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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
| Baystate Health | OTHER |
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The goal of this study is to refine and test CONFIDENCE, a multi-component clinic-based intervention in pediatric or family practice clinical settings. Using a randomized control trial design, the investigators will assess preliminary effectiveness of the intervention to increase COVID-19 vaccine intention among parents of under-vaccinated children ages 5 to 17.
Participating clinics will receive a brief intervention consisting of: (1) webinar training focused on communication with vaccine-hesitant parents, (2) parent-facing educational materials about COVID-19 vaccination, (3) support to create a personalized, poster campaign featuring providers. Clinics in the control condition will receive the intervention approximately 12 months after the clinics in the intervention condition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Condition | Experimental |
| |
| Waitlist Condition | Active Comparator | Clinics in this condition will receive the intervention approximately 12 months after the intervention condition. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CONFIDENCE | Behavioral | This clinic-based, multicomponent intervention consists of 3 parts:
|
| Measure | Description | Time Frame |
|---|---|---|
| COVID-19 vaccine intention | Parent exit survey in clinics: Parents will report their intention to vaccinate their children for COVID-19. See survey question below: "Did you decide to vaccinate your child against COVID-19 today? Yes/No" | Data collection will occur in the four weeks following implementation |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility: Recruitment | Completion of the parent exit surveys will be documented and used to calculate the percentage of eligible parents (those who received a form) who completed the survey. | End of study; approximately 15 months |
| Feasibility: Data Completeness |
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Practice site inclusion criteria
Inclusion Criteria for Parents:
The following inclusion criteria will be applied to parents (on behalf of their children):
Exclusion Criteria for Parents:
°Parent under age of 18
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| Name | Affiliation | Role |
|---|---|---|
| Stephenie C Lemon, PhD | University of Massachusetts, Worcester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UMass Chan Medical School | Worcester | Massachusetts | 01605 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36470798 | Background | Ryan GW, Goulding M, Borg A, Minkah P, Beeler A, Rosal MC, Lemon SC. Development and Beta-Testing of the CONFIDENCE Intervention to Increase Pediatric COVID-19 Vaccination. J Pediatr Health Care. 2023 May-Jun;37(3):244-252. doi: 10.1016/j.pedhc.2022.11.002. Epub 2022 Nov 17. |
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A de-identified individual-level dataset will be made available to researchers who make a reasonable request to the principal investigator. Data will be made available upon publication of the primary outcomes manuscript.
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Data will be available will be available upon publication of the primary outcomes manuscript from this project.
Data will be made available upon reasonable request from researchers.
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| ID | Term |
|---|---|
| D000088823 | Vaccination Hesitancy |
| ID | Term |
|---|---|
| D000072758 | Vaccination Refusal |
| D016312 | Treatment Refusal |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
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| ID | Term |
|---|---|
| D016001 | Confidence Intervals |
| ID | Term |
|---|---|
| D013223 | Statistics as Topic |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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The investigators will be using a cluster, randomized control trial design, in which clinics are assigned to either the intervention or control group. Clinics in the control group or "waitlist" condition, will receive the intervention approximately 12 months later.
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Clinics will know if they are assigned to the intervention or control condition. However, individual participants (parents of children ages 5 to 17) will not know if their clinic is in the intervention or control condition.
|
Data completeness/missing data for all participant-level measures from the parent exit survey at the item-level will be examined. An exploratory analysis will be conducted to further decipher the quality of COVID-19 vaccination data in electronic medical records to determine its potential utility in a future trial. |
| End of study; approximately 15 months |
| Feasibility: Randomization | Recruitment, data completion and participant characteristics will be compared across the two study conditions to determine if differences emerge. | End of study; approximately 15 months |
| Acceptability: Parents | Perceived acceptability will be assessed via the survey question "How satisfied were you with the conversations about COVID-19 vaccination for your child at your visit today", which will have a 3-point Likert response scale, ranging from not at all to very satisfied. | Four to eight weeks post implementation |
| Perceived appropriateness: Parents | Perceived appropriateness will be assessed via the survey question "How appropriate were the conversations about COVID-19 vaccination for your child at your visit today?" | Four to eight weeks post implementation |
| Implementation Fidelity | Implementation fidelity will be assessed by three questions that ask about provider's behavior regarding the intervention: "Did you and the provider discuss COVID-19 vaccination for your child today?"; "Did the provider share their own COVID-19 experience with you?"; and "Did the doctor give you any materials about the COVID-19 vaccination today?". | Four to eight weeks post implementation |
| Acceptability: Providers and clinic staff | Will be assessed qualitatively through semi-structured interviews using questions like "How satisfied were you with intervention activities?" | Four to eight weeks post implementation |
| Perceived Appropriateness: Providers and clinic staff | Will be assessed qualitatively through semi-structured interviews using questions like "How relevant were intervention components and how compatible was the intervention with values and the workflow of the practice?" | Four to eight weeks post implementation |
| Perceived feasibility: Providers and clinic staff | Will be assessed qualitative through semi-structured interviews using questions like "What is the likelihood of sustaining the implementation of the intervention component in practice after the research study concludes." | Four to eight weeks post implementation |
| D001519 | Behavior |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |