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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
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Literacy

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    June 27, 2022
    Last Updated
    February 2, 2023
    Sponsor
    University of Colorado, Denver
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    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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