Self-management Intervention for Children With Chronic Medical Complexity: Pilot Feasibility Trial
Phase: NA
Conditions: Children With Medical Complexity
Sponsor: University of Utah

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IRB_00088596
1. Contacts and Title
Date: Friday, July 9, 2021 9:58:39 AM
IRB_00088596
Created: 12/9/2015 12:01 PM  
PI: Flory Nkoy MD, MS, MPH
Submitted: 2/12/2016  
Title: SELF-MANAGEMENT INTERVENTION FOR CHILDREN
WITH CHRONIC MEDICAL COMPLEXITY
 
1. Study Introduction
1. Responsible Investigator:
Flory Nkoy
Email
Training
CoI Date
flory.nkoy@hsc.utah.edu 10/16/2019 SMG
6/14/2021
a. Position of the Investigator:
Faculty or Non-Academic Equivalent
Student
Staff
Resident/Fellow
Other
2. Contact Persons for the Responsible Investigator:
Name
Email
Training
Angela Zhu
angela.zhu@hsc.utah.edu
7/14/2020 SMCG
3. Guests of the Responsible Investigator:
Last Name
First Name
E-Mail
There are no items to display
4. What type of application is being submitted?
New Study Application (or Amendment/Continuing Review)
5. Title Of Study:
SELF-MANAGEMENT INTERVENTION FOR CHILDREN WITH CHRONIC MEDICAL COMPLEXITY
6. Study Purposes and Objectives:
Our Specific Aims are: Aim 1. Partner with caregivers to develop the MyChildCMC application: 1.a. Assess caregiver
needs, preferences and capability for CMC self-management through focus groups; 1.b. Develop the MyChildCMC
application to engage caregivers in ongoing monitoring of crosscutting symptoms, alerting the clinic care coordinator
if a child’s symptoms worsen to prompt timely interventions, and monitoring caregiver burden to prevent burnout; and
1.c. Explore the MyChildCMC usability to incorporate user suggestions and enhance user acceptance and
performance of the application. Aim 2. Assess the impact of the MyChildCMC app by comparing outcomes for the: 2.a.
child (QOL and ED/hospital admissions); 2.b. caregiver (satisfaction, self-management skills, QOL and burden); and
2.c. health care provider (satisfaction), between child/caregiver dyads randomized to either MyChildCMC or usual
care. Aim 3. Assess whether the effect of the MyChildCMC intervention on child outcomes varies across caregiver
characteristics (ethnicity, education, health literacy, and insurance).

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7. Is this a multi-site study, where more than one site needs IRB approval?
    Yes  No
8. Background and Introduction:
Year 1. Focus Groups (only) there are only consents for the Focus Groups participants, in year 2 we will amend the IRB to add PP and
other consents to enroll participants.
Year 2. Usability Testing
Year 3. Participants to use tool
Participants included in this retrospective portion will be consented to participate in the research project. Consents will
happen prior to the retrospective portion of the study. Collecting retrospective will be clearly outlined in the
consent/parent permission  
The first year of the CMC study is the development of the self-management tool. In that first year we will hold 3 two hour focus groups
is to assess your opinion, preferences and the usefulness of developing an electronic mobile application to support care and Self-
Management for Children with Chronic Medical Complexity (MyChildCMC).
About 1 in 7 U.S. children < 18 years are classified as children with special health care needs (CSHCN) and require
health services beyond routine care. Among CSHCN is a vulnerable subgroup, known as children with medical
complexity (CMC), who has life-threatening, complex, multisystem conditions, frequent emergency department (ED)
and hospital admissions, and account for 1/3 of pediatric health care expenditures. CMC often have severe
neurological impairment, marked intellectual and physical disabilities, and depend on technology to sustain life. CMC
prevalence among hospital admissions is increasing nationally, mainly due to improved survival of children with
conditions previously incompatible with life. Once discharged, CMC continue to experience frequent acute
deteriorations of their health status often for potentially avoidable causes and/or technology malfunctions that lead to
recurrent ED/hospital admissions. Overall, CMC have significant ongoing care needs and require substantial care
coordination and constant caregiver attention. Long-term caregiving can stress family caregivers and impose a
significant caregiver burden, leading to burnout, which may affect caregivers’ health and thereby ability to provide
care to CMC, setting up a vicious cycle of negative outcomes. To reduce the risk of acute deteriorations of a chronic
condition, self-management is recommended. Better support for self-management improves outcomes. Existing self-
management support interventions focus primarily on non-complex, single system conditions. No intervention exist to
address the variable, multisystem diagnoses of CMC or to target caregiver burden. Despite variable diagnoses, CMC
are often admitted to the ED/hospital for common, crosscutting symptoms. Such similarity presents an opportunity for
innovative self-management interventions, appropriate to CMC. We propose to develop and test the impact of a
mobile health application to engage caregivers in self-management of CMC (MyChildCMC), targeting crosscutting
symptoms coupled with ongoing monitoring of caregiving burden to promote timely decision-making. 

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IRB_00088596
2. Study Location and Sponsors
IRB_00088596
Created: 12/9/2015 12:01
PM
 
PI: Flory Nkoy MD, MS,
MPH
Submitted: 2/12/2016  
Title: SELF-MANAGEMENT INTERVENTION FOR
CHILDREN WITH CHRONIC MEDICAL COMPLEXITY
 
2. Study Location and Sponsors
1. Add all locations applying for approval of research via the University of Utah IRB or Human Research
Protection Program (HRPP).
Click the appropriate button(s) below to add locations:
 
Site Name
Investigators Name
Covered Entity
Sub Sites
View Intermountain Primary Children's Hospital
Flory Nkoy
Yes
 
2. Will a Central IRB (CIRB) or Single IRB (SIRB) model be used for review of this study for the sites listed in
this application?
  Yes  No
3. Indicate the source(s) of funding obtained or applied for to support this study.
 
Sponsor
Sponsor
Type
Sponsor Contact Information
Prime
Sponsor
Prime
Sponsor
Type
View HRSA MATERNAL & CHILD
HEALTH BUREAU
Federal
Government
Marie Y Mann, MD, MPH, FAAP
Senior Medical Advisor/Acting Deputy
Director
Division of Services for Children with
Special Health Needs
Maternal and Child Health Bureau
301-443-4925 office
202-498-8178 mobile
mmann@hrsa.gov
 
 
4. Does this study have functions assigned to a Contract Research Organization (CRO)?
  Yes  No
5. Does this study involve use of the Utah Resource for Genetic and Epidemiologic Research (RGE)?
Examples: Utah Population Database (UPDB), Utah Cancer Registry (UCR), All Payers Claims Database (APCD),
etc.
  Yes  No

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IRB_00088596
View/Edit
IRB_00088596
Created: 12/9/2015 12:01 PM  
PI: Flory Nkoy MD, MS, MPH
Submitted: 2/12/2016  
Title: SELF-MANAGEMENT INTERVENTION FOR CHILDREN WITH
CHRONIC MEDICAL COMPLEXITY
 
Addition of a Site
1. Site Name:
Intermountain Primary Children's Hospital
2. Site Principal Investigator
Mark if Same as Responsible Investigator (syncs with investigator on
the first page) 
Flory Nkoy
Email
Training
CoI Date
flory.nkoy@hsc.utah.edu 10/16/2019
SMG
6/14/2021
a. Position of the Site Principal Investigator
Faculty or Non-Academic Equivalent
b. Will the Site PI consent participants?    Yes  No
3. Site Contact Persons, if different from the Site PI:
Mark if Same as Contacts for Responsible Investigator (syncs with
contacts on the first page)
Name
Email
Training
Angela Zhu
angela.zhu@hsc.utah.edu
7/14/2020 SMCG
4. Site Staff and Sub-Investigators
Name
Email
Training
Obtaining
Consent
CoI Date
Bernhard
Fassl
bernhard.fassl@hsc.utah.edu 1/8/2020
MG

