5.1 Intervention Arm
Participants who are randomised to receive the Spotlight Consultations intervention will be sent a unique secure link to the Spotlight-AQ platform.
Telemedicine or In Clinic Visits: Participants will have a telemedicine or in-person clinic visit as per their usual routine care during the trial. Study participants will complete a personal assessment on study tablet devices if face-to-face visit. The support of a research assistant will be available if required. HCPs will also access the results and care pathway options, via their own secure portal logins. HCPs and participants will discuss the priorities and possible options collaboratively in a co-decision making, person-centred approach. Participants will be invited for repeat assessment as per routine care.
5.2 Control Arm
Participants in the control group will continue to receive usual care. Control group participants will be offered access to the Spotlight platform and pre-clinic assessment at the end of the RCT, for use in their next schedule routine outpatient appointment.
5.3 Follow Up
After the participants are randomised to either the intervention or control arm, data will be collected from them at the following timepoints:
- Pre scheduled routine outpatient appointment (baseline)
- Three, six, nine and twelve months post visit
Types of data that will be collected, in addition to the baseline questionnaires that will be repeated, will be:
- Adverse events
- Health economic questions
Healthcare professional questionnaire data will be collected at baseline, six and twelve months. Key healthcare professionals involved in the delivery of the intervention will be interviewed once around 12 months after the start of the trial in their centre.
5.4 Qualitative Evaluation
The aims of the qualitative evaluation are to understand and explore:
- Participants’ experiences, including gender specific experiences, of receiving Spotlight Consultations tool and health professionals’ views about delivering it.
- The perceived benefits of Spotlight Consultations from participants’ and health professionals’ perspectives; and, their recommendations for future refinements.
- Any changes participants make to their diabetes self-management practices and treatment goals after receiving Spotlight Consultations intervention and why.
- Whether, in what ways and, why, Spotlight Consultations is delivered and received differently in different settings
- Whether there are any site-specific differences in how participants self-manage their diabetes after receiving Spotlight Consultations, and why.
5.4.1 Participant interviews
20 participants randomized to receive the intervention will be interviewed prior to receiving the intervention to explore expectations, reasons for participation and perceived facilitators and barriers to achieving treatment goals. The same participants will be re-interviewed 6 months later to look at whether, how and, why, their diabetes self-management practices and treatment goals have changed in the intervening 6 months; and, any perceived barriers to achieving future changes and goals. These interviews will explore their experiences of receiving Spotlight Consultations tool; any changes made to their diabetes self-management practices, and why; short- and long-term treatment goals and the reasons for these; and perceived barriers and facilitators to achieving these goals. These interviews will also include detailed exploration of participants’ historical diabetes management practices; previous contact with health professionals and diabetes management programs; and, their everyday work and family lives. The interviews will also explore participants’ information and support needs and whether, and in what ways, the intervention and follow-up care could be changed or improved.
5.4.2 Health professional interviews
Health professionals involved in Spotlight Consultations delivery will be interviewed once at the end of the trial. Interviews will explore: previous experiences of delivering self-management interventions for adults with diabetes; perceived benefits of Spotlight Consultations as compared to other interventions; experiences of, and views about, the training received to deliver Spotlight Consultations; barriers and facilitators to intervention delivery; perceived impact of Spotlight Consultations on participants’ diabetes self-management practices; and, how Spotlight Consultations could be changed/improved for future use.
Qual Topic guides: Participant and health professional interviews will be informed by topic guides, with questioning kept sufficiently flexible to enable individual issues to be identified and explored. All interviews will be audio-recorded, transcribed in full, and early interviews will be reviewed by the research team to determine whether any alterations to the topic guides need to be made.
5.4.3 Process Evaluation
The process evaluation will be undertaken ‘to explain discrepancies between expected and observed outcomes, to understand how context influences outcomes, and to provide insights to aid implementation’. Interviews will be held with a subgroup of participants (n=6), healthcare professionals (n=3) and clinical triallists (n=2).