Remote Monitoring and Virtual Collaborative Care For Hypertension Control To Prevent Cognitive Decline: Phase I
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 33
- Locations
- 1
- Primary Endpoint
- Feasibility of system wide adoptability as assessed by survey responses
Study Overview
Brief Summary
This purpose of this study is to examine an aggressive method of blood pressure control that involves home blood pressure monitoring and management of medications by a team of clinical pharmacists in coordination with a primary care physician.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
- •Elevated blood pressure as defined by:
- •Systolic Blood Pressure >140 at current visit AND documented history of hypertension OR Systolic Blood Pressure > 140 at current visit and at another visit in last 18 months OR Systolic Blood Pressure >160 at current visit
- •Sufficiently fluent in English to participate in study procedures
- •Adequate vision and hearing to complete study procedures
Exclusion Criteria
- •Clinically significant illness that may affect safety or completion per their treating Primary Care Physician or study physician
- •End stage renal disease on dialysis
- •Chronic active disease with expected life expectancy < 2 years as determined by the study team
Arms & Interventions
Virtual Collaborative Care Clinic
The Virtual Collaborative Care Clinic arm participants use a home blood pressure monitor and routine blood pressure measurements will be uploaded to a dashboard monitored by clinical pharmacists. Blood pressure will be managed aggressively by the clinical pharmacists in coordination with Primary Care Physicians.
Intervention: Virtual Collaborative Care Clinic (Other)
Control Intervention
The control intervention will consist of providing the participant with educational material and a home blood pressure monitor. The patients in the control group will not have support from Virtual Collaborative Care Clinic pharmacists. Routine blood pressure measures using their device will not be collected via the dashboard and will not be available for pharmacist review. Participants will continue to see their physicians for their usual care for blood pressure management.
Outcomes
Primary Outcomes
Feasibility of system wide adoptability as assessed by survey responses
Time Frame: 3 Months Post Baseline
Primary Care Physicians and vCCC Pharmacists will be asked for feedback on feasibility of implementation via a survey. The vCCC pharmacists and PCPs will be surveyed to assess feasibility and changing views of feasibility. Brief, validated scales will be delivered via email (REDCap surveys) to assess the construct of feasibility.
Feasibility of system wide adoptability as assessed by Physician Advisory Board meetings discussion
Time Frame: Through study completion, an average of 9 months
Members of the Physician Advisory Board will be asked for feedback on system wide adoptability during the monthly Physician Advisory Board meetings. The meetings will be recorded and summarized.
Feasibility of system wide adoptability as assessed by vCCC Pharmacist Interviews
Time Frame: Up to 2 months Post Baseline
Virtual Collaborative Care Clinic Pharmacists will be asked for feedback on feasibility of system wide adoption. We will conduct one-time semi-structured qualitative interviews with the Virtual Collaborative Care Clinic pharmacists. The Virtual Collaborative Care Clinic pharmacist will be interviewed to assess implementation factors including the auto-referral process and open-ended questions on the process and suggestions for improvement.
Replicability to other health systems as assessed by survey responses
Time Frame: 3 Months Post Baseline
Primary Care Physicians and vCCC Pharmacists will be asked for feedback on replicability to other health systems via a survey. Brief, validated scales will be delivered via email (REDCap surveys) to assess the construct of replicability to other health systems.
Replicability to other health systems as assessed by Physician Advisory Board meetings discussion
Time Frame: Through study completion, an average of 9 months
Members of the Physician Advisory Board will be asked for feedback on replicability to other health systems during the monthly Physician Advisory Board meetings. The meetings will be recorded and summarized.
Replicability to other health systems as assessed by vCCC Pharmacist Interviews
Time Frame: Up to 2 months Post Baseline
vCCC Pharmacists will be asked for feedback on replicability to other health systems. We will conduct one-time semi-structured qualitative interviews including open-ended questions.
Feasibility of system wide adoptability as assessed by survey responses
Time Frame: Baseline
Primary Care Physicians and vCCC Pharmacists will be asked for feedback on feasibility of implementation via a survey. The vCCC pharmacists and PCPs will be surveyed to assess feasibility and changing views of feasibility. Brief, validated scales will be delivered via email (REDCap surveys) to assess the construct of feasibility.
Replicability to other health systems as assessed by survey responses
Time Frame: Baseline
Primary Care Physicians and vCCC Pharmacists will be asked for feedback on replicability to other health systems via a survey. Brief, validated scales will be delivered via email (REDCap surveys) to assess the construct of replicability to other health systems.
Secondary Outcomes
No secondary outcomes reported
Investigators
Jeff Burns, MD
Co-Director Alzheimer's Disease Center
University of Kansas Medical Center