Effects of a Dietitian-Led, Telehealth Lifestyle Intervention on Blood Pressure: Results of a Randomized, Controlled Trial.

Background Limited data exist on the benefits of lifestyle behavior change delivered using telehealth and web-based applications with varied support on blood pressure (BP). Methods and Results We conducted a 2-site randomized controlled trial at Geisinger (January 2019-March 2021) to compare the efficacy of 2 remotely delivered strategies using web-based applications in participants with 24-hour systolic BP 120-160 mm Hg and body mass index ≥25 kg/m2. Both arms received access to web-based applications and the same lifestyle guidance per American Heart Association guidelines. One arm received minimal nonclinical staff support, and the other arm received dietitian support with motivational interviewing during weekly calls. The primary outcome was 12-week change in 24-hour systolic BP. A total of 187 participants were randomly assigned, with 156 (83.4%) completing the trial. In both arms, 24-hour systolic BP was reduced at follow-up, but the difference in BP change was not significant (dietitian-led arm, -6.73 mm Hg [95% CI, -8.64 to -4.82]; minimal-support arm, -4.92 [95% CI, -7.01 to -2.77]; P comparing groups=0.2). The dietitian-support arm had greater 12-week improvements in the secondary outcomes sleep systolic BP (mean, -6.92 versus -1.45; P=0.004), sleep diastolic BP (-3.31 versus 0.73; P=0.001), and self-reported physical activity (866 versus -243 metabolic equivalent task minutes per week; P=0.01) and tended to have improvements in weight loss (-5.11 versus -3.89 kg; P=0.1) and Healthy Eating Index-2015 score (9.23 versus 6.43 units; P=0.09). Conclusions Both the dietitian- and minimal-support interventions reduced 24-hour systolic BP similarly, although the dietitian-led intervention led to greater improvements in several secondary cardiometabolic outcomes. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT03700710.

Effects of Dietary App-Supported Tele-Counseling on Sodium Intake, Diet Quality, and Blood Pressure in Patients With Diabetes and Kidney Disease.

OBJECTIVES: The aim of this study is to examine the effect of a telehealth intervention that used a dietary app, educational website, and weekly dietitian tele-counseling on sodium intake, diet quality, blood pressure, and albuminuria among individuals with diabetes and early-stage chronic kidney disease. DESIGN AND METHODS: We examined the effects of a dietary app-supported tele-counseling intervention in a single center, single arm study of 44 participants with type 2 diabetes and stage 1-3a chronic kidney disease. Participants recorded and shared dietary data via MyFitnessPal with registered dietitians, who used motivational interviewing to provide telephone counseling weekly for 8 weeks. After the 8-week intensive intervention, participants were followed at 6 and 12 months. Outcomes included 24-hour urine sodium (2 collections per timepoint), Healthy Eating Index 2015 score (three 24-hour dietary recalls per timepoint), 24-hour systolic blood pressure (SBP) and diastolic blood pressure (DBP), and 24-hour urine albumin excretion. RESULTS: Out of 44 consented participants (mean age 60.3 ± 11.9 years, 43% female, 89% white, median estimated glomerular filtration rate was 78.5 mL/min/1.73 m2, median urine albumin excretion 52.9 mg/day, 84% hypertension), 32 (73%) completed 8-week follow-up, 27 (61%) completed 6-month follow-up, and 25 (57%) completed 12-month follow-up. Among participants who completed 12-month follow-up, reported sodium intake decreased by 638 mg/day from baseline of 2,919 mg/day (P < .001). The 24-hour mean urine sodium and albumin excretion did not decline over the study period. Healthy Eating Index 2015 score improved by 7.76 points at 12 months from a mean baseline of 54.6 (P < .001). Both 24-hour SBP and DBP declined at 12 months from baseline (SBP -5.7 mm Hg, 95% confidence interval -10.5 to -1.0, P = .02; DBP -4.1 mm Hg, 95% confidence interval -7.2 to -1.1, P = .01). CONCLUSIONS: Overall, this study demonstrates that a short, intensive, remotely delivered dietary intervention for adults with type 2 diabetes and early chronic kidney disease at high risk for disease progression and cardiovascular complications led to improvement in blood pressure and self-reported sodium intake and diet quality, but no improvement in albuminuria. Future research studies are needed to examine whether remotely delivered dietary interventions can ultimately improve kidney health over time.

Integrated Digital Health System Tools to Support Decision Making and Treatment Preparation in CKD: The PREPARE NOW Study.

