Clinical trial NCT06124716: Collaboration Oriented Approach to Controlling High Blood Pressure
Official title: Collaboration Oriented Approach to Controlling High Blood Pressure
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension
Multiple Chronic Conditions
Keywords: Pragmatic trial
Primary care
Clinical decision support
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: University of Missouri-Columbia
name: Vanderbilt University Medical Center
First posted: 2023-11-09
Enrollment: 550
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Mixed methods design with qualitative RE-AIM inquiry nested within a pragmatic multi-site randomized trial
Primary purpose: TREATMENT

Brief summary: Hypertension is a significant contributor to poor cardiovascular outcomes. Self-management support tools can increase patient behaviors to improve blood pressure. The investigators created a clinical decision support app, called COACH, to integrate home blood pressure data and goals into EHR reporting and workflow with communications informed by behavioral economics principles to support shared decision-making. The study aims to measure the effectiveness of the COACH intervention in a pragmatic multi-site randomized trial in a primary care setting.

Detailed description: This protocol addresses the challenge of implementing scalable, interoperable clinical decision support (CDS) and the patient-centered outcome of avoiding heart attacks and strokes through high blood pressure control in the setting of multiple chronic illnesses. It leverages substantial extant work to build patient-centered CDS for high blood pressure, electronic care planning and health coaching at scale, implementing and testing these tools in new primary care settings. This protocol implements a new patient-facing CDS across multiple clinic sites spanning three major health systems and in the nation's two leading EHR vendor platforms. Controlling blood pressure is a singularly important goal; nearly 50% of adults in health care have high blood pressure, which increases their risk of heart attack and stroke. However, managing blood pressure requires navigation within a narrow therapeutic index, where overtreatment leads to substantial complications, including kidney damage, low blood pressure, falls, and mood disorders. Balancing treatment to reduce risk while avoiding harm requires engaging patients directly in intensive goal setting, shared care planning around nonpharmacologic and pharmacologic treatments, and self-monitoring for effectiveness and adverse events.

Hypertension rarely occurs alone; providing clinical decision support, care planning, and self-management support in the context of multiple chronic illnesses is required.

The study team will address patient-centered needs by scaling our implemented, patient-facing CDS for eCare Planning, Collaboration Oriented Approach to Controlling High blood pressure (COACH) to 3 sites and testing whether it reduces blood pressure and risk of heart attack and stroke. To do so, we embed a diverse patient perspective into a robust, feasible, and effective CDS implementation and evaluation process by 1) capturing patient input throughout the CDS lifecycle; 2) adapting the COACH CDS to patient preferences, values, and goals; and 3) disseminating the tested FHIR-based (Fast Healthcare Interoperability Resources) patient-facing application into organizations