One-4-ALL Initiative

Not Applicable

Recruiting

• Conditions: Burden, Caregiver; Health Care Utilization; Literacy
• Interventions: Behavioral: Control; Behavioral: One-4-ALL Initiative

• Registration Number: NCT05454969
• Lead Sponsor: University of Colorado, Denver

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2022-06-27
• Study First Submitted QC: 2022-07-07
• Study First Posted: 2022-07-12
• Study Start: 2023-09-01
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-27
• Last Update Posted: 2024-09-30
• Primary Completion: 2025-12-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

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Exclusion Criteria

• None.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control	Will receive standard care.
One-4-ALL Initiative	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.

Primary Outcome Measures

Name	Time	Method
Health care quality	post-intervention (12 weeks)	Health care quality will be assessed using six domains; safety, effective, patient-centered, timely, efficient, and equitable. Likert scale 1-5, higher score is best.
Acceptability of program tool	post-intervention (12 weeks)	Patient's ability to engage and understand the program tool. Likert scale 1-5, higher score is better.
Provider satisfaction	post-intervention (12 weeks)	Provider job satisfaction including level of burden and overall job satisfaction. Likert scale 1-5, higher score is best.; physical and mental health
Patient satisfaction	post-intervention (12 weeks)	Patient's satisfaction of the program tool. Likert scale 1-5, higher score is best.; literacy of the patient \& their family, patient \& family anxiety pre-surgery.

Trial Locations

Locations (1)

Children's Hospital Colorado; 🇺🇸 Aurora, Colorado, United States