Randomized trial protocol for remote monitoring for equity in advancing the control of hypertension in safety net systems (REACH-SNS) study.

BACKGROUND: Self-measured blood pressure monitoring (SMBP) is essential to effective management of hypertension. This study aims to evaluate effectiveness and implementation of SMBP that leverages: cellular-enabled home BP monitors without a need for Wi-Fi or Bluetooth; simple communication modalities such as text messaging to support patient engagement; and integration into existing team-based workflows in safety-net clinics. METHODS: This study will be conducted with patients in San Francisco who are treated within a network of safety-net clinics. English and Spanish-speaking patients with diagnosed hypertension will be eligible for the trial if they have recent BP readings ≥140/90 mmHg and do not have co-morbid conditions that make home BP monitoring more complex to manage. This study will implement a three-arm randomized controlled trial to compare varying levels of implementation support: 1) cellular-enabled BP monitors (with minimal implementation support), 2) cellular-enabled BP monitors with protocol-based implementation support (text reminders for patients; aggregated BP summaries sent to primary care providers), and 3) cellular-enabled BP monitors and pharmacist-led support (pharmacist coaching and independent medication adjustments). RESULTS: For the main analysis, we will use mixed effects linear regression to compare the change in primary outcome of systolic BP. Secondary outcomes include BP control (<140/90 mmHg), medication intensification, patient-reported outcomes, and implementation processes (i.e., engagement with the intervention). DISCUSSION: This study will design and test a digital health intervention for use in marginalized populations treated within safety net settings, evaluating both effectiveness and implementation to advance more equitable health outcomes.

Satisfaction can co-exist with hesitation: qualitative analysis of acceptability of telemedicine among multi-lingual patients in a safety-net healthcare system during the COVID-19 pandemic.

BACKGROUND: The COVID-19 pandemic triggered unprecedented expansion of outpatient telemedicine in the United States in all types of health systems, including safety-net health systems. These systems generally serve low-income, racially/ethnically/linguistically diverse patients, many of whom face barriers to digital health access. These patients' perspectives are vital to inform ongoing, equitable implementation efforts. METHODS: Twenty-five semi-structured interviews exploring a theoretical framework of technology acceptability were conducted from March through July 2020. Participants had preferred languages of English, Spanish, or Cantonese and were recruited from three clinics (general medicine, obstetrics, and pulmonary) within the San Francisco Health Network. Both deductive and inductive coding were performed. In a secondary analysis, qualitative data were merged with survey data to relate perspectives to demographic factors and technology access/use. RESULTS: Participants were diverse with respect to language (52% non-English-speaking), age (range 23-71), race/ethnicity (24% Asian, 20% Black, 44% Hispanic/Latinx, 12% White), & smartphone use (80% daily, 20% weekly or less). All but 2 had a recent telemedicine visit (83% telephone). Qualitative results revealed that most participants felt telemedicine visits fulfilled their medical needs, were convenient, and were satisfied with their telemedicine care. However, most still preferred in-person visits, expressing concern that tele-visits relied on patients' abilities to access telemedicine, as well as monitor and manage their own health without in-person physical evaluation. CONCLUSIONS: High satisfaction with telemedicine can co-exist with patient-expressed hesitations surrounding the perceived effectiveness, self-efficacy, and digital access barriers associated with a new model of care. More research is needed to guide how healthcare systems and clinicians make decisions and communicate about visit modalities to support high-quality care that responds to patients' needs and circumstances.

Conducting Internet-Based Visits for Onboarding Populations With Limited Digital Literacy to an mHealth Intervention: Development of a Patient-Centered Approach.

BACKGROUND: The COVID-19 pandemic has propelled patient-facing research to shift to digital and telehealth strategies. If these strategies are not adapted for minority patients of lower socioeconomic status, health inequality will further increase. Patient-centered models of care can successfully improve access and experience for minority patients. OBJECTIVE: This study aims to present the development process and preliminary acceptability of altering in-person onboarding procedures into internet-based, remote procedures for a mobile health (mHealth) intervention in a population with limited digital literacy. METHODS: We actively recruited safety-net patients (English- and Spanish-speaking adults with diabetes and depression who were receiving care at a public health care delivery system in San Francisco, United States) into a randomized controlled trial of text messaging support for physical activity. Because of the COVID-19 pandemic, we modified the in-person recruitment and onboarding procedures to internet-based, remote processes with human support. We conducted a preliminary evaluation of how the composition of the recruited cohort might have changed from the pre-COVID-19 period to the COVID-19 enrollment period. First, we analyzed the digital profiles of patients (n=32) who had participated in previous in-person onboarding sessions prior to the COVID-19 pandemic. Next, we documented all changes made to our onboarding processes to account for remote recruitment, especially those needed to support patients who were not very familiar with downloading apps onto their mobile phones on their own. Finally, we used the new study procedures to recruit patients (n=11) during the COVID-19 social distancing period. These patients were also asked about their experience enrolling into a fully digitized mHealth intervention. RESULTS: Recruitment across both pre-COVID-19 and COVID-19 periods (N=43) demonstrated relatively high rates of smartphone ownership but lower self-reported digital literacy, with 32.6% (14/43) of all patients reporting they needed help with using their smartphone and installing apps. Significant changes were made to the onboarding procedures, including facilitating app download via Zoom video call and/or a standard phone call and implementing brief, one-on-one staff-patient interactions to provide technical assistance personalized to each patient's digital literacy skills. Comparing recruitment during pre-COVID-19 and COVID-19 periods, the proportion of patients with digital literacy barriers reduced from 34.4% (11/32) in the pre-COVID-19 cohort to 27.3% (3/11) in the COVID-19 cohort. Differences in digital literacy scores between both cohorts were not significant (P=.49). CONCLUSIONS: Patients of lower socioeconomic status have high interest in using digital platforms to manage their health, but they may require additional upfront human support to gain access. One-on-one staff-patient partnerships allowed us to provide unique technical assistance personalized to each patient's digital literacy skills, with simple strategies to troubleshoot patient barriers upfront. These additional remote onboarding strategies can mitigate but not eliminate digital barriers for patients without extensive technology experience. TRIAL REGISTRATION: Clinicaltrials.gov NCT0349025, https://clinicaltrials.gov/ct2/show/NCT03490253.

