NCT02870387

Brief Summary

The investigators will conduct a pilot quality improvement trial to assess the impact of offering inpatient consultation to further optimize coordination and improve care for high-risk chronically ill children receiving comprehensive care in an enhanced medical home.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
342

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 5, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 17, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 26, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 26, 2018

Completed
Last Updated

July 13, 2018

Status Verified

March 1, 2018

Enrollment Period

1.3 years

First QC Date

August 5, 2016

Last Update Submit

July 11, 2018

Conditions

Chronic Illnesses

Keywords

chronic illnesschildrenchildren with medical complexitymedical homeinpatient consultation

Outcome Measures

Primary Outcomes (1)

  • Number of hospital days per child-year

    Total number of hospital days at Children's Memorial Hermann Hospital (CMHH) per child-year

    Within study period

Secondary Outcomes (9)

  • Parent/caregiver satisfaction

    Within 10 days after discharge from CMHH

  • Number of parents/caregivers that receive a follow-up phone call from an HRCC provider within 36 hours after discharge from CMHH

    Within 36 hours of discharge from CMHH

  • Number of patients that receive a follow-up clinic visit in the HRCC within 10 days after discharge from CMHH.

    Within 10 days after discharge from CMHH

  • Number of inpatient consultations with the CMHH inpatient physician team during admissions

    Between CMHH admission and discharge

  • Number of PICU days

    Within study period

  • +4 more secondary outcomes

Study Arms (2)

Usual Inpatient Care

ACTIVE COMPARATOR

Usual Inpatient Care: High-Risk Children's Clinic (HRCC) patients randomized to the usual inpatient care group who are admitted to Children's Memorial Hermann Hospital (CMHH) will receive usual inpatient care from the primary hospital admitting team (residents and fellows supervised by pediatric faculty physicians) with usual occasional communication with the patient's assigned HRCC provider. HRCC patients admitted to CMHH in this treatment group will receive usual inpatient care that is not modified by the study protocol.

Other: Usual Inpatient Care

Comprehensive Care with Inpatient Consultation

EXPERIMENTAL

Comprehensive care with Inpatient Consultation: HRCC patients randomized to the comprehensive care with inpatient consultation group that are admitted to CMHH will receive inpatient consultation by HRCC providers during their stay with input and recommendations conveyed to the hospital inpatient team on admission and at discharge at a minimum (in person consultations on weekdays and phone consultations on the weekends). The HRCC providers will review the inpatient care plan and will make treatment and discharge recommendations with a focus on coordination and integration of inpatient and outpatient care. Ideally, the inpatient consultations are face-to-face meetings with the hospital inpatient team but could also be a phone call or a consult note written in the medical record.

Other: Comprehensive Care with Inpatient consultation

Interventions

Comprehensive Care with Inpatient consultationOTHER

Comprehensive care with Inpatient Consultation: HRCC patients randomized to the comprehensive care with inpatient consultation group that are admitted to CMHH will receive inpatient consultation by HRCC providers during their stay with input and recommendations conveyed to the hospital inpatient team on admission and at discharge at a minimum (in person consultations on weekdays and phone consultations on the weekends). The HRCC providers will review the inpatient care plan and will make treatment and discharge recommendations with a focus on coordination and integration of inpatient and outpatient care. Ideally, the inpatient consultations are face-to-face meetings with the hospital inpatient team but could also be a phone call or a consult note written in the medical record.

Comprehensive Care with Inpatient Consultation
Usual Inpatient CareOTHER

High-Risk Children's Clinic (HRCC) patients randomized to the usual inpatient care group who are admitted to Children's Memorial Hermann Hospital (CMHH) will receive usual inpatient care from the primary hospital admitting team (residents and fellows supervised by pediatric faculty physicians) with usual occasional communication with the patient's assigned HRCC provider. HRCC patients admitted to CMHH in this treatment group will receive usual inpatient care that is not modified by the study protocol.

