Study design and overview
This is a parallel two-armed feasibility randomized controlled trial comparing Telehealth After Stroke Care (TASC) intervention (multidisciplinary team care inclusive of pharmacists with home BP monitoring with centralized remote nursing call support and tailored infographics to facilitate understanding of BP data) with usual care. It aims to evaluate the feasibility of a telehealth-based model providing multidisciplinary access including nursing, pharmacy, and physician care, and assess feasibility of an integrated telehealth approach to blood pressure management after stroke. The primary outcome of BP control will be defined by change in mean awake systolic blood pressure from baseline through remote monitoring at 3 months.
Remote BP monitoring will be provided with communication through tailored electronic tablet devices with feedback to centralized nurses for tailored telephone-based counseling and communication to providers as needed for elevated readings (figure 2). We will randomize 25 patients to the TASC intervention, including remote blood pressure monitoring, and 25 patients to usual care. Feasibility measures of interdisciplinary team competency, recruitment, retention, fidelity of implementation, and telehealth patient satisfaction surveys will be assessed in the intervention arm.
To our knowledge, no studies providing accessible integrated care including telehealth and remote BP monitoring with multidisciplinary teams including pharmacy and nursing have been conducted. Such an intervention may reduce racial disparities in post-stroke BP control by providing access to care and facilitating self-efficacy to improve health outcomes.
Setting and sample
Patients will be enrolled from the Columbia University Irving Medical Center (CUIMC) Comprehensive Stroke Center in the underserved area of Northern Manhattan that serves a majority Hispanic low-income community, as the representative Northern Manhattan Study (NOMAS) cohort reports a 53% Hispanic race/ethnicity with 44% on Medicaid/no insurance. The CUIMC Comprehensive Stroke Center refers patients post-discharge with Medicare/Medicaid to the Ambulatory Care Network (ACN) stroke clinic. Our hospital’s ACN, serving a predominantly Hispanic, and Black low-income urban population, started to provide telehealth general neurology visits with tele-pharmacy support to identify gaps in medication education and reconciliation before the coronavirus pandemic.
Eligible patients would include those with an acute ischemic or hemorrhagic stroke that are discharged home after hospitalization (Box 1) Hospital and clinic records contain other data including patient demographics and medical information. Efforts will be made to collect social determinants of health through validated measures for financial, food and housing insecurity along with demographics including income, education and housing information. Questions regarding internet use and access to electronics will also be asked in addition.
Patients who lack capacity
Many patients with stroke likely lack capacity to make decisions about their care. To be as inclusive as possible, we will include those patients who have caregivers but are able to respond to self-reported questions about their health. Capacity will be assessed during the screening process, and initial approach. If patients lack capacity, attempts will be made to identify and recruit an informal caregiver (such as family or friend) who can aid the patient, is involved in the medical decision-making process, and serves as the legally authorized representative. Such an individual will be noted in the informed consent.
The study starts recruitment after IRB approval, and each participant will be followed for three months from the time of acute stroke hospitalization setting in till three months post-acute stroke in the home setting (Figure 1). Table 1 details the schedule of study enrollment, interventions, and assessments planned through the study till completion. The SPIRIT checklist which details the recommended items to include in a clinical trial protocol, is available in Additional file 1.
Screening and identification
Suitably qualified research staff and team members will screen and identify eligible patients from the stroke center admitted with acute stroke. All patients admitted with acute stroke will be screened for eligibility. To achieve adequate participant enrolment to reach target sample size, recruitment will be expanded to patients homebound from our inpatient acute rehabilitation if we are not able to meet recruitment targets. Detailed screening logs will record numbers of eligible patients, key reasons for ineligibility, and recruitment/refusal rates. Screening data will be used to complete the CONSORT diagram for interventional trials.  This will document the flow of participants through the study. Patients enrolled in other intervention trials will not approached without approval of principal investigators and with team consensus. Patients will continue to receive care through inpatient team and upon discharge, with outpatient providers at the patient’s discretion.
IRB (Institutional Review Board) approval has been obtained for all processes. Recruitment is expected to take 6 months. To ensure a diverse patient population, bilingual research and clinical coordinators will be available as an integral part of the team for patient engagement at the time of enrollment. All instruments used will be available in English and Spanish versions for ease of use. Providers will be sensitive to need for translation services as applicable. Additional hospital-based interpretation services will be utilized on site on through telephone services if needed for Spanish speaking patients. Any participant requesting a willing family member to provide translation will also be included.
Approach and consent
In addition to screening patients for inclusion and exclusion criteria, clinical team members will be consulted prior to approaching the patient (e.g., if they are well enough or available, not undergoing clinical testing and planned for discharge). Sequential eligible patients will be approached prior to discharge from the hospital to assess their interest in enrollment. The research team will provide verbal explanation of the study, and patients will have an opportunity to ask questions and consider their participation. If patients wish to take part, they will be provided with a written consent form to consider and complete. Legally Authorized Representatives (LARs) will provide consent for patients with aphasia who are otherwise interested. Baseline assessments of socioeconomic determinants of health and patient reported measures with validated surveys will be completed prior to participant randomization.