RATIONALE & OBJECTIVE: Digital health system tools to support shared decision making and preparation for kidney replacement treatments for patients with chronic kidney disease (CKD) are needed. STUDY DESIGN: Descriptive study of the implementation of digital infrastructure to support a patient-centered health system intervention. SETTING & PARTICIPANTS: 4 CKD clinics within a large integrated health system. EXPOSURE: We developed an integrated suite of digital engagement tools to support patients' shared decision making and preparation for kidney failure treatments. Tools included an automated CKD patient registry and risk prediction algorithm within the electronic health record (EHR) to identify and prioritize patients in need of nurse case management to facilitate shared decision making and preparation for kidney replacement treatments, an electronic patient-facing values clarification tool, a tracking application to document patients' preparation for treatments, and an EHR work flow to broadcast patients' treatment preferences to all health care providers. OUTCOMES: Uptake and acceptability. ANALYTIC APPROACH: Mixed methods. RESULTS: From July 1, 2017, through June 30, 2018, the CKD registry identified 1,032 patients in 4 nephrology clinics, of whom 243 (24%) were identified as high risk for progressing to kidney failure within 2 years. Kidney Transitions Specialists enrolled 117 (48%) high-risk patients by the end of year 1. The values tool was completed by 30/33 (91%) patients who attended kidney modality education. Nurse case managers used the tracking application for 100% of patients to document 287 planning steps for kidney replacement therapy. Most (87%) high-risk patients had their preferred kidney replacement modality documented and displayed in the EHR. Nurse case managers reported that the tools facilitated their identification of patients needing support and their navigation activities. LIMITATIONS: Single institution, short duration. CONCLUSIONS: Digital health system tools facilitated rapid identification of patients needing shared and informed decision making and their preparation for kidney replacement treatments. FUNDING: This work was supported through a Patient-Centered Outcomes Research Institute (PCORI) Project Program Award (IHS-1409-20967). TRIAL REGISTRATION: ClinicalTrials.gov NCT02722382.

Telehealth versus self-directed lifestyle intervention to promote healthy blood pressure: a protocol for a randomised controlled trial.

INTRODUCTION: Weight loss, consumption of a Dietary Approaches to Stop Hypertension dietary pattern, reduced sodium intake and increased physical activity have been shown to lower blood pressure (BP). Use of web-based tools and telehealth to deliver lifestyle counselling could be potentially scalable solutions to improve BP through behavioural modification though limited data exists to support these approaches in clinical practice. METHODS AND ANALYSIS: This randomised controlled trial will compare the efficacy of a telehealth versus self-directed lifestyle intervention in lowering 24-hour SBP in patients with overweight/obesity (body mass index ≥25 kg/m2) and 24-hour SBP 120-160 mm Hg. All participants receive personalised recommendations to improve dietary quality based on a web-based Food Frequency Questionnaire, access to an online comprehensive weight management programme and a smartphone dietary app. The telehealth arm additionally includes weekly calls with registered dietitian nutritionists who use motivational interviewing. The primary outcome is change from baseline to 12 weeks in 24-hour SBP. Secondary outcomes include changes from baseline in 24-hour diastolic BP, daytime SBP, nighttime SP, daytime diastolic BP, nighttime diastolic BP, total Healthy Eating Index-2015 score, weight, waist circumference and physical activity. Other prespecified outcomes will include change in individual components of the Healthy Eating Index-2015 score, and satisfaction with the Healthy BP research study measured on a 5-point Likert scale. ETHICS AND DISSEMINATION: The study has been approved by the Geisinger Institutional Review Board. Results will be disseminated through peer-reviewed publications and conference presentations. TRIAL REGISTRATION NUMBER: NCT03700710.

Targeting Patient and Health System Barriers To Improve Rates of Hemodialysis Initiation with an Arteriovenous Access.

Background: Guidelines recommend pre-emptive creation of arteriovenous (AV) access. However, <20% of US patients initiate hemodialysis (HD) with a functional AV access. We implemented a quality improvement (QI) program to improve pre-HD vascular access care. Methods: After conducting qualitative research with key informants, we implemented a 7-month vascular access support QI program at Geisinger Health. The program targeted patient and health system barriers to AV access through education, needs assessment, peer support, care navigation, and electronic supports. We performed pre-, intra-, and postprogram stakeholder interviews to identify program barriers and facilitators and to assess acceptability. In a research substudy, we compared pre- and postprogram self-efficacy, knowledge, and confidence navigating vascular access care. Results: There were 37 patient and 32 clinician/personnel participants. Of the 37 patients, 34 (92%) completed vascular access-specific education, 33 (89%) underwent needs assessment, eight (22%) engaged with peer mentors, 21 (57%) had vein mapping, 18 (49%) had an initial surgical appointment, 15 (40%) underwent AV access surgery, and six (16%) started HD during the 7-month program. Qualitative findings demonstrated program acceptability to participants and suggested that education provision and emotional barrier identification were important to engaging patients in vascular access care. Research findings showed pre- to postprogram improvements in patient self-efficacy (28.1-30.8, P=0.05) and knowledge (4.9-6.9, P=0.004), and trends toward improvements in confidence among patients (8.0-8.7, P=0.2) and providers (7.5-7.8, P=0.1). Conclusions: Our intervention targeting patient and health system barriers improved patient vascular access knowledge and self-efficacy. Clinical Trial registry name and registration number: Breaking Down Care Process and Patient-level Barriers to Arteriovenous Access Creation Prior to Hemodialysis Initiation, NCT04032613.

