Quantitative
Participants
Twenty-eight schools (14 e-consent and 14 paper consent schools) comprising 3219 girls (1733 in paper consent and 1486 in e-consent schools) were included in the study. Of those schools, 26 were state and 2 were private schools. Twenty-one of the schools had no religious affiliation, 3 were Roman Catholic (all paper consent), 3 Church of England (2 e-consent, 1 paper consent) and 1 was another Christian faith school (paper consent).
The proportion of pupils eligible for free school meals, with English as an additional language and students’ ethnicity profile was similar between the e-consent and paper consent schools (Table 1).
Return of consent forms ahead of session
Overall 83% of consent forms (paper or e-consent) were returned prior to the vaccination session. However, compared with paper schools timely (prior to the planned session) return was lower in the e-consent schools (73.3% (n=11) vs 91.6% (n=11), p=0.008). We could only measure this difference in 22 matched schools.
Outcome of consent
There was no statistically significant difference in the proportion of pupils for whom a “yes” consent was received (prior to or on the day of the session) between the paper (n=14) and e-consent (n=14) schools (85% in e-consent schools, 83% in paper consent schools, p=0.89).
Vaccination uptake
There was no statistically significant difference in the proportion of pupils that were vaccinated at the scheduled vaccination session between the paper (n=14) and e-consent (n=14) schools (80.6% vs 81.3%, p=0.93). These figures did not include those who were absent on the day and vaccinated later. The final vaccine uptake across all the schools was over 86%.
Qualitative
Thematic mapping and participants
The results of the ToC thematic analytical mapping are presented under relevant headings (‘input’, ‘activities’, ‘pathways’, ‘outputs’, ‘outcomes’) followed by an overarching theme on managing change. In this analysis we drew on data collected from participants between June-Dec 2018 (seven observations of immunisation sessions in e-consent schools, 14 school (seven e-consent, seven paper) feedback forms, four immunisation team interviews, 12 interviews with parents/adolescents who used the intervention) and June-July 2019 (two group interviews with HRCH staff, one FGD with eight adolescent girls from an e-consent school).
Inputs
Resources and Training
There was a ‘buzz’ about the development of the e-consent intervention and its potential to streamline the consent process and facilitate safer data collection. Programme commissioners had provided financial support and the HRCT wanted to pilot it during the 2017/18 HPV vaccine programme. Immunisation team members were positive but expressed some reservations about the implications for practice (e.g. not able to review paper consent forms prior to immunisation) and the speed of change. Due to tight deadlines only one main orientation/training session took place before the e-consent intervention was introduced, which meant that the bulk of learning happened on the job.
“I think as well, it was probably four days before our first session, we didn’t know what we were doing. …so I do feel we are running before we can walk.” (Immunisation Team 2)
Intervention not fully operational
The data platform component of the online portal was not operational prior to implementation. Parents were able to access and complete the e-consent form, but the immunisation teams could not use the portal’s data platform to review student’s consent forms or upload data during immunisation sessions. Instead large (A3) paper sheets with information about who had provided consent were provided by the data management team for nurses to record immunisation details and subsequently upload to recording systems. The sheets were difficult to decipher during busy sessions and nurses were less able to prepare cohort figures and tally sheets in advance.
“It was an anti-climax not being able to use the laptops and still have a paper sheet in front of me.” (Immunisation Team 4)
Mobilizing and resourcing schools
There was limited time to engage with schools prior to the start of the vaccination programme, although all e-consent implementing schools were provided guidance on how to disseminate the weblink. A few schools declined to use the intervention due to concerns about barriers to electronic communication with parents (e.g. lack of email addresses). These concerns were more pronounced in city centre schools which served many families for whom English was not their first language.
School immunisation liaison staff (school-link) reported a ‘loss of control’ associated with the change in their access to consent forms. They could no longer see ‘who had said yes, and who had said no’, which restricted their ability to follow-up unreturned forms. Paper-consent schools could monitor this directly by counting forms, but with e-consent schools immunisation teams had to check parental responses and tell schools which families had not replied.