Randomization and blinding
We will randomize patients (1:1) to intervention versus usual care using a computer-generated block design for parallel assignment. The randomization allocation sequence will be developed by a statistician not involved in the enrollment procedures. The outcomes assessors will be blinded after participant assignment to intervention We plan to stratify based on race to assure that the groups are balanced with respect to baseline risk and sample.
The rights of the patients to withdraw will be respected in the study. They will be informed of this in the consent process, and their care or treatment will not be affected. Data previously collected will be used in analysis and where possible, a reason for withdrawal will be recorded. If patients are unexpectedly discharged from the hospital to a nursing care facility, other than short period of acute rehabilitation stay, they will become ineligible and will be withdrawn.
TASC intervention program (components)
TASC program components of integrated care and multidisciplinary team approach are discussed as below and outlined in Box 2.
Multidisciplinary team inclusive of a pharmacist
The newly assembled team consists of nursing, pharmacy, and physician care. This is a project that has brought together faculty from diverse disciplines who have not previously been involved as collaborators in post-stroke care.
A team providers meeting will be held bimonthly as a “share and learn” touch point. Patients undergoing follow up visits and remote BP monitoring will be discussed, issues identified, and an action plan generated to improve processes in care provided. Fidelity of implementation for each patient will also be reviewed with all providers. Any problems identified in providing the intervention, as well as mediators in enforcing follow ups and monitoring will used to inform further aims of the intervention.
Staff training will be provided to implement visually tailored infographics to patients regarding BP readings. Most recent recorded BP will be used to discuss BP goals and provide education regarding need for BP control. Remote BP monitoring team nurses will receive feedback regarding changes made to medication regimens at telehealth visits to provide guided support to patients at touch point calls. Staff schedulers and coordinators will work closely with providers and patients to schedule follow up appointments and coordinate patient care with updated contact information within discussed time frames. They will receive additional training in trial requirements and provide support for team members.
Remote BP monitoring
Our integrated care includes remote BP monitoring and electronic tablet devices provided through New York Presbyterian at no charge to patients with remote support including centralized telehealth nursing calls to patients for elevated readings and driven by patient feedback for frequency.
Patients randomized to telehealth services will be set up with a Philips Remote Blood Pressure Monitoring (RBPM) kit including an electronic device (Samsung tablet with 2-way video capable of telemedicine) and BP/pulse monitor and set up for remote monitoring. These services are designed to reduce disparities in technology literacy with home or remote installation as needed along with step-by-step instructions and explanations provided to each participant in their language of preference. Further, there is no need for patients to have their own technology or internet services as a tablet is included with data transfer capability. BP devices provided have been validated for use.
Certified nurses will touch base through phone calls with patients at intervals set to patient preference and escalate severely elevated BP readings to providers (Figure 2). BP monitoring results as well as patient reported surveys completed on the electronic tablet are wirelessly transmitted to electronic health records and to a web-based platform (eCare Coordinator) available for the telehealth nurses and the patient’s treating clinical team to see. Critical BP or pulse readings will be shared via system alerts, at which point the call center nurse will contact the patient and assess. If unable, this is to be followed with escalation calls for elevated readings that require immediate attention to the TASC team for resolution (Figure 2). If patients fail to measure BP data at home for a week that the device automatically transmits, they will be contacted by the call center nurse to enquire. If device trouble shooting is needed, technical assistance will be provided in person or remotely as indicated.
Telehealth visits by each discipline
Patients/caregivers will receive instructions regarding equipment use for telehealth video visits and the first telehealth visits after discharge will be scheduled with the nurse practitioner at 1-2 weeks (±5d), pharmacist at 4 and 8 weeks (±5d), and physician at 6 and 12 weeks (±5d). These visits are set at different intervals to serve as different points of visual contact with the patient and reduce duration burden of each visit. At the first visit, patients will be shown on their tablet screen an infographic tailored with their most recent BP value at hospital discharge integrated into a transitions of care management visit with a primary care nurse practitioner (see Figure 4). The infographic will serve as the centerpiece of a motivational interview about addressing barriers to medication adherence. The pharmacist will meet with patient to review medication adherence, effectiveness through BP log, and lifestyle modifications. When not well controlled and evidence-based guideline driven, the pharmacist will adjust medications under the collaborative drug therapy management agreement. Tele-pharmacy visits are possible through the collaborative drug therapy management law in New York State which allows eligible pharmacists to formulate agreements with physicians for chronic disease management. They will also address side effects and interactions of medications at these visits. Treatment of hypertension and selection of BP lowering medications will be in accordance with latest published guidelines for BP management. The physician will provide patient tailored adjustments to the care plan and monitor for any adverse events, and stroke related complications.
