LiteracyNCT05454969
One-4-ALL Initiative
A study testing One-4-ALL Initiative in people with Literacy and Burden, Caregiver, run by University of Colorado, Denver at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Literacy, Burden, Caregiver, Health Care Utilization
- What is being tested?
- One-4-ALL Initiative
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2023to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All guardians of patients and the providers (surgeons, doctors, nurses, etc) that serve these patients.
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Children's Hospital Colorado
Aurora, Colorado, 80045
Jill Landsbaugh Kaar, PhD, 720-777-3571, jill.kaar@cuanschutz.edu
About this study
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)
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.
Read the 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.
- Conditions
- Literacy, Burden, Caregiver, Health Care Utilization
- Being tested
- One-4-ALL Initiative, Control
- Medical subject headings
- Literacy, Caregiver Burden, Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One-4-ALL InitiativeBehavioural
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.
ControlBehavioural
Patients will receive standard of care.
| Study group | Role | What they receive |
|---|---|---|
| One-4-ALL Initiative | Active comparator | The health app arm will pilot the intervention and key outcome measures will be compared between the Health App group and the placebo control. Receives: Behavioral: One-4-ALL Initiative |
| Control | Placebo comparator | Will receive standard care. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: post-intervention (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2022
- Study start1 Sep 2023
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LiteracyStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jill Landsbaugh Kaar, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05454969
- Sponsor's protocol ID
- 22-0995
- Status last verified
- Sep 2024
- First submitted
- 27 Jun 2022
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05454969
- Acronym / sponsor ID
- 22-0995
- Conditions
- Literacy, Burden, Caregiver, Health Care Utilization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 12 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a randomized controlled trial to examine pre-post differences between individuals that use the app versus the standard of care.
| Arm | Type | Receives |
|---|---|---|
| One-4-ALL Initiative | Active comparator | Behavioral: One-4-ALL InitiativeThe health app arm will pilot the intervention and key outcome measures will be compared between the Health App group and the placebo control. |
| Control | Placebo comparator | Behavioral: ControlWill receive standard care. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All guardians of patients and the providers (surgeons, doctors, nurses, etc) that serve these patients.
Key exclusion criteria (1 listed)
- None.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| One-4-ALL InitiativeWe 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. | Behavioural | One-4-ALL Initiative |
| ControlPatients will receive standard of care. | Behavioural | Control |
Primary outcome
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.
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
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jill Landsbaugh Kaar, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing One-4-ALL Initiative in people with Literacy and Burden, Caregiver, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jill Landsbaugh Kaar, PhD (17207773571, jill.kaar@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health care quality (time frame: post-intervention (12 weeks)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.