Children With Complex Chronic ConditionsGET2HOMENCT05568355
Garnering Effective Telehealth 2 Help Optimize Multidisciplinary Team Engagement
A study testing GET2HOME Intervention in people with Children With Complex Chronic Conditions, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
The purpose of this study is to determine the effectiveness of the GET2HOME Intervention bundle. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Children With Complex Chronic Conditions
- What is being tested?
- GET2HOME Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 638 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2022to 31 Dec 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with complex chronic disease based on a Pediatric Medical Complexity Algorithm (PMCA) score of 3 and their families and their primary care providers
- Discharged from pediatric hospital medicine service at our hospital
Who cannot join
- Patients who live independently without a parent or guardian in the home, including those that live at skilled nursing facilities
- Patients admitted for end of life care
- Patients admitted for suicidal or homicidal ideation
- Patients who previously enrolled in the study
- Patients in county custody
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
The purpose of this study is to determine the effectiveness of the GET2HOME Intervention bundle.
- Conditions
- Children With Complex Chronic Conditions
- Being tested
- GET2HOME Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GET2HOME InterventionBehavioural
Intervention bundle designed to improve discharge effectiveness
| Study group | Role | What they receive |
|---|---|---|
| Standard Hospital-Based Care Coordination | No intervention | Patients and families randomized to this arm will receive best practice standard of care hospital-based transition planning in the hospital with routine outpatient care team follow-up post-discharge. |
| GET2HOME Intervention | Experimental | The GET2HOME intervention includes: 1) a pre-discharge telehealth huddle with the family, inpatient team, primary care team, and home care nursing; 2) a visual discharge task tracker (DTT) to monitor progress across care management tasks; and if desired by family and primary care 3) a post-discharge telehealth huddle 2-7 days after discharge with the family, inpatient team, primary care team, and home care nursing Receives: Behavioral: GET2HOME Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urgent healthcare reutilization
Yes/no to any: unplanned hospital readmission, ED revisit, or urgent care visit
Measured: 30-days post-discharge
Secondary outcomes (2)
Global Quality of Life Scale
Quality of Life assessment for child, caregiver and family; minimum score 0, maximum score 100; higher score means a better outcome
Measured: 7-, 30-, 60-, and 90-days post-discharge
Return to baseline
Capturing the time it takes to return to a normal routine (family designed measure)
Measured: 7-, 30-, 60-, and 90-days post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2022
- Study start1 Nov 2022
- Primary completion29 Sep 2025
- Study completion31 Dec 2025
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 Children With Complex Chronic ConditionsStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 638 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05568355
- Sponsor's protocol ID
- 2022-0511
- Acronym
- GET2HOME
- Status last verified
- Feb 2026
- First submitted
- 3 Oct 2022
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Warniment A, Sauers-Ford H, Brady PW, Beck AF, Callahan SR, Giambra BK, Herzog D, Huang B, Loechtenfeldt A, Loechtenfeldt L, Miller CL, Perez E, Riddle SW, Shah SS, Shepard M, Sucharew HJ, Tegtmeyer K, Thomson JE, Auger KA; GET2HOME Trial Group. Garnering effective telehealth to help optimize multidisciplinary team engagement (GET2HOME) for children with medical complexity: Protocol for a pragmatic randomized control trial. J Hosp Med. 2023 Oct;18(10):877-887. doi: 10.1002/jhm.13192. Epub 2023 Aug 21.
PubMed 37602537
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Garnering Effective Telehealth 2 Help Optimize Multidisciplinary Team Engagement
- ClinicalTrials.gov ID
- NCT05568355
- Acronym / sponsor ID
- GET2HOME / 2022-0511
- Conditions
- Children With Complex Chronic Conditions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 638 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 29 Sep 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 5 Oct 2022 (actual)
- 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.
The purpose of this study is to determine the effectiveness of the GET2HOME Intervention bundle.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Hospital-Based Care Coordination | No intervention | –Patients and families randomized to this arm will receive best practice standard of care hospital-based transition planning in the hospital with routine outpatient care team follow-up post-discharge. |
| GET2HOME Intervention | Experimental | Behavioral: GET2HOME InterventionThe GET2HOME intervention includes: 1) a pre-discharge telehealth huddle with the family, inpatient team, primary care team, and home care nursing; 2) a visual discharge task tracker (DTT) to monitor progress across care management tasks; and if desired by family and primary care 3) a post-discharge telehealth huddle 2-7 days after discharge with the family, inpatient team, primary care team, and home care nursing |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with complex chronic disease based on a Pediatric Medical Complexity Algorithm (PMCA) score of 3 and their families and their primary care providers
- Discharged from pediatric hospital medicine service at our hospital
Key exclusion criteria (5 listed)
- Patients who live independently without a parent or guardian in the home, including those that live at skilled nursing facilities
- Patients admitted for end of life care
- Patients admitted for suicidal or homicidal ideation
- Patients who previously enrolled in the study
- Patients in county custody
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 |
|---|---|---|
| GET2HOME InterventionIntervention bundle designed to improve discharge effectiveness | Behavioural | GET2HOME Intervention |
Primary outcome
Urgent healthcare reutilization
Time frame: 30-days post-discharge
Yes/no to any: unplanned hospital readmission, ED revisit, or urgent care visit
2 secondary outcomes
Global Quality of Life Scale
Time frame: 7-, 30-, 60-, and 90-days post-discharge
Return to baseline
Time frame: 7-, 30-, 60-, and 90-days post-discharge
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 4 Feb 2026.
- Derived from this study: PubMed 37602537Warniment A, Sauers-Ford H, Brady PW, Beck AF, Callahan SR, Giambra BK, Herzog D, Huang B, Loechtenfeldt A, Loechtenfeldt L, Miller CL, Perez E, Riddle SW, Shah SS, Shepard M, Sucharew HJ, Tegtmeyer K, Thomson JE, Auger KA; GET2HOME Trial Group. Garnering effective telehealth to help optimize multidisciplinary team engagement (GET2HOME) for children with medical complexity: Protocol for a pragmatic randomized control trial. J Hosp Med. 2023 Oct;18(10):877-887. doi: 10.1002/jhm.13192. Epub 2023 Aug 21.
- Individual participant dataSharing planned: No
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RecruitingObservational study
Turkish Adaptation of a Sleep Screening Tool for Pediatric Complex Chronic Conditions
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GET2HOME Intervention in people with Children With Complex Chronic Conditions, run by Children's Hospital Medical Center, Cincinnati 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 2 inclusion and 5 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 4 Feb 2026. 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?
Urgent healthcare reutilization (time frame: 30-days post-discharge). 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 NCT05568355, 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 4 Feb 2026.