Aim, Design and Setting of the study
The aim of the study was to evaluate the effects of TTOC (weekly video visits with daily remote patient monitoring), to standard of care. The methods and study design have been previously published and are adherent to the CONSORT Statement guidelines (22, 23). The primary outcome measures of the study are hospital readmissions and ED visits within 30 days of the index hospitalization discharge (Table 3). Secondary outcome measures include, patient experience (Table 2), medication adherence and management, mortality, and access to care (days to PCP follow up) (Table 3)”. This study was performed by the Family and Internal Medicine Departments at Stony Brook Medicine, which is a 603-bed teaching institution on the northern part of Long Island, New York. The hospital mostly services the population of Suffolk County with an annual admission of 31,715 patients. Over 75 percent of patients were serviced by the Family Medicine physicians, in an ambulatory practice serving about 32,000 patients annually, who do not currently serve uninsured patients (whom are referred to our affiliated Federally Qualified Health Centers and our free student run clinic not officially part of the Family Medicine practice).
Participant Characteristics
The sample consisted of 102 patients who fulfilled the eligibility criteria, were randomized to receive either TTOC or Standard of Care (Figure 1). Randomization was conducted using a computer-generated 1:1 random number allocation sequence through REDCap (22). Eligible patients were adult patients (≥ 30 years), with 2 or more chronic disease processes, English speakers, with good cognitive function, a life expectancy greater than 6 months, with an ability to provide consent. All patients were hospitalized at Stony Brook University Hospital and discharged to the patient home, with the follow up care in either the Family or Internal Medicine clinical practices. Patients self-identified as living within reasonable commute to the Family or Internal Medical Group clinics and were able to complete a technological aptitude test of turning on the telehealth technology and following the prompts. Patients were excluded if they had physical limitations prohibiting the use of the telehealth equipment, were uninsured (who received referrals elsewhere for follow up care), if involved in another research study, were pregnant or actively trying to conceive, or if admitted for a primary psychiatric diagnosis.
Study Design
We conducted a 2-arm, parallel group, randomized controlled trial between June 1, 2017 to June 1, 2018. The standard of care upon hospital discharge, was the provision of a discharge summary and patient instructions encouraging follow up with the PCP within 7-14 days and scheduled specialist appointments as indicated. A clinical summary with detailed instructions were provided by the discharge nurse. The Telehealth intervention involved the provision of a smart phone device and Bluetooth-enabled blood pressure monitoring cuff, weighing scale, and pulse oximeter within 48 hours after hospital discharge (Figure 2)(24). Telehealth patients measured their vitals daily using the tele-equipment and had weekly virtual visits with a transition of care physician (teledoc). During visits with the teledoc, medicine reconciliation was documented and medication adherence assessed in concordance with best practice from published studies (25) Physicians were trained to ask open-ended questions to assess medications taken, as well as perform validation of patient histories using Electronic Medical Record (EMR) and pharmacy data. Clinicians documented adherence if there were no discrepancies between physician prescription and patient self-report and data. Upon consent, patients participated in the trial for the length of thirty days following hospital discharge. All patients were consented and enrolled in the Health Information Exchange.
Data Collection
Study data was collected and managed using REDCap (26) electronic data capture tools hosted at Stony Brook Medicine. Primary Outcomes of hospital readmission and ED utilization were assessed using Health Information Exchange and EMR data. Secondary outcomes were assessed through phone surveys, whose data was hosted on REDCap. Medication adherence and reconciliation data was collected in REDCap during the virtual visit. For the control group, the EMR medicine reconciliation records and clinical notes were reviewed by a physician, for documented non-adherence to the discharge summary treatment plan.
Data Analysis
Frequencies and percentages were calculated for categorical variables, e.g. Re-admission and ED visit for each randomized group. Means and standard deviations (SD) were calculated for continuous variables if the data followed a normal distribution (e.g. age). If the data did not follow the normal distribution, medians and ranges were calculated instead. Chi-square tests or Fisher’s exact tests were used to compare the percentages of categorical variables between the Telehealth and control groups. T tests or Wilcoxon rank sum tests were used to compared means and medians between the two randomized groups. To evaluate the associations between Readmission, ED visit and adhere with telehealth and other factors, multivariable logistic regression models were performed, and odds ratios and their 95% confidence intervals were estimated.
SAS v9.3 (Cary, NC) and SPSS v25 (Chicago, IL) were used to conduct all statistical analyses.