4/14/2021
Namita
Mahtta
namita.mahtta@hsc.utah.edu 7/11/2018
SMG

5/27/2021
Grace
Perry
grace.perry@hsc.utah.edu
6/20/2019
SMV*CG

5/4/2021
Bryan
Stone
bryan.stone@hsc.utah.edu
10/16/2019
SMCG

3/9/2021
Angela
Zhu
angela.zhu@hsc.utah.edu
7/14/2020
SMCG

4/20/2021
5. Site Guests:
Name
Email
Training
There are no items to display
6. Select HIPAA coverage for this study:
Study procedures will be conducted within a HIPAA Covered Entity at this site
(HIPAA Privacy Rule applies)

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7. Select the study procedures that will be conducted at this site:
Recruitment
Consent/Enrollment
Data collection
Data analysis
Do you have an enrollment goal or anticipated enrollment number
for this site?
 
Yes
No
Enrollment Number:
300  
8. Select the University of Utah department responsible for this research:
PEDIATRICS
9. Add any additional sites that are part of this performance group
There are no items to display

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IRB_00088596
IRB Smart Form
IRB_00088596
Created: 12/9/2015 12:01 PM  
PI: Flory Nkoy MD, MS, MPH
Submitted: 2/12/2016  
Title: SELF-MANAGEMENT INTERVENTION FOR CHILDREN
WITH CHRONIC MEDICAL COMPLEXITY
 
 
Sponsor Information
Please review these previously entered fields as you fill out the new form:
Sponsor: HRSA MATERNAL & CHILD HEALTH BUREAU
Contact: Marie Y Mann, MD, MPH, FAAP
Senior Medical Advisor/Acting Deputy
Director
Division of Services for Children with Special Health Needs
Maternal and Child
Health Bureau
301-443-4925 office
202-498-8178 mobile
mmann@hrsa.gov

Grant Number: HHSH25020170038G
Awardee: University of Utah, Flory Nkoy
Effective Date Start: 12/19/2018
a. Are you receiving award or contract management for the
sponsored funds through the University of Utah Office of
Sponsored Projects?
  Yes  No
If yes, select the associated OSP Proposal ID/DSS through eAward to link it
to the ERICA system.
You must have a fully approved Proposal ID/DSS number through eProposal
which will show up in eAward after OSP has integrated the ID. To access the
eAward application, use the instructions on the OSP website.
Link to a Proposal ID/DSS through eAward

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IRB_00088596
3. Participants
IRB_00088596
Created: 12/9/2015 12:01 PM  
PI: Flory Nkoy MD, MS, MPH
Submitted: 2/12/2016  
Title: SELF-MANAGEMENT INTERVENTION FOR CHILDREN WITH
CHRONIC MEDICAL COMPLEXITY
 
 
3. Participants
1. Ages of Participants:
Less than 7 years old
(Parental permission form needed)
7 to 17 years old
(Parental permission and assent form needed)
18 and older
(Consent form needed)
2. Specific age range of participants (e.g., 7-12 years old, 60+, etc.):
Children age 1-20 years old with complex medical conditions and their parent caregivers
3. Indicate any vulnerable participant groups (other than children) included:
Individuals with Cognitive or Decisional Impairment
 
  If "Other", please specify: 
 
  If "None" and no children are involved, answer the following question.
Has the participant selection process overprotected potential subjects who are considered
vulnerable so that they are denied opportunities to participate in research?
  Yes  No
4. Number of participants to be included and/or enrolled in this entire study, across all study locations:
300
 
At Utah prior to October 2019: 300
5. Characteristics of Participants/Inclusion Criteria:
1. Complex Medical Conditions ages 1-20 years with their caregivers (primary person caring for the child) 
2. been seen at Primary Children's Hospital within 365 days, 
3. own a smartphone or a tablet computer with Internet access
 
4. English speaking. 
 
Since we are recruiting from Primary Children's Hospital, we will use physician diagnosis to determine CMC 
 
Focus Groups/ Decision Support/ Usability 
1. Parents of children with CMC 
6. Participant Exclusion Criteria:
1. Critically ill children in imminent death.
2. Non English Speakers
7. Is a substantial percentage of the participant population anticipated to be non-English
speaking?
  Yes  No

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IRB_00088596
- Vulnerable Populations
IRB_00088596
Created: 12/9/2015 12:01 PM  
PI: Flory Nkoy MD, MS, MPH
Submitted: 2/12/2016  
Title: SELF-MANAGEMENT INTERVENTION FOR CHILDREN
WITH CHRONIC MEDICAL COMPLEXITY
 
 
Vulnerable Populations
 
Justification Requirements for the Inclusion of Vulnerable Populations
1. How does the nature of the research require or justify using the proposed subject population?
About 1 in 7 US children < 18 years or 10.2 million are classified as children with special health care needs (CSHCN) and
require health services beyond routine care. Among CSHCN is a subgroup, known as children with medical complexity
(CMC), who have complex, multisystem diseases, frequent emergency department (ED) and hospital admissions, and
consume about 1/3 of pediatric health care costs. CMC often have severe neurological impairment, marked intellectual
and physical disabilities, and depend on technology to sustain life. 
The prevalence of CMC among hospital admissions is increasing, mainly due to advances in health care, leading to
improved survival of children with conditions previously incompatible with life. At home, CMC continue to have significant
ongoing care needs, requiring substantial care coordination and constant caregiver attention. Care coordination is
beneficial, but also time consuming and limited by lack of payer support, lack of training and nursing shortages. Long-term
caregiving imposes a significant caregiver burden, which may affect caregivers’ health and ability to provide care, setting
up a vicious cycle of negative outcomes. Caregivers often feel unsupported, overwhelmed, and are not trained to detect
early signs of deterioration of their child’s health and/or technology malfunction, and lack tools to guide them in early
recognition and decision making. Thus, many CMC continue to have frequent ED/hospital admissions for avoidable acute
deteriorations of health. 
To reduce the risk of acute deteriorations of chronic conditions, self-management is recommended. In pediatrics, self-
management enables caregivers, in collaboration with a health care provider (HCP), to assume a primary role in
managing their child’s condition at home including monitoring symptoms, identifying signs of deteriorations, using
medications appropriately, and determining when medical attention is needed. Better self-management support improves
outcomes.
2. Would it be possible to conduct the study with other, less vulnerable subjects?
  Yes  No
 
  If yes, justify the inclusion of vulnerable subjects:
3. Is this population being included primarily for the convenience of the researcher?
  Yes  No
 
  If yes, explain:
4. Does the scientific merit of the study warrant the inclusion of subjects who may either be
susceptible to pressure or who are already burdened?
  Yes  No

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IRB_00088596
4. Study Information
IRB_00088596
Created: 12/9/2015 12:01 PM  
PI: Flory Nkoy MD, MS, MPH
Submitted: 2/12/2016  
Title: SELF-MANAGEMENT INTERVENTION FOR CHILDREN
WITH CHRONIC MEDICAL COMPLEXITY
 
