and illustrative quotations.

Category	Subcategory	Illustrative quotation
Usefulness factors	Ability to identify and address medication error in real time	“We actually had a day that my husband had forgotten to give meds while I was gone at work. So, we would have been really in trouble had I not gone through with the app and we would have missed really important medication for the day.”
	Share tracking with the healthcare team	“If a doctor asks when was the last time you gave him [a medication], and why did you give him that? [I could check the app to see that] okay, this month or this week, I'm giving [the medication] like a couple of times.”
	Ensure care delivered reliably	“I found it was really useful to have, to kind of have a reminder with, [child] has some different meds that she takes one dose at one time, and then a different dose another time. It was kind of nice to have a reminder of like the different dosages so I could just make sure that’s what I gave her.”
	Establish new care routines/changing care routines	“We came home from the trach placement with like three or four different new medications, plus like a dozen-plus new routines we had to add into our life. And so we were just so frazzled and overwhelmed. And I think this would have been really beneficial for us then.”
	Made care less overwhelming	“It can be kind of overwhelming at first, and so like [the @HOME app] breaks it down into, you know, more manageable things. Especially at first with a kid with a g‑tube, it can be a little overwhelming.”
Opportunities to improve usefulness	Different interface for primary and secondary	“And then maybe just being able to do a check mark or something, instead of actually physically having to put in the amount, at least not for the main user, I feel like, just because we do them so often.”
	More flexibility in routines for atypical days	“At this point, we don’t have a rigid schedule. We’re flexible based on schooling and work and travel and all those other kinds of things. Instead of having preset times, we said, here are our tasks for the whole day.”
	Notification when a routine has not been completed	“I would kind of want a like an alert 30 minutes post, or, you know, let me set a time, if they donť enter the routine by 30 minutes past due.”
	Expand beyond enteral care focus	“And I think if you could include [in Tubes@HOME], you know, kind of like all aspects of the [care routines for] patient and child, I would probably even pay to have something like that if I could, if you could have all of that in one spot.”
	Integrate with the healthcare system	“If there would be a way to like incorporate MyChart info into it, so it would pull in like your upcoming appointment times and like clinic phone numbers, that sort of thing.”
	Provide additional tracking capability	[Other features I wish the app had] “is just a bowel movement tracker as well,” “Other things that like we personally chart is like sleep patterns, like her sleep at night, like when she was awake. I don’t know if other people have problems with that or not. And then number of wet diapers”
	Photo and file uploads to care routines	“It would be nice to be able to take the care plan and add it as a file into the app”

DISCUSSION

Expanding on the earlier human-centered co-design of a highly usable Tubes@HOME app,²⁹ this study established the feasibility of longitudinal use and the acceptability of the current Tubes@HOME features. Participants used most app features, and data suggests that use was sustained across the month-long trial. They found the app useful and expressed an assurance that safe, high-quality care was delivered to their child because of the app. They recommended expanding the focus of the app beyond enteral care and integrating the app with healthcare, e.g., during clinical encounters, linking to the electronic health record, to further increase the usefulness of Tubes@HOME.

These findings, which confirm and extend our formative design work,²⁹ are critical to sustained use of chronic disease-focused apps.^{30, 31} The high protocol uptake, retention, and fidelity to the intended study activities, paired with the acceptability of Tubes@HOME are consistent with findings from recent studies that suggest the promise of and need for mobile health interventions to support families with special healthcare needs.^32–36 Importantly, our app appears to be acceptable across a broad range of education levels. Although long-term sustainable use will be determined in future work, observing one month of longitudinal use suggests Tubes@HOME is feasible for daily use by families and the child’s other caregivers. Further, families’ input on expanding the app’s focus to other aspects of care (e.g., tracheostomy, medication safety) points to the potential for apps such as Tubes@HOME to improve outcomes beyond enteral care.

Short-term pilot studies such as this provide valuable insights, uncovering the refinements needed to optimize the feasibility and acceptability of mobile health apps. The design improvements identified by our participants are similar to those recognized in mobile app design requirements in other studies involving CMC, such as alerts, communication and coordination support, and features that span the child’s care needs.^35–38 In particular, to enhance engagement toward daily use, our results suggest that expanding beyond the focus on enteral care to include all aspects of the child’s care are important adjuncts to such technology, e.g., tracking personal health indicators, facilitating communication and coordination with the child’s clinicians through image upload, and being notified when a care routine is not completed within the scheduled time. Although families did not prioritize health record integration in the initial co-design work,²⁹ in this study, it was a suggested opportunity for improvement.

