Design of a randomized controlled trial of digital health and community health worker support for diabetes management among low-income patients.

BACKGROUND: Insulin-dependent diabetes is a challenging disease to manage and involves complex behaviors, such as self-monitoring of blood glucose. This can be especially challenging in the face of socioeconomic barriers and in the wake of the COVID-19 pandemic. Digital health self-monitoring interventions and community health worker support are promising and complementary best practices for improving diabetes-related health behaviors and outcomes. Yet, these strategies have not been tested in combination. This protocol paper describes the rationale and design of a trial that measures the combined effect of digital health and community health worker support on glucose self-monitoring and glycosylated hemoglobin. METHODS: The study population was uninsured or publicly insured; lived in high-poverty, urban neighborhoods; and had poorly controlled diabetes mellitus with insulin dependence. The study consisted of three arms: usual diabetes care; digital health self-monitoring; or combined digital health and community health worker support. The primary outcome was adherence to blood glucose self-monitoring. The exploratory outcome was change in glycosylated hemoglobin. CONCLUSION: The design of this trial was grounded in social justice and community engagement. The study protocols were designed in collaboration with frontline community health workers, the study aim was explicit about furthering knowledge useful for advancing health equity, and the population was focused on low-income people. This trial will advance knowledge of whether combining digital health and community health worker interventions can improve glucose self-monitoring and diabetes-related outcomes in a high-risk population.

Clinical and radiological characteristics of acute pulmonary embolus in relation to 28-day and 6-month mortality.

BACKGROUND: Patients with acute pulmonary embolism (PE) exhibit a wide spectrum of clinical and laboratory features when presenting to hospital and pathophysiologic mechanisms differentiating low-risk and high-risk PE are poorly understood. OBJECTIVES: To investigate the prognostic value of clinical, laboratory and radiological information that is available within routine tests undertaken for patients with acute PE. METHODS: Electronic patient records (EPR) of patients who underwent Computed Tomography Pulmonary Angiogram (CTPA) scan for the investigation of acute PE during 6-month period (01.01.2016-30.06.2016) were examined. Data was gathered from EPR for patients that met inclusion criteria and all CTPA scans were re-evaluated. Biochemical thresholds of low-grade and high-grade inflammation, serum CRP >10mg/L and >150mg/L and serum albumin concentrations <35g/L and <25 g/L, were combined in the Glasgow Prognostic Score (GPS) and peri-operative Glasgow Prognostic Score (poGPS) respectively. Neutrophil Lymphocyte ratio (NLR) was also calculated. Pulmonary Embolus Severity Index score was calculated. RESULTS: Of the total CTPA reports (n = 2129) examined, 245 patients were eligible for inclusion. Of these, 20 (8%) patients had died at 28-days and 43 (18%) at 6-months. Of the 197 non-cancer related presentations, 28-day and 6-month mortality were 3% and 8% respectively. Of the 48 cancer related presentations, 28-day and 6-month mortality were 29% and 58% respectively. On univariate analysis, age ≥65 years (p<0.01), PESI score ≥100(p = <0.001), NLR ≥3(p<0.001) and Coronary Artery Calcification (CAC) score ≥ 6 (p<0.001) were associated with higher 28-day and 6-month mortality. PESI score ≥100 (OR 5.2, 95% CI: 1.1, 24.2, P <0.05), poGPS ≥1 (OR 2.5, 95% CI: 1.2-5.0, P = 0.01) and NLR ≥3 (OR 3.7, 95% CI: 1.0-3.4, P <0.05) remained independently associated with 28-day mortality. On multivariate binary logistic regression analysis of factors associated with 6-month mortality, PESI score ≥100 (OR 6.2, 95% CI: 2.3-17.0, p<0.001) and coronary artery calcification score ≥6 (OR 2.3, 95% CI: 1.1-4.8, p = 0.030) remained independently associated with death at 6-months. When patients who had an underlying cancer diagnosis were excluded from the analysis only GPS≥1 remained independently associated with 6-month mortality (OR 5.0, 95% CI 1.2-22.0, p<0.05). CONCLUSION: PESI score >100, poGPS≥1, NLR ≥3 and CAC score ≥6 were associated with 28-day and 6-month mortality. PESI score ≥100, poGPS≥1 and NLR ≥3 remained independently associated with 28-day mortality. PESI score ≥100 and CAC score ≥6 remained independently associated with 6-month mortality. When patients with underlying cancer were excluded from the analysis, GPS≥1 remained independently associated with 6-month mortality. The role of the systemic inflammatory response (SIR) in determining treatment and prognosis requires further study. Routine reporting of CAC scores in CTPA scans for acute PE may have a role in aiding clinical decision-making regarding treatment and prognosis.

Effect of Community Health Worker Support on Clinical Outcomes of Low-Income Patients Across Primary Care Facilities: A Randomized Clinical Trial.

Importance: Addressing the social determinants of health has been difficult for health systems to operationalize. Objective: To assess a standardized intervention, Individualized Management for Patient-Centered Targets (IMPaCT), delivered by community health workers (CHWs) across 3 health systems. Design, Setting, and Participants: This 2-armed, single-blind, multicenter randomized clinical trial recruited patients from 3 primary care facilities in Philadelphia, Pennsylvania, between January 28, 2015, and March 28, 2016. Patients who resided in a high-poverty zip code, were uninsured or publicly insured, and who had a diagnosis for 2 or more chronic diseases were recruited, and patients were randomized to either the CHW intervention or the control arm (goal setting only). Follow-up assessments were conducted at 6 and 9 months after enrollment. Data were analyzed using an intention-to-treat approach from June 2017 to March 2018. Intervention: Participants set a chronic disease management goal with their primary care physician; those randomized to the CHW intervention received 6 months of tailored support. Main Outcomes and Measures: The primary outcome was change in self-rated physical health. The secondary outcomes were self-rated mental health, chronic disease control, patient activation, patient-reported quality of primary care, and all-cause hospitalization. Results: Of the 592 participants, 370 (62.5%) were female, with a mean (SD) age of 52.6 (11.1) years. Participants in both arms had similar improvements in self-rated physical health (mean [SD], 1.8 [11.2] vs 1.6 [9.9]; P = .89). Patients in the intervention group were more likely to report the highest quality of care (odds ratio [OR], 1.8; 95% CI, 1.4-2.4; risk difference [RD], 0.12; P < .001) and spent fewer total days in the hospital at 6 months (155 days vs 345 days; absolute event rate reduction, 69%) and 9 months (300 days vs 471 days; absolute event rate reduction, 65%). This reduction was driven by a shorter average length of stay (difference, -3.1 days; 95% CI, -6.33 to 0.22; P = .06) and a lower mean number of hospitalizations (difference, -0.3; 95% CI, -0.6 to 0.0; P = .07) among patients who were hospitalized. Patients in the intervention group had a lower odds of repeat hospitalizations (OR, 0.4; 95% CI, 0.2-0.9; RD, -0.24; P = .02), including 30-day readmissions (OR, 0.3; 95% CI, 0.1-0.9; RD, -0.17; P = .04). Conclusions and Relevance: A standardized intervention did not improve self-rated health but did improve the patient-perceived quality of care while reducing hospitalizations, suggesting that health systems may use a standardized intervention to address the social determinants of health. Trial Registration: ClinicalTrials.gov identifier: NCT02347787.

Case study: design may influence use of seclusion and restraint.

OBJECTIVE: The psychiatric emergency room is a dynamic and sometimes volatile environment. Its design may be an important variable in patient care, but most design decisions are based on models of thought and treatment with a minimal evidence base. BACKGROUND: The concept of open design, increasing access of patients to nursing staff, for inpatient psychiatric units has recently gained widespread acceptance, despite a dearth of empirical data. METHODS: We examined rates of seclusion and restraint before and after a design change that reduced the openness of the unit in a dedicated emergency psychiatric service in a general university hospital. Quality assurance data regarding the census, occurrence of assaults, and the use of seclusion and restraint were queried. Two independent analyses utilizing a test of proportional data were performed to replicate the findings. RESULTS: After placement of a door to restrict patients' access to the waiting area of the unit, the rate of the use of seclusion and restraint went from 0.03 (44/777) to 0.0185 (27/1,514; z = 2.02, p < .04). Replication over a separate time period saw reduction from 0.029 (67/2,277) to 0.018 (44/2,431), z = 2.44, p < .02). CONCLUSION: A design change that reduced the openness of the unit resulted in the reduction of seclusion and restraint.

Pharmacological and other interventions for head and neck cancer pain: a systematic review.

OBJECTIVES: Pain is a common complication in head and neck cancer. The aim of this paper is to evaluate the evidence from randomised control trials investigating pharmacological and non-pharmacological methods of pain management in head and neck cancer. MATERIAL AND METHODS: Medline, Embase and the Cochrane library databases were searched. Squamous cell carcinomas of the head and neck excluding nasopharyngeal and salivary gland cancers were included. The limits were "human" and "randomised clinical trials". A quality assessment was carried out. RESULTS: 13 studies were included with a total of 644 participants. The primary outcome for most of these papers was pain control post-treatment. Levels of bias varied between the studies. Majority (12 out of the 13 studies) reported intervention to be superior to the control or standard therapy in pain management. Only 46% of the studies were carried out on an intention to treat basis. Two studies reported high dropout rates, with one at 66%. CONCLUSIONS: There is insufficient evidence from randomised clinical trials to suggest an optimal pharmacological intervention for head and neck cancer pain post-treatment. Further high quality randomised clinical trials should be conducted to develop an optimal management strategy for head and neck cancer pain.