 
4. Study Information
1. Design of Study (select all that apply):
Non-Experimental and/or Descriptive Research Design:
Secondary/Archival Data Analysis or Retrospective Chart Review
Interviews and Focus Groups
Observational Research
Experimental and/or Interventional Research Design:
Prospective Biomedical Intervention or Experiment
 Development of a research resource (repositories, databases, etc.)
 Other
If Other, describe:
Quality Improvement
2. Does your study involve the use of any placebo?
  Yes  No
3. Length of entire study, from initiation through closeout:
5 years
4. How will participants be recruited or identified for inclusion in the study?
a. Select all methods that will be used:
In-person contact (e.g., patients, students, etc.)
Written or electronic record review
Written advertising (flyers, brochures, website postings, newspaper ads, etc.)
b. Describe the recruitment/participant identification process in detail (e.g. who will review charts or
records, who can refer participants to the study, where will flyers be posted, how often will recruitment
letters be sent, when will follow-up phone calls be made, etc.):
Study timeline:
Year 1. Focus Groups
Year 2. Usability Testing
Year 3. Participants to use tool
Participants included in this retrospective portion will be consented to participate in the research project. Consents
will happen prior to the retrospective portion of the study. Collecting retrospective will be clearly outlined in the
consent/parent permission  
The first year of the CMC study is the development of the self-management tool. In that first year we will hold 3
two hour focus groups is to assess your opinion, preferences and the usefulness of developing an electronic

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mobile application to support care and Self-Management for Children with Chronic Medical Complexity
(MyChildCMC).
 
In the second year there will be two usability testing sessions to get input and feedback about the usefulness of
the self-management tool.
 
In the third year we will invite participants to join the study. We will run a pilot study for feasibility for 3 months. 
 
Focus Groups and Usability testing session will generate valuable input/feedback about the how the
MyChildCMC tool will be develop and used. We will add IRB amendments for the parent permission consent
when we are ready to add participants. Because we cannot anticipate all the changes we have just added the
first consent (attached) for the Focus Group.
 
 Focus Groups: three focus groups (6-8 parent participants per session) with 24 parent participants in Year 1
and two usability testing cycles, each assessing 6 parent participants (for a total of 12 parent participants) in
Year 2. Participants will receive participant remuneration equivalent to a $50 gift card after participating in each
focus group and usability testing. The PI and all members of the Research Team will adhere to all University of
Utah Payments to Human Research Participants rules and regulations.
A written flyer describing the study will be displayed in Comprehensive Care Clinic at Primary Children's
Hospital (Dr. Nancy Murphy (Co-I) is the medical director in this clinic) to recruit potential participants.  If a
parent is interested in participating, a research staff will approach them to consent and enroll in the study.  
Patients/Parents will be identified  by the CMC study coordinator (Angela Zhu, Nancy Murphy)  in CMC clinics
or the inpatient at PCH, or those who express interest in participating in the study after seeing the written flyer
posted in the clinic.  The family will then be approached by the study coordinator to participate in the study if
they meet criteria. The study coordinator will obtain a signed consent form from the patient/parent to participate
in the study. After enrollment, patients/parents will be trained during the formal education about the
MyChildCMC app, the dynamic run chart report (including definitions of the scale and colors) as well as the
Patient Portal. Participants will download the MyChildCMC app onto their smartphones and create a log-in
account. Patients will be trained in how to use the system. Patients also will be encouraged to bring the form to
their primary care provider at the time of follow-up visit. A contact number will available for questions and
support regarding any technical aspects of the MyChildCMC. 
 
5. How will consent be obtained?
Informed Consent Process (with or without a document)
6. Describe all the procedures chronologically, from screening/enrollment through study closeout, which will be
completed in the research project.
The MyChildCMC app will be uploaded into the Apple and Google Play app store for participants to download.  As
part of the app store publishing process, a legal privacy policy is required and was uploaded.  In the privacy policy,
there is a link where a potential participant may access the approved consent document to review before
downloading the app.  
Participant Recruitment and Enrollment: Screening will occur using inclusion/exclusion criteria. Potential
participants will be directly approached or invited to participate in the study by project coordinators. Enrollment will be
conducted in a private location in the clinic (e.g., exam room). Patient/parent dyads meeting eligibility and agreeing to
participate will complete an informed consent document (for parents) and parental permission (for their child).
Because the children participants have cognitive impairment, no assent will be obtained.  All participants will receive
general training on self-management of crosscutting symptoms, how to take measurement and how to identify acute
deteriorations. Those randomized to MyChildCMC will receive additional training about MyChildCMC use. 
While use of the children participants' PHI is required to achieve the aims and objects of this research, the children
will not be asked to complete or perform any study related interventions or interactions. 

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Randomization Procedure: Randomization will be performed using a computer-generated randomized allocation
sequence made available online for the clinic care coordinator, and will be stratified by WeeFIM score as mild (18-
54), moderate (55-90) and severe (≥ 91) disability, and age group (1-11 and 12-18 years), and performed using
random permuted blocks to ensure assignment of subjects to the intervention and usual care groups is balanced over
time. Participants randomized to MyChildCMC will receive support to install the app, a temporary password (modified
upon login) and full MyChildCMC access. At the first login (in the clinic), the care coordinator will guide participants
through baseline surveys and first assessment of crosscutting symptoms/ caregiver burden, thereafter caregivers will
use the MyChildCMC app over 3 months. All alerts about changing patient health status/caregiver burden will be
directed to the care coordinator, who will follow-up with families to determine if an action, or a visit with a HCP or
social worker is needed. The care coordinator will also access the dashboard to see participants not adherent with
MyChildCMC use and follow-up with those in need of supports. Participants randomized to usual care will receive
general self-management education, be encouraged to monitor their child’s symptoms/caregiver burden and identify
deteriorations but without MyChildCMC, and will complete surveys and provided incentive on the same schedule as
the intervention group.
Data Collection: Upon first login, caregivers will complete a demographic survey (only once), including caregiver
education level, a series of baseline surveys assessing the child (QOL) and caregiver (satisfaction, self-management
skills, QOL and burden). Also, we will collect caregiver health literacy (only once) to be used in analysis of spec aims
3, and severity of child disability using WeeFIM which will be used in analysis of aims 2 and 3. 2 Baseline and follow-
up surveys will be collected online by RedCAP within 3 months. 
 Validated surveys will be used to collect data, including a 37-item Caregiver Priorities and Child Health Index of Life
with Disabilities (CPCHILD) Questionnaire (child QOL), 12-item Parent satisfaction questionnaire, which includes one
open-ended question assessing participant’s perception of burden related to MyChildCMC use, 13-item Patient
Activation Measure (caregiver self-management skills), 12-item Short Form health survey (caregiver QOL), and a 6-
item Newest Vital Sign (NVS) for caregiver health literacy. At each QOL, we will also collect caregiving burden
summary over the past month for both the intervention and control groups. All HCP caring for CMC during the study
period will be surveyed at the end of the study to assess their satisfaction with care using the 6-item HCP Satisfaction
Questionnaire. ED and hospital admissions will be collected using the Intermountain enterprise data warehouse
(EDW),152 an integrated database linking data of 22 hospitals in Utah and Idaho. Intermountain Healthcare provides
services for > 95 % of children in Utah. 
7. Are all procedures for research purposes only (non-standard or non-standard of care procedures)?
  Yes  No
If no, list the procedures that are performed for research purposes only (non-standard or non-standard
of care procedures):
8. Is there a safety monitoring plan for this study?
  Yes  No
9. Provide a summary of the statistical methods, data analysis, or data interpretation planned for this study.
Factors for determining the proposed sample size (e.g., power) should be stated.
Data Analysis. We will assess Feasibility, using family’s participation, retention, adherence, and dropout rates. We will
also assess parent responses to interactive activities such as response to reminders and alerts, to inform the future
enhancement, and the appropriateness of the alerts triggered by the MyChildCMC app. Preliminary Impact: The
primary outcome is QOL score, obtained at baseline, 1 and 3 months. Secondary outcomes are QOL sub-domains
(comfort, emotions, communication and social interaction, health, and overall QOL), ED/hospital admissions and
caregiver satisfaction. Further detail will be provided during phase 2.
AIM 2
Data Analysis: The primary outcome is the CPCHILD total score, which will summarize the child’s QOL at baseline,
and at 3, 6, 9 and 12 months of follow-up. Secondary outcomes include additional CPCHILD sub-domains beyond the
total CPCHILD (comfort and emotions; communication and social interaction; health; and overall QOL), child
ED/hospital admission, and caregiver satisfaction, self-management skills, caregiver burden, and HCP satisfaction.
The primary and secondary analyses will be performed in accordance with intention-to-treat, with patients analyzed in
accordance with the randomized treatment assignment irrespective of compliance. Numeric outcome variables
exhibiting positive skewness may be transformed to better approximate normality. Analyses will be performed with
SAS version 9.4 or higher. Standard statistics including means, standard deviations, medians, and interquartile
ranges for continuous variables and frequencies and percent for categorical variables will be used to compare
characteristics of randomized vs. non-randomized patients and to compare baseline characteristics between
randomized groups. Open-ended questions of caregiver and HCP satisfaction will be analyzed using standard
qualitative analysis as described in Aim 1.

