One-4-ALL Initiative

NCT ID: NCT05454969

Last Updated: 2024-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2025-12-30

Brief Summary

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This study aims to improve health outcomes of individuals and populations, enhance the patient experience, reduce the per capita cost of care, and ensure the well-being of our healthcare providers (quadruple aim). These goals are increasingly difficult to achieve, given the challenges of changes to workflow, staffing shortages, and increased costs brought on by the COVID-19 pandemic. Further, the pandemic brought to light the critical need to transform healthcare access for our racially and culturally minoritized and low-income families that have long been victims of health disparities, specifically with poorer health outcomes.

Detailed Description

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The overall objective is to successfully implement a patient app that will be used by families to 1) increase throughput for all patients, including minoritized, low-income, and low health literacy patients, and 2) reduce administrative burdens on providers.

To evaluate this hypothesis, the following specific aims will be examined:

Aim 1: Document modifiable factors that negatively and positively impact providers' ability to provide high-quality patient care in a post-pandemic healthcare system while addressing health disparities through implementation science.

Aim 2: Create a "boarding pass' experience for providers and patients using technology (app) which allows patients and their families to fully prepare for their clinical visits and bridge care between home, primary care providers, and specialty care.

Aim 3: Investigate multilevel contextual factors related to app implementation, to inform future strategies to promote scalability and sustainability of app in all specialties.

Conditions

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Literacy Burden, Caregiver Health Care Utilization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a randomized controlled trial to examine pre-post differences between individuals that use the app versus the standard of care.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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One-4-ALL Initiative

The health app arm will pilot the intervention and key outcome measures will be compared between the Health App group and the placebo control.

Group Type ACTIVE_COMPARATOR

One-4-ALL Initiative

Intervention Type BEHAVIORAL

We can successfully implement a patient app that will be used by families to 1) increase throughput for all patients, including minoritized, low-income, and low health literacy patients, and 2) reduce administrative burdens on providers.

Control

Will receive standard care.

Group Type PLACEBO_COMPARATOR

Control

Intervention Type BEHAVIORAL

Patients will receive standard of care.

Interventions

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One-4-ALL Initiative

We can successfully implement a patient app that will be used by families to 1) increase throughput for all patients, including minoritized, low-income, and low health literacy patients, and 2) reduce administrative burdens on providers.

Intervention Type BEHAVIORAL

Control

Patients will receive standard of care.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* All guardians of patients and the providers (surgeons, doctors, nurses, etc) that serve these patients.

Exclusion Criteria

* None.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jill Landsbaugh Kaar, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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Children's Hospital Colorado

Aurora, Colorado, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jill Landsbaugh Kaar, PhD

Role: CONTACT

17207773571

Facility Contacts

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Jill Landsbaugh Kaar, PhD

Role: primary

720-777-3571

Other Identifiers

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22-0995

Identifier Type: -

Identifier Source: org_study_id

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