Use of patient-reported outcome measures (PROMs) in clinical diabetes consultations: the DiaPROM randomised controlled pilot trial

Ingvild Hernar, Marit Graue, David A Richards, Ragnhild B Strandberg, Roy Miodini Nilsen, Magne Rekdal, Karianne Fjeld Løvaas, Tone V Madsen, Grethe S Tell, Anne Haugstvedt, Ingvild Hernar, Marit Graue, David A Richards, Ragnhild B Strandberg, Roy Miodini Nilsen, Magne Rekdal, Karianne Fjeld Løvaas, Tone V Madsen, Grethe S Tell, Anne Haugstvedt

Abstract

Objective: To 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.

Design: Two-arm pilot RCT.

Participants: Adults 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 intervention: All 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.

Outcomes: Recruitment 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.

Results: We 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).

Conclusions: The 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.

Keywords: diabetes & endocrinology; general diabetes; quality in health care.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
The DiaPROM pilot trial’s consolidated standards of reporting trials flow diagram. (CONSORT, Consolidated Standards of Reporting Trials; DiaPROM, Diabetes Patient-Reported Outcome Measures; DDS, Diabetes Distress Scale; PAID, Problem Areas In Diabetes; PCDS, Perceived Competence for Diabetes Scale.)

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