Effect of home blood pressure telemonitoring and pharmacist management on blood pressure control: a cluster randomized clinical trial
Effect of home blood pressure telemonitoring and pharmacist management on blood pressure control: a cluster randomized clinical trial
Importance: Only about half of patients with high blood pressure (BP) in the United States have their BP controlled. Practical, robust, and sustainable models are needed to improve BP control in patients with uncontrolled hypertension.
Objectives: To determine whether an intervention combining home BP telemonitoring with pharmacist case management improves BP control compared with usual care and to determine whether BP control is maintained after the intervention is stopped.
Design, setting, and patients: A cluster randomized clinical trial of 450 adults with uncontrolled BP recruited from 14,692 patients with electronic medical records across 16 primary care clinics in an integrated health system in Minneapolis-St Paul, Minnesota, with 12 months of intervention and 6 months of postintervention follow-up.
Interventions: Eight clinics were randomized to provide usual care to patients (n = 222) and 8 clinics were randomized to provide a telemonitoring intervention (n = 228). Intervention patients received home BP telemonitors and transmitted BP data to pharmacists who adjusted antihypertensive therapy accordingly.
Main outcomes and measures: Control of systolic BP to less than 140 mm Hg and diastolic BP to less than 90 mm Hg (<130/80 mm Hg in patients with diabetes or chronic kidney disease) at 6 and 12 months. Secondary outcomes were change in BP, patient satisfaction, and BP control at 18 months (6 months after intervention stopped).
Results: At baseline, enrollees were 45% women, 82% white, mean (SD) age was 61.1 (12.0) years, and mean systolic BP was 148 mm Hg and diastolic BP was 85 mm Hg. Blood pressure was controlled at both 6 and 12 months in 57.2% (95% CI, 44.8% to 68.7%) of patients in the telemonitoring intervention group vs 30.0% (95% CI, 23.2% to 37.8%) of patients in the usual care group (P = .001). At 18 months (6 months of postintervention follow-up), BP was controlled in 71.8% (95% CI, 65.0% to 77.8%) of patients in the telemonitoring intervention group vs 57.1% (95% CI, 51.5% to 62.6%) of patients in the usual care group (P = .003). Compared with the usual care group, systolic BP decreased more from baseline among patients in the telemonitoring intervention group at 6 months (-10.7 mm Hg [95% CI, -14.3 to -7.3 mm Hg]; P<.001), at 12 months (-9.7 mm Hg [95% CI, -13.4 to -6.0 mm Hg]; P<.001), and at 18 months (-6.6 mm Hg [95% CI, -10.7 to -2.5 mm Hg]; P = .004). Compared with the usual care group, diastolic BP decreased more from baseline among patients in the telemonitoring intervention group at 6 months (-6.0 mm Hg [95% CI, -8.6 to -3.4 mm Hg]; P<.001), at 12 months (-5.1 mm Hg [95% CI, -7.4 to -2.8 mm Hg]; P<.001), and at 18 months (-3.0 mm Hg [95% CI, -6.3 to 0.3 mm Hg]; P = .07).
Conclusions and relevance: Home BP telemonitoring and pharmacist case management achieved better BP control compared with usual care during 12 months of intervention that persisted during 6 months of postintervention follow-up.
Effect of telehealth on use of secondary care and mortality: findings from the Whole System Demonstrator cluster randomised trial
The Whole Systems Demonstrator (WSD) trial found that telehealth was associated with lower rates of emergency hospital admissions than usual care amongst patients with long-term health conditions. However, admission rates increased amongst the control group shortly after recruitment, leading to concerns about whether the estimated treatment effect reflected telehealth, or was an artefact of the trial. We have conducted further analyses of this issue, and summarise these below as they have implications for the generalisability of the WSD trial. Attention to generalisability is important because trials typically estimate treatment effects for the sample of individuals recruited, rather than for the whole target population. The two might differ due to differences in the patients, centres or treatments.
Outcomes of a telehealth intervention for homebound older adults with heart or chronic respiratory failure: a randomized controlled trial
Purpose: Telehealth care is emerging as a viable intervention model to treat complex chronic conditions, such as heart failure (HF) and chronic obstructive pulmonary disease (COPD), and to engage older adults in self-care disease management.
Design and methods: We report on a randomized controlled trial examining the impact of a multifaceted telehealth intervention on health, mental health, and service utilization outcomes among homebound medically ill older adults diagnosed with HF or COPD. Random effects regression modeling was used, and we hypothesized that older adults in the telehealth intervention (n = 51) would receive significantly better quality of care resulting in improved scores in health-related quality of life, mental health, and satisfaction with care at 3 months follow-up as compared with controls (n = 51) and service utilization outcomes at 12 months follow-up.
