Abstract

<h3>Context:</h3> There is mixed evidence regarding the benefit of type 2 diabetes mellitus (T2DM) self-management support (SMS) programs on clinical outcomes. SMS program benefits may be limited if they fail to engage with patients around their social and behavioral health challenges that can impede successful diabetes outcomes. <h3>Objectives:</h3> (1) To compare T2DM-related clinical outcomes of an evidence-based SMS program (Connection to Health; CTH) with an enhanced version that adds a patient engagement protocol to elicit and address patient social and behavioral health challenges (EE-CTH). (2) To explore patient social risks and psychological distress as moderators of intervention impact. <h3>Study Design and Analysis:</h3> Cluster randomized pragmatic trial. CTH and EE-CTH were examined relative to non-randomized usual care groups from the same clinical sites and to one another. General linear mixed effects examine change in hemoglobin A1c (HbA1c) and body mass index (BMI) by study arm and moderators of change in the clinical outcomes. <h3>Setting or Dataset:</h3> 12 Community Health Center (CHC) sites affiliated with the San Francisco Bay Collaborative Research Network in California. <h3>Population Studied:</h3> 967 CHC adult patients with T2DM. <h3>Intervention/Instrument:</h3> Healthcare team members from CHCs were trained on and delivered CTH, a web-based SMS program including a health survey and collaborative action planning, or EE-CTH, including all elements of CTH plus additional relationship building training/support. <h3>Outcome Measures:</h3> 12-month change in HbA1c and BMI. <h3>Results:</h3> Similar improvements in HbA1c were noted in both study arms, with greater improvements for EE-CTH vs. their comparison group (p = .04). Greater reductions in BMI were noted in both CTH and EE-CTH relative to their comparison groups (p = .05 EECTH; p= .06 CTH). No overall CTH vs. EE-CTH group differences on HbA1c or BMI were observed. However, patients who reported baseline social risks or health distress benefited from greater BMI and HbA1c reductions in EE-CTH relative to CTH (all p &lt; .05). <h3>Conclusions:</h3> As delivered within existing CHCs clinical workflows and resources, CTH and EE-CTH demonstrated positive clinical impacts for T2DM in CHCs, with greater benefits from EE-CTH than CTH for individuals experiencing social risks or psychological health-related distress. Increased attention to relationship building strategies in diabetes primary care is warranted and may be particularly impactful for individuals with

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