|Background: The demands of type 1 diabetes (T1D) may constitute a great burden for people living with the disease. Diabetes distress reflects a range of emotional experiences, such as worry, guilt, and fear, potentially impairing self-management and glycaemic control. Serious diabetes distress is reported by 20-40% of adults with T1D. Consequently, regular assessment in clinical care is recommended. Using Patient-Reported Outcome Measures (PROMs) to assess diabetes distress is considered useful as tools to improve screening and communication between clinicians and people with T1D. Therefore, we developed the Diabetes Patient-Reported Outcome Measure (DiaPROM) trial, an empowerment-based intervention using the Problem Areas in Diabetes (PAID) scale to assess diabetes distress and as a dialogue tool in adult T1D consultations.
Aims: The overall aim of the studies conducted as part of this thesis was to feasibility and pilot test the DiaPROM trial, thereby investigate uncertainties associated with running a full-scale randomised controlled trial (RCT). The specific aims were as follows:
1. To examine the feasibility and acceptability of capturing PROMs electronically on a touchscreen computer in clinical diabetes practice (Paper I).
2. To develop a study protocol for the DiaPROM pilot trial (Paper II).
3. To pilot test the proposed DiaPROM trial components and address uncertainties associated with conducting a full-scale RCT in order to evaluate whether the trial methods and the intervention are feasible (Paper III).
4. To explore young adults’ experiences with outpatient follow-up appointments, completing electronic PROMs and using the PAID scale during the DiaPROM pilot trial (Paper IV).
Materials and methods: Three studies designed to complement each other: a feasibility study, a pilot trial and a qualitative study, were conducted at the endocrinology outpatient clinic at Haukeland University Hospital, Bergen. Eligible participants were adults with T1D and a minimum of one year diabetes duration. In the feasibility study, we invited adults ≥ 40 years to avoid including potential candidates for the upcoming pilot trial, in which we recruited younger adults aged 18-39 years. In the qualitative study, we invited pilot trial participants after they had attended the 12-month follow-up visit.
The feasibility study had a cross-sectional design (Paper I). The participants completed a set of electronic PROMs on a touchscreen computer at the outpatient clinic. The set contained five validated PROMs (42 items; covering diabetes distress, emotional wellbeing, perceived diabetes competence, hypoglycaemia awareness and health-related quality of life), three glucose variability items and two items concerning current glucose monitoring. Participants also completed a paper questionnaire regarding their perceptions about the PROMs. In addition, we monitored the touchscreen computer’s technical performance, observed the participants’ actions and collected data on the time needed to complete the PROMs, and we also recorded any missing items.
The pilot trial was a two-arm RCT with baseline and 12-month data collection points (Papers II & III). All participant completed electronic PROMs before two annual check-ups. We used computer-generated block-randomisation without blinding to assign participants in a 1:1 ratio, stratified by sex, to receive the intervention or standard care. All intervention arm participants’ PAID scores were reviewed by and discussed with a physician, and participants with PAID scores ≥30 or items scored ≥3 were offered additional follow-up. During a minimum of two diabetes specialist nurse consultations guided by an empowerment-based communication manual, reported problem areas were further discussed. Our primary outcome measure was the Diabetes Distress Scale (DDS), secondary outcome measures were the WHO 5-Well-being Index, the Perceived Competence for Diabetes Scale and glycaemic control measured by HbA1c. The pilot trial outcomes were recruitment and retention rates, estimation of variance, between-group differences of follow-up scores and correlations of DDS scores to assist sample size calculations and, finally, participants’ perceptions about the intervention components.
In the qualitative study, we performed semi-structured individual telephone interviews of pilot trial participants, asking about their experiences with diabetes follow-up and participation in the pilot trial (Paper IV). We analysed the data using Braun & Clarke’s thematic analysis.
Results: In the feasibility study, we recruited 69 participants (50.7% men; median age 51.0 years; median diabetes duration 26.0 years). The median time for completing the electronic PROMs was 8 minutes and 19 seconds, and the average completion rate was 81.4%. Overall, the touchscreen computer functioned well, and the participants found the PROMs understandable and relevant and acceptable for annual completion.
In the pilot trial, we randomised 80 participants (mean age 27.2 years; mean diabetes duration 13.7 years) to the control or intervention arm (one participant was later excluded); 23 of 39 intervention arm participants qualified for additional consultations and 17 of these were referred. At 12 months, 67 participants attended the follow-up (15.2% attrition); thereof, 5 (29.4%) of the 17 referred to additional nurse consultations were lost to follow-up. Participants found the PROMs relevant and acceptable but rated the additional nurse consultations’ usefulness as moderate. Furthermore, using results from the primary outcome measure, the DDS, we estimated that at least 107 participants would be required per arm in a fully powered, single-site RCT.
In the qualitative study, we interviewed 19 participants (age 22-39 years; diabetes duration 5-32 years): 8 from the control arm and 11 from the intervention arm. The analyses generated three themes, each with two subthemes: (1) Follow-up with limitations; Marginal dialogue about everyday challenges and Value of supportive relationships and continuity indicated that the participants experienced the previous follow-up as challenging and insufficient. (2) New insights and raised awareness; More life-oriented insights and Moving out of the comfort zone suggested mostly positive experiences with completing the PAID and using the scores in the dialogue. (3) Addressing problem areas with an open mind; Need for elaboration and Preparedness for dialogue indicated that further exploration of the PAID scores and openness were essential.
Conclusions: The studies’ findings highlight the value of combining quantitative and qualitative methods in feasibility and pilot testing to uncover factors that may impede effective interventions in clinical practice. Capturing electronic PROMs was technically feasible and accepted by the participants. Although they found it somewhat uncomfortable and challenging to disclose their diabetes-related problem areas, addressing diabetes distress as part of the consultations was considered highly relevant and important for future diabetes follow-up. Using the PAID helped the healthcare providers see beyond biomedical outcomes, which promoted patient empowerment and person-centred care and facilitated improved patient-provider relationships.
However, we decided not to proceed directly to a full-scale evaluation trial. This decision was based on findings indicating attrition, fidelity issues related to implementation and low acceptance or over-inclusion of cases, suggesting that the intervention requires additional development. Consequently, before commencing a full-scale RCT, the intervention requires modifications and additional development and possibly further feasibility and acceptability testing, focusing on inclusion criteria, intervention flexibility and healthcare provider training, specifically using the PAID in the patient-provider interaction.
|Paper III: Hernar I, Graue M, Richards DA, Strandberg RB, Nilsen RM, Rekdal M, Løvaas KF, Madsen TV, Tell GS, Haugstvedt A. Use of patient-reported outcome measures (PROMs) in clinical diabetes consultations: the DiaPROM randomised controlled pilot trial. BMJ Open. 2021;11(4):e042353. The article is available at: <a href="https://hdl.handle.net/11250/2767018" target="blank">https://hdl.handle.net/11250/2767018</a>