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Remote Monitoring and Virtual Collaborative Care For Hypertension Control to Prevent Cognitive Decline Phase II (vCCC 2)

Primary Purpose

Hypertension

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual Collaborative Care Clinic
Sponsored by
University of Kansas Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 65 and older
  • Active patient in participating primary care clinic
  • Access to compatible "smartphone" or device (i.e., Android, Kindle or Apple with internet connectivity or mobile network)
  • Elevated BP as defined by
  • SBP >140 at current visit AND documented history of hypertension OR SBP > 140 at current visit and at another visit in last 18 months OR SBP >160 at current visit
  • Sufficiently fluent in English to participate in study procedures
  • Adequate hearing to complete study procedures
  • Able to give their own signed consent
  • Health insurance coverage by Medicare

Exclusion Criteria:

  • Clinically significant illness that may affect safety or completion per their treating PCP or study physician
  • Needing interpreter for clinic visits (through Electronic Health Record)
  • Currently in hospice care
  • Currently receiving chemotherapy
  • Unable to take accurate BP measurement, either due to inability to follow protocol to check BP or due to medical conditions such as lymphedema or dialysis access on both arms.
  • Currently participating in another intervention trial
  • End stage kidney disease on dialysis
  • Diagnosis of dementia (i.e., dementia, Alzheimer's disease, vascular dementia, dementia with Lewy bodies, frontotemporal dementia)
  • Chronic active disease with expected life expectancy < 2 years as determined by the study team

Sites / Locations

  • University of Kansas Health SystemRecruiting
  • University of UtahRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual Care with Education

Virtual Collaborative Care Clinic

Arm Description

The participant will be provided with educational material and a home BP monitor. Control participants will continue to see their physicians for their usual care for BP management (their BP data will not be reviewed by pharmacists and the patients will not have support from vCCC pharmacists)

Participants will partake in the virtual collaborative care clinic

Outcomes

Primary Outcome Measures

Systolic Blood Pressure (SBP) Control At 24 Months
Our primary outcome is achieving SBP control (<130 mmHg). Blood pressure measures will be collected in a dashboard system and will be integrated into the common data model table for final analysis. Investigators will utilize the Benjamini-Hochberg approach to control for multiple testing in our primary outcome.

