PROmotion of COvid-19 VA(X)Ccination in the Emergency Department - PROCOVAXED

NCT05142332 | Terminated Results DMC

• 2 other identifiers: 21-34004R01AI166967-01
• Study Type: interventional
• Target: 541
• Locations: 1 country
• Sites: 7

Brief Summary

The goal of this research is to increase COVID-19 vaccine acceptance and uptake in vulnerable populations whose primary (and often only) health care access occurs in emergency departments (ED Usual Source of Care Patients). Toward this goal, the investigators will conduct one on one interviews and focus groups with ED Usual Source of Care Patients and community partners and produce trusted messaging informational platforms (PROmotion of COvid-19 VA(X)ccination in the Emergency Department - PROCOVAXED) that will address barriers to COVID-19 vaccination, especially vaccine hesitancy. The investigators will then conduct a cluster-randomized, controlled trial of PROCOVAXED platforms in six EDs to determine whether their implementation is associated with greater COVID-19 vaccine acceptance and uptake in ED Usual Source of Care Patients.

Conditions

Covid-19 Vaccine; Vaccine Hesitancy

Outcome Measures

Primary Outcomes (2)

• Covid-19 Vaccine Acceptance in the Emergency Department: PROCOVAXED

  Participant acceptance of the COVID-19 vaccine assessed by the question "Would you accept the COVID-19 vaccine in the emergency department today if your doctor or provider asked you to get it?" The response choices for this question are "Yes", "No", and "No, but I might consider getting it at some other time". This question will be asked once at the end of the Emergency Department visit.

  Within 6 hours of intervention

• Covid-19 Vaccine Uptake: PROCOVAXED

  Participation uptake of the COVID-19 vaccine 30 days after enrollment assessed by confirmation of receipt of vaccine in one of 3 ways: 1. Receipt in emergency department during index (enrollment) visit 2. Electronic health record review 30 days after index visit 3. Follow up phone call to participant at 28 to 30 days - We are asking patients if they received a COVID-19 vaccine since their index emergency department visit.

  Within 30 days of intervention

Study Arms (2)

Intervention Arm: PROCOVAXED

EXPERIMENTAL

Covid vaccine educational intervention consisting of vaccine messaging platforms (flyers, videos, scripted face-to-face messaging)

Other: Covid-19 vaccine education materials

Non-interventional Arm: PROCOVAXED

NO INTERVENTION

Usual care

Interventions

Covid-19 vaccine education materials OTHER

videos and flyers containing Covid-19 vaccine educational information

Intervention Arm: PROCOVAXED

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (\>18 years of age) patients who are receiving care at participating Emergency Departments and have not yet received a COVID-19 vaccine (PROCOVAXED)

You may not qualify if:

• major trauma patients
• patients transferred from another hospital, chronic care facility, nursing home or hospice,
• patients unable to participate in an interview because of intoxication, altered mental status or critical illness
• incarcerated patients
• patients on psychiatric holds
• patients who have received a COVID-19 vaccine
• under suspicion for acute COVID-19 illness

Sponsors & Collaborators

• University of California, San Francisco: lead
• Duke University: collaborator
• Thomas Jefferson University: collaborator
• University of Washington: collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (7)

San Francisco General Hospital Emergency Department

San Francisco, California, 94110, United States

Location

University of California, San Francisco - Parnassus

San Francisco, California, 94143, United States

Location

Duke University Hospital

Durham, North Carolina, 27708, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Jefferson Torresdale Hospital

Philadelphia, Pennsylvania, 19114, United States

Location

Jefferson Methodist Hospital

Philadelphia, Pennsylvania, 19148, United States

Location

University of Washington-Harborview Emergency Department

Seattle, Washington, 98104, United States

Location

Related Publications (3)

• Rodriguez RM, Nichol G, Eucker SA, Chang AM, O'Laughlin KN, Pauley A, Rising KL, Eswaran V, Morse D, Li C, Patel A, Duber HC, Arreguin M, Shughart L, Glidden D; PROCOVAXED Study Network. Effect of COVID-19 Vaccine Messaging Platforms in Emergency Departments on Vaccine Acceptance and Uptake: A Cluster Randomized Clinical Trial. JAMA Intern Med. 2023 Feb 1;183(2):115-123. doi: 10.1001/jamainternmed.2022.5909.

  PMID: 36574256 DERIVED

• Gentsch AT, Butler J, O'Laughlin K, Eucker SA, Chang A, Duber H, Geyer RE, Guth A, Kanzaria HK, Pauley A, Rising KL, Chavez CL, Tupetz A, Rodriguez RM. Perspectives of COVID-19 vaccine-hesitant emergency department patients to inform messaging platforms to promote vaccine uptake. Acad Emerg Med. 2023 Jan;30(1):32-39. doi: 10.1111/acem.14620. Epub 2022 Nov 22.

  PMID: 36310395 DERIVED

• Rodriguez RM, O'Laughlin K, Eucker SA, Chang AM, Rising KL, Nichol G, Pauley A, Kanzaria H, Gentsch AT, Li C, Duber H, Butler J, Eswaran V, Glidden D. PROmotion of COvid-19 VA(X)ccination in the Emergency Department-PROCOVAXED: study protocol for a cluster randomized controlled trial. Trials. 2022 Apr 21;23(1):332. doi: 10.1186/s13063-022-06285-x.

  PMID: 35449064 DERIVED

MeSH Terms

Conditions

Vaccination Hesitancy

Condition Hierarchy (Ancestors)

Vaccination Refusal; Treatment Refusal; Treatment Adherence and Compliance; Health Behavior; Behavior

Results Point of Contact

• Title: Robert Rodriguez
• Organization: University of California San Francsico

Robert.Rodriguez@ucsf.edu

(628) 206-5875

Study Officials

• Robert Rodriguez, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parent Cluster Randomized Trial: Intervention arm is delivery of Covid vaccine messaging Non-intervention arm is usual care. (2 arms)

Study Record Dates

• First Submitted: November 30, 2021
• First Posted: December 2, 2021
• Study Start: December 6, 2021
• Primary Completion: July 28, 2022
• Study Completion: August 30, 2022
• Last Updated: December 13, 2023
• Results First Posted: December 13, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)