JMIR Publications

ABSTRACT

Background:

Living with type 1 diabetes is challenging, and to support self-management, repeated consultations in specialist outpatient care are often required. The emergence of new digital solutions has revolutionised how healthcare services can be patient centred, providing unprecedented opportunities for flexible, high-quality care. However, there is a lack of studies exploring how the use of digital patient-reported outcome (PRO) measures for flexible specialist care affects diabetes self-management. To provide new knowledge on the relevance of using PRO measures in standard care, we have designed a multimethod prospective study.

Objective:

The overall aim is to describe our multimethod prospective observational study to investigate digital PRO measures in a routine specialist outpatient setting for flexible patient-centred diabetes care: the DigiDiaS.

Methods:

This protocol outlines the design of a multimethod prospective observational cohort study that includes data from electronic health records, self-reported questionnaires, clinical consultation field observations and individual in-depth interviews with patients and diabetes healthcare personnel. All patients with type 1 diabetes at one designated outpatient clinic were invited to participate and make use of the digital PRO measure implemented in clinical care. Both users and nonusers of the digital PRO measure were eligible for the prospective study, allowing for a comparison of the two groups. Data were collected at baseline and after 12 months, including self-management as the primary outcome assessed using the patient activation measure (PAM), along with the secondary outcomes of digital health literacy, quality of life, health economy and clinical variables such as HbA1c.

Results:

The digital solution was implemented for routine clinical care in the department from November 2021, and data collection for the prospective study started in October 2022. Per September 6, 2023 n = 186 patients have consented to participate among the participants of the digital PRO measure and n = 34 among the nonusers. We expect the study to have enough participants by autumn 2023. With one year of follow-up, results are expected by spring 2025.

Conclusions:

In conclusion, a multimethod prospective observational cohort study can offer valuable insights into the relevance, effectiveness and acceptability of digital tools by utilising PRO measures in diabetes specialist care. Such elaborate knowledge is crucial for achieving a broad and successful implementation and use of these tools in a large diabetes outpatient clinic. Clinical Trial: NA