Children With Medical Complexity
Conditions
Keywords
medical complexity, multiple chronic conditions, children
Brief summary
The investigators have developed a tool to facilitate self-management for children with medical complexity (complex, multisystem chronic diseases) called MyChildCMC (My Child's Complex Medical Condition). MyChildCMC is an online, phone application (app) that engages parents daily in ongoing monitoring of common, crosscutting acute symptoms, including respiratory distress, inadequate feeding/fluid intake, fever, altered mental status, pain, and seizure status. The MyChildCMC app also guides parents to recognize early warning signs for health deteriorations to avoid acute events (i.e., ED visits and/or hospitalizations). Parent comments during the development of the MyChildCMC application revealed that the tool had potential in helping them manage their child's chronic conditions. This study will be the first to explore if online home monitoring using online technology is feasible, scalable, and can lead to improved CMC outcomes. This pilot trial for the MyChildCMC app was designed to determine preliminary impact by comparing outcomes (child QOL, child emergency department and hospital admissions, and parent/caregiver satisfaction with care) between the intervention and control groups. If successful, our approach will be a model for improving CMC care and reducing costs for families and children with medical complexity. Future MyChildCMC trials will integrate care coordination and a more robust alert system to help facilitate care and follow-up for patients.
Detailed description
Aim: Investigators will assess the impact of the MyChildCMC app by comparing the following outcomes for the child and caregiver: 1. Child Quality of Life (QOL) 2. Child Emergency Department (ED) and hospital admissions 3. Number of hospital days 4. Parent/Caregiver satisfaction with care
Interventions
OTHERMyChildCMC app
Patients/parents will self-monitor their symptoms daily using the MyChildCMC app completing the daily vitals form. After patient/parents complete the daily form, the app provides in-app alerts and graphs showing symptom data over time.
Sponsors
HRSA/Maternal and Child Health Bureau
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 20 Years
Healthy volunteers
No
Inclusion criteria
Participant Inclusion Criteria: Children with complex medical conditions\* ages 1 through 20 years with their primary caregiver (primary person caring for the child) who: * have been seen at Primary Children's Hospital within 365 days, * own a smartphone or a tablet computer with Internet access, and * are English speaking \*Physician diagnosis was used to determine CMC diagnosis
Exclusion criteria
* Critically ill children in imminent death * Non-English speakers
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Quality of Life (QOL) | Quality of Life assessed at baseline, then compared to 1 month and 3 months from start of study/intervention | Compared Mean QOL Change from Baseline to Each Follow-up Assessment Between the Two study Groups, using the Ellzey et. al.'s QOL survey questionnaire for children with complex medical conditions, which assesses multiple domains including physical health, mental health, sleep, pain, activities and general QOL. The total QOL score was reported and standardized to 100 points, with scores ranging from 20 (the lowest QOL) to 100 (the highest QOL). Higher QOL scores represent a better outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Emergency Department (ED)/Hospitalization | Change in ED/hospital admission between 3-month prior and 3-month post start of study/intervention | Compare NUMBER of ED and hospital admissions 3-month pre, and 3-month post study initiation between the intervention and Usual care groups. |
| Number of Hospital Days | 3-month pre and 3-month post study start | Number of days (duration) participants were hospitalized |
| Parent/Caregiver Satisfaction With Care | Collected once at study end (3 months) | Caregiver satisfaction with overall care of their children, using an adapted version (by Ellzey et. al) of Client Satisfaction Questionnaire for children with complex medical conditions, which has 6 questions measuring caregiver's confidence with ability to take care of child's health, consistency in doing things needed to take care of the child, availability of medical professional support, availability of social support, availability of a monitory system to help with child's home care and stress about child's health. We reported the total caregiver satisfaction scores, which range from 5 (the lowest satisfaction) to 30 (the highest satisfaction). Higher caregiver satisfaction scores represent a better outcome. |
Countries
United States
Participant flow
Recruitment details
Recruitment period was between June 2019 to December 2019. Recruitment occurred at Primary Children's Hospital in Salt Lake City, Utah.