Remote Dietary Counseling Using Smartphone Applications in Patients With Stages 1-3a Chronic Kidney Disease: A Mixed Methods Feasibility Study.

OBJECTIVE(S): Although healthy dietary patterns are associated with decreased mortality in patients with chronic kidney disease (CKD), few patients receive dietitian counseling due to concerns such as dietitian availability, travel distance, and cost. Our objective was to determine the feasibility of dietary smartphone application-supported telecounseling to reduce sodium intake and improve dietary quality in patients with early CKD. METHODS: This was a pre-post, mixed methods feasibility study of 16 patients with Stage 1-3a CKD in central/northeast Pennsylvania. Patients recorded and shared dietary data via smartphone applications with registered dietitians, who used motivational interviewing to provide telephone counseling weekly for 8 weeks. Seven patients were assigned to a customized study-specific application and nine patients to a commercially available, free application (MyFitnessPal). Participant satisfaction was assessed via survey, and participants were invited to complete a semistructured interview. Outcomes assessed included sodium intake, Healthy Eating Index 2015 score, weight, and 24-hour blood pressure (BP). RESULTS: Mean age was 64.7 years, 31% were female, 100% were white, 13% had income <$25,000. Adherence was excellent with 14 (88%) entering dietary data at least 75% of total days. Patients reported high satisfaction with the intervention and dietitian telecounseling. Use of dietary apps was viewed positively for allowing tracking of sodium and energy intake although some participants experienced functionality issues with the customized application that were not generally experienced by those using the commercially available free application. Sodium intake (-604 mg/day, 95% confidence interval [CI]: -1,104 to -104), Healthy Eating Index 2015 score (3.97, 95% CI: 0.03-7.91), weight (-3.4, 95% CI: -6.6 to -0.1), daytime systolic BP (-5.8, 95% CI: -12.1 to 0.6), and daytime diastolic BP (-4.1, 95% CI: -7.9 to -0.2) improved after the intervention. CONCLUSIONS: An application-supported telecounseling program with a registered dietitian appears to be a feasible and well-accepted strategy to improve dietary quality and improve cardiovascular risk factors in patients with early kidney disease.

Improving proteinuria screening with mailed smartphone urinalysis testing in previously unscreened patients with hypertension: a randomized controlled trial.

BACKGROUND: Proteinuria screening is recommended for patients with hypertension to screen for kidney disease and identify those at elevated risk for cardiovascular disease. However, screening rates among hypertensive patients are low. Home testing strategies may be useful in improving proteinuria screening adherence. METHODS: We conducted an individual-level, randomized trial at 55 primary care clinic sites in the Geisinger Health System to evaluate the effectiveness of a strategy using home smartphone urinalysis test (Dip.io) to complete proteinuria screening in previously unscreened non-diabetic patient portal users with hypertension. All patients received an educational letter and a standing urinalysis lab order, and then were randomized to control (usual care) or intervention. Intervention arm participants were invited to complete proteinuria screening with a mailed home smartphone urinalysis test. Co-primary outcomes were completion of proteinuria screening and number of albuminuria cases (albumin/creatinine ratio [ACR] ≥ 30 mg/g or protein/creatinine ratio ≥ 150 mg/g) at the end of 3 months. We also evaluated patient satisfaction with the home test, and compliance with recommendations for patients with newly detected albuminuria. RESULTS: A total of 999 patients were randomized to intervention or control. Out of 499 patients assigned to the intervention arm, 253 were reached by phone, and 69/97 (71.1%) consented patients completed the home test. Overall, the intervention increased proteinuria screening completion (28.9% vs. 18.0%; p < 0.001) with no effect on the number of albuminuria cases (4 vs. 4) although only 6/57 (10.5%) patients with trace or 1+ urine dipstick protein had a follow-up quantitative test. Among the 55 patients who completed a survey after the home test, 89% preferred testing at home rather than the physician's office. CONCLUSIONS: A strategy using a home urinalysis smartphone test increased proteinuria screening rates in previously unscreened patients with hypertension and may be useful in increasing rates of proteinuria screening compliance. Future studies should evaluate use of home testing kits to screen for and confirm albuminuria, and determine whether improving early detection of kidney disease can improve future kidney health. TRIAL REGISTRATION: Clinical Trial Registry: NCT03470701 (First posted 3/20/2018) https://clinicaltrials.gov/ct2/show/NCT03470701 . This study was retrospectively registered.

