One-4-ALL Initiative
Primary Purpose
Literacy, Burden, Caregiver, Health Care Utilization
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
One-4-ALL Initiative
Control
Sponsored by
About this trial
This is an interventional health services research trial for Literacy
Eligibility Criteria
Inclusion Criteria:
- All guardians of patients and the providers (surgeons, doctors, nurses, etc) that serve these patients.
Exclusion Criteria:
- None.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
One-4-ALL Initiative
Control
Arm Description
The health app arm will pilot the intervention and key outcome measures will be compared between the Health App group and the placebo control.
Will receive standard care.
Outcomes
Primary Outcome Measures
Health care quality
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.
Provider satisfaction
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
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.
Acceptability of program tool
Patient's ability to engage and understand the program tool. Likert scale 1-5, higher score is better.
Secondary Outcome Measures
Full Information
NCT ID
NCT05454969
First Posted
June 27, 2022
Last Updated
February 2, 2023
Sponsor
University of Colorado, Denver
1. Study Identification
Unique Protocol Identification Number
NCT05454969
Brief Title
One-4-ALL Initiative
Official Title
Transforming Healthcare in Post-Pandemic Recovery: Innovation in Process & Technology to Increase Patient Throughput While Reducing Clinician Burden and Addressing Health Disparities (One-4-ALL Initiative)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 1, 2023 (Anticipated)
Primary Completion Date
July 30, 2024 (Anticipated)
Study Completion Date
July 30, 2024 (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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Literacy, Burden, Caregiver, Health Care Utilization
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a randomized controlled trial to examine pre-post differences between individuals that use the app versus the standard of care.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
One-4-ALL Initiative
Arm Type
Active Comparator
Arm Description
The health app arm will pilot the intervention and key outcome measures will be compared between the Health App group and the placebo control.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Will receive standard care.
Intervention Type
Behavioral
Intervention Name(s)
One-4-ALL Initiative
Intervention Description
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
Intervention Name(s)
Control
Intervention Description
Patients will receive standard of care.
Primary Outcome Measure Information:
Title
Health care quality
Description
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.
Time Frame
post-intervention (12 weeks)
Title
Provider satisfaction
Description
Provider job satisfaction including level of burden and overall job satisfaction. Likert scale 1-5, higher score is best.
physical and mental health
Time Frame
post-intervention (12 weeks)
Title
Patient satisfaction
Description
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.
Time Frame
post-intervention (12 weeks)
Title
Acceptability of program tool
Description
Patient's ability to engage and understand the program tool. Likert scale 1-5, higher score is better.
Time Frame
post-intervention (12 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
All guardians of patients and the providers (surgeons, doctors, nurses, etc) that serve these patients.
Exclusion Criteria:
None.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
One-4-ALL Initiative
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