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The primary analysis of the CPCHILD total score will be performed by applying a linear mixed effects model to
compare the mean QOL score over the 3, 6, 9 and 12-month assessments between the intervention and control
groups. The mixed effects model will incorporate an unstructured covariance matrix to account for serial correlation
within the same patients, and will include fixed effect terms for the randomized treatment assignment, the baseline
CPCHILD total score, Clinic, and the WeeFIM and age group randomization strata as well as interaction terms
between each of these factors and follow-up visit. Adjustment for the baseline CPCHILD total score will account for
any baseline imbalances in the outcome variable and regression to the mean, thereby increasing statistical power. In
addition to the primary comparison of the mean CPCHILD total score over all 4 follow-up assessments between the
randomized groups, secondary contrasts will be constructed to estimate treatment effect on the mean total score at
each individual follow-up visits and to compare the size of the treatment effects between different follow-up visits to
determine if the treatment effect attenuates or increases over time. Secondary outcomes will be compared between
the randomized groups using similar linear mixed models for numeric outcomes (e.g., other CPCHILD subscales,
caregiver/HCP satisfaction, PAM score, and burden score) or generalized linear models with use of robust empirical
standard errors for categorical outcomes. Similar analysis will be used to compare caregiver burden subscales
(stress and coping). The rate of ED visits and hospital admissions will be compared between randomized groups
using negative binomial regression, possibly augmented to account for 0-inflation if the proportion of subjects with 0
ED events or hospitalizations exceeds that accounted for by the negative binomial model
Statistical Power: Cohen et al. 19 reported a standard deviation (SD) of 15.4 in the CPCHILD total score in 81
children with complex comorbidities. Assuming SD = 15.4 and allowing for up to 10% loss to follow-up, a sample size
of 220 will provide at least 85% power with a 2-sided α=0.05 to detect a mean relative reduction of 6.59 points,
representing a moderate effect size of 43% of 1 SD. The calculation is conservative because it does not account for
repeated follow-up assessments or an expected positive correlation between the baseline and follow-up CPCHILD
scores. For example, if the average correlation between the baseline and follow-up scores is at least 0.5, the
detectable effect size will be reduce to no more than 5.73 points, or 37% of 1 SD. 
AIM 3
Data Analysis: The CPCHILD total score for Aim 2 will also be treated as the primary endpoint for testing for the
presence of baseline effect moderators. Each baseline moderator will be investigated in separate analyses by
including the moderator and interaction terms between the moderator and an indicator variable for treatment
assignment as additional predictor variables in the linear mixed model for the primary outcome in Aim 2. Forest plots
will be constructed to display 95% confidence intervals for the treatment effects for subgroups defined by each
potential moderating factor, with p-values for treatment by moderator interactions included on the plots. Given limits in
statistical power in subgroup analyses, the p-values will not be directly adjusted for multiple comparisons. However,
additional assessments will be performed using bootstrap resampling to indicate the probabilities of 1, 2, 3 or more
nominally significant results to aid in the interpretation of results.159 Exploratory analyses of the presence of baseline
moderators for treatment effects will be performed for other QOL indices and the caregiver burden score by applying
similar linear mixed effects models with interaction terms for the hypothesized baseline effect moderators to these
outcomes. In exploratory analyses, the possibility of effect moderation by frequency of e-AT use will be investigated
by subdividing the intervention group based on those who satisfy the 60% threshold for frequent use, and then
applying a linear mixed model to relate the CPCHILD total scores to indicator variables defined by the infrequent and
frequent user’s groups, with the control group serving as the reference. Because the classification of frequent users is
a post-randomization covariate, these as-treated analyses will incorporated covariate adjustment for an extended set
of baseline covariates to reduce confounding, and results will be interpreted with appropriate caution.160 Application
of marginal structural models incorporating adjustment for time dependent confounding may also be considered.
Statistical Power: Under the same assumptions described for the primary analysis of the CPCHILD total score, the
sample size of 220 randomized subjects will provide 85% power with 2-sided α = 0.05 to detect relative reductions of
12.0, 9.3, or 7.9 in the total score for the intervention compared to the control arms within subgroups including 30%,
50%, or 70% of randomized subjects. The minimum detectable interaction effects are given by differences in total
score ranging from 13.2 to 14.4 points for subgroups of the same size. 

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IRB_00088596
- Consent Process
IRB_00088596
Created: 12/9/2015 12:01 PM  
PI: Flory Nkoy MD, MS, MPH
Submitted: 2/12/2016  
Title: SELF-MANAGEMENT INTERVENTION FOR CHILDREN
WITH CHRONIC MEDICAL COMPLEXITY
 
