Scientific summary
Chapter 2 Methodology and methods of case studies and the characteristics of the cases
T
his chapter reports the methodology and methods for the case studies, and describes these case studies. Methods for the systematic scoping reviews, review of PROMs and consensus conference are reported in the relevant chapters.The main empirical work for this study utilises a case study approach. Robert Yin describes a case study as‘an empirical inquiry that investigates a contemporary phenomenon in depth and within its real-life context, especially when the boundaries between phenomenon and context are not clearly evident’ (p. 18).62In this research, the contemporary phenomenon we study is the use of DCC and the context is specialist NHS care provision for young people with LTCs. In-depth study allows us to simultaneously focus on several different elements of care provision, such as patient safety and ethical concerns.
When conducting a case study, one of the first steps is to develop propositions to identify what to study.62 Our propositions are that DCC fits with young people’s day-to-day mode of communication and, therefore, they would prefer it to other means of communication with their clinical team; and clinicians use DCC to encourage young people with LTCs to engage with their health care and improve their health outcomes (even if this puts other aspects of clinical service provision, such as record-keeping, at risk). Based on these propositions, we need to look for evidence to answer our research questions from the young people and clinical teams. The young person with a LTC in communication with their clinical teams (i.e. young person–communication–clinical team) is our unit of analysis. This unit of analysis is embedded within the wider clinic, the NHS and contemporary society.62
Ethics and research governance permissions
The study was approved by the National Research Ethics Service Committee West Midlands, The Black Country on 5 March 2014 (reference number 14/WM/0066). A substantial amendment was granted on 26 February 2015 to allow the following changes to the invitation letters and participant information sheets: offer a £20 voucher as a thank you for participating in the study; include information regarding the study’s insurance and indemnity; and include information about whom participants should contact to make a complaint. In addition, the amendment approved a further two‘invitation to interview’ letters specifically aimed at young people who did not attend (DNA) their appointments. A second amendment approved on 18 June 2015 covered the following amendments: (1) change to the protocol to make recruitment of parents/carers easier, enabling the researcher to contact a participant’s parent/carer directly once the consent of the participant was given; (2) taking the burden of recruitment away from research nurses by enabling the research team to contact the parent/carer; (3) extending the £20 voucher as a thank you for participation to parents/carers; (4) changes to the patient information leaflet to reflect the above changes; (5) changes to the recruitment poster to include information about the £20 voucher (which we had in error omitted from this participant information); (6) changing the term‘long term’ to
‘health’ in patient information leaflets in cancer care clinics as the clinicians felt that the term ‘health condition’ would better reflect the patients’ view of their condition; and (7) request permission for a number of students undertaking health-related graduate and undergraduate studies to undertake data analysis. Research governance approvals were awarded by 16 participating NHS trusts hosting our 20 research sites. Details of these NHS trusts are withheld from this report to protect the identities of participating health professionals, many of whom were using digital communication methods at the time of interview under the radar of their NHS trust IG policies and procedures.
Clinical case site recruitment
Case site inclusion criteria
Inclusion criteria for clinical sites were as follows.
l The clinic provided specialist care for young people with LTCs.
l The LTC was currently expensive to the NHS.
l The clinical team expressed interest in the use of two-way digital communications to a minimum, moderate or large extent.
We sampled clinical teams for diversity of long-term health conditions experienced by young people.
Case site recruitment
As a relatively large number of case sites were required, multiple recruitment strategies were used.
An extensive internet search of grey literature was conducted to identify technology being used for clinical communications in the UK. An internet search using the search engine Google (Google Inc., Mountain View, CA, USA) was undertaken between December 2013 and February 2014. The keywords used were e-health, telehealth, telemedicine, digital communication, young people and young persons. Combined, the searches returned 24,626,063 hits. The first 35 pages of each search were scrutinised for relevance.
In the case of potentially relevant projects, detailed information was sourced from individual trust websites, documents and reports. Further details were obtained by contacting key individuals and project leads.
This search identified 71 projects involving DCC, running at 38 different NHS trusts, health-care organisations and universities. We tried to contact 14 sites that seemed eligible for participation (the search was not limited to young people with LTCs). Additionally, one clinical team was identified via the internet and approached.
Snowball recruitment was also used: the research co-applicants sent out recruitment e-mails to their colleagues and asked that they pass the information on to anyone else who may be interested; in addition, specific clinical teams were suggested by the research co-applicants, based on the known use of communication technology in their usual practice. The research team contacted 51 different clinical teams using this approach. Research team members attending academic and applied health conferences advertised the study with poster presentations and recruited potential case sites through networking sessions. Seven contacts were made this way. Finally, the research team was approached by seven NHS trusts that had seen the study listed in the National Institute for Health Research’s (NIHR’s) portfolio. A further 24 contacts were made after people already in discussion with the research team snowballed the study information to others they thought would be interested. Overall, we made initial contact with a total of 104 different clinical teams.
Interview participant recruitment
We aimed to conduct brief interviews with members of the clinical team, up to 15 patients aged 16–24 years and an IG officer at each site. Where the clinical team was< 15 patients, we aimed to interview all members of staff. Parents/carers/household members of young people with a LTC were also invited to participate in an interview.
