Quality of LifeNCT01834456
Comprehensive Care of Children With Medical Complexity
A study testing Med Complex Children Intervention in people with Quality of Life and Chronic Disease, run by Seton Healthcare Family at 1 site in United States.
Trial summary
Under the auspice of 'Specially for Children and with funding from the Seton Healthcare Family, Children's Comprehensive Care (CCC) in Austin, Texas, has developed a coordinated and integrated model of care for children with medical complexity. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Quality of Life, Chronic Disease, Chronic Illness
- What is being tested?
- Med Complex Children Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to 30 Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- between the ages of birth to 17 years
- has profound autism and one other significant medical condition
- are determined by the study team to be complex when considering multiple diagnoses, functional impairment, use of medical technology, or contextual needs, or by a combination of these things
Who cannot join
- primary diagnosis is related to an oncologic diagnosis
- primary diagnosis is Cystic Fibrosis
- has Down Syndrome and does not have significant comorbid diagnoses
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Comprehensive Care at 'Specially for Children
Austin, Texas, 78723
About this study
Official title: Comprehensive Care of Children With Medical Complexity: Piloting an Innovative Model
Under the auspice of 'Specially for Children and with funding from the Seton Healthcare Family, Children's Comprehensive Care (CCC) in Austin, Texas, has developed a coordinated and integrated model of care for children with medical complexity. This model serves as the patient's Medical Home (primary care provider, (PCP)), and uses extensivists (physicians who work as hospitalists and within the PCP) and nurse practitioners to provide continuous care between hospital and primary care. This model seeks to provide a system of care that more fully meets the complex needs of the child and family, while implementing innovations in care delivery, fully implementing family-centered practice, and "embedding" behavioral, psychiatric, psychosocial, and palliative care. This study is a randomized intervention trial that evaluates the effectiveness of the newly-created Children's Comprehensive Care on two outcomes: utilization and cost of care; and, evaluation of the experience of parents and their families.
Read the detailed description
Advances in medical technology and more effective treatment for life-limiting illness have allowed children with complex chronic conditions to survive not only the neonatal period but also their adolescent years, with an ever-increasing number living well into adulthood.
Often their families are not well prepared or supported. Currently, outpatient pediatric health care services are designed primarily for episodic diagnosis and treatment of acute diseases, and are not designed to provide holistic, comprehensive, family-center care that is directed at improving the quality of life of these children and their families. There is usually no mechanism for effective coordination between subspecialists. As a result, care is fragmented, redundant, inefficient, and very costly. Despite their small number, this population accounts for a disproportionate amount of the costs associated with pediatric medicine. Furthermore, current services are rarely comprehensive and some services such as pain-management, sleep-management, life-span palliative care, and psychosocial and behavioral interventions (including transition to adult medicine) are often inconsistently accessible or non-existent.
The investigators plan to enroll 450 patients into this study, randomizing about half to the new care at Children's Comprehensive Care (CCC) and half to a control group which continues in the care that they are currently receiving. If they are randomized to the intervention group, the child will receive primary care, including preventative care, acute care, well checks, and immunizations from CCC. If this child is hospitalized at Dell Children's Medical Center (not including day surgery procedures), a practitioner from CCC will visit the child shortly after admission and collaborate with the hospital team to coordinate care at discharge. In addition, CCC will coordinate and monitor all other aspects of the child's medical, dental, behavioral, and developmental care, including the development of individualized care plans that are reviewed annually or with change of medical status, and implemented and maintained by CCC. Other changes to care delivery include access to embedded palliative, developmental, and behavioral care; use of a consultant-model for specialist care; use of telemedicine, greater use of care coordination and case management; and, holistic care of child and family-including psycho-social screening and referral. CCC will use Social Workers, Registered Nurse (RN) Case-managers, and a Child Life Specialist to offer more holistic care coordination, family support, and case-management.
If they are randomized to the control group they will continue in whatever type care they are currently being treated and will be given no clinical intervention by Children's Comprehensive Care.
