Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01AI166967-01 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
met interim analysis criteria for early termination
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Duke University | OTHER |
| Thomas Jefferson University | OTHER |
| University of Washington | OTHER |
| National Institute of Allergy and Infectious Diseases (NIAID) |
Not provided
Not provided
Not provided
Not provided
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.
The investigator's preliminary work research at 15 ED sites across the US indicates that ED Usual Source of Care patients have particular health care access barriers, needs, and perceptions about vaccines (vaccine hesitancy) that require specific review beyond traditional (non-ED user) community engagement techniques. To gain insight about messaging that effectively addresses these barriers, needs, and perceptions, the investigators will conduct one on one interviews and focus group meetings with ED Usual Source of Care Patients and community partners.
At five safety net EDs (Zuckerberg San Francisco General, Thomas Jefferson University Hospital [Philadelphia], Methodist Hospital [Philadelphia], Harborview Medical Center [Seattle], and Duke University Medical Center [Durham, NC], the investigators will conduct a cluster-randomized, controlled trial of implementation of PROCOVAXED platforms, with COVID-19 and influenza vaccine acceptance rates on post-intervention ED surveys as the primary outcomes. Hypothesis: Implementation of PROCOVAXED platforms in EDs will be associated with increased acceptance of COVID-19 vaccines in ED patients.
One month after subjects' index ED visit enrollment in our PROCOVAXED implementation trial, the investigators will conduct electronic health record review and phone follow-up surveys to determine ED patient uptake (receipt) of COVID-19 vaccines. Hypothesis: Implementation of PROCOVAXED platforms in EDs will be associated with greater COVID-19 vaccine uptake in ED patients.
The investigators will conduct a cluster-randomized, controlled trial (RCT) of implementation of our PROCOVAXED platforms in 5 high-volume, safety net hospital EDs, testing two hypotheses that implementation of PROCOVAXED platforms will be associated with increased acceptance and uptake of COVID-19 vaccines in ED Usual Source of Care Patients.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Arm: PROCOVAXED | Experimental | Covid vaccine educational intervention consisting of vaccine messaging platforms (flyers, videos, scripted face-to-face messaging) |
|
| Non-interventional Arm: PROCOVAXED | No Intervention | Usual care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Covid-19 vaccine education materials | Other | videos and flyers containing Covid-19 vaccine educational information |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| Within 30 days of intervention |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Robert Rodriguez, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Francisco General Hospital Emergency Department | San Francisco | California | 94110 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36574256 | Derived | 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. | |
| 36310395 | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Zuckerberg San Francisco Hospital | First Condition: Control |
| FG001 | University of California San Francisco Hospital -Parnassus | First Condition: Control |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 3, 2022 |
Not provided
| NIH |
Parent Cluster Randomized Trial: Intervention arm is delivery of Covid vaccine messaging Non-intervention arm is usual care. (2 arms)
Not provided
Not provided
Not provided
| University of California, San Francisco - Parnassus |
| San Francisco |
| California |
| 94143 |
| United States |
| Duke University Hospital | Durham | North Carolina | 27708 | United States |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| Jefferson Torresdale Hospital | Philadelphia | Pennsylvania | 19114 | United States |
| Jefferson Methodist Hospital | Philadelphia | Pennsylvania | 19148 | United States |
| University of Washington-Harborview Emergency Department | Seattle | Washington | 98104 | United States |
| 35449064 | 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. |
| FG002 | Duke University Hospital | First condition: Intervention |
| FG003 | Thomas Jefferson University Hospital | First Condition: Control |
| FG004 | Jefferson Torresdale Hospital | First Condition: Intervention |
| FG005 | Jefferson Methodist Hospital | First Condition: Intervention |
| FG006 | University of Washington-Harborview Emergency Department | First condition: Control |
|
| Received PROCOVAXED Intervention |
|
| C C Control |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Arm: PROCOVAXED | Covid vaccine educational intervention consisting of vaccine messaging platforms (flyers, videos, scripted face-to-face messaging) Covid-19 vaccine education materials: videos and flyers containing Covid-19 vaccine educational information |
| BG001 | Non-interventional Arm: PROCOVAXED | Usual care |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
| |||||||||||||||
| Sex/Gender, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Participants could answer more than one race or ethnicity | Count of Participants | Participants |
| |||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Has a primary care clinic or physician | Count of Participants | Participants |
| ||||||||||||||||
| Primary language | Count of Participants | Participants |
| ||||||||||||||||
| Housing status | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Intent to treat | Posted | Count of Participants | Participants | Within 6 hours of intervention |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | 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:
| Intent to treat | Posted | Count of Participants | Participants | Within 30 days of intervention |
|
|
30 days
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Arm: PROCOVAXED | Covid vaccine educational intervention consisting of vaccine messaging platforms (flyers, videos, scripted face-to-face messaging) Covid-19 vaccine education materials: videos and flyers containing Covid-19 vaccine educational information | 0 | 221 | 0 | 221 | 0 | 221 |
| EG001 | Non-interventional Arm: PROCOVAXED | Usual care | 0 | 275 | 0 | 275 | 0 | 275 |
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Rodriguez | University of California San Francsico | (628) 206-5875 | Robert.Rodriguez@ucsf.edu |
| Apr 18, 2023 |
| Prot_SAP_001.pdf |
| ID | Term |
|---|---|
| D000088823 | Vaccination Hesitancy |
| ID | Term |
|---|---|
| D000072758 | Vaccination Refusal |
| D016312 | Treatment Refusal |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
Not provided
Not provided
| Male |
|
| Other |
|
| American Indian or Alaskan Native |
|
| Asian |
|
| Latinx |
|
| Native Hawaiian or Pacific Islander |
|
| White, non-Latinx |
|
| Other |
|
| No |
|
| Unsure |
|
| Spanish |
|
| Other |
|
| Marginal |
|
| Unhoused |
|
| No answer given |
|
|
|