Two weeks prior to fieldwork commencing, a research nurse from the local clinical research network or NHS trust identified eligible patients attending the clinic on days when a Long-term conditions Young people Networked Communication (LYNC) study researcher was present. These patients were sent (via post, or e-mail if appropriate) a study information sheet and given an option of contacting the researcher in advance to express interest in participating. Patients were also recruited by the researcher during their time in clinic, usually while waiting for their appointment. Patients were asked to bring examples of recent DCCs to inform interview discussion. The research nurse also identified patients who frequently DNA clinic appointments from clinic records and sent a separate recruitment letter to these patients. Young people were given a choice of medium for their interviews: in the clinic, over the telephone or via other technology chosen by the participant (including e-mail and Facebook). The researcher asked for consent either during recruitment or prior to commencement of the interview. For telephone interviews, consent was given
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verbally and a dated note was made by the researcher. All participants were offered a £20 high-street voucher as a thank-you token. At the end of the interview, researchers asked the patient if they were willing for their parent/carer/household member to be interviewed for the study. If they agreed, they provided contact details for the research nurse to send out an invitation letter. These interviews were conducted over the telephone, at a time convenient for the participant.
Clinic staff were recruited on an ad hoc basis during fieldwork. Prior to the start of fieldwork the
researchers attended a team meeting to introduce themselves and the research, and to make staff aware of their presence on site. We aimed to interview any clinic staff who used (or would potentially use) DCC, such as nurses, doctors, professions allied to medicine and administrative staff. We specifically sampled for diversity of job role and experience of, and opinion about, DCC within each case study. Within each clinic we aimed to interview as many team members as were willing to participate, up to 15 members of staff.
In small clinics we interviewed all relevant team members. In large clinics we aimed to get representation across all specialties and grades of staff. Interviews took place over the telephone, or in a location chosen by the participant (clinic space, offices, cafes, etc.). Participants were reassured that the information they provided would be confidential and that it would not be possible to identify specific clinics or staff members from our research report. It was also explained that if a concern arose about unethical or unsafe clinical practice, the researcher would need to report this to a principal investigator (PI) who would decide if it was necessary to initiate action through normal professional channels. However, no such practice was reported. During data collection we were asking clinic staff to reveal activities that may breach IG policies.
This was a difficult issue, as these clinicians were likely to be rich sources of data. We therefore drew up a protocol of action for serious breaches of confidentiality (see Appendix 2). However, we did not expect to take action for activity that we found was common practice.
At each case site we aimed to interview a trust-wide IG officer. We aimed to conduct this interview prior to fieldwork commencing, so that the researcher would not inadvertently disclose clinic practices that may be out of step with trust IG policies. Additionally, this enabled an understanding of the local context in which the clinical staff operated. Interviews with IG officers took place on site in trust offices or over the telephone.
Data collection
Non-participant observation
Non-participant observation of the clinic and shadowing of clinic staff took place at each clinical site.
Using an observation pro forma, the researchers noted how the clinic functioned, how DCC was used and monitored within the team and what evidence there was for more widespread use of digital communication within the clinic space (e.g. clinic staff using computers, patients using smartphones in waiting rooms). When shadowing members of the clinical team, the researchers reported if, and how, digital communication was used for clinical purposes, describing the context and content of the dialogue.
Shadowing lasted for up to 2 hours, whereas clinic observation lasted for the duration of the clinic (up to 8 hours) and were designed to note the use of digital communications between appointments.
When possible, observations preceded interviews. The researchers made patients and staff aware of their presence in the clinic by wearing a T-shirt identifying them as LYNC study researchers and putting up posters advertising the study. Observation schedules are available in Report Supplementary Material 1.
Semistructured interviews
All interview schedules focused on how digital communication was used for clinical purposes and the advantages and concerns participants had about this use, specifically identifying risk and ethical concerns. The interview schedules were a guide and we covered the part of the schedule relevant to each interviewee. Based on initial analysis of interviews we adjusted interview schedules to ensure that we obtained the richest possible data (e.g. altering question wording). During individual interviews we adjusted the words we used to refer to digital communication according to the words used by the interviewee in response to early questions.
Additional data on ethics, safety and the generic PROMs were collected from specific sites. Data from a cancer and liver conditions site were initially analysed with a focus on ethical concerns. Based on this analysis, the interview schedule was amended to focus on emerging ethical issues, such as equity in access, consent, privacy and confidentiality, risks/benefits to staff, patient–clinician relationship, patient autonomy and duty of care. This interview schedule was used to collect data from a further three sites (renal, cystic fibrosis and mental health). These sites were chosen based on their use of DCC and diversity in health condition. Additional data on safety were collected from two clinics (diabetes mellitus and cancer) which used DCC. The diabetes mellitus clinic was chosen as the self-management of diabetes mellitus involves the young person making decisions several times a day about their dose of insulin and errors in these decisions can quickly lead to adverse events. The cancer clinic was chosen as these young people are likely to be on medication with potentially serious side effects and are coping with psychological distress as a result of their life-threatening diagnosis. At these two sites, the interview schedule was amended to focus on important safety issues, such as risks, the importance of risks to patients, how risks are accepted or reduced, engagement with treatment regime, adverse events, unintended outcomes and benefits. In the later sites, the interview schedule was revised to focus on undertaking cognitive interviews to assess the two generic PROMs identified in the literature review and from PPI activity. This interview schedule was used with seven patients and seven clinicians.
