COVID-19 Vaccine Uptake Amongst Underserved Populations in East London
- Conditions
- Vaccination RefusalInfluenzaCOVID-19
- Interventions
- Device: Patient Engagement tool
- Registration Number
- NCT05866237
- Lead Sponsor
- Queen Mary University of London
- Brief Summary
This is a randomised controlled feasibility study to evaluate a patient engagement tool (PET) that has been designed for the target population. The PET will be evaluated from previous qualitative data collected from community this feasibility trial. Eligible patients from six GP practises from Tower Hamlets and Newham will be randomised to the intervention or control during the study.
- Detailed Description
It is imperative that local residents' views are heard, particularly in underserved communities, when trying to address poor vaccine uptake. We are interested to elicit a wide range of views, and channel these to co-design a feasible and acceptable intervention with community groups.
This intervention will be evaluated in this randomised pilot study to assess feasibility, practicality and acceptability. This will be in preparation of a fully powered randomised controlled trial to evaluate the efficacy afterwards.
Eligible patients at all n=6 practices will be enrolled into the study at two time points (see below). Patients will be individually randomised 1:1 to receive the PET or routine care. We will use the Appt-Health workflow tool for both groups, although patients in the control group will be monitored but will not receive additional interventions than routine care. The comparison between those randomised to the intervention or control group is envisaged to be the primary comparison in a subsequent trial to evaluate efficacy (vaccination uptake). Individual randomisation will be stratified by GP, using a random block allocation list implemented into the software used for the study.
Participating centres All practices will be selected based on list size (larger practices with \>10,000 patients), technological and practice infrastructure and procedures (to ensure smooth operability of the PET), demography of the practice population (to ensure good representation of underserved population groups) and capability and capacity (decided by the practice and network leads).
Randomisation The practices will be randomised by the study statistician. Individuals will be randomised, stratified by centre, using randomised block randomisation list allocations in the practice software. This will be done on the same day or shortly after the eligible list is determined. The randomised allocation will be visible to staff, but we will use the feasibility study to explore ways of blinding staff and patients for the definitive study.
Data collection and Analysis Eligible patients will be identified through the practice IT system (EMISWeb). We will provide some initial support and training to enable practices to complete missing ethnicity data. However, patients with unknown ethnicity resident in areas with index of multiple deprivation greater than the bottom quintile would not be included. The database associated with the software will record randomisation group, and record of the intervention to each participant, as well as engagement with different aspects of the tool (see secondary outcomes).
For analysis, we will extract pseudo-anonymised data and storage in the CASTOR database and analyse this on a secure research database and environment within the Barts Cancer Centre network at QMUL. Ethics and information governance approval will be sought for this.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- 2400
-
• Patient registered at study site (included GP surgery)
- Adult (aged 18y+) at time of randomisation
- Eligible for COVID-19 and/or Flu vaccination (ie. Not received either a first, second or booster vaccination)
AND
From an underserved population group, defined
- non-white ethnicity OR
- resident in a postcode in the bottom 20% of index of multiple deprivation OR
- Those receiving little or no income
We will determine age, ethnicity, post-code and immunisation status from the patients' EMIS records.
- They are unable or unwilling to consent (including those who do not consent to text messaging; those who opt out from taking part in research studies.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention group Patient Engagement tool Individuals allocated to this group will be receiving care from their GP as well as the patient engagement tool (intervention). This will include messages being sent to patients in regards to vaccine information and uptake at different time points (three times).
- Primary Outcome Measures
Name Time Method Vaccine uptake through engagement with tool (PET) Through study completion, an average of 1 year To determine the feasibility, acceptability, and implementation of a patient-engagement tool (PET) for increasing uptake of COVID-19 and Flu vaccination.
- Secondary Outcome Measures
Name Time Method Vaccine uptake and feasibility of using PET Through study completion, an average of 1 year 1. Vaccination uptake in patients after 3- and 9-months follow-up (\>90 and \>270 days). This will be measured as the number (percent) of relevant SNOMED codes in eligible patients identified during the period.
2. Mean vaccination rate after 3-, 6- and 9-months follow-up. This will be measured as the number of patients vaccinated divided by the follow-up time. Time is defined as time from randomisation until the earliest of vaccination, leaving the GP, withdrawal the consent of use of data, or death.
3. Feasibility of the intervention and randomisation
4. Acceptability of the intervention to patients and staff (healthcare workers)
5. Feasibility of the study design for a subsequent trial
Trial Locations
- Locations (1)
Church Road Health
🇬🇧London, United Kingdom