Pre-assignment details
Of the 68 subjects whose medical records were reviewed, 6 did NOT meet eligibility criteria (5 non-English speaking parents and 1 was on palliative care) and were NOT invited to participate. Of the 62 POTENTIALLY eligible subjects who were invited to participate in the study, 12 DECLINED to participate and WERE NOT enrolled, and 50 subjects AGREED to participate and were enrolled. Of the 50 subjects who were enrolled, 24 were randomized to MyChildCMC and 26 to usual care.
Participants by arm
| Arm | Count |
|---|---|
| MyChildCMC Intervention Group Parents/patients randomized into the MyChildCMC Intervention Group will use the MyChildCMC app to monitor their child's daily symptoms for the duration of the study period (3 months). The MyChildCMC app includes a daily form consisting of 12 questions assessing child's vitals, pain, seizures, mood, and feeding as well as caregiver worry for the day. Daily reminders are sent to the parent to fill out the vitals form in the app. Parents/participants will also fill out a quality of life survey at baseline, 1 month, and 3 months as well as a caregiver satisfaction survey at 3 months.
MyChildCMC app: Patients/parents will self-monitor their symptoms daily using the MyChildCMC app completing the daily vitals form. After patient/parents complete the daily form, the app provides in-app alerts and graphs showing symptom data over time. | 24 |
| Usual Care Group Parents/patients randomized into the Usual Care Group do not use the MyChildCMC app to monitor their child's daily symptoms and are instructed to continue with regular care for their child and to continue monitoring their child's symptoms on their own without the use of the app for the duration of the study period (3 months). Parents/participants will also fill out a quality of life survey at baseline, 1 month, and 3 months as well as a caregiver satisfaction survey at 3 months. | 26 |
| Total | 50 |
Baseline characteristics
| Characteristic | MyChildCMC Intervention Group | Usual Care Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 24 Participants | 24 Participants | 48 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 2 Participants | 2 Participants |
| Age, Continuous | 7.29 years | 9.65 years | 8.52 years |
| Race/Ethnicity, Customized Hispanic | 3 Participants | 8 Participants | 11 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 20 Participants | 18 Participants | 38 Participants |
| Region of Enrollment United States | 24 participants | 26 participants | 50 participants |
| Sex: Female, Male Female | 9 Participants | 12 Participants | 21 Participants |
| Sex: Female, Male Male | 15 Participants | 14 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 24 | 0 / 26 |
| other Total, other adverse events | 0 / 24 | 0 / 26 |
| serious Total, serious adverse events | 0 / 24 | 0 / 26 |
Outcome results
Primary
Patient Quality of Life (QOL)
Compared Mean QOL Change from Baseline to Each Follow-up Assessment Between the Two study Groups, using the Ellzey et. al.'s QOL survey questionnaire for children with complex medical conditions, which assesses multiple domains including physical health, mental health, sleep, pain, activities and general QOL. The total QOL score was reported and standardized to 100 points, with scores ranging from 20 (the lowest QOL) to 100 (the highest QOL). Higher QOL scores represent a better outcome.