A specific interview schedule was developed for use with IG officers, with input from our IG
co-applicants. This focused on if, and how, technology was used within the trust for communication about clinical issues, what policies instruct the use of technology, recorded DCC-related incidents and their professional opinions on the use of digital technologies in their respective NHS trusts. When DCC was not used, the key professionals were asked whether or not there were any future ambitions to introduce these types of communication, and if there were any barriers to, and enablers of, this introduction. Interview schedules are available in Report Supplementary Material 1.
Collection of impact data
Data are broadly categorised in two groups: (1) the cross-clinic and condition outcome data and (2) clinic-specific outcomes. Cross-clinic outcomes are appointment status (attended, cancelled or not attended), A&E attendance and hospital admission. Such outcomes, from most sites, were obtained from the information technology (IT) departments of trusts, with contact initiated by the site contact (PI, consultant, etc.) or the service manager. For tertiary care case study sites, A&E attendance and hospital admission data for their clinic patients were not available, as the patients would attend their local A&E department or hospital for emergencies.
Clinic-specific outcomes are outcomes specific to the various health conditions and sites studied. These were identified in discussion with the clinical team as being key indicators of patients’ health. These outcomes were HbA1cand glucose levels for diabetes mellitus sites; body mass index (BMI); forced expiratory volume in 1 second (FEV1) as a percentage of predicted (FEV1% predicted); bed-days to receive intravenous (i.v.) therapy for cystic fibrosis sites; time to discharge for a dermatology site, where patients are discharged from the service when the skin condition is successfully treated; tacrolimus level for a liver cancer site; viral load for a human immunodeficiency virus (HIV) site; urine protein and serum creatinine levels for a renal site; and self-harm incidents and self-harm ward attendances for mental health sites.
Tacrolimus level data from the liver cancer site, and BMI and FEV1% predicted data from one of the cystic fibrosis sites, were extracted by the clinic staff, whereas all the other clinic-specific outcomes were provided by IT specialists from trusts. These aggregated data were collected for all patients in the age range of our study on these cross-clinic and clinic-specific outcomes. Data collection periods were for the year prior to the escalation of DCC in each service and every year following to the point of fieldwork commencement.
Collection of economic data about the digital communication system
A structured questionnaire was developed to collect data on resource use associated with DCC (see Report Supplementary Material 1), during staff interviews. The questionnaire was based on initial case study observation and semistructured interviews with staff. All staff, at each case study site, who
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participated in an interview, and whose role involved any degree of contact with patients, were asked to complete the questionnaire. Where possible, the questionnaire was given during the interview, otherwise it was sent by e-mail after the interview had taken place. The questionnaire asked staff members to report the time they spent each day on DCC-related activities, broken down by the channel of communication used (e-mail, mobile phone calls, text messaging or other, such as VoIP). Staff were not asked to report a precise figure; instead they were asked to report usage for each channel by selecting from boxes corresponding to time intervals (e.g. 0–15 minutes, 15–30 minutes). The questionnaire also asked staff to report what technology they used for DCC (laptop, desktop personal computer, mobile phone or tablet) and who provided this equipment (i.e. whether it was provided by the clinic or themselves). Data were obtained from a site administrator, or suitable equivalent, at each site on the grade of each staff member and the number of days worked per week.
A further aim of the LYNC study was to explore, qualitatively and quantitatively, the value DCC provided service users, and how this value might be elicited. A number of‘value’ questions were explored in the interview schedule, whereby patients at each site were asked how much they would hypothetically be willing to pay for a service which used DCC compared with one which did not. After interviews at the first two case sites, the question focusing on value to patients was changed from a willingness-to-accept format (as cited in the protocol) to a willingness-to-pay format, as patients struggled to understand the original question. An open-ended question was used, but where patients struggled to respond, we tried using prompts suggesting values ranging from £5 to £50 in order to understand what values respondents might consider plausible. In sites where technology was not used for clinical communication, clinic staff and patients were asked about how they currently communicated, how happy they were with the current situation and what DCC they would find useful in the future.
Documents collated
Current trust policies and procedures were collated with help from lead clinicians and IG managers.
These documents were used to inform the IG interviews. IG managers were asked to tell us about any adverse events relating to the use of DCC.
Data management
All interviews were audio-recorded. At each case site, individual participants were given a unique code to identify all data collected from them. After each case site visit, field notes were typed up and interviews transcribed and anonymised. Qualitative data were managed by NVivo 11 (QSR International, Warrington, UK) and all files were stored on a secure server.
Impact data were supplied in Microsoft Excel®spreadsheets (Microsoft Corporation, Redmond, WA, USA).
For each Excel file provided, a copy to be analysed was made. Both the original Excel files and analysed
For each Excel file provided, a copy to be analysed was made. Both the original Excel files and analysed