Outcomes of a risk assessment and management program using telecare consultation among patients with diabetes mellitus in general out-patient clinic: a hybrid effectiveness-implementation study protocol

Abstract

Diabetes Mellitus (DM) is a chronic disease characterized by abnormally uncontrolled high blood glucose level. The Risk Assessment and Management Program (RAMP) in Hong Kong has been providing long-term face-to-face follow-up to DM patients in the government out-patient clinics since 2009. However, under the current outbreak of COVID-19, these face-to-face consultations were ceased over and over again to lower the risk of disease transmission. With the advancement in technology, the recent emergence of telecare has provided an alternative to replace the conventional consultations in the clinics. Its clinical effectiveness on DM patients has also been supported by numerous studies. Yet, there is only a paucity of literatures discussing the practicality of such implementation design in the real-world settings. This study aims at studying both the effectiveness and implementation outcomes of telecare in Hong Kong DM patients. It adopts a type 2 hybrid effectiveness-implementation design. It will be conducted in seven government out-patient clinics in Hong Kong. The subjects will be randomly assigned to an intervention group or a control group when they 1) are aged 18 or above, 2) have a confirmed diagnosis of diabetes, and 3) are having regular follow-up appointment in the clinic. Subjects in the intervention group will receive a 84-week Risk Assessment and Management Program (RAMP) in an alternate telecare and face-to-face consultations mode, while the control group will receive the same program but in usual face-to-face consultation mode. RE-AIM is employed as the implementation and effectiveness outcome evaluation framework. The primary outcome measure will be HbA1c. Data will be collected pre-intervention (T1), 42-week (T2), and 84-week (T3). The study will provide effectiveness-implementation assessment of telecare mode for DM patients in Hong Kong, as an alternative or in addition to conventional face-to-face consultations. It also aimed to provide insights for the future adoption in a broader health care setting.

Keywords:

• Diabetes
• telecare
• implementation science
• hybrid effectiveness-implementation
• clinic
• consultation

Authors’ contributions

AW and FW conceptualized the programme. All authors provided intellectual input into the study design, methodology and evaluation. AW and AL drafted the manuscript. All authors contributed to, reviewed, and approved the manuscript.

Disclosure statement

No potential conflict of interest was reported by the author(s).

Ethics statement

The study was approved by the Human Subjects Ethics Application Committee of the Hong Kong Polytechnic University (No. HSEARS20200619003). Written consent will be provided to all participants.

Data availability statement

The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.

Additional information

Funding

This study was funded by the Health and Medical Research Fund (Award no. 18191221). The funders had no role in the study design, data collection and analysis, the decision to publish, or the preparation of the manuscript.