- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05454969
One-4-ALL Initiative
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 Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jill Landsbaugh Kaar, PhD
- Phone Number: 17207773571
- Email: jill.kaar@cuanschutz.edu
Study Locations
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- Recruiting
- Children's Hospital Colorado
-
Contact:
- Jill Landsbaugh Kaar, PhD
- Phone Number: 720-777-3571
- Email: jill.kaar@cuanschutz.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- All guardians of patients and the providers (surgeons, doctors, nurses, etc) that serve these patients.
Exclusion Criteria:
- None.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 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.
|
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.
|
|
Placebo Comparator: Control
Will receive standard care.
|
Patients will receive standard of care.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Health care quality
Time Frame: 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.
|
post-intervention (12 weeks)
|
|
Provider satisfaction
Time Frame: 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 |
post-intervention (12 weeks)
|
|
Patient satisfaction
Time Frame: 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. |
post-intervention (12 weeks)
|
|
Acceptability of program tool
Time Frame: post-intervention (12 weeks)
|
Patient's ability to engage and understand the program tool.
Likert scale 1-5, higher score is better.
|
post-intervention (12 weeks)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jill Landsbaugh Kaar, PhD, University of Colorado - Anschutz Medical Campus
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22-0995
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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