Secondary Outcome Measures

Cognitive Measures
Investigators will use composite z score obtained by averaging standardized z scores of individual NP test scores and use z scores of individual tests to determine changes in a single test that may be obscured with the measurement of a global score. The tests are Montreal Cognitive Assessment (MoCA) Blind, Rey Auditory Verbal Learning Test (RAVLT), Number Span Forwards and Backwards (NSFB), Oral Trail Making Test (OTMT), Category Fluency, Verbal Fluency, Rey Auditory Verbal Naming Test Delayed Recall and Recognition, and Verbal Naming Test (VNT). MoCA Blind has 22 possible points, with19 or above normal. NSFB gives 2 scores, total number of correct trials and longest sequence repeated correctly with higher score indicating better working memory. The category fluency has 2 possible scores with a higher number of unique names indicating a better semantic memory. For the Verbal Fluency test the score reflects the number of unique responses with a higher score indicating better memory
Major Adverse Cardiovascular Events (MACE)
Data from the electronic health record (EHR) will be extracted. MACE will be identified by will be identified by International Statistical Classification of Diseases and Related Health Problems (ICD) and Current Procedural Terminology (CPT) codes for hospitalization due to myocardial infarction (MI), nonfatal stroke, coronary revascularization, and heart failure, which will be identified by combining observations from EHR
Atherosclerotic Cardiovascular Disease Risk (ASCVD)
Data from the EHR will be extracted. (ASCVD) score will be estimated by age, sex, race, BP, total cholesterol, HDL cholesterol, history of diabetes, smoking status, HTN treatment, statin and aspirin therapy. ASCVD score is given as a percentage. A 0 to 4.9% risk is considered low risk, 5 to 7.4% is considered borderline, a 7.5 to 20% risk is considered intermediate, and a score above 20% is considered high.
Health Care Resource Utilization: Charges Per Patient
Health utilization outcome measurement will be ascertained mainly by CMS claims data. The utilization outcome measurement will include charges per patient (measured as total and average dollar amount of charges).
Mortality
All-cause mortality, as a composite endpoint, will be obtained from Common Data Model DEATH table and be ascertained by linked Medicare Beneficiary Summary File available from Centers for Medicare and Medicaid Services (CMS)
Systolic Blood Pressure (SBP) Control At 12 Months
Our primary outcome is achieving SBP control (<130 mmHg). Blood pressure measures will be collected in a dashboard system and will be integrated into the common data model table for final analysis. Investigators will utilize the Benjamini-Hochberg approach to control for multiple testing in our primary outcome.
Health utilization outcome measurement: Carrier Claims
Health utilization outcome measurement will be ascertained mainly by CMS claims data. The utilization outcome measurement will include healthcare-facility-metrics, such as carrier (physician Part B) claims (measured as total and average counts of distinct claims)
Health utilization outcome measurement: facility claims
Health utilization outcome measurement will be ascertained mainly by CMS claims data. The utilization outcome measurement will include outpatient, inpatient, skilled nursing facility claims (measured as total and average counts of distinct claims).
Health utilization outcome measurement: coronary care claims
Health utilization outcome measurement will be ascertained mainly by CMS claims data. The utilization outcome measurement will include component-of-care metrics, such as coronary care claims (measured as total and average counts of distinct claims)
Health utilization outcome measurement: coronary care expenditures
Health utilization outcome measurement will be ascertained mainly by CMS claims data. The utilization outcome measurement will include component-of-care metrics, such as coronary care expenditures (measured as total and average dollar amount of charges) per patient
Health utilization outcome measurement: coronary care unit days
Health utilization outcome measurement will be ascertained mainly by CMS claims data. The utilization outcome measurement will include component-of-care metrics, such as coronary care unit days (measured as total length of stay in coronary care unit).
Health utilization outcome measurement: intensive care unit (ICU) days
Health utilization outcome measurement will be ascertained mainly by CMS claims data. The utilization outcome measurement will include component-of-care metrics, such as ICU days (measured as total length of ICU stay) per patient.
Health utilization outcome measurement: general drug claims
Health utilization outcome measurement will be ascertained mainly by CMS claims data. The utilization outcome measurement will include component-of-care metrics such as general drugs and/or IV therapy claims (measured as total and average counts of distinct claims) per patient.
Health utilization outcome measurement: durable medical equipment Medicare payments
Health utilization outcome measurement will be ascertained mainly by CMS claims data. The utilization outcome measurement will include component-of-care metrics such as durable medical equipment Medicare payments (measured as total and average dollar amount of charges) per patient.
Health utilization outcome measurement: imaging and laboratory events
Health utilization outcome measurement will be ascertained mainly by CMS claims data. The utilization outcome measurement will include component-of-care metrics such as imaging and laboratory events (measured as total and average counts of distinct claims suggesting imaging and laboratory events).
Health utilization outcome measurement: imaging and laboratory expenditures
Health utilization outcome measurement will be ascertained mainly by CMS claims data. The utilization outcome measurement will include component-of-care metrics such as imaging and laboratory expenditures (measured as total and average dollar amount of charges) per patient.