Although families’ insights about opportunities to improve Tubes@HOME are critical to improving usefulness and engagement, multiple factors ultimately influence design decisions. For example, researchers must consider the potential influence of added features on intervention complexity (i.e., usability), the feasibility of changes in terms of available resources, and on the overall goal of the intervention. Overall, user-generated design iterations are helpful to designers, researchers, and clinicians by illuminating what families need; they also are a necessary step towards successfully completing a randomized clinical trial to test the effect of Tubes@HOME on CMC and family outcomes. Moreover, the high protocol feasibility we observed suggests that larger studies with rigorous designs are appropriate. These iterations are helpful to designers, researchers, and clinicians by illuminating what families need; they also are a necessary step towards successfully completing a randomized clinical trial to test the effectiveness of Tubes@HOME on CMC and family outcomes. Moreover, the high protocol feasibility we observed suggests that larger studies with rigorous designs are appropriate.

Similar to our original co-design process, a unique focus in our work is the highlighted need for an app that connects all of the child’s caregivers around the care of the child.^{29, 38} This need is consistent with evidence that the quantity and quality of daily care needed by CMC typically exceed the capacity of what one individual can do, and what is considered safe in industries involving human safety.³⁹ To meet their child’s needs, parents establish caregiving networks with others who care for their child (e.g., extended family, home nurses, respite, school personnel, etc.).^{29, 40} Although our study had a median of two users per child, families told us that the COVID-19 pandemic significantly reduced their ability to engage with their caregiving networks, and most families were unable to have outside help in the home or school for extended periods. This may also explain why two features related to care network functions, i.e., communication feature and personalized action plans were not used by all participants, as these features are designed specifically for care network communication and coordination. The COVID19-related isolation families described likely artificially reduced the number of non-primary caregivers invited to use Tubes@HOME at the time of the study. Despite this challenge, our results affirm the need for mobile app supports for caregiving network communication and coordination.

Although our study deliberately did not attempt to quantify changes in health outcomes with app use, mobile health interventions have promising potential to improve a broad range of outcomes for families and children.⁴¹ Enteral tube complications can cause infections, bleeding, and inadequate nutrition, hydration, or medication administration, any of which can lead to health services use, health declines, or death.^{9, 17, 42} We expect that Tubes@HOME can improve outcomes, including enteral tube complications, through the primary mechanism of improving caregiver self-efficacy (knowledge, skill, confidence) related to daily enteral care. Enteral tube complications likely comprise a meaningful proportion of CMC ED and hospital encounters,⁷ which both add to strain and may at times be a manifestation of limited support provided to caregivers. Guided by behavioral intervention theory⁴³ and findings from our research on preventing CMC hospitalization,^{1, 4, 44–46} our current conceptual model illustrates how Tubes@HOME may reduce enteral care associated caregiving strain and health services use by increasing perceived enteral care self-efficacy. Increased self-efficacy influences caregiving network capacity to handle routine enteral care and complications, ultimately reducing acute enteral care health services use (Supplemental Figure 2). Our future research will test this hypothesis in a randomized trial.

Our findings should be interpreted with consideration of certain limitations. The study took place within a complex care program at a single institution, and results may not be generalizable to other settings. Future research on efficacy and effectiveness should expand to multiple sites to increase the generalizability of findings. Our recruitment success may be attributed to a history of high engagement between PCCP families and the research team, and since PCCP families co-designed Tubes@HOME. Recruiting from other contexts would likely have lower uptake.

Further, although our sample was diverse in terms of education and rurality, participants were primarily non-Hispanic, white mothers, and the current version of Tubes@HOME is only available in English. In addition, our sample included children who had enteral devices for an average of 6.5 years. Our future work will strive to enroll participants with different caregiving roles, diverse backgrounds and languages, and less experience with enteral care. We did not systematically capture the number of care routines that were needed for each child to compare with the number of care routines created within Tubes@HOME, but we plan to capture this data during the planned efficacy trial. Scores on the family caregiver activation in transitions tool indicate that participants were engaged caregivers. It is possible that this score is related to the measure, which was not designed specifically for families caring for CMC and underscores the need to have activation measures developed for CMC families. This also suggests the need to enroll non-complex care CMC in general CMC research, which we plan to do in our subsequent clinical trial. Due to study constraints, the first version of Tubes@HOME was only available on Apple iOS, limiting who could participate in our study. Our immediate next step is to develop the Android version of Tubes@HOME to increase its reach.

Conclusion

Mobile health apps such as Tubes@HOME have the potential to improve outcomes for families and CMC. The present study established the feasibility and acceptability of using Tubes@HOME longitudinally across the caregiving network. Results inform the design changes to increase feasibility and acceptability for a subsequent randomized trial to test the effectiveness of Tubes@HOME to improve CMC and family outcomes.