CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 23,768 enrolled
Drug / intervention
High touch multi-pronged behavioral interventionbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04732819
NCT04732819N/ACompleted

IMPACT-C: Improving Vaccine Uptake in Skilled Nursing Facilities

Brown University·interventional·Posted Feb 1, 2021·Updated Sep 5, 2021

In Brief

A clinical study evaluating High touch multi-pronged behavioral intervention for COVID-19 Vaccines. Completed, enrolled 23,768 participants across 4 sites.

Detailed Summary

SARS-CoV-2 vaccine, now being administered to skilled nursing facility (SNF) residents and staff, has highly variable acceptance between facilities. The investigators need to develop and disseminate effective strategies to increase vaccination immediately. For SNF residents and staff, the investigators will develop and implement a scalable multi-pronged intervention that educates, builds trust and supports the informed consent process aimed to increase SARS-CoV-2 vaccination. The investigators will conduct a cluster randomized trial to compare the effect of electronic messaging and education (i.e., usual care) versus a multi-pronged 'high touch' intervention to reduce vaccine hesitancy in skilled nursing facility staff and residents among a random sample of facilities across four SNF chains. As part of the 'high touch' intervention, the investigators will identify and train local opinion leaders. The investigators will offer these leaders assistance through real-time support for questions and provide consenting specialists. During the second wave of vaccination, the investigators will provide the intervention facilities with positive reinforcement for staff and will identify local champions to garner support and empowerment of staff. Finally, in the intervention facilities, the investigators will provide additional funds to support COVID-19 testing, in order that facilities have access to enough testing kits for patient or staff who develops symptoms following vaccination. This trial will be randomized within four SNF chains in order to evaluate the effect of a multi-pronged strategy to improve SARS-CoV-2 vaccine acceptance among direct care staff and long-stay nursing home residents. In four chains, eligible facilities will undergo randomization between usual care versus adding the 'high touch' intervention, implemented in two waves. Randomization and roll out of the intervention will occur at the facility level. The investigators hypothesize that: (1) the intervention will increase vaccination of SNF residents by at least 10 percentage points versus facilities usual care alone; (2) staff of SNFs with the intervention will have at least a 10 percentage point greater vaccine uptake of vaccine than staff in SNFs that do not participate in the high touch intervention; and (3) within intervention SNFs, improvements in vaccine uptake will be similar across staff and resident race/ethnicities.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedFeb 1, 2021
Enrollment StartDec 21, 2020
Primary CompletionMar 31, 2021
Study CompletionApr 16, 2021
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 5.4 years ago

Interventions

High touch multi-pronged behavioral interventionbehavioral

In this intervention, facilities will work with our research team to accomplish the following: 1. Identify and engage a Facility Opinion Leader. 2. Employ Consenting Specialists to facilitate the clinical consent for vaccination process. 3. Engage well respected persons in the community who are willing to provide messages that promote trust in the vaccine and that will be distributed widely within a facility by email, website, text and/or social media. 4. Distribute buttons, T-shirts, and masks that promote awareness about vaccination (e.g., Ask me about the COVID-19 vaccine!) through facility leadership. 5. Acquire additional COVID-19 testing kits using funds provided by our research team.