 
Consent Process
1. The following investigators and internal staff will obtain consent (as indicated on the Study Location and
Sponsors Page):
Namita Mahtta
Intermountain Primary Children's Hospital
Grace Perry
Intermountain Primary Children's Hospital
Angela Zhu
Intermountain Primary Children's Hospital
List by name, role, and affiliation any others who will obtain consent (e.g. Dr. John Smith, Co-Investigator, etc.).
2. Describe the location(s) where consent will be obtained.
PCH, Outpatient Clinics
3. Describe the consent process(es), including the timing of consent. Describe whether there is a waiting period
between the consent process and obtaining consent from the participant (i.e., any time between informing
participants and actually obtaining consent).
Participants included in this retrospective portion will be consented to participate in the research project. Consents will
happen prior to the retrospective portion of the study. Collecting retrospective will be clearly outlined in the
consent/parent permission 
Patients/Parents will be identified via Patient Tracker while in the hospital or during Complex Medical conditions clinic
(Dr Murphy's clinic). Family will then be approached by the study coordinator to participate in the study.The study
coordinator will obtain a signed consent form from the patient/parent to participate in the study. After enrollment,
patients/parents will be trained about the MyChildCMC app.the dynamic run chart report (including definitions of the
scale and colors) as well as the Patient Portal. A Web link to the Patient Portal and temporary password will be given to
the patient/caregiver to access the system and establish a permanent password. Patients will be trained in how to use
the system and its potential benefits before discharge. Patients also will be encouraged to bring the form to their primary
care provider at the time of follow-up visit. A contact number will available for questions and support regarding any
technical aspects of the MyChildCMC app.
Re-consent process: Patients over the age of 18 will be contacted via phone/email to be re-consented using their LAR
and updated consent documents will be mailed to them for them to review, sign, and send back. A copy of the consent
form will be provided to them. 
For the Focus & Usability Groups:
Participants will be asked to sign a consent document before participation and will be given the opportunity to ask
questions to the members of the study team. 
All participants will be given the opportunity to ask questions to the members of the study team.
4. Describe what measures will be taken to minimize the possibility of coercion or undue influence.
Parents/patients and providers will be explained that participation will be voluntary and will not influence the care that
their child receives. It will also be explained that they may withdraw from the study at any time. A copy of the consent
form will be provided to them.
5. Describe the provisions that are made to allow adequate time to exchange information and questions between
the investigator and participant.
All questions will be answered by a member of the research team or study coordinator. If the parent pr provider wishes,
they may think about participating in the study and contact the research team later if they decide they want to
participate.
6. Will a legally authorized representative (LAR) be used?

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  Yes  No
Describe when the use of an LAR might arise in this study population and what the frequency of an LAR will
be during the enrollment period.
We are adding the use of a legally authorized representative (LAR) for when participants over the age of 18 who are
cognitively and/or decisionally impaired are enrolled into the study and are unable to give consent and authorization
themselves to participate in the study. We expect ~10% of all enrolled participants to use an LAR. 
Re-consent process: Patients over the age of 18 will be contacted via phone/email to be re-consented using their LAR
and updated consent documents will be mailed to them for them to review, sign, and send back.
7. Will a language other than English be used to obtain consent?
  Yes  No
8. Are you requesting that documentation of informed consent be waived by the IRB (a consent process in place,
but no documentation of consent, e.g. questionnaire cover letter, web-based consent, consent without
signature, etc.)?
  Yes  No
If yes, complete the following:
a. Explain why the waiver of consent documentation is being requested.
b. Justification for the waiver is one of the following:
There are no items to display

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IRB_00088596
- - Additional Consent Considerations
IRB_00088596
Created: 12/9/2015 12:01
PM
 
PI: Flory Nkoy MD, MS,
MPH
Submitted: 2/12/2016  
Title: SELF-MANAGEMENT INTERVENTION FOR
CHILDREN WITH CHRONIC MEDICAL
COMPLEXITY
 
 
Additional Consent Considerations
 
Individuals with Cognitive or Decisional Impairment or Mental Disability
1. Please describe the nature of the cognitive/decisional impairment or mental disability and how
this affects decision-making ability:
Children with medical complexities (CMC) have life limiting, complex, multisystem chronic diseases, and often have
medical technology dependencies and substantial daily care needs. CMC targeted for this pilot also have severe
neurological impairments with marked intellectual and physical disabilities that affect their decision-making capacity.
2. In the opinion of the principal investigator, is an assent process appropriate for these
individuals, along with informed consent from a legal representative?
  Yes  No
 
  Please justify your response:
Neurologically and cognitively impaired children with medical complexities (CMC) and severe multi-system chronic
health conditions, and medical technology dependencies will not be able to participate in an assent process. For those
CMC patients over the age of 18, we will obtain the informed consent and authorization of their Legally Authorized
Personalized Representative (normally their guardian appointed to make medical decisions for them).
3. In the opinion of the principal investigator, is it possible that cognitively/decisionally impaired
participants may recover an adequate amount of decision-making capacity during the course
of the study (N/A for mentally disabled persons)?
No
 
  If yes, are there plans to obtain full informed consent from the participant at that time?
  Yes  No
 
  Please justify your response:

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IRB_00088596
5. Data Monitoring
IRB_00088596
Created: 12/9/2015 12:01 PM  
PI: Flory Nkoy MD, MS, MPH
Submitted: 2/12/2016  
Title: SELF-MANAGEMENT INTERVENTION FOR CHILDREN
WITH CHRONIC MEDICAL COMPLEXITY
 
 
5. Data Monitoring Plan
1. Privacy Protections: Privacy refers to persons and to their interest in controlling access of others to themselves. Privacy
can be defined in terms of having control over the extent, timing and circumstances of sharing oneself (physically,
behaviorally, or intellectually) with others. What precautions will be used to ensure subject privacy is protected?
 
Select all that apply:
Discussing the study with participants individually instead of in front of a group
The collection of information about participants is limited to the amount necessary to achieve the aims of the research, so
that no unneeded information is being collected
Other or additional details (specify):
 
  Other or additional details (specify):
We will respect the privacy of patients to help them feel safe while participating in the study by speaking quietly when
discussing the study in a waiting room or other public area, we will avoid using participant’s names in public hallways
and elevators, and conduct procedures that may be uncomfortable or embarrassing to participants in non-public
locations. We will interview participants about sensitive topics individually instead of in front of a group. We will limit
access to study data to only a few members of the study team.
2. Confidentiality Precautions: Confidentiality is an extension of the concept of privacy; it refers to the subject's
understanding of, and agreement to, the ways identifiable information will be stored and shared. Identifiable information
can be printed information, electronic information or visual information such as photographs. What precautions will be
used to maintain the confidentiality of identifiable information?
 
Select all that apply:
Storing research data on password protected computers or in locked cabinets or offices
Complete de-identification of study data
 
 
Other or additional details (specify):
The raw data from surveys, chart review, administrative databases will be stored on the PI’s secure computer in his
secured office at PCH. Only he and his research assistant will have access to data containing PHI.
Web-based reports will be stored within the Intermountain firewall, which includes authentication and authorization
protection. A specific provider will only see his/her performance using his/her user name and password.
All data analyses will be performed on data sets created with identifiers, allowing linkage of individual patients to their
records. Individual identifier information will be removed from study data files as soon as possible in the data
processing steps.
All source/legacy data files will be stored behind the Intermountain fire wall and will be accessed only by staff members
working on the study. Only the PI and the research assistant will know who the subjects are.
3. Will photos, audio recordings, or video recordings, or medical images of participants be made
during the study? 
  Yes  No
 
  If yes, describe the recording/images and what will become of them after creation (e.g.,
shown at scientific meetings, stored in the medical/research record, transcribed, erased,
etc.):
4. How will study data and documentation be monitored throughout the study?
 
Select all that apply:

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Periodic review and confirmation of participant eligibility
Periodic review of informed consent documentation
Confirmation that all appropriate information has been reported to the sponsor, oversight agencies (such as the FDA),
and/or IRB
 
  Other additional details (specify):
5. Who will be the primary monitor of the study data and documentation?
 
Select all that apply:
Principal Investigator
Study Coordinator or Research Nurse
 
  Other or additional details (specify):
6. How often is study data and documentation monitoring planned (e.g., monthly, twice a year,
annually, after N participants are enrolled, etc.)?
Monthly on a continued bases

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IRB_00088596
6. Risks and Benefits
IRB_00088596
Created: 12/9/2015 12:01 PM  
PI: Flory Nkoy MD, MS, MPH
Submitted: 2/12/2016  
Title: SELF-MANAGEMENT INTERVENTION FOR CHILDREN
WITH CHRONIC MEDICAL COMPLEXITY
 
 
6. Risks and Benefits
1. Describe the reasonable foreseeable risks or discomforts to the participants:
We recognize that there are some potential patient risks related to the study. We will work closely with the Institutional
Review Board at the University of Utah to ensure that procedures are in place to protect the rights and welfare of patients
and parents. Use of the Self-Management for Children with Medical Complexity (MyChildCMC) application will not interfere
with or change health care provider usual care of the patient’s conditions other than by increasing parent engagement in
the care of their child’s complex chronic conditions and by providing additional objective data for health care providers to
augment their ability to make informed medical decisions for timely treatments. No adverse events that would harm study
participants are anticipated. Participation in ongoing assessments of crosscutting symptoms and caregiver burden is
voluntary and individuals can discontinue participation at any time. The principal risks to participants of this research are
loss of privacy and confidentiality, including use of electronic databases for potential subject identification, and potential
breach of confidentiality through disclosure of protected health information for parents responding to the ongoing
assessment of crosscutting symptoms. Installing rigorous security protections on data management, issuing regular
reminders to project staff to change their passwords often, and adherence to HIPAA and IRB privacy and data security
requirements will mitigate these risks. We will monitor positive and potential adverse outcomes that may arise to
participants in this study. 
2. Describe the potential benefits to society AND to participants (do not include compensation):
This study will facilitate early identification of acute deteriorations of crosscutting symptoms to facilitate timely decision-
making in order to prevent an ED or hospital admission. We are not making any claims that participants will benefit
directly from participation in this study. However, based on our preliminary studies with the electronic-AsthmaTracker
showing significant reduction in ED/hospital admissions, it is likely that patient in the current study will have improved
outcomes, including improved QOL and reduced ED/hospital admissions. In addition, we anticipate that parents will have
improved satisfaction, self-management skills, QOL, and reduced impact of caregiving. Further, the health care provider
will benefit from additional objective data to facilitate timely decision-making. Our project will provide useful information
about factors critical to caregiver self-management engagement and burnout that can be addressed to facilitate broad
dissemination of self-management support interventions to improve the care of CMC at home. We anticipate that our
interventions, tools, measurement systems or versions of them, may be adopted by clinics and health care organizations
nationwide to improve care of CMC overall. 
3. Are there any costs to the participants from participation in research?
  Yes  No
 
 
If yes, specify:
4. Is there any compensation to the participants?
  Yes  No
 
a.
If yes, answer the following:
Specify overall amount:
Participants in the focus group and usability testing will receive $50 gift card for participating. 
Participants enrolled to use the MyChildCMC app will be compensated in total $120 in gift cards: 
$40 for completing enrollment and baseline surveys
$40 each for 2 follow-up surveys that will be sent via RedCAP. 
All participants enrolled to use the MyChildCMC app will receive a new pulse oximeter (valued at $20) to
measure their child's blood oxygen level as part of the study. 
Participants randomized to MyChildCMC group will receive a stethoscope (valued at $5) to measure their
child's respiratory rate as part of the study. 

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b. Specify when participants will be paid (e.g. at each visit, at end of study, etc.):
Participants in focus group and usability testing will receive $50 gift card at then end of the session. 
Participants enrolled to use the MyChildCMC app will receive $40 gift card and a new pulse oximeter and a
stethoscope at end of enrollment and completing baseline surveys. Thereafter, they will receive $40 gift card as they
complete two follow-up surveys that will be sent via RedCAP. The gift cards will be sent by email once confirming that
the follow-up surveys have been completed.
 
c. If applicable, please specify payment by visit or other time interval (e.g. $10 per visit, etc.):
$40 at enrollment, pulse oximeter at enrollment, $40 for first follow-up survey completion, $40 for second follow-up
survey completion.
 
d. If applicable, explain plan for prorating payments if participant does not complete the study:
Not applicable.

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IRB_00088596
7. HIPAA & the Covered Entity
IRB_00088596
Created: 12/9/2015 12:01
PM
 
PI: Flory Nkoy MD, MS,
MPH
Submitted: 2/12/2016  
Title: SELF-MANAGEMENT INTERVENTION FOR
CHILDREN WITH CHRONIC MEDICAL COMPLEXITY
 
 
7. HIPAA and the Covered Entity
1. Does this study involve Protected Health Information (PHI) or de-identified health
information?
  Yes  No
a. Select the method(s) of authorization that will be used:
(Consent and) Authorization Document
Waiver or Alteration of Authorization
b. Will PHI be disclosed outside the Covered Entity?
  Yes  No
Does this study involve any of the following:
2. The investigational use of a drug?
  Yes  No
3. The investigational use of a medical device?
  Yes  No
4. Is this an investigator-initiated drug or device trial lead by the Principal Investigator?
  Yes  No
5. Exposure to radioisotopes or ionizing radiation?
  Yes  No
6. A Humanitarian Device Exemption (HDE)?
  Yes  No
7. Genetic testing and/or analysis of genetic data?
  Yes  No
8. Creating or sending data and/or samples to a repository to be saved for future research
uses?
  Yes  No
9. Are you:
Collecting samples of blood, organs or tissues from participants for research purposes;  
Introducing Recombinant or Synthetic Nucleic Acids (e.g. viral vectors, oligonucleotides) or cells
containing recombinant nucleic acids (e.g. CAR-T) into participants; OR  

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Introducing other biological materials (e.g. bacteria, viruses) into participants.  
  Yes  No
10. Does this study involve any of the following?
Cancer Patients
Cancer Hypothesis
Cancer risk reduction
Cancer prevention
  Yes  No
11. Any component of the Center for Clinical and Translational Science (CCTS)?
  Yes  No
The Clinical Services Core (CSC)?
  Yes  No

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IRB_00088596
- Request for Waiver of Authorization
IRB_00088596
Created: 12/9/2015 12:01
PM
 
PI: Flory Nkoy MD, MS,
MPH
Submitted: 2/12/2016  
Title: SELF-MANAGEMENT INTERVENTION FOR
CHILDREN WITH CHRONIC MEDICAL
COMPLEXITY
 
Request for Waiver or Alteration of Authorization
 
Request for Waiver of Authorization for Recruitment Only
This option must only be used if you are reviewing PHI in order to identify eligible participants BEFORE approaching them to obtain consent and
authorization.  All other waiver requests must be entered below.
Other Requests for Waivers of Authorization:
 
Click "Add" below to add a new waiver request to this application.
Click the waiver name link to edit a waiver that has already been created.
To delete a waiver request, contact the IRB.
 
Date
Created
Type of Request
Purpose of Waiver Request
View 1/12/2016
Waiver of AuthorizationRecord review for recruitment and chart review for all data collection through EDW.