BP infographics (Figure 3) are to be used to provide self-management awareness and BP visual education. These will be tailored to the patient’s blood pressure at the time of discharge and shared on the screen during the first telehealth visit to drive a motivational interview guided by patient responses regarding health behaviors.
Comparison group (usual care)
Participants randomized to comparison group will receive a one- and three-month post-stroke follow-up appointment. They will receive a transitional care management visit at 1-2 weeks post discharge in addition to stroke physician visits as part of the study to ensure timely follow ups. Although these may not be routinely possible, these are considered best practices. Patient-reported outcomes will be collected after consent and at three months follow-up including surveys and BP measurement.
Feasibility for the project will be monitored with metrics of at least one subject per week to be recruited, weekly and monthly recruitment rates assessed with estimates of these rates gathered at the end of the study. We will also assess completion rates of remote BP monitoring among intervention participants compared to usual care; as well as telehealth visit follow ups with multidisciplinary team in all recruited subjects. We will also assess feasibility of workflow of the randomization procedure. Patients will receive BP monitors at different times to meet ethical and clinical standards, either at the start for patients in the intervention arm or at study end in the usual care arm.
Fidelity of implementation will be assessed using a brief checklist at each patient visit by each discipline. An internally designed and validated survey, Telemedicine Satisfaction and Usefulness Questionnaire (TSUQ) provides measures of patient satisfaction and will be collected at 3 months among intervention patients to assess patient satisfaction with telehealth (Box 3). Self-Assessment of Interdisciplinary Research Competencies will be surveyed at the beginning and end of the project to establish progress and satisfaction among TASC providers and investigators in this collaboration.[67-69]
RBPM will be conducted among participants in the intervention arm from time of discharge through to 3 months. Readings from the first 24 hours at 3 months in control will be collected.
Patient reported outcomes will be collected using the PROMIS tools (self-efficacy of medication adherence and treatment, Neuro-QOL Depression and Cognitive Function) as well as Patient Activation Measure (PAM) at time of consent and at three months among all participants. The effect of empowering stroke survivors’ self-management can be assessed through surveys of medication adherence and treatment self-efficacy, and activation in health behaviors.
Patient demographics, social determinants of health (age, education, race/ethnicity, address, income, insurance type, along with food, housing, and income security), internet and electronic devices access questions, and medical characteristics (risk factors, comorbidity burden, stroke adjudication) will be collected from the patient and electronic medical records in a data collection form at discharge and at three months.
RBPM will be set up for the intervention arm through to 3 months. Patients in the usual care arm will receive the BP monitoring kit with remote assistance at 11 weeks and provide readings at 3 months for outcome assessment. They will also be aided through the remote monitoring team with survey completion if needed. All completed surveys and BP readings will be converted to transferrable format and transmitted via the online platform to REDCap database at 3 months for study completion. Electronic medical records will also be revisited at study end for any additional surveys conducted during patient visits for clinical screening and management purposes.
Data management, monitoring, and safety reporting
Patient data will be recorded on case report forms (CRFs) built into a REDCap (Research Electronic Data Capture) dictionary hosted at the Neurological Institute of New York, Columbia University. REDCap is a secure, web-based application designed to support data capture for research studies. Participants will be assigned a unique code identification number and all data will be completely anonymized for purpose of analysis and reporting. Electronic data and hard copies will be stored securely.
Data will also be monitored for quality and completeness. Investigators will do their utmost to ensure data completeness, and any missing data will be chased unless confirmed not to be available at the time of each patient close-out visit. Survey data will be directly collected from participants, and thus will not be subject to data verification. All consent forms will be encrypted and stored securely in the Neurological Institute. Any unexpected adverse effects will be reviewed by the primary investigator and reported to the sponsor and ethics committee.
Patient reported outcomes (PROs) such as post-stroke depressive symptoms and cognitive function will be captured through web-based tablet-enabled software provided by Patient Reported Outcome Measurement Information System (PROMIS), developed by National Institutes of Health funded endeavors to provide precise and flexible electronically administrable tools. Surveys would also be uploaded to the tablet included in the RPBM kit for patients to complete and send automatically from the tablet. RBPM data and online surveys will be collected on a web-based platform and transferred in configured format to integrate into REDCap as patients complete the study. Telehealth visit data will be collected from electronic medical records. The video platform utilized will be noted, to ensure that only currently available HIPAA compliant applications are used.
As this is a feasibility study with a small sample size, pilot data will be used to assess feasibility and estimate the variability in the endpoint, while provide preliminary evidence for BP control. A subsequent trial designed will be powered to detect the clinically significant difference to plan a larger confirmatory trial. However, more importantly, descriptive statistics will characterize the randomized patients completing surveys and outcome assessments. Generalized linear modeling will evaluate systolic BP outcome 90 days post discharge as a function of treatment, race/ethnicity and the interaction of treatment arm and race/ethnicity. We will explore moderating effects of race/ethnicity as secondary analysis. Decisions regarding the pursuit of a subsequent trial will be based on feasibility of the trial, and analysis of all other measures will be hypothesis generating.