NCT03530709

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2021

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

April 18, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 21, 2018

Completed
3 years until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

November 8, 2023

Status Verified

November 1, 2023

Enrollment Period

1.5 years

First QC Date

April 18, 2018

Last Update Submit

November 6, 2023

Conditions

Chronic Illness

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Caregiver Perception of integrated care

    Baseline, 3 months and 6 months

Other Outcomes (1)

  • Caregiver Satisfaction with Telehealth

    After every telehealth visit (up to 3 visits)

Study Arms (2)

Experimental

EXPERIMENTAL

videoconferencing

Other: videoconferencing

Control

NO INTERVENTION

Usual care

Interventions

videoconferencingOTHER

Parents/caregivers will use smartphones to videoconference in their SCC provider during PCP visits

Experimental

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jeanne Van Cleave

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2018

First Posted

May 21, 2018

Study Start

June 1, 2021

Primary Completion

November 15, 2022

Study Completion

December 31, 2022

Last Updated

November 8, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)