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IRB_00088596
IRB Smart Form
IRB_00088596
Created: 12/9/2015 12:01 PM  
PI: Flory Nkoy MD, MS, MPH
Submitted: 2/12/2016  
Title: SELF-MANAGEMENT INTERVENTION FOR CHILDREN
WITH CHRONIC MEDICAL COMPLEXITY
 
 
Request for Waiver or Alteration of Authorization
1. Purpose of the Waiver Request: 
Record review for recruitment and chart review for all data collection through
EDW.
2. Type of Request:
Waiver of Authorization
3. List the identifying information you plan to collect or keep a link
to (e.g. names, dates, or identification numbers such as social
security numbers or medical record numbers, etc).
EMPI, Encounter, Admit Date, Discharge Date, Date of Birth, Age, Sex, Race,
Weight, Height, PCP, Insurance Code, Composite Score, Length of Stay, Cost,
Hospital/ED Readmissions
4. Explain why the PHI to be used or disclosed is the minimum
necessary to accomplish the research objectives:
The PHI is a prerequisite to identifying and pulling charts for manual review, and
for administrative database information retrieval. The PHI we are collecting will be
used to improve our ability to provide high quality complex medical care and will
provide critical information for quality improvement.
5. Explain why the research could not practicably be conducted
without the waiver of authorization. For example, complete the
following sentence: "If I had to obtain authorization, the research
could not be conducted because..."
The PHI accessed through chart review will provide Quality Improvement (QI)
data as it will be given to pediatric clinical program leaders. Impacts of QI
interventions on hospitalization outcomes and patient related measures targeted
at reducing re-admissions have not been evaluated. By obtaining authorization,
selection bias is introduced, which minimizes the generalizability of the study
outcomes.
6. Describe your plan to protect the identifiers from improper use
and disclosure, and indicate where the PHI will be stored and
who will have access: 
All investigators and project staff sign confidentiality pledges annually and receive
IRB and HIPAA privacy and data security compliance training annually. All
source/legacy data files regarding patient EDW data will be stored behind the
Intermountain fire wall and will be accessed only by staff members working on this
study.
7. The identifiers must be destroyed at the earliest opportunity
consistent with conduct of the research, unless there is a health
or research justification for retaining the identifiers or such
retention is otherwise required by law. Describe how and when
you will destroy the identifiers, or justify their retention: 
Individual identifier information will be removed from study data files as soon as
possible in the data processing steps. Unique study-specific identifiers will be
assigned to support accurate linkage of data on the same individual across
multiple data files. We will maintain a data dictionary linking the study identifier to
the personal identifiers until 7 years after the IRB approval for the study expires
(to permit re-analysis of the data files to respond reviewers comments for
publication purposes).
8. Describe the measures you will take to ensure the PHI will not

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be reused or disclosed to any other person or entity, except as
required by law, for authorized oversight of the research study,
or for other research approved by the IRB:
Installing rigorous security protections on data management, and adherence to
HIPAA and IRB privacy and data security requirements will help mitigate potential
risks. At the completion of the study and after publication of results, all data will be
destroyed.

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IRB_00088596
8. Resources and Responsibilities
IRB_00088596
Created: 12/9/2015 12:01
PM
 
PI: Flory Nkoy MD, MS,
MPH
Submitted: 2/12/2016  
Title: SELF-MANAGEMENT INTERVENTION FOR
CHILDREN WITH CHRONIC MEDICAL COMPLEXITY
 
 
8. Resources and Responsibilities
1. * State and justify the qualifications of the study staff:
The clinical research coordinator ,Angela Zhu, will be consenting and collecting data from participants. This individual is qualified by
education, training, and experience to perform the delegated tasks.  
2. * Describe the training that study staff and investigators will receive in order to be informed
about the protocol and understand their research-related duties and functions:
The PIs Dr. Nkoy, Stone, Murphy, Hofmann and Fassl as well as the clinical research coordinator, Angela Zhu, will be
involved in research-related activities. Meetings will occur between the PI and other members of the research team
weekly regarding study procedures and research-related duties. The PI and staff have completed all required training
regarding regulatory requirements including proper conduct of research.  
3. * Describe the facilities where the research activities will be performed (e.g. hospitals,
clinics, laboratories, classrooms/schools, offices, tissue banks, etc.).
Inpatient floors at PCH, Outpatient Services PCH
4. * Describe the medical or psychological resources available at this site (and other
participating sites, if applicable) that participants might require as a consequence of the
research. If not applicable, please state.
Not Applicable

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IRB_00088596
Documents and Attachments
IRB_00088596
Created: 12/9/2015 12:01 PM  
PI: Flory Nkoy MD, MS, MPH
Submitted: 2/12/2016  
Title: SELF-MANAGEMENT INTERVENTION FOR
CHILDREN WITH CHRONIC MEDICAL COMPLEXITY
 
Documents and Attachments
If any of your documents (such as investigational brochures, sponsor protocols, advertisements, etc.) are not available in an electronic format, please scan
and save them as PDF files or contact our office for assistance.
Naming Documents: Please use the title field to clearly indicate the content of each form. The name you enter will be listed on your approval letter. Use
names that will differentiate from earlier versions.
Examples:
Consent Document Control Group 04/14/05
Consent Document Treatment Group 4/14/05
Sponsor Protocol 04/14/05 Version 2
Assent Document(Highlighted Changes)
Apple/Macintosh Users:MS Word documents must have a .doc file extension. See ERICA home page for instructions.
Print View: IRB Draft Protocol Summary
eProtocol Summary:
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Grant Application:
The Federal Government is a direct or indirect sponsor of your research. You are required to provide a copy of the grant
proposal, grant award, or sub-award.
By submitting to the IRB, you are confirming the grant and the study protocol are consistent (Design, Study Population,
Study Objectives and Goals, Test Interventions and Procedures, etc.)
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Principal Investigator's Scholarly Record (CV/Resume):
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VersionDate Created
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Approved
Nkoy_NIH_Biosketch_Dec_2012(0.01)
0.01
12/18/2012 10:38
PM
12/18/2012 10:38
PM
 
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IRB_00088596
- Primary Children's Information Form
IRB_00088596
Created: 12/9/2015 12:01
PM
 
PI: Flory Nkoy MD, MS,
MPH
Submitted: 2/12/2016  
Title: SELF-MANAGEMENT INTERVENTION FOR
CHILDREN WITH CHRONIC MEDICAL
COMPLEXITY
 

PCH Administrative Research
Questions

You have indicated Primary Children's Hospital is a study location. Please
complete the following questions so Primary Children's can confirm that
your study:
1. Aligns with Primary Children's Mission, Vision and Values
2. Receives approval from the Primary Children's resources impacted
(e.g.: lab, radiology, infant unit, etc.); and
3. Identifies Primary Children's study related charges from standard of
care charges
If you have any questions or concerns regarding this form or the associated
Primary Children's approval process, please contact us with the contact
information below:
Email: PCHResearch@imail.org
Phone: 801-408-1991 opt 1

Principal Investigator: Flory Nkoy, 801-588-3927, 
flory.nkoy@hsc.utah.edu
Contact Person(s):
Last Name
First Name
E-Mail
Phone
Zhu
Angela
angela.zhu@hsc.utah.edu
801-662-3675
IRB_00088596
Title: SELF-MANAGEMENT INTERVENTION FOR CHILDREN WITH
CHRONIC MEDICAL COMPLEXITY
Description of Study: 
Our Specific Aims are: Aim 1. Partner with caregivers to develop the
MyChildCMC application: 1.a. Assess caregiver needs, preferences and
capability for CMC self-management through focus groups; 1.b. Develop
the MyChildCMC application to engage caregivers in ongoing monitoring of
crosscutting symptoms, alerting the clinic care coordinator if a child’s
symptoms worsen to prompt timely interventions, and monitoring caregiver

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burden to prevent burnout; and 1.c. Explore the MyChildCMC usability to
incorporate user suggestions and enhance user acceptance and
performance of the application. Aim 2. Assess the impact of the
MyChildCMC app by comparing outcomes for the: 2.a. child (QOL and
ED/hospital admissions); 2.b. caregiver (satisfaction, self-management
skills, QOL and burden); and 2.c. health care provider (satisfaction),
between child/caregiver dyads randomized to either MyChildCMC or usual
care. Aim 3. Assess whether the effect of the MyChildCMC intervention on
child outcomes varies across caregiver characteristics (ethnicity, education,
health literacy, and insurance).
 