The investigators' goal is to evaluate whether children who are patients at Children's Comprehensive Care receive better care or not, as defined by cost and utilization, parent-report for quality and satisfaction, and impact-on-family.
Cost and Utilization matrices include-hospitalizations, Emergency Department (ED) visits, and specialist visits within the Seton system of care (locally, Dell Children's Hospital, a member of the Seton Healthcare Family is the only Children's hospital in the Austin area.) Investigators will also evaluate quality and satisfaction using the Consumer Assessment of Healthcare and System (CAHPS) 12-Month Survey with Patient-Centered Medical Home (PCMH), and impact-on-family using the PedsQL Family Impact Module (version 2.0). This study will seek to analyze three years worth of data.
- Conditions
- Quality of Life, Chronic Disease, Chronic Illness
- Being tested
- Med Complex Children Intervention
- Keywords
- Medically Complex Children, Family Experience in Healthcare, Patient Centered Care, Family Centered Care, Case Management, Care Management, Care Coordination, Care Plan, Extensivist, Medical Home, Children with Special Health Care Needs, Coordinated Care, Quality in Healthcare, Satisfaction in Healthcare, Cost, Utilization, Impact on Family, Quality of Life, Palliative Care, Complex Chronic Conditions
- Medical subject headings
- Chronic Disease, Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Med Complex Children InterventionOther
Comprehensive Care, including creating a care plan, offering and integrating developmental and behavioral care, with added care coordination in a Medical Home/Primary Care Practice
| Study group | Role | What they receive |
|---|---|---|
| Med Complex Children Intervention | Experimental | Children with Medical Complexity, previously defined in research as, "children with complex chronic conditions," "children with life-limiting conditions," "fragile children," "complex chronic illness," or a subset of "children with special healthcare needs." Meeting criteria for complexity is a combination of high utilization, multiple chronic diagnoses, use of medical technology (g-tube, tracheostomy, shunt, etc.), functional impairment, and contextual needs.
Medically Complex Children in the Intervention group will be treated at an innovative primary care facility designed for their care. This includes actively addressing QOL, care coordination, and behavioral needs of the child, and addressing contextual and support needs for the child's family. Receives: Other: Med Complex Children Intervention |
| Med Complex Children Control | No intervention | Children with Medical Complexity, previously defined in research as, "children with complex chronic conditions," "children with life-limiting conditions," "fragile children," "complex chronic illness," or a subset of "children with special healthcare needs." Meeting criteria for complexity is a combination of high utilization, multiple chronic diagnoses, use of medical technology (g-tube, tracheostomy, shunt, etc.), functional impairment, and contextual needs. The control group will continue to receive usual care as they did before they enrolled in this study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Healthcare Utilization and Cost of Care
The investigators will compare cost and utilization between children enrolled int the intervention group and the usual care group, including ED visits, hospitalizations, and specialist visits.
Measured: Assessed every 2 months for three years
Secondary outcomes (3)
Change in Quality and Satisfaction, using the CAHPS Clinician & Group Survey, Version: 12-Month Survey with Patient-Centered Medical Home (PCMH) Items
Standard instruments will be used to assess Quality and Satisfaction with the patient's current medical home, primary care practice
Measured: at entry into study, after 1 year, and then annually thereafter, for a total of three years
Change in Family Impact, using the PedsQL Family Impact Module
Standard instruments will be used to assess the impact of illness to study families
Measured: at entry into study, after 1 year, and then annually thereafter, for a total of three years
Change in family experience, using Qualitative Interviews
40 Structured qualitative interviews will be conducted with the parents of children who are enrolled in the study. 20 interviews will be with Spanish-speaking-only parents. 20 interviews will be conducted with English-speaking parents. Parents will be randomized and drawn from both the control and treatment groups.
