COVER-ME: Covid-19 Vaccination Coverage Among Underserved Populations: Developing and Evaluating Community-based Interventions in East London Minority Ethnicity (ME) Populations; Underserved Migrants and Persons With Low Income.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 5,903
- Locations
- 6
- Primary Endpoint
- The primary outcome is vaccination uptake in patients individually randomised.
Study Overview
Brief Summary
This is a randomised controlled pilot study evaluating and assessing the feasibility of a co-designed PET. The PET was co-designed in the qualitative work packages with members of the community as well as healthcare professionals (Ethical approval: REF QMERC22.266) that precedes this pilot 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Masking Description
Eligible patients to be randomised 1:1. None of these patients would have received the vaccine prior to entry to the study. These patients who are eligible for the intervention, randomised are to receive one of two workflows on an individual basis (standard of care or the PET).
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •• 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)
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
Intervention group
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).
Intervention: Patient Engagement tool (Device)
Control Group
The individuals in this group will receive standard care from their GP and nothing additional to this.
Outcomes
Primary Outcomes
The primary outcome is vaccination uptake in patients individually randomised.
Time Frame: Through study completion, until 6 months follow-up (>180 days since randomisation).
This will be measured as the number (percent) of relevant SNOMED codes in eligible patients. Uptake will be measured from the time that the eligible group in each practice is identified (and randomised) until 6 months follow-up (\>180 days since randomisation).
Secondary Outcomes
- Acceptability of the intervention(at 6 months)
- Feasibility of the intervention and randomisation(6 months)
- Feasibility of the study design for a subsequent trial(6 months)