 
 
 
 
 
 
 
 
 
 
Assigned IRB Coordinator: Beth Kollman
Anticipated Length of Study: 5 years
1. Describe how this study furthers excellence in the provision of
health care for children.
The current project capitalizes on our prior experience in
developing and implementing the eAT to support self-management
at 12 primary care clinics in Utah and our ability to sustain parent
engagement. The variable, multisystem diagnoses of CMC, makes
it difficult to implement self-management interventions. Our project
will introduce a novel, but practical approach to supporting CMC
self-management, that focuses on crosscutting symptoms leading
to ED/hospital admissions among CMC rather than an unrealistic
approach targeting multiple diseases individually. Our study is the
first to address CMC self-management and will establish a
systematic approach to routinely screen and address caregiver
burden to prevent burnout. We will identify factors critical to
caregiver engagement that can be addressed to facilitate use of
SM-CMC beyond our study population. If successful, our approach
will serve as a model for improving CMC care and reducing acute
health care use and costs that can also be generalized to adults
with multiple chronic conditions who also disproportionally use
health care resources.
2. In simple, brief and specific terms, tell us what this study will
be doing.
To reduce the risk of acute deteriorations of chronic conditions,
self-management is recommended. To date, no self-management
intervention for CMC exists. While evidence of mHealth tool use for
supporting self-management of non-complex, single diseases is
substantial, no tool exists to address the complex needs of CMC
self-management. Our project will implement and test the
effectiveness of a novel approach to support CMC self-
management, by targeting crosscutting symptoms, while monitoring

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caregiver burden. If successful, our approach will serve as a model
for improving CMC care and reducing costs that can be
generalized to adults with multiple chronic conditions who also
disproportionally use health care resources.  
3. Project Funding Type:
 
Sponsor
Sponsor
Type
Sponsor Contact
Information
Prime
Sponsor
Prime
Sponsor
Type
View
HRSA
MATERNAL
& CHILD
HEALTH
BUREAU
Federal
Government
Marie Y Mann,
MD, MPH, FAAP
Senior Medical
Advisor/Acting
Deputy Director
Division of
Services for
Children with
Special Health
Needs
Maternal and
Child Health
Bureau
301-443-4925
office
202-498-8178
mobile
mmann@hrsa.gov
 
 

a. Identify funding type (grant, contract, subcontract,
other):
grant 
b. Explain any specific billing requirements (e.g: hold all
charges, etc):
none 
c. Has the project funding already been approved by the
sponsor or funding agency?
Approved
d. Location of Research in addition to Primary
Children's (i.e., PCH Riverton, or other
Intermountain facilities

None   
4. Will data be pulled from any PCH or Intermountain electronic
system(s)?
  Yes  No 
5. Do you need a qualified data analyst from intermountain to
query an Intermountain or PCH database in order to produce a
limited data set for your study?
  Yes  No 
6. Will individuals associated with this study need to be granted
access to PCH or Intermountain information systems?
  Yes  No 
7. Will patient consent be obtained for access to the patient
information?
  Yes  No 

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8. Could there be any inventions developed from this research?
  Yes  No 
9. Does this study involve inpatients?
  Yes  No
Check all that apply:
Infant Medical Surgical Unit (IMSU)
Children's Medical Unit (CMU)
Pediatric Intensive Care Unit (PICU)
10. Does this study involve outpatients?
  Yes  No 
a. Percent Inpatient:
20 
b. Percent Outpatient:
80 
c. Check all that apply:
Other (List)
If Other, please list:
Outpatient Services  
11. Will ANY of the participants be non-English speaking?
  Yes  No 
12. Does this study involve any other PCH departments?
  Yes  No 
13. Will the PI, study coordinator, research assistant or other
person associated with this proposal need access to PCH
facilities, systems, or equipment that they don't already have?
  Yes  No 
14. Will PCH staff be required to perform any duties associated
with this study in addition to routine patient care activities?
  Yes  No 
15. Are diagnostic studies required as part of this study?
  Yes  No 
16. Are any diagnostic studies requested above standard of care
intended to be charged to an institutional account?
  Yes  No 
17. This study is not an investigational drug study.
This study is not an investigational use of a medical device
study.
 
Participants PCH 1st year:
24 
Participants PCH total study:
300 

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18. Cybersecurity Questions for
Intermountain
Intermountain CyberSecurity conducts risk assessments on
research projects involving Intermountain Data. Intermountain Data
is considered to be any information that originates from an
Intermountain owned and/or managed information system. For
example: iCentra, HELP2, Intermountain's EDW, SelectHealth, etc.
The following set of questions is designed to gather study-specific
information regarding data handling and security considerations for
any component of the research project using Intermountain Data or
systems and should be answered within this context.

Chart Review

For the purposes of this study will you export, transcribe,
abstract, or otherwise copy information from an Intermountain
information system?
  Yes  No
19. Data Storage
Where will the Intermountain Data that you have obtained for
use in the study be stored?
There are no items to display
20. Describe all entities that will have access to Intermountain
Data:
 
21. Data Sharing:

How will Intermountain Data be sent or provided to the
University of Utah?
There are no items to display
22. Approximately how many Intermountain patient records will
be shared with the University of Utah for this study?
 
23. The University of Utah will utilize which of the following
Intermountain Data types/elements:
There are no items to display
24. Will you send Intermountain Data to an individual or entity
outside of Intermountain or the University of Utah?
  Yes  No 
25. Will Intermountain be required to send Intermountain Data
directly to entities other than the University of Utah (e.g.
spreadsheet, database, electronic documents)?
  Yes  No 
26. Will any data be transferred, stored, or accessed outside the
United States?
  Yes  No 
27. Additional Questions:

Will the sponsor or other participating organizations provide
medical devices that will require access to Intermountain
networks?

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  Yes  No 
28. Will the sponsor or other participating organizations provide
computer hardware (e.g. laptops, tablets, mobile devices) for
this study that will store Intermountain Data or require access
to Intermountain networks?
  Yes  No 
29. Will the study require the use or installation of computer
software/applications on Intermountain computing devices
(e.g. laptops, workstations)?
  Yes  No 
30. Will you need support from PCH in the creation, deployment,
modification, or configuration of software?
  Yes  No 
Please contact us with any questions or concerns regarding completion of this. Please note
both IRB approval and PCH administrative approval is required prior to starting the project.
Thanks again for your support as together we put the Child First and Always.
PCHResearch@imail.org || 801-408-1991 opt 1

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IRB_00088596
Finish
IRB_00088596
Created: 12/9/2015 12:01 PM  
PI: Flory Nkoy MD, MS, MPH
Submitted: 2/12/2016  
Title: SELF-MANAGEMENT INTERVENTION FOR CHILDREN WITH
CHRONIC MEDICAL COMPLEXITY
 
 
Finish Instructions
 
Finish Instructions
1. To view errors, select the "Validate" option at the top-left of the page. If you have errors on your application,
you won't be able to submit it to the IRB.
2. Selecting the Finish button will NOT submit the application to the IRB.
You MUST select the "Submit" option on the workspace once you've selected the "Finish" button.
3. If your study has a faculty sponsor: Once the PI submits the application, it will be sent to the faculty sponsor
for final approval. The IRB cannot review the study until the faculty sponsor submits the application to the IRB.