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ObjectiveTo pilot test the proposed DiaPROM trial components and address uncertainties associated with conducting a full-scale randomised controlled trial (RCT) to evaluate whether such a trial is feasible.DesignTwo-arm pilot RCT.ParticipantsAdults aged ≥18–39 years, with minimum 1 year type 1 diabetes duration, attending outpatient follow-up. Exclusion criteria were pregnancy, severe cognitive, somatic or psychiatric conditions and impaired vision.Randomisation and interventionAll participants completed electronic Patient-Reported Outcome Measures (PROMs) prior to the annual diabetes consultation. Using computer-generated block-randomisation without blinding, we assigned participants in a 1:1 ratio stratified by sex to receive standard care or an intervention. Physicians reviewed diabetes distress scores (Problem Areas In Diabetes scale) and referred individuals with scores ≥30 or single item(s) ≥3 to minimum two diabetes nurse consultations where reported problems were reviewed and discussed.OutcomesRecruitment and retention rates; participants perceptions about intervention components. Variance and estimated between-group differences in follow-up scores (Diabetes Distress Scale (DDS), WHO 5-Well-being Index, Perceived Competence for Diabetes Scale and glycaemic control) and DDS correlation with baseline scores, to assist sample size calculations.ResultsWe randomised 80 participants to the control or intervention arm (one participant was later excluded). 23/39 intervention arm participants qualified for additional consultations and 17 attended. 67/79 attended the 12-month follow-up (15.2% attrition); 5/17 referred to additional consultations were lost to follow-up (29.4% attrition). Participants reported PROMs as relevant (84.6%) and acceptable (97.4%) but rated the usefulness of consultations as moderate to low. Baseline mean±SD DDS score was 2.1±0.69; DDS SD was 0.71 (95% CI: 0.60 to 0.86) at follow-up; correlation between baseline and follow-up DDS scores was 0.8 (95% CI: 0.7 to 0.9).ConclusionsThe pilot trial revealed need for intervention modifications ahead of a full-scale trial to evaluate use of PROMs in diabetes consultations. Specifically, participant acceptability and intervention implementation need further investigation.

Background: Diabetes distress is a potential barrier to self-management and satisfactory glycaemic control. A structured focus on diabetes distress using the Problem Areas in Diabetes (PAID) scale may improve the health of people with diabetes. We designed the DiaPROM trial, evaluating the effect of using electronically captured PAID in clinical practice, to reduce diabetes distress among adults with type 1 diabetes. Methods: In this pilot trial, we aimed to evaluate PAID scores pre and post intervention and identify patients with elevated scores. We randomly assigned participants (18-≤40 yrs) at an outpatient clinic to standard care or an intervention were physicians referred individuals with a PAID score ≥30 or single item(s) ≥3 (moderately high distress) to minimum two nurse appointments. Following a communication manual based on empowerment and self-determination theory, reported problem areas were reviewed and discussed. Results: We recruited 79 adults with type 1 diabetes (age 27.2 ±5.0 yrs, diabetes duration 13.7 ±7.0 yrs, HbA1c 65.4 ±14.5 mmol/mol). In the intervention group (n=39), baseline PAID score was 27.7 ±16.8; 23 (59%) participants qualified for additional follow up and 17 (44%) accepted referral, attending a mean of 2.2 ±1.1 appointments. At 12 month follow up, the intervention group (n=31) mean score was 21.7 ±14.4 (mean change 3.7 ±13.0), with 13 (42%) reporting moderately high distress. The control group (n=40) scored 24.1 ±14.3 at baseline and 26.2 ±14.5 at 12 months (n=36), with respectively 19 (48%) and 20 (56%) patients reporting moderately high distress. Between-group difference at 12 months was 5.5 (95% CI 0.25, 10.7). Conclusion: Half of the participants reported diabetes distress levels qualifying for additional follow up, which has consequences for scaling a future RCT. Although the study was not powered to estimate intervention effects, we identified a promising PAID score reduction in the intervention group which was not observed for the controls. Disclosure I. Hernar: None. M. Graue: None. D. Richards: None. R.B. Strandberg: None. K.F. Løvaas: None. T. Madsen: None. G.S. Tell: None. A. Haugstvedt: None.

Background: The NDR-A is a national diabetes quality register. Norwegian health authorities specify that quality registers must include data from Patient-Reported Outcome Measures (PROMs) in addition to biomedical data. NDR-A retrieves data from electronic patient records (EPR). This raises the possibility of utilizing PROMs in clinical consultations. The main PROM included in NDR-A is the Problem Areas in Diabetes scale (PAID). Aim: To test the feasibility of using electronic delivery mode to collect PROMs and examine how patients and health care providers experience the electronic PROMs and the EPR’s interfaces. Methods: We invited 441 adults (>18 yrs) with type 1 diabetes to complete PROMs via 1) a web interface from their home (n=304) or 2) a kiosk (touch-screen computer) in the outpatient clinic (n=137). Using a paper questionnaire and qualitative interviews, we examined patients and health care providers experiences with the electronic PROMs and the EPR’s interfaces. Results: Through the web interface, we reached out to 215 (71 %) of the patients of which 114 (38 %) responded. On the kiosk in the clinic, 69 (50 %) patients completed the PROMs, 24 (18 %) did not attend scheduled consultations, 5 (4 %) did not participate due to technical problems, 20 (15 %) declined participation, and 19 (14 %) did just not approach the kiosk as instructed (when a researcher was not present to remind them). Patients who completed the paper questionnaire experienced the PROMs to be relevant and were in high degree willing to complete PROMs annually. In the qualitative interviews, health care providers reported the PROMs and the EPR’s interfaces to be appropriate to improve the focus on patients’ diabetes-related psychological and emotional challenges and needs. Conclusion: The tested modes for electronic capture of PROMs have limitations in reaching patients. However, both patients who completed the PROMs and the health care providers were satisfied with the electronic PROMs and the EPR’s interfaces. Disclosure A. Haugstvedt: None. I. Hernar: None. R.B. Strandberg: None. J.G. Cooper: None. K.F. Løvaas: None. T. Madsen: None. M. Rekdal: Employee; Self; DIPS AS. M.M. Iversen: None. M. Graue: None.

Objective: To assess the status of type 2 diabetes care in general practice and changes in the quality of care between 2005 and 2014, and to identify areas of diabetes care requiring improvement. Research design and methods: Two cross-sectional surveys were performed that included patients with type 2 diabetes in selected areas (n=9464 in 2014, n=5463 in 2005). Quality of care was assessed based on key recommendations in national guidelines. Differences in clinical performance between 2005 and 2014 were assessed in regression models adjusting for age, sex, counties and clustering within general practices. Results: Treatment targets were achieved in a higher proportion of patients in 2014 compared with 2005: hemoglobin A1c ≤7.0% (≤53 mmol/mol) in 62.8% vs 54.3%, blood pressure ≤135/80 mm Hg in 44.9% vs 36.6%, and total cholesterol ≤4.5 mmol/L in 49.9% vs 33.5% (all adjusted P≤0.001). Regarding screening procedures for microvascular complications, fewer patients had recorded an eye examination (61.0% vs 71.5%, adjusted P