Usual Inpatient Care

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • HRCC patients who require admission to CMHH

You may not qualify if:

  • HRCC patients with a Do-Not-Resuscitate (DNR) order
  • HRCC patients with congenital heart disease if repair is needed
  • HRCC patients seen solely for compassionate care
  • HRCC patients who are ≥ 18 years of age at study initiation
  • HRCC patients with active cancer
  • HRCC patients with mitochondrial disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas Medical School at Houston

Houston, Texas, 77030, United States

Location

Related Publications (8)

  • Mosquera RA, Avritscher EB, Samuels CL, Harris TS, Pedroza C, Evans P, Navarro F, Wootton SH, Pacheco S, Clifton G, Moody S, Franzini L, Zupancic J, Tyson JE. Effect of an enhanced medical home on serious illness and cost of care among high-risk children with chronic illness: a randomized clinical trial. JAMA. 2014 Dec 24-31;312(24):2640-8. doi: 10.1001/jama.2014.16419.

    PMID: 25536255BACKGROUND

  • Homer CJ, Klatka K, Romm D, Kuhlthau K, Bloom S, Newacheck P, Van Cleave J, Perrin JM. A review of the evidence for the medical home for children with special health care needs. Pediatrics. 2008 Oct;122(4):e922-37. doi: 10.1542/peds.2007-3762.

    PMID: 18829788BACKGROUND

  • Jackson GL, Powers BJ, Chatterjee R, Bettger JP, Kemper AR, Hasselblad V, Dolor RJ, Irvine RJ, Heidenfelder BL, Kendrick AS, Gray R, Williams JW. The patient centered medical home. A systematic review. Ann Intern Med. 2013 Feb 5;158(3):169-78. doi: 10.7326/0003-4819-158-3-201302050-00579.

    PMID: 24779044BACKGROUND

  • Drummond MF, Sculpher MJ, Torrance GW, et al. Methods for the Economic Evaluation of Health Care Programmes. 3rd ed. New York, NY: Oxford University Press; 2005.

    BACKGROUND

  • Gold MR, Siegel JE, Russell LB, Weinstein MC. Cost-Effectiveness in Health and Medicine. New York, NY: Oxford University Press;1996.

    BACKGROUND

  • Siegel JE, Weinstein MC, Russell LB, Gold MR. Recommendations for reporting cost-effectiveness analyses. Panel on Cost-Effectiveness in Health and Medicine. JAMA. 1996 Oct 23-30;276(16):1339-41. doi: 10.1001/jama.276.16.1339.

    PMID: 8861994BACKGROUND

  • Sanders GD, Neumann PJ, Basu A, Brock DW, Feeny D, Krahn M, Kuntz KM, Meltzer DO, Owens DK, Prosser LA, Salomon JA, Sculpher MJ, Trikalinos TA, Russell LB, Siegel JE, Ganiats TG. Recommendations for Conduct, Methodological Practices, and Reporting of Cost-effectiveness Analyses: Second Panel on Cost-Effectiveness in Health and Medicine. JAMA. 2016 Sep 13;316(10):1093-103. doi: 10.1001/jama.2016.12195.

    PMID: 27623463BACKGROUND

  • Mosquera RA, Avritscher EBC, Pedroza C, Bell CS, Samuels CL, Harris TS, Eapen JC, Yadav A, Poe M, Parlar-Chun RL, Berry J, Tyson JE. Hospital Consultation From Outpatient Clinicians for Medically Complex Children: A Randomized Clinical Trial. JAMA Pediatr. 2021 Jan 1;175(1):e205026. doi: 10.1001/jamapediatrics.2020.5026. Epub 2021 Jan 4.

    PMID: 33252671DERIVED

MeSH Terms

Conditions

Chronic Disease

Interventions

Comprehensive Health Care

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Patient Care ManagementHealth Services Administration

Study Officials

  • Ricardo Mosquera, MD

    The University of Texas Medical School at Houston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 5, 2016

First Posted

August 17, 2016

Study Start

October 1, 2016

Primary Completion

January 26, 2018

Study Completion

January 26, 2018

Last Updated

July 13, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)