Virtually-integrated Co-management Between Complex Care and Community-based Primary Care Providers (CoTS)

Traditional vs Virtually-integrated Co-management of Children With Medical Complexity Between Complex Care and Community-based Primary Care Providers

This is a pilot trial to test whether tertiary center-affiliated pediatricians with expertise in medical complexity joining medical visits with patients' community primary care providers is feasible and acceptable. We will also collect data on a range of patient-centered and utilization outcomes to determine effect compared to usual care.

Study Overview

• Status: Completed
• Conditions: Chronic Illness
• Intervention / Treatment: Other: videoconferencing

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria: Caregiver of patient seen for co-managed care in Special Care Clinic; caregiver has a smartphone that will accept the technology; PCPs office has wireless internet connection -

Exclusion Criteria: Child is in foster care

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Usual care
Experimental: Experimental; videoconferencing	Other: videoconferencing; Parents/caregivers will use smartphones to videoconference in their SCC provider during PCP visits

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of co-managed visits scheduled that are completed through videoconferencing	To determine the feasibility of scheduled visits that are completed through videoconferencing	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Caregiver Perception of integrated care	Instrument that measures the perception of how well care is integrated. This is a validated, caregiver-reported outcome	Baseline, 3 months and 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Caregiver Satisfaction with Telehealth	Adapted validated, caregiver-reported measure of satisfaction with the telehealth visit	After every telehealth visit (up to 3 visits)

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Jeanne Van Cleave, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Actual): November 15, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: April 18, 2018
• First Submitted That Met QC Criteria: May 8, 2018
• First Posted (Actual): May 21, 2018

Study Record Updates

• Last Update Posted (Estimated): November 8, 2023
• Last Update Submitted That Met QC Criteria: November 6, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Chronic Disease
• Other Study ID Numbers: 17-1889

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No