An interventional study of One-4-ALL Initiative and Control in Literacy, Burden, Caregiver and Health Care Utilization, sponsored by University of Colorado, Denver. Recruiting at 1 site in United States. Open to participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-01.
Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Health services research
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.
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.
422 studies on the registry are indexed under Caregiver Burden; 151 are open to participants now.
This study's planned enrollment of 100 is above the median of 73 across 330 interventional studies indexed under Caregiver Burden.
Browse Caregiver Burden studies →University of Colorado, Denver is the lead sponsor of 1,499 studies on the registry; 315 are open to participants now.
Of its 139 completed or terminated interventional studies of FDA-regulated products, 89 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The health app arm will pilot the intervention and key outcome measures will be compared between the Health App group and the placebo control.
Behavioral: One-4-ALL Initiative
Will receive standard care.
Behavioral: Control
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.
Patients will receive standard of care.
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.
Time frame: post-intervention (12 weeks)
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
Time frame: post-intervention (12 weeks)
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.
Time frame: post-intervention (12 weeks)
Acceptability of program tool
Patient's ability to engage and understand the program tool. Likert scale 1-5, higher score is better.
Time frame: post-intervention (12 weeks)
Plan to share: No
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University of Colorado, Denver