Nonsurgical Periodontal Therapy in CKD: Findings of the Kidney and Periodontal Disease (KAPD) Pilot Randomized Controlled Trial.

RATIONALE & OBJECTIVE: Observational studies have suggested that periodontal disease may be a modifiable risk factor for chronic kidney disease (CKD). The Kidney and Periodontal Disease (KAPD) Study was designed to determine the feasibility of conducting a periodontal disease treatment trial among a high-risk (mostly poor and racial/ethnic minority) population and estimate the magnitude and variability of kidney and inflammatory biomarker levels in response to intensive periodontal treatment. STUDY DESIGN: Single-center, unmasked, intention-to-treat, randomized, controlled, pilot trial with 2:1 allocation to the treatment and comparison groups. SETTING & PARTICIPANTS: English- and Spanish-speaking individuals aged 20 to 75 years receiving primary care within the San Francisco Community Health Network with evidence of both moderate to severe periodontal disease and CKD. INTERVENTION: Immediate intensive nonsurgical periodontal treatment versus rescue treatment for progressive disease at baseline and 4, 8, and 12 months. OUTCOMES: Feasibility and process outcomes. Levels of biomarkers of kidney function, kidney injury, and systemic inflammation obtained at baseline and 4 and 12 months. RESULTS: KAPD randomly assigned 51 participants to the immediate (34 participants) or rescue (17 participants) groups. 14% dropped out of the study (4 immediate, 3 rescue) and 80% completed all 4 visits of the 12-month protocol (28 immediate, 13 rescue). Fewer than half the teeth recommended for extraction were extracted and 40% of immediate group visits were outside the protocol window. Bleeding on probing and probing depth improved more in the immediate group than in the rescue group; there was no significant separation in periodontal status. Levels of markers of vascular endothelial and systemic injury declined in both groups. LIMITATIONS: No true control group. CONCLUSIONS: This 12-month, pilot, randomized, controlled trial successfully recruited and retained a high-risk population but was less successful observing treatment adherence, treatment effect, and variability of biomarker levels. Although KAPD did not meet all of its goals, important lessons learned can be applied to future studies. FUNDING: National Institute of Diabetes and Digestive and Kidney Disease (Bethesda, MD; grant number 1K23DK093710-01A1) and Harold Amos Medical Faculty Development Program of the Robert Wood Johnson Foundation, Princeton, NJ. Funders had no role in study design; collection, analysis, or interpretation of data; writing the report; or the decision to submit the report for publication. TRIAL REGISTRATION: NCT01802216.

The Kidney and Periodontal Disease (KAPD) study: A pilot randomized controlled trial testing the effect of non-surgical periodontal therapy on chronic kidney disease.

INTRODUCTION: Chronic kidney disease (CKD) remains a prevalent public health problem that disproportionately affects minorities and the poor, despite intense efforts targeting traditional risk factors. Periodontal diseases are common bacterial plaque-induced inflammatory conditions that can respond to treatment and have been implicated as a CKD risk factor. However there is limited evidence that treatment of periodontal disease slows the progression of CKD. METHODS/DESIGN: We describe the protocol of the Kidney and Periodontal Disease (KAPD) study, a 12-month un-blinded, randomized, controlled pilot trial with two intent-to-treat treatment arms: 1. immediate intensive non-surgical periodontal treatment or 2. rescue treatment with delayed intensive treatment. The goals of this pilot study are to test the feasibility of conducting a larger trial in an ethnically and racially diverse, underserved population (mostly poor and/or low literacy) with both CKD and significant periodontal disease to determine the effect of intensive periodontal treatment on renal and inflammatory biomarkers over a 12-month period. RESULTS: To date, KAPD has identified 634 potentially eligible patients who were invited to in-person screening. Of the 83 (13.1%) of potentially eligible patients who attended in-person screening, 51 (61.4%) were eligible for participation and 46 enrolled in the study. The mean age of participants is 59.2years (range 34 to 73). Twenty of the participants (43.5%) are Black and 22 (47.8%) are Hispanic. DISCUSSION: Results from the KAPD study will provide needed preliminary evidence of the effectiveness of non-surgical periodontal treatment to slow CKD progression and inform the design future clinical research trials.