“Because it is all down to the link person, because if that link person is more pro e-things, they will just go ‘Oh great, you saved my life, no more paperwork’, but if that link person is kind of old fashioned, ‘I want my pen and paper, I want my hard copy’”. (Immunisation Team 3)
Activities
Dissemination of the online e-consent portal weblink to parents
E-consent schools used different electronic means (parent mail, email, school website, newsletters, letters) to send parents the weblink to the online portal. Blanket reminders were mainly sent electronically, unless immunisation teams provided schools with details of non-responders. In this case follow-up could be more targeted and involve text messages and phone calls as wells as emails. One school used a translator to engage parents who did not understand the consent process due to language barriers. Another school was not willing to send out emails and asked the immunisation team to provide them with printed letters referring to the weblink to send to parents.
Of the seven e-consent schools who completed the feedback form, four were positive about the intervention and how it had been implemented stating that it had reduced their workload. Another school was mainly positive but noted that some parents had found the e-consent form difficult to access, another reported that their parent cohort had found the system very difficult to access and use, and the last school was the one who had used letters to disseminate the weblink.
Pathways
Navigating the e-consent form and related information
The e-consent form included links to an HPV vaccination leaflet. However, none of the interviewees had downloaded or read this leaflet for the following reasons: accessed information elsewhere, already sufficiently informed, older daughter vaccinated, positive about vaccination.
Proactive information seeking was more common in families who were vaccine hesitant. Parents who were more confident about vaccines restricted their information seeking to NHS sources but suggested that a ‘road map’ to adolescent vaccination could be useful since they lacked information about this.
Adolescents reported a variety of information seeking behaviours. Some just accepted HPV vaccination as ‘something that needs to be done’ and felt reassured that it was recommended by the NHS: “I think because it’s like by the NHS - it kind of gives it validation.” (Adolescent 9 - Yes). Others wanted the HPV vaccine leaflet to include more information about HPV and related health risks and vaccine side-effects, so that they did not panic if they experienced any of these.
In the FGD students expressed a preference for paper leaflets and discussed how the e-consent could bypass them: “…because like if it's emailed, like your mum doesn't have to share it with you. And like if I have something done like an injection, I'd like to know what's going on and when. But like she filled out the form without like telling me, so like if they'd been given out in school then I could have read it and see what's happening.”
Parental and adolescent HPV vaccine decision-making processes
Interviews with parents and adolescents suggested that communication about vaccine decision-making varied between - very limited discussion - to a heads up as what to expect - to parents offering to answer questions - to more in-depth discussions. Some parents thought they did not need to talk to their daughters in detail since it was their responsibility to decide and others did not want to talk too much in case this induced anxiety, particularly if their daughters were needle phobic.
The ‘heads up’ approach was about making sure adolescent knew what to expect and this exchange usually occurred shortly prior to the scheduled immunisation session. Offering to answer questions was part of this and depended mainly on the adolescents’ desire to find out more. More in-depth discussions involved parents and adolescents discussing the vaccine programme, sometimes looking for more information and deciding whether to take part.
“I had done my own research and we’d looked at it together…so, we talked about what it was, why it was important.” (Parent 10 – declined vaccination)
Adolescent FGD participants reflected on the locus of responsibility for vaccine decision-making and concurred that they would like their parents to decide. Where they differed was whether they wanted to discuss the vaccination with their parent.
“I wouldn’t like to be given the option to like not to have the injection done…so I'm kind of glad that my mum just decided,but I would have liked her to talk it through with me…” (FGD participant)
Using the e-consent intervention
The parents who were interviewed found the system easy to use and usually completed the form as soon as they received it. A few parents would have liked an email confirmation after they had completed the e-consent form.
“I thought it was very easy. I think you’re probably going to get more responses that way from parents in this day and age. However, the downside is obviously you may not get that chance to discuss it. (Parent 5 – Yes)
According to feedback from nurses and schools not all parents found the intervention easy to access or use with language barriers accounting for some difficulties. The key issue however related to the receipt and use of the online portal weblink. In some cases, students told nurses that their parents had not signed up for the school parent mail system and therefore did not receive the weblink. Nurses also received a significant number of calls from parents asking for guidance; some reported that the weblink would not open or that webpages would freeze making it difficult to complete and submit the form. Other parents had limited access to the internet or were less confident about using technology. During an immunisation session one student stated: “my dad said I should have the vaccine, but he did not understand the whole google business about it”. In some instances, the weblink closed a few days prior to an immunisation session to give immunisation teams time to screen student information prior to sessions. Some parents who had missed the last sign-up date sent notes to school on the session date to confirm their consent/non-consent for vaccination.
