The Patient Activation through Community Empowerment/Engagement for Diabetes Management (PACE-D) protocol: a non-randomised controlled trial of personalised care and support planning for persons living with diabetes

BACKGROUND: Personalised care and support planning (CSP) has been shown to improve diabetes outcomes, patient experience and provider morale in the care of persons living with diabetes. However, this has not been confirmed in controlled studies. Patient Activation through Community Empowerment/Engagement for Diabetes Management (PACE-D) is a pragmatic controlled trial that evaluates the effectiveness of personalised CSP in persons living with diabetes in the public primary care setting in Singapore. METHODS: Teamlet-empanelled patients with diabetes at four polyclinics are recruited for this study. Participants who attend either of the two Intervention clinics are sent their investigation results in a care planning letter (CPL) to prepare them for the CSP conversation. This conversation is facilitated by a trained CSP practitioner who engages them in discussion of concerns, goals and action plans, and documents their plans for subsequent review. Participants in the two Control clinics will receive standard diabetes care. Participants will complete two or more CSP conversations (Intervention) or regular consultations (Control) at the annual review visits within the 18 months of the study. The sample size is calculated at 1620 participants, with glycated haemoglobin (HbA1c) as the primary outcome measure. Secondary outcome measures include patient activation (as measured by PAM-13) and changes in healthcare utilisation and cost. DISCUSSION: This study is a pragmatic trial that evaluates the effectiveness of personalised CSP in persons living with diabetes in a real world setting. It promises to provide insights with regard to the implementation of this model of care in Singapore and the region. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT04288362. Retrospectively registered on 28 February 2020.