Full Information

First Posted
September 22, 2021
Last Updated
August 1, 2023
Sponsor
University of Kansas Medical Center
Collaborators
University of Utah, University of Missouri-Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT05138601
Brief Title
Remote Monitoring and Virtual Collaborative Care For Hypertension Control to Prevent Cognitive Decline Phase II
Acronym
vCCC 2
Official Title
Remote Monitoring and Virtual Collaborative Care For Hypertension Control to Prevent Cognitive Decline Phase II
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 16, 2021 (Actual)
Primary Completion Date
March 31, 2026 (Anticipated)
Study Completion Date
June 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kansas Medical Center
Collaborators
University of Utah, University of Missouri-Columbia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a randomized, controlled, pragmatic trial designed as a "type I hybrid effectiveness-implementation trial" that tests a hypertension program integrating a virtual Collaborative Care Clinic (vCCC), home blood pressure monitoring, and telehealth for lowering blood pressure (BP) in two health systems.
Detailed Description
This study tests a hypertension program integrating a virtual Collaborative Care Clinic (vCCC), home blood pressure monitoring, and telehealth for lowering blood pressure (BP) in two health systems (University of Kansas Health System [UKHS] and the University of Utah Health [UUtah]). The vCCC is staffed by clinical pharmacists who remotely monitor home BP and use telehealth to work with patients to lower systolic blood pressure (SBP) to <130 mmHg, as recommended by the current American College of Cardiology/American Heart Association (ACC/AHA) guidelines. Eligible patients with uncontrolled hypertension (HTN) are identified automatically through the electronic health record (EHR) during visits to their Primary Care Provider (PCP) and referred for enrollment into the vCCC.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Usual Care with Education
Arm Type
No Intervention
Arm Description
The participant will be provided with educational material and a home BP monitor. Control participants will continue to see their physicians for their usual care for BP management (their BP data will not be reviewed by pharmacists and the patients will not have support from vCCC pharmacists)
Arm Title
Virtual Collaborative Care Clinic
Arm Type
Experimental
Arm Description
Participants will partake in the virtual collaborative care clinic
Intervention Type
Other
Intervention Name(s)
Virtual Collaborative Care Clinic
Intervention Description
Trained clinical pharmacists will monitor BP, prescribe and adjust medications and monitor for side effects of medications under the license of, and in communication with, the patient's physician.
Primary Outcome Measure Information:
Title
Systolic Blood Pressure (SBP) Control At 24 Months
Description
Our primary outcome is achieving SBP control (<130 mmHg). Blood pressure measures will be collected in a dashboard system and will be integrated into the common data model table for final analysis. Investigators will utilize the Benjamini-Hochberg approach to control for multiple testing in our primary outcome.
Time Frame
24 months.
Secondary Outcome Measure Information:
Title
Cognitive Measures
Description
Investigators will use composite z score obtained by averaging standardized z scores of individual NP test scores and use z scores of individual tests to determine changes in a single test that may be obscured with the measurement of a global score. The tests are Montreal Cognitive Assessment (MoCA) Blind, Rey Auditory Verbal Learning Test (RAVLT), Number Span Forwards and Backwards (NSFB), Oral Trail Making Test (OTMT), Category Fluency, Verbal Fluency, Rey Auditory Verbal Naming Test Delayed Recall and Recognition, and Verbal Naming Test (VNT). MoCA Blind has 22 possible points, with19 or above normal. NSFB gives 2 scores, total number of correct trials and longest sequence repeated correctly with higher score indicating better working memory. The category fluency has 2 possible scores with a higher number of unique names indicating a better semantic memory. For the Verbal Fluency test the score reflects the number of unique responses with a higher score indicating better memory
Time Frame
0 months, 12 months, and 24 months
Title
Major Adverse Cardiovascular Events (MACE)
Description
Data from the electronic health record (EHR) will be extracted. MACE will be identified by will be identified by International Statistical Classification of Diseases and Related Health Problems (ICD) and Current Procedural Terminology (CPT) codes for hospitalization due to myocardial infarction (MI), nonfatal stroke, coronary revascularization, and heart failure, which will be identified by combining observations from EHR
Time Frame
24 months
Title
Atherosclerotic Cardiovascular Disease Risk (ASCVD)
Description
Data from the EHR will be extracted. (ASCVD) score will be estimated by age, sex, race, BP, total cholesterol, HDL cholesterol, history of diabetes, smoking status, HTN treatment, statin and aspirin therapy. ASCVD score is given as a percentage. A 0 to 4.9% risk is considered low risk, 5 to 7.4% is considered borderline, a 7.5 to 20% risk is considered intermediate, and a score above 20% is considered high.
Time Frame
24 months
Title
Health Care Resource Utilization: Charges Per Patient
Description
Health utilization outcome measurement will be ascertained mainly by CMS claims data. The utilization outcome measurement will include charges per patient (measured as total and average dollar amount of charges).
Time Frame
2 years
Title
Mortality
Description
All-cause mortality, as a composite endpoint, will be obtained from Common Data Model DEATH table and be ascertained by linked Medicare Beneficiary Summary File available from Centers for Medicare and Medicaid Services (CMS)
Time Frame
2 years
Title
Systolic Blood Pressure (SBP) Control At 12 Months
Description