Outputs
Nurses access to e-consent forms and student information
The immunisation sessions at e-consent schools were affected by the low return of consent forms and nurses not being able to access information about students and their consent status electronically during sessions. Instead they had to review student details and their consent status on A3 paper lists created by the HRCH data management team. The nurses found this more difficult than reviewing individual paper consent forms in the way they were used to. They understood that this was an interim measure and were looking forward to the opportunity to be able to access and input real-time data electronically in the future.
The low return of consent forms in e-consent schools resulted in administrative and logistical challenges (e.g. predicting cohort numbers and tallying consents received before and during sessions). To manage these challenges immunisation teams increased the number of nurses and administrative assistants who attended e-consent school immunisation sessions.
The lower return of consent forms in e-consent schools resulted in nurses reporting that they had to contact more parents than usual during immunisation sessions to obtain verbal consent. This had implications for the nurses’ workload distribution and the length of sessions.
“…we had 80 consent forms outstanding at a big school. But, normally, if you only have a couple it’s fine. It meant us was making calls all morning, it took a nurse out of immunising to be able to do that, so that did have a big impact.” (Immunisation Team 2)
Conducting phone calls during sessions was not straightforward. Firstly, nurses had to rely on students (if they had phones with them) or staff to help them access correct contact details. Secondly, immunisations sessions were busy and noisy which impeded communication and privacy. Thirdly, it was not always possible to reach parents who were at work or out of the house during day-time hours. If parents were uncontactable the nurses assessed if students who wanted to be vaccinated had sufficient maturity and intelligence to understand and appraise the nature and implications of the proposed vaccination(12, 13). This process was time-consuming and not all nurses felt comfortable about vaccinating without verbal or written parent permission.
Transition: adapting to change and iterative development
The initial ‘buzz’ about the e-consent intervention decreased over time amongst some staff within the four immunisation teams. Whilst some staff remained positive and receptive to the implementation coordinators enthusiasm and vision, others expressed a sense of half-heartedness about having to adapt quickly from a known way of obtaining consent, albeit with flaws (e.g. cost of paper, mileage clocked up in collection paper consent forms from schools), to a new technology enabled way with some functional limitations in Year 1 (see Figure 1).
“Change is always difficult isn’t it…it was the initial meetings that we went to, and nothing seemed to be concrete. Everything was like, “Well, we’ll look into that.” Time, as we all know, goes so quickly. It didn’t feel prepared, it felt really rushed…” (Immunisation Team 2)
In the HRCH staff group interviews conducted in July 2019 members of the immunisation teams reflected on lessons learnt from their experience of transitioning to a ‘brand new way of working’ over the past year. Key learning points from an internal organisational perspective were: (i) adopt right pace of progress when introducing new interventions with have several components, (ii) be clear about which part of a multi-component intervention is being piloted and implemented (e.g. in Year 1 it was primarily about the e-consent form), (iii) importance of timely communication, quick thinking, and flexibility when things do not quite go to plan.
In terms of school engagement HRCH staff emphasised the importance of close collaboration with schools to establish appropriate means of consent in different educational and social contexts. The right balance of responsibility between schools and immunisation teams needs to be negotiated to maintain positive working relationships and ensure that adolescents can access essential vaccines.
“I would also say the idea of just changing to e-consent… schools need different things… it is really important to work with the school and a make sure that they are happy with everything and it suits that school, because some schools it might just not suit right now. It might suit them in a couple of years, but right now it just doesn’t work.” (HRCH immunisers group interview, July 2019)
HRCH made several changes to the implementation of the e-consent intervention in Year 2 (2018/19) based on the Year 1 (2017/18) experience and evaluation findings that were shared at several stages during the study (Text Box 2). These changes mainly related to the inputs, activities and pathways parts of the ToC and distribution of the e-consent form and related information. The data platform component of the intervention was undergoing further iterative development as part of the Year 2 implementation in 22 schools across South London.
Text Box 2: E-consent intervention implementation changes between Yr1 and Yr2
- Taking more time to engage (emails, phone calls and meetings) with schools in preparations to find the right level of involvement
- Ensuring students receive a paper copy of the HPV adolescent programme leaflet produced by Public Health England in addition to information provided in the e-consent form
- Pushing more for assemblies and contact with adolescent girls prior to the immunisation sessions
- Providing ongoing training and mentoring of immunisation teams on use of the intervention