Measured: 6 months and 1 year post-enrollment to the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2013 (estimated)
- Study startNov 2011
- Primary completion30 Sep 2016
- Study completion30 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seton Healthcare Family
- Sponsor type
- University, hospital or other
- Collaborators
- University of Texas at Austin
- Responsible party
- Sponsor
- Investigators
- Mark Shen, M.D., Principal investigator, Seton Healthcare Family, Children's Comprehensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01834456
- Sponsor's protocol ID
- CR-11-125
- Status last verified
- Oct 2019
- First submitted
- 21 Dec 2012
- Last updated
- 9 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lalji R, Koh L, Francis A, Khalid R, Guha C, Johnson DW, Wong G. Patient navigator programmes for children and adolescents with chronic diseases. Cochrane Database Syst Rev. 2024 Oct 9;10(10):CD014688. doi: 10.1002/14651858.CD014688.pub2.
PubMed 39382077
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Care of Children With Medical Complexity: Piloting an Innovative Model
- ClinicalTrials.gov ID
- NCT01834456
- Acronym / sponsor ID
- CR-11-125
- Conditions
- Quality of Life, Chronic Disease, Chronic Illness
- Keywords
- Medically Complex Children, Family Experience in Healthcare, Patient Centered Care, Family Centered Care, Case Management, Care Management, Care Coordination, Care Plan
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Seton Healthcare FamilyUniversity, hospital or other
- Collaborators
- University of Texas at Austin
- Study start
- Nov 2011
- Primary completion
- 30 Sep 2016 (actual)
- Study completion
- 30 Sep 2016 (actual)
- First posted
- 17 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Under the auspice of 'Specially for Children and with funding from the Seton Healthcare Family, Children's Comprehensive Care (CCC) in Austin, Texas, has developed a coordinated and integrated model of care for children with medical complexity. This model serves as the patient's Medical Home (primary care provider, (PCP)), and uses extensivists (physicians who work as hospitalists and within the PCP) and nurse practitioners to provide continuous care between hospital and primary care. This model seeks to provide a system of care that more fully meets the complex needs of the child and family, while implementing innovations in care delivery, fully implementing family-centered practice, and "embedding" behavioral, psychiatric, psychosocial, and palliative care. This study is a randomized intervention trial that evaluates the effectiveness of the newly-created Children's Comprehensive Care on two outcomes: utilization and cost of care; and, evaluation of the experience of parents and their families.
Detailed description
Advances in medical technology and more effective treatment for life-limiting illness have allowed children with complex chronic conditions to survive not only the neonatal period but also their adolescent years, with an ever-increasing number living well into adulthood.
Often their families are not well prepared or supported. Currently, outpatient pediatric health care services are designed primarily for episodic diagnosis and treatment of acute diseases, and are not designed to provide holistic, comprehensive, family-center care that is directed at improving the quality of life of these children and their families. There is usually no mechanism for effective coordination between subspecialists. As a result, care is fragmented, redundant, inefficient, and very costly. Despite their small number, this population accounts for a disproportionate amount of the costs associated with pediatric medicine. Furthermore, current services are rarely comprehensive and some services such as pain-management, sleep-management, life-span palliative care, and psychosocial and behavioral interventions (including transition to adult medicine) are often inconsistently accessible or non-existent.
The investigators plan to enroll 450 patients into this study, randomizing about half to the new care at Children's Comprehensive Care (CCC) and half to a control group which continues in the care that they are currently receiving. If they are randomized to the intervention group, the child will receive primary care, including preventative care, acute care, well checks, and immunizations from CCC. If this child is hospitalized at Dell Children's Medical Center (not including day surgery procedures), a practitioner from CCC will visit the child shortly after admission and collaborate with the hospital team to coordinate care at discharge. In addition, CCC will coordinate and monitor all other aspects of the child's medical, dental, behavioral, and developmental care, including the development of individualized care plans that are reviewed annually or with change of medical status, and implemented and maintained by CCC. Other changes to care delivery include access to embedded palliative, developmental, and behavioral care; use of a consultant-model for specialist care; use of telemedicine, greater use of care coordination and case management; and, holistic care of child and family-including psycho-social screening and referral. CCC will use Social Workers, Registered Nurse (RN) Case-managers, and a Child Life Specialist to offer more holistic care coordination, family support, and case-management.