Our primary outcome is achieving SBP control (<130 mmHg). Blood pressure measures will be collected in a dashboard system and will be integrated into the common data model table for final analysis. Investigators will utilize the Benjamini-Hochberg approach to control for multiple testing in our primary outcome.
Time Frame
12 Months
Title
Health utilization outcome measurement: Carrier Claims
Description
Health utilization outcome measurement will be ascertained mainly by CMS claims data. The utilization outcome measurement will include healthcare-facility-metrics, such as carrier (physician Part B) claims (measured as total and average counts of distinct claims)
Time Frame
2 years
Title
Health utilization outcome measurement: facility claims
Description
Health utilization outcome measurement will be ascertained mainly by CMS claims data. The utilization outcome measurement will include outpatient, inpatient, skilled nursing facility claims (measured as total and average counts of distinct claims).
Time Frame
2 years
Title
Health utilization outcome measurement: coronary care claims
Description
Health utilization outcome measurement will be ascertained mainly by CMS claims data. The utilization outcome measurement will include component-of-care metrics, such as coronary care claims (measured as total and average counts of distinct claims)
Time Frame
2 years
Title
Health utilization outcome measurement: coronary care expenditures
Description
Health utilization outcome measurement will be ascertained mainly by CMS claims data. The utilization outcome measurement will include component-of-care metrics, such as coronary care expenditures (measured as total and average dollar amount of charges) per patient
Time Frame
2 years
Title
Health utilization outcome measurement: coronary care unit days
Description
Health utilization outcome measurement will be ascertained mainly by CMS claims data. The utilization outcome measurement will include component-of-care metrics, such as coronary care unit days (measured as total length of stay in coronary care unit).
Time Frame
2 years
Title
Health utilization outcome measurement: intensive care unit (ICU) days
Description
Health utilization outcome measurement will be ascertained mainly by CMS claims data. The utilization outcome measurement will include component-of-care metrics, such as ICU days (measured as total length of ICU stay) per patient.
Time Frame
2 years
Title
Health utilization outcome measurement: general drug claims
Description
Health utilization outcome measurement will be ascertained mainly by CMS claims data. The utilization outcome measurement will include component-of-care metrics such as general drugs and/or IV therapy claims (measured as total and average counts of distinct claims) per patient.
Time Frame
2 years
Title
Health utilization outcome measurement: durable medical equipment Medicare payments
Description
Health utilization outcome measurement will be ascertained mainly by CMS claims data. The utilization outcome measurement will include component-of-care metrics such as durable medical equipment Medicare payments (measured as total and average dollar amount of charges) per patient.
Time Frame
2 years
Title
Health utilization outcome measurement: imaging and laboratory events
Description
Health utilization outcome measurement will be ascertained mainly by CMS claims data. The utilization outcome measurement will include component-of-care metrics such as imaging and laboratory events (measured as total and average counts of distinct claims suggesting imaging and laboratory events).
Time Frame
2 years
Title
Health utilization outcome measurement: imaging and laboratory expenditures
Description
Health utilization outcome measurement will be ascertained mainly by CMS claims data. The utilization outcome measurement will include component-of-care metrics such as imaging and laboratory expenditures (measured as total and average dollar amount of charges) per patient.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 65 and older Active patient in participating primary care clinic Access to compatible "smartphone" or device (i.e., Android, Kindle or Apple with internet connectivity or mobile network) Elevated BP as defined by SBP >140 at current visit AND documented history of hypertension OR SBP > 140 at current visit and at another visit in last 18 months OR SBP >160 at current visit Sufficiently fluent in English to participate in study procedures Adequate hearing to complete study procedures Able to give their own signed consent Health insurance coverage by Medicare Exclusion Criteria: Clinically significant illness that may affect safety or completion per their treating PCP or study physician Needing interpreter for clinic visits (through Electronic Health Record) Currently in hospice care Currently receiving chemotherapy Unable to take accurate BP measurement, either due to inability to follow protocol to check BP or due to medical conditions such as lymphedema or dialysis access on both arms. Currently participating in another intervention trial End stage kidney disease on dialysis Diagnosis of dementia (i.e., dementia, Alzheimer's disease, vascular dementia, dementia with Lewy bodies, frontotemporal dementia) Chronic active disease with expected life expectancy < 2 years as determined by the study team
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandra Dahlgren
Phone
(913) 945-7668
Email
adahlgren@kumc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Amber Wilson
Email
vCCC@kumc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Burns, MD, MS
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Health System
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heidi Anderson
Email
handerson8@kumc.edu
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kaylene Zupan
Email
vCCC@hsc.utah.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Remote Monitoring and Virtual Collaborative Care For Hypertension Control to Prevent Cognitive Decline Phase II

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