Results: At follow-up, the telehealth intervention group reported greater increases in general health and social functioning, and improved in depression symptom scores as compared with usual care plus education group. The control group had significantly more visits to the emergency department than the telehealth group. There was an observed trend toward fewer hospital days for telehealth participants, but it did not reach significance at 12 months.
Implications: Telehealth may be an efficient and effective method of systematically delivering integrated care in the home health sector. The use of telehealth technology may benefit homebound older adults who have difficulty accessing care due to disability, transportation, or isolation.
Potential impact of optimal implementation of evidence-based heart failure therapies on mortality
Potential impact of optimal implementation of evidence-based heart failure therapies on mortality
Background: Although multiple therapies have been shown to lower mortality in patients with heart failure (HF) and reduced left ventricular ejection fraction, their application in clinical practice has been less than ideal. To date, empiric estimation of the potential benefits that could be gained from eliminating these existing treatment gaps with optimal implementation has not been quantified.
Methods: Eligibility criteria for each evidence-based HF therapy, the estimated frequency of use/nonuse of specific treatments, the case fatality rates, and the risk reductions due to treatment were obtained from published sources. The numbers of deaths prevented or postponed because of each guideline-recommended therapy and overall were determined.
Results: Among patients with HF with reduced left ventricular ejection fraction in the United States (n = 2,644,800), the number eligible but not currently treated ranged from 139,749 for hydralazine/isorbide dinitrate to 852,512 for implantable cardioverter defibrillators. The comparative number of deaths that could potentially be prevented per year with optimal implementation of angiotensin-converting enzyme inhibitor/angiotensin receptor antagonist is 6,516; β-blockers, 12,922; aldosterone antagonists, 21,407; hydralazine/isorbide dinitrate, 6,655; cardiac resynchronization therapy, 8,317; and implantable cardioverter defibrillators, 12,179. If these treatment benefits were additive, optimal implementation of all 6 therapies could potentially prevent 67,996 deaths a year.
Conclusions: A substantial number of HF deaths in this country could potentially be prevented by optimal implementation of evidence-based therapies. These data may underscore the importance of performance improvement efforts to translate evidence-based therapy to routine clinical practice so as to reduce contemporary HF mortality.
Noninvasive Home Telemonitoring for Patients With Heart Failure at High Risk of Recurrent Admission and Death: The Trans-European Network-Home-Care Management System (TEN-HMS) study
Noninvasive Home Telemonitoring for Patients With Heart Failure at High Risk of Recurrent Admission and Death: The Trans-European Network-Home-Care Management System (TEN-HMS) study
Objectives
We sought to identify whether home telemonitoring (HTM) improves outcomes compared with nurse telephone support (NTS) and usual care (UC) for patients with heart failure who are at high risk of hospitalization or death.
Background
Heart failure is associated with a high rate of hospitalization and poor prognosis. Telemonitoring could help implement and maintain effective therapy and detect worsening heart failure and its cause promptly to prevent medical crises.
Methods
Patients with a recent admission for heart failure and left ventricular ejection fraction (LVEF) <40% were assigned randomly to HTM, NTS, or UC in a 2:2:1 ratio. HTM consisted of twice-daily patient self-measurement of weight, blood pressure, heart rate, and rhythm with automated devices linked to a cardiology center. The NTS consisted of specialist nurses who were available to patients by telephone. Primary care physicians delivered UC. The primary end point was days dead or hospitalized with NTS versus HTM at 240 days.
Results
Of 426 patients randomly assigned, 48% were aged >70 years, mean LVEF was 25% (SD, 8) and median plasma N-terminal pro-brain natriuretic peptide was 3,070 pg/ml (interquartile range 1,285 to 6,749 pg/ml). During 240 days of follow-up, 19.5%, 15.9%, and 12.7% of days were lost as the result of death or hospitalization for UC, NTS, and HTM, respectively (no significant difference). The number of admissions and mortality were similar among patients randomly assigned to NTS or HTM, but the mean duration of admissions was reduced by 6 days (95% confidence interval 1 to 11) with HTM. Patients randomly assigned to receive UC had higher one-year mortality (45%) than patients assigned to receive NTS (27%) or HTM (29%) (p = 0.032).
Conclusions
Further investigation and refinement of the application of HTM are warranted because it may be a valuable role for the management of selected patients with heart failure.
Adherence Monitoring and Drug Surveillance in Chronic Opioid Therapy
Adherence Monitoring and Drug Surveillance in Chronic Opioid Therapy
Monitoring adherence with chronic opioid therapies is a critical yet often difficult task. Because chronic opioid therapy is often fraught with complex pharmacological, psychological, social, and legal issues, its application is often controversial or altogether avoided. Improved drug monitoring and surveillance may help reduce some of the reluctance to use chronic opioid therapy in patients with chronic pain states. We review the literature on patient adherence/compliance with chronic administration of opioids as well as novel methods by which adherence with opioid therapy can be measured.