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Understanding Community Considerations, Opinions, Values, Impacts, and Decisions for COVID-19 (UC-COVID)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04373135
Recruitment Status : Active, not recruiting
First Posted : May 4, 2020
Last Update Posted : October 14, 2020
Sponsor:
Information provided by (Responsible Party):
Russell G. Buhr, MD, PhD, University of California, Los Angeles

Brief Summary:
The novel coronavirus (COVID-19) is affecting the way many people live their lives, including seeking medical care and maintaining good self-care to keep healthy. Additionally, in the event many people become critically ill at once, COVID-19 has the possibility of overwhelming hospitals to the point where they have to make decisions about how to determine who receives intensive care and life-support measures. Many hospitals as well as local or state governments have been working on policies to determine how to make these decisions. This study seeks to learn about how COVID-19 has affected the way patients and healthcare providers care for themselves and about their thoughts and concerns about policies that may "ration" life-support resources.

Condition or disease Intervention/treatment Phase
Covid-19 Critical Illness Attitude of Health Personnel Attitude to Health Health Behavior Health Care Utilization Behavioral: Brief educational video Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Pre-/post-intervention survey with random allocation of a brief educational intervention about scarce resource allocation policy
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: A Study to Evaluate Health Behavior and Access Impacts Due to COVID-19 and for Community Engagement of Stakeholders Surrounding Scarce Resource Allocation Policy.
Actual Study Start Date : May 8, 2020
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : March 2021

Arm Intervention/treatment
Experimental: Experimental
Subjects will be provided a brief educational intervention prior to completing follow up survey about SRA attitudes and knowledge
Behavioral: Brief educational video
A brief educational video will be displayed explaining the mechanics of how SRA policies operate, how they are decided, and what patients' and healthcare workers' rights are surrounding them.

No Intervention: Control
Subjects will not be provided any prior to completing follow up survey about SRA attitudes and knowledge



Primary Outcome Measures :
  1. Improvement in knowledge surrounding SRA policy [ Time Frame: 1 month, 6 months ]
    Improvement in knowledge item score of 2 points on follow up after intervention delivery and at final follow up

  2. Improvement in anxiety surrounding SRA policy [ Time Frame: 1 month, 6 months ]
    Improvement in anxiety scale of 2 points responses on follow up after intervention delivery and at final follow up

  3. Improvement in trust surrounding SRA policy [ Time Frame: 1 month, 6 months ]
    Improvement in trust scale of 2 points responses on follow up after intervention delivery and at final follow up



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participants shall be adults aged 18 years or older
  • Willingness and ability to participate in an internet-based survey

Exclusion Criteria:

  • Children under age 18

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04373135


Locations
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United States, California
University of California, Los Angeles
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
Investigators
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Principal Investigator: Russell G Buhr, MD, PhD Division of Pulmonary & Critical Care Medicine, UCLA
Principal Investigator: Lauren E Wisk, PhD Division of General Internal Medicine & Health Services Research, UCLA
Additional Information:
Publications:

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Responsible Party: Russell G. Buhr, MD, PhD, Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT04373135    
Other Study ID Numbers: UCLA-20-000683
First Posted: May 4, 2020    Key Record Dates
Last Update Posted: October 14, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data requests for analysis may be approved by the investigators upon reasonable request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Analytic Code
Time Frame: Within 4 months of study closure
Access Criteria: Reasonable request to investigators

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Russell G. Buhr, MD, PhD, University of California, Los Angeles:
health disparity
scarce resource allocation
triage
community engagement
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes