Clinical trial NCT06027905: Novartis - Closing the Gap in Cardiovascular Risk: Engage, Empower, Evaluate
Official title: Novartis - Closing the Gap in Cardiovascular Risk: Engage, Empower, Evaluate
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hypertension
Keywords: hypertension
self-monitoring
social determinants of health
adherence
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
Collaborators: name: Novartis Pharmaceuticals
First posted: 2023-09-07
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aims to decrease the racial gap in high blood pressure in African American and Latinx patients in Rush University Medical Center clinics.

Detailed description: The study is a clinic-based study with remote patient monitoring that uses a team based intervention composed of community health worker (CHW), nurse (RN), pharmacist, and social worker (SW). Eligible patients are those who are 18 years old and over, African American and/or LatinX with elevated CVD risk starting with stage II hypertension following with a primary care provider in an eligible Rush primary care clinic who have access to a phone or device with call or video capabilities in their home. Eligible patients will be enrolled in the study by their participating Rush clinician via two methods: 1) encountering eligible patients during a clinic visit and enrolling them directly into the program with a community health worker (CHW); 2) generating a list of eligible elevated CVD risk patients and CHWs remotely calling patients to enroll in the program. Patients enrolled in the program will receive the intervention of additional resources for improvement of cardiovascular risk in addition to usual care.

For patients who are enrolled with a CHW onsite, the patient will proceed directly to a visit with the CHW. During the CHW visit, the patient will be introduced to the program, and will undergo verbal consent for the program. Screening for the social determinants of health (SDOH) (using the clinic questionnaire already in use at all Rush primary care clinics) will be completed if not already completed prior to the clinic visit. If patients screen positive for more than three social determinants of health needs, or if they screen positive for homelessness or violence independently, they will be referred to the program social worker who will proceed with a tailored social work intervention remotely during the 3 month course of the study. Patients will also complete the ARMS (Adherence to Refills and Medications Scale) medication adherence screening questionnaire, and receive a cellular enable blood pressure cuff provided from the company HealthSnap. The CHW will provide training on usage of the cuff and enroll the patient in the remote monitoring HealthSnap dashboard. HealthSnap and the remote dashboard are already in use for remote monitoring at Rush for other programs.

Patients will then start daily blood pressures at home which will automatically be transmitted via the cuff's cellular capabilities to the HealthSnap dashboard. They will continue to have weekly CHW virtual visits during the first month of the program that cover education around blood pressure monitoring compliance, medication adherence, social needs and lifestyle modifications via diet and activity for improvement of CVD risk as per the Heart2Heart Manual created by the Heart2Heart study at Rush. Additionally, directly after enrollment, the patient will receive a virtual visit from the program's nurse (RN) in 48 hours to complete a medication reconciliation. The RN will proceed by remotely monitoring the patient blood pressure readings in the HealthSnap portal. Settings have been created to trigger RN notification for action. These settings include a blood pressure greater than 180/110. In this case, the RN will call the patient and triage the patient for symptoms using the standard of care RN triage model in use in Rush's primary care clinics. If necessary, patient's will be scheduled for clinic follow-up or ED follow-up. Patient's who continue to have stage II hypertension without improvement over 14 days but do not tigger the alerts with elevated pressure, will be monitored at least once every 14 days by the RN, and if not improving, will be forwarded to a remote virtual study pharmacist visit for medication titration.

The study will proceed for a total of 12 weeks, with remote blood pressures recorded for patients daily in the HealthSnap portal. Study goals include improvement of blood pressure to below 130/90 and/or a decrease in systolic blood pressure by 10 mmHg points. If patients reach the goal prior to the end of the study, they will continue with the study until the the completion of the 12-week period, after which they will return to usual care. Patients who do not achieve the goal at the end of the 12-week period will return back to the standard of care model in the primary care clinic. Patients will receive a repeat SDOH screening questionnaire at completion of the study at 12 weeks and on follow-up at a 3-6 month window. A repeat blood pressure will be collected remotely at a 3-6 month window follow-up to assess adherence.

Study goals include enrollment of 150 patients during each 12-week intervention with rolling enrollment. The study will conclude after a 3 year period.

Each of the E3 team members (the CHW, RN, pharmacist, and SW) will document their interactions with the patient in Epic and REDCap as outreach encounters. The encounters will be structured so that important information, such as SDOH screening, race, ethnicity, sex, marital status, zip code, co-morbidities (obesity, diabetes, chronic kidney disease, heart failure, obstructive sleep apnea, and smoking), number of medications, insurer, and number of visits can be data-mined from the Epic notes for analysis. Patient information will be stored in a data base managed by the study data manager and analyst with de-identified patient information.

Data will be analyzed in a pre-intervention and post-intervention manner. Change in blood pressure will be noted, with special attention paid to corresponding changes in SDOH needs based on screening, number of intervention outreaches, and time spent during outreaches. The converse, a lack of a change in blood pressure will also be compared to SDOH needs documented in CHW and social work intervention outreaches as well as successful intervention outreaches.

Eligibility criteria: Inclusion Criteria:

* African American and/or Latinx self-identifying
* Stage II hypertension (140/90) or greater
* Following with Rush primary care provider in eligible Rush primary care clinic
* Access to phone or device with video capabilities in the home

Exclusion Criteria:

* Dialysis patient
* Organ transplant recipient

Primary outcomes:
measure: Percentage of total participants with improvement of hypertension to below 130/80 mmHg and/or a decrease of 10mmHg in systolic readings
timeFrame: Baseline, 12 weeks
measure: Percentage of total participants with sustained improvement of blood pressure below 130/80 mmHg at 3-6 month follow-up
timeFrame: 3-6 month follow-up after the 12 week intervention
Secondary outcomes:
measure: Correlation of change in SDOH survey score in relation to hypertension control below 130/80 mmHg
timeFrame: Baseline, 12 weeks
measure: Correlation of initial SDOH survey score in relation to hypertension control below 130/80 mmHg
timeFrame: Baseline, 12 weeks
measure: Correlation of frequency of self monitoring with post intervention ARMS survey scores
timeFrame: Baseline, 12 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
affiliation: Rush University Medical Center
name: David A Ansell, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Rush University Medical Center
name: Laura J Zimmermann, MD
role: PRINCIPAL_INVESTIGATOR
References: