Protocol for the diabetes, distress and disparities (3D) study: an explanatory sequential mixed-methods design

Abstract

Introduction: Psychosocial factors impact diabetes outcomes, yet healthcare systems remain inadequately equipped to address these needs. Research centring on the experiences of people with diabetes (PWD) can inform programme implementation, policies and partnerships to address psychosocial care needs. The goals of the diabetes, distress and disparities (3D) study are to quantify the psychosocial care needs of PWD in a large academic medical centre, generate insights regarding how psychosocial factors shape diabetes outcomes and identify modifiable determinants of psychosocial care.

Methods and analysis: The 3D study is recruiting adults with type 1 (T1D), type 2 (T2D), latent autoimmune diabetes in adults (LADA) and gestational diabetes (GD) from the Caswell Diabetes Registry at Michigan Medicine. The 3D study uses an explanatory sequential mixed-methods design with two phases. Phase I (P1: target n=500, began July 2023) consists of an online survey to quantify prevalence and examine correlates of a wide range of psychosocial factors (eg, diabetes-related distress, depression, stigma). This survey was refined through consultation with PWD. Phase II (P2) involves semi-structured telephone interviews with n=40 P1 respondents, recruited using maximum variation sampling informed by demographic characteristics and responses to psychosocial survey measures. P2 will explore a subset of factors (eg, patient-provider communication, social support, barriers/promoters to care). To date, n=573 (5% response rate) have completed P1. In March 2024, we identified a target sample of P1 respondents (n=65) for recruitment into P2. All data collection was completed by September 2024. Analysis will involve quantitative linear and logistic regression to understand correlates of psychosocial outcomes from P1, and qualitative content analysis to clarify potential points of intervention from P2.

Ethics and dissemination: This study is approved by the University of Michigan Institutional Review Board (HUM00223735). Protocol materials are available at https://osf.io/yfz6b/. Findings from this study will be disseminated through peer-reviewed publications, presentations at conferences and outreach to key stakeholders, including creating educational materials for patient advocacy groups and interprofessional practice.

Keywords: cross-sectional studies; epidemiology; general diabetes; mental health; public health.

Figure 1. Study design of the diabetes, distress and disparities (3D) study: an explanatory sequential mixed-methods design. CDI, Caswell Diabetes Institute; GD, gestational diabetes; PWD, people with diabetes; T1D, type 1 diabetes; T2D, type 2 diabetes.

Figure 2. Flow chart of participant recruitment into the diabetes, distress and disparities (3D) study. This flow chart illustrates the participant recruitment process for phases I and II of the 3D study. For phase I, the flow begins with the target sample of patients with diabetes seen at the University of Michigan (UM) and details the steps leading to the final sample of survey respondents (n=573, 5% response rate). Participants in phase II (n=40, 62% response rate) were targeted for recruitment based on their responses to phase I on five features: (1) diabetes control (eg, self-reported haemoglobin A1c), (2) symptoms of depression and anxiety (eg, GAD-7, PHQ-9), (3) symptoms of diabetes distress (eg, PAID-11), (4) history of mental health treatment and (5) social factors such as experiences of discrimination and stigma. We also considered demographic characteristics (eg, age, race, sex, educational attainment and household income) in constructing the phase II target sample. GD, gestational diabetes; GAD-7, Generalised Anxiety Disorder-7; PAID-11, Problem Areas in Diabetes-11; PHQ-9, Patient Health Questionnaire-9; T1D, type 1 diabetes; T2D, type 2 diabetes.