Remote patient monitoring (RPM), also known as telemonitoring (TM), is the collection and analysis of the individual's physiologic data (e.g., weight, blood pressure, pulse, pulse oximetry, and other condition-specific data) (remote physiologic monitoring) and the individual's adherence and response to therapy data (remote therapeutic monitoring) through a medical device, as defined by Section 201(h) of the Federal Food, Drug, and Cosmetic Act, that are used to develop and manage a treatment plan related to a chronic and/or acute health illness or condition.
RPM is not intended to be an ongoing modality; it is intended to
be an intervention in response to a complication, decompensation, or instability of a medical
condition. It may be used during the stabilization period, while an individual returns to the baseline
of their condition, or establishes a new baseline. Once baseline is achieved, RPM is no longer
an integral part of a plan of care.
RPM can reduce the number of hospitalizations, readmissions, and lengths of stay in hospitals, which help to improve quality of life and contain costs.
HEART FAILURE (HF)
The evidence for HF consists of systematic reviews,meta-analyses, and randomized controlled trials (RCTs). Recent systematic reviews and meta-analyses have shown a positive effect on HF-related admissions and mortality rates and all-cause mortality rates. It remains that a considerable proportion of the literature consists of low-quality and inconsistent evidence about the beneficial effects of RPM. Overall, the literature produced mixed results, with the best-quality evidence from RCTs has not been consistently favorable reporting between systematic reviews when comparing RPM to usual care for HF rates of all-cause and HF mortality, and all-cause and HF hospital admissions. RPM has been shown to lower the risk of all-cause and HF mortality, and all-cause and HF hospital admissions in cohort analyses and nonrandomized trials, results from larger-scale RCTs have demonstrated no or negative effects, and while other RCTs establish decreases in HF-related admissions, emergency department visits. Earlier publications reported fewer positive data. More recently, evidence from RCTs have shown support for the use of RPM in the HF population. In aggregate, the evidence suggest that RPM may be considered as an adjunctive therapy for individuals with CHF and may result in positive overall net health outcomes.
Ong et al. (2016) randomly assigned 1437 individuals hospitalized for HF to the intervention arm (715 individuals) or to the usual care arm (722 individuals) of the Better Effectiveness After Transition-Heart Failure (BEAT-HF) study and observed them for 180 days. The primary outcome was readmission for any cause within 180 days after discharge. Secondary outcomes were all-cause readmission within 30 days, all-cause mortality at 30 and 180 days, and quality of life measures.
The intervention combined health coaching telephone calls and TM. The TM arm utilized RPM electronic equipment that collected daily information about blood pressure, heart rate, symptoms, and weight. These measurements were analyzed by centralized registered nurses, who conducted RPM reviews, protocolized actions, and telephone calls.
The intervention and usual-care groups did not differ significantly in readmissions for any cause 180 days after discharge, which occurred in 50.8% (363 of 715) and 49.2% (355 of 722) of individuals, respectively (adjusted hazard ratio, 1.03; 95% CI, 0.88-1.20; P=0.74). In secondary analyses, there were not significant differences in 30-day readmission or 180-day mortality, but there was a significant difference in 180-day quality of life between the intervention and usual care groups. No adverse events were reported in the trial associated with the treatment assignment. Among individuals previously hospitalized for HF, combined health coaching telephone calls and TM did not significantly reduce 180-day readmissions.
Koehler et al. (2018) report on a German, prospective, randomized, controlled, parallel-group, unmasked multicenter trial (n=1571). The primary outcome was percentage of days lost due to unplanned cardiovascular hospital admissions or all-cause death. Secondary outcomes were all-cause and cardiovascular mortality. A total of 765 individuals were assigned to the RPM group and 773 were in the usual-care group. The percentage of days lost due to unplanned cardiovascular hospital admissions and all-cause death was 4.88% (95% confidence interval [CI], 4.55–5.23) in the RPM group and 6.64% (6.19–7.13) in the usual-care group (ratio, 0.80; 95% CI, 0.65–1.00; P=0.0460). Individuals assigned to RPM reported an average loss of 17.8 days (95% CI, 16.6–19.1) per year to 24.2 days (22.6–26.0) per year, compared to those assigned to usual care. The all-cause death rate was 7.86 (95% CI 6·14–10·10) per 100 person-years of follow-up in the RPM group compared with 11.34 (9·21–13·95) per 100 person-years of follow-up in the usual-care group (hazard ratio [HR] 0.70; 95% CI, 0.50–0.96; P=0.0280).The authors reported that for cardiovascular mortality there was not a significantly difference between the two groups (HR, 0.671; 95% CI, 0.45–1.01; P=0·0560). Additional well-designed studies are required to validate reduction in hospitalizations for the HF population.
Yun et al. (2018) performed a systematic review and meta-analysis of TM versus usual care for HF. The researchers identified 37 studies (n=9582 individuals) for clinical effectiveness: mortality (n=24 studies), hospitalizations (n=17- all cause; 12 HF hospitalizations), and emergency room (ER) visits (n=5) and patient-reported outcomes. The risks of all-cause mortality (risk ratio [RR], 0.81, 95% CI, 0.70–0.94) and HF-related mortality (RR, 0.68; 95% CI, 0.50–0.91) were significantly lower in the monitoring group than in the usual-care arm. TM showed a significant benefit when >2 biometric data points are transmitted or when transmissions occurred daily. TM also reduced mortality risk in studies that monitored individuals' symptoms, medication adherence, or prescription changes. Daily transmission occurred in 28 studies, with another 3 studies reporting transmissions once- per week, and 5 studies were either uncategorized or two of the included studies report on data transmission.
The researchers found that TM interventions reduces the risk of mortality in individuals with HF, and intensive monitoring with more frequent transmissions of patient data increase that effectiveness. The authors demonstrated three or more measurable biometric data points measures resulted in the largest significant benefit in mortality risk for individuals with CHF.
Ding et al. (2020) conducted a multicenter RCT with a 6-month follow-up on 184 participants (141/184, 76.6% male), with a mean age of 70.1 (standard deviation [SD], 12.3) years. Participants were randomly assigned either to receive innovative TM-enhanced care (ITEC-CHF) (n=91) or usual care (control; n=93), of which 67 ITEC-CHF and 81 control participants completed the intervention.
For the compliance criterion of weighing at least 4 days per week, the proportion of compliant participants in the ITEC-CHF group was not significantly higher than that in the control group (ITEC-CHF: 67/91, 74% vs control: 56/91, 60%; P=0.06). However, the proportion of ITEC-CHF participants achieving the stricter compliance standard of at least 6 days a week was significantly higher than that in the control group (ITEC-CHF: 41/91, 45% vs control: 23/93, 25%; P=0.005). The ITEC-CHF treatment arm improved participant compliance with weight monitoring, although the withdrawal rate was high. RPM may be considered a promising method for supporting individuals in the management of CHF. However, the researchers do note that further studies are required to optimize this model of care.
In a growing number of recent publications of systematic review, the research is suggesting that RPM may reduce all-cause hospitalizations, and mortality for individuals with heart failure. In a shift from prior recommendations, the American Heart Association (AHA, 2019), endorses the use of RPM in this vulnerable population.
Future research should focus on understanding the process by which RPM works in terms of improving HF-related outcomes, identify optimal strategies and the duration of follow-up for which it confers benefits, and further investigate whether there is differential effectiveness between chronic HF groups and various types of available RPM technologies.