Using pharmacists to improve risk stratification and management of stage 3A chronic kidney disease: a feasibility study.

BACKGROUND: Measurement of albuminuria to stratify risk in chronic kidney disease (CKD) is not done universally in the primary care setting despite recommendation in KDIGO (Kidney Disease Improving Global Outcomes) guidelines. Pharmacist medication therapy management (MTM) may be helpful in improving CKD risk stratification and management. METHODS: We conducted a pragmatic, cluster-randomized trial using seven primary care clinic sites in the Geisinger Health System to evaluate the feasibility of pharmacist MTM in patients with estimated glomerular filtration rate (eGFR) 45-59 ml/min/1.73 m2 and uncontrolled blood pressure (≥150/85 mmHg). In the three pharmacist MTM sites, pharmacists were instructed to follow a protocol aimed to improve adherence to KDIGO guidelines on testing for proteinuria and lipids, and statin and blood pressure medical therapy. In the four control clinics, patients received usual care. The primary outcome was proteinuria screening over a follow-up of 1 year. A telephone survey was administered to physicians, pharmacists, and patients in the pharmacist MTM arm at the end of the trial. RESULTS: Baseline characteristics were similar between pharmacist MTM (n = 24) and control (n = 23) patients, although pharmacist MTM patients tended to be younger (64 vs. 71 y; p = 0.06) and less likely to have diabetes (17 % vs. 35 %; p = 0.2) or baseline proteinuria screening (41.7 % vs. 60.9 %, p = 0.2). Mean eGFR was 54 ml/min/1.73 m2 in both groups. The pharmacist MTM intervention did not significantly improve total proteinuria screening at the population level (OR 2.6, 95 % CI: 0.5-14.0; p = 0.3). However, it tended to increase screening of previously unscreened patients (78.6 % in the pharmacist MTM group compared to 33.3 % in the control group; OR 7.3, 95 % CI: 0.96-56.3; p = 0.05). In general, the intervention was well-received by patients, pharmacists, and providers, who agreed that pharmacists could play an important role in CKD management. A few patients contacted the research team to express anxiety about having a CKD diagnosis without prior knowledge. CONCLUSIONS: Pharmacist MTM may be useful in improving risk stratification and management of CKD in the primary care setting, although implementation requires ongoing education and multidisciplinary collaboration and careful communication regarding CKD diagnosis. Future studies are needed to establish the effectiveness of pharmacist MTM on slowing CKD progression and improvement in cardiovascular outcomes. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02208674 Registered August 1, 2014, first patient enrolled September 30, 2014.

Patients, care partners, and shared access to the patient portal: online practices at an integrated health system.

OBJECTIVE: To describe the characteristics and online practices of patients and "care partners" who share explicit access to a patient portal account at a large integrated health system that implemented shared access functionality in 2003. MATERIALS AND METHODS: Survey of 323 patients and 389 care partners at Geisinger Health System with linked information regarding access and use of patient portal functionality. RESULTS: Few (0.4%) registered adult patient portal users shared access to their account. Patients varied in age (range: 18-102); more than half had a high school education or less (53.6%). Patient motivations for sharing access included: to help manage care (41.9%), for emergency reasons (29.7%), lack of technology experience (18.4%), or care partner request (10.0%). Care partners were parents (39.8%), adult children (27.9%), spouses (26.2%), and other relatives (6.1%). Patients were more likely than care partners to have inadequate health literacy (54.8% versus 8.8%, P < .001) and less confident in their ability to manage their care (53.0% versus 88.1%; P < .001). Care partners were more likely than patients to perform health management activities electronically (95.5% versus 48.4%; P < .001), access the patient portal (89.2% versus 30.3%; P < .001), and use patient portal functionality such as secure messaging (39.6% versus 13.9%; P < .001). Care partners used their own credentials (89.1%) and patient credentials (23.3%) to access the patient portal. DISCUSSION AND CONCLUSION: Shared access is an underused strategy that may bridge patients' health literacy deficits and lack of technology experience and that helps but does not fully resolve concerns regarding patient and care partner identity credentials.