Process Evaluation of a Randomised Controlled Trial for TeleClinical Care, a Smartphone-App Based Model of Care

Background A novel smartphone app-based model of care (TeleClinical Care – TCC) for patients with acute coronary syndrome (ACS) and heart failure (HF) was evaluated in a two-site, pilot randomised control trial of 164 participants in Sydney, Australia. The program included a telemonitoring system whereby abnormal blood pressure, weight and heart rate readings were monitored by a central clinical team, who subsequently referred clinically significant alerts to the patients' usual general practitioner (GP, also known as primary care physician in the United States), HF nurse or cardiologist. While the primary endpoint, 30-day readmissions, was neutral, intervention arm participants demonstrated improvements in readmission rates over 6 months, cardiac rehabilitation (CR) completion and medication compliance. A process evaluation was designed to identify contextual factors and mechanisms that influenced the results, as well as strategies of improving site and participant recruitment and the delivery of the intervention, for a planned larger effectiveness trial of over 1,000 patients across the state of New South Wales, Australia (TCC-Cardiac). Methods Multiple data sources were used in this mixed-methods process evaluation, including interviews with four TCC team members, three GPs and three cardiologists. CR completion rates, HF outreach service (HFOS) referrals and cardiologist follow-up appointments were audited. A patient questionnaire was also analysed for evidence of improved self-care as a hypothesised mechanism of the TCC app. An implementation research logic model was used to synthesise our findings. Results Rates of HFOS referral (83 vs. 72%) and cardiologist follow-up (96 vs. 93%) were similarly high in the intervention and control arms, respectively. Team members were largely positive towards their orientation and training, but highlighted several implementation strategies that could be optimised for TCC-Cardiac: streamlining of the enrolment process, improving the reach of the trial by screening patients in non-cardiac wards, and ensuring team members had adequate time to recruit (>15 h per week). GPs and cardiologists viewed the intervention acceptably regarding potential benefit of closely monitoring, and responding to abnormalities for their patients, though there were concerns of the potential additional workload generated by alerts that did not merit clinical intervention. Clear delineation of which clinician (GP or cardiologist) was primarily responsible for alert management was also recommended, as well as a preference to receive regular summary data. Several patients commented on the mechanisms of improved self-management because of TCC, which could have led to the outcome of improved medication compliance. Discussion Use of TCC was associated with several benefits, including higher patient engagement and completion rates with CR. The conduct and delivery of TCC-Cardiac will be improved by the findings of this process evaluation to optimise recruitment, and establishing the roles of GPs and cardiologists as part of the model.