If they are randomized to the control group they will continue in whatever type care they are currently being treated and will be given no clinical intervention by Children's Comprehensive Care.
The investigators' goal is to evaluate whether children who are patients at Children's Comprehensive Care receive better care or not, as defined by cost and utilization, parent-report for quality and satisfaction, and impact-on-family.
Cost and Utilization matrices include-hospitalizations, Emergency Department (ED) visits, and specialist visits within the Seton system of care (locally, Dell Children's Hospital, a member of the Seton Healthcare Family is the only Children's hospital in the Austin area.) Investigators will also evaluate quality and satisfaction using the Consumer Assessment of Healthcare and System (CAHPS) 12-Month Survey with Patient-Centered Medical Home (PCMH), and impact-on-family using the PedsQL Family Impact Module (version 2.0). This study will seek to analyze three years worth of data.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Med Complex Children Intervention | Experimental | Other: Med Complex Children InterventionChildren with Medical Complexity, previously defined in research as, "children with complex chronic conditions," "children with life-limiting conditions," "fragile children," "complex chronic illness," or a subset of "children with special healthcare needs." Meeting criteria for complexity is a combination of high utilization, multiple chronic diagnoses, use of medical technology (g-tube, tracheostomy, shunt, etc.), functional impairment, and contextual needs. Medically Complex Children in the Intervention group will be treated at an innovative primary care facility designed for their care. This includes actively addressing QOL, care coordination, and behavioral needs of the child, and addressing contextual and support needs for the child's family. |
| Med Complex Children Control | No intervention | –Children with Medical Complexity, previously defined in research as, "children with complex chronic conditions," "children with life-limiting conditions," "fragile children," "complex chronic illness," or a subset of "children with special healthcare needs." Meeting criteria for complexity is a combination of high utilization, multiple chronic diagnoses, use of medical technology (g-tube, tracheostomy, shunt, etc.), functional impairment, and contextual needs. The control group will continue to receive usual care as they did before they enrolled in this study |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- between the ages of birth to 17 years
- has profound autism and one other significant medical condition
- are determined by the study team to be complex when considering multiple diagnoses, functional impairment, use of medical technology, or contextual needs, or by a combination of these things
Key exclusion criteria (3 listed)
- primary diagnosis is related to an oncologic diagnosis
- primary diagnosis is Cystic Fibrosis
- has Down Syndrome and does not have significant comorbid diagnoses
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Med Complex Children InterventionComprehensive Care, including creating a care plan, offering and integrating developmental and behavioral care, with added care coordination in a Medical Home/Primary Care Practice | Other | Med Complex Children Intervention |
Primary outcome
Change in Healthcare Utilization and Cost of Care
Time frame: Assessed every 2 months for three years
The investigators will compare cost and utilization between children enrolled int the intervention group and the usual care group, including ED visits, hospitalizations, and specialist visits.
3 secondary outcomes
Change in Quality and Satisfaction, using the CAHPS Clinician & Group Survey, Version: 12-Month Survey with Patient-Centered Medical Home (PCMH) Items
Time frame: at entry into study, after 1 year, and then annually thereafter, for a total of three years
Change in Family Impact, using the PedsQL Family Impact Module
Time frame: at entry into study, after 1 year, and then annually thereafter, for a total of three years
Change in family experience, using Qualitative Interviews
Time frame: 6 months and 1 year post-enrollment to the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2019.
- Derived from this study: PubMed 39382077Lalji R, Koh L, Francis A, Khalid R, Guha C, Johnson DW, Wong G. Patient navigator programmes for children and adolescents with chronic diseases. Cochrane Database Syst Rev. 2024 Oct 9;10(10):CD014688. doi: 10.1002/14651858.CD014688.pub2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Shen, M.D. principal investigator
Seton Healthcare Family, Children's Comprehensive Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Med Complex Children Intervention in people with Quality of Life and Chronic Disease, run by Seton Healthcare Family at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Healthcare Utilization and Cost of Care (time frame: Assessed every 2 months for three years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01834456, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2019.