Back to resultsVirtually-integrated Co-management Between Complex Care and Community-based Primary Care Providers (CoTS)
Primary Purpose
Chronic Illness
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
videoconferencing
Sponsored by
About this trial
This is an interventional health services research trial for Chronic Illness
Eligibility Criteria
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
-
Sites / Locations
- University of Colorado
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental
Control
Arm Description
videoconferencing
Usual care
Outcomes
Primary Outcome Measures
Proportion of co-managed visits scheduled that are completed through videoconferencing
To determine the feasibility of scheduled visits that are completed through videoconferencing
Secondary Outcome Measures
Caregiver Perception of integrated care
Instrument that measures the perception of how well care is integrated. This is a validated, caregiver-reported outcome
Full Information
NCT ID
NCT03530709
First Posted
April 18, 2018
Last Updated
May 26, 2021
Sponsor
University of Colorado, Denver
1. Study Identification
Unique Protocol Identification Number
NCT03530709
Brief Title
Virtually-integrated Co-management Between Complex Care and Community-based Primary Care Providers
Acronym
CoTS
Official Title
Traditional vs Virtually-integrated Co-management of Children With Medical Complexity Between Complex Care and Community-based Primary Care Providers
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 2021 (Anticipated)
Primary Completion Date
May 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Illness
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
videoconferencing
Arm Title
Control
Arm Type
No Intervention
Arm Description
Usual care
Intervention Type
Other
Intervention Name(s)
videoconferencing
Intervention Description
Parents/caregivers will use smartphones to videoconference in their SCC provider during PCP visits
Primary Outcome Measure Information:
Title
Proportion of co-managed visits scheduled that are completed through videoconferencing
Description
To determine the feasibility of scheduled visits that are completed through videoconferencing
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Caregiver Perception of integrated care
Description
Instrument that measures the perception of how well care is integrated. This is a validated, caregiver-reported outcome
Time Frame
Baseline, 3 months and 6 months
Other Pre-specified Outcome Measures:
Title
Caregiver Satisfaction with Telehealth
Description
Adapted validated, caregiver-reported measure of satisfaction with the telehealth visit
Time Frame
After every telehealth visit (up to 3 visits)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeanne Van Cleave, MD
Phone
303-724-8323
Email
jeannemarie.vancleave@childrenscolorado.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeanne Van Cleave
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeanne Van Cleave
Phone
303-724-8323
Email
jeannemarie.vancleave@childrenscolorado.org
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Virtually-integrated Co-management Between Complex Care and Community-based Primary Care Providers
We'll reach out to this number within 24 hrs