Time frame: Quality of Life assessed at baseline, then compared to 1 month and 3 months from start of study/intervention
Population: Analysis included 50 participants at baseline (including 24 participants in the intervention group and 26 in the usual care group ), 40 participants at 1 months (including 16 in the intervention group and 24 in the usual care group), and 37 participants at 3 months (including 15 participants in the intervention and 22 participants in the usual care group).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MyChildCMC Intervention Group | Patient Quality of Life (QOL) | Baseline QOL score | 62.7 score on a scale, range from 20 to 100 | Standard Deviation 14.8 |
| MyChildCMC Intervention Group | Patient Quality of Life (QOL) | 1-month QOL score | 59.8 score on a scale, range from 20 to 100 | Standard Deviation 16.9 |
| MyChildCMC Intervention Group | Patient Quality of Life (QOL) | 3-month QOL score | 55.2 score on a scale, range from 20 to 100 | Standard Deviation 15.3 |
| Usual Care Group | Patient Quality of Life (QOL) | Baseline QOL score | 54.4 score on a scale, range from 20 to 100 | Standard Deviation 15 |
| Usual Care Group | Patient Quality of Life (QOL) | 1-month QOL score | 51.9 score on a scale, range from 20 to 100 | Standard Deviation 12.2 |
| Usual Care Group | Patient Quality of Life (QOL) | 3-month QOL score | 50.8 score on a scale, range from 20 to 100 | Standard Deviation 15.6 |
Comparison: We used a generalized estimating equation model for repeated assessments, with a common unstructured residual covariance matrix to account for correlation in repeated measurements in the same patient, to compare QoL total score at baseline, 1 month, and 3 months between the groups. We hypothesized that MyChildCMC users would have better outcomes for the child (higher QoL, fewer ED and/or hospital use and hospital days) and parent (higher satisfaction with child's care).p-value: >0.05generalized estimating equation model
Secondary
Number of Hospital Days
Number of days (duration) participants were hospitalized
Time frame: 3-month pre and 3-month post study start
Population: Number of hospital days were compared between the Intervention group participants and Usual Care group participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MyChildCMC Intervention Group | Number of Hospital Days | 3-Month Pre | 9.25 Days | Standard Deviation 18.3 |
| MyChildCMC Intervention Group | Number of Hospital Days | 3-Month Post | 4.54 Days | Standard Deviation 6.95 |
| Usual Care Group | Number of Hospital Days | 3-Month Pre | 1.08 Days | Standard Deviation 1.88 |
| Usual Care Group | Number of Hospital Days | 3-Month Post | 2.46 Days | Standard Deviation 3.84 |
p-value: <0.00195% CI: [0.39, 0.62]Mixed Models Analysis
Secondary
Parent/Caregiver Satisfaction With Care
Caregiver satisfaction with overall care of their children, using an adapted version (by Ellzey et. al) of Client Satisfaction Questionnaire for children with complex medical conditions, which has 6 questions measuring caregiver's confidence with ability to take care of child's health, consistency in doing things needed to take care of the child, availability of medical professional support, availability of social support, availability of a monitory system to help with child's home care and stress about child's health. We reported the total caregiver satisfaction scores, which range from 5 (the lowest satisfaction) to 30 (the highest satisfaction). Higher caregiver satisfaction scores represent a better outcome.
Time frame: Collected once at study end (3 months)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MyChildCMC Intervention Group | Parent/Caregiver Satisfaction With Care | 26.93 score on a scale, ranging from 5 to 30 | Standard Deviation 2.22 |
| Usual Care Group | Parent/Caregiver Satisfaction With Care | 24.14 score on a scale, ranging from 5 to 30 | Standard Deviation 4.21 |
p-value: 0.03595% CI: [1.01, 1.22]Mixed Models Analysis
Secondary
Patient Emergency Department (ED)/Hospitalization
Compare NUMBER of ED and hospital admissions 3-month pre, and 3-month post study initiation between the intervention and Usual care groups.
Time frame: Change in ED/hospital admission between 3-month prior and 3-month post start of study/intervention
Population: Using intention-to-treat analysis, we compared numbers of ED/hospital admissions and hospital days (3-month pre- and 3-month post-enrollment; enrollment hospitalization excluded) between the groups using generalized linear models with logarithmic link and Poisson regression analysis, estimating rate ratios (RR) and 95% confidence intervals (CI). Covariates included age, sex, and race/ethnicity.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MyChildCMC Intervention Group | Patient Emergency Department (ED)/Hospitalization | 3-month pre-study | 1.13 number of ED and hospital admissions | Standard Deviation 1.26 |
| MyChildCMC Intervention Group | Patient Emergency Department (ED)/Hospitalization | 3-month post-study | 1.08 number of ED and hospital admissions | Standard Deviation 1.25 |
| Usual Care Group | Patient Emergency Department (ED)/Hospitalization | 3-month pre-study | 0.85 number of ED and hospital admissions | Standard Deviation 1.05 |
| Usual Care Group | Patient Emergency Department (ED)/Hospitalization | 3-month post-study | 0.88 number of ED and hospital admissions | Standard Deviation 1.11 |
p-value: 0.88295% CI: [0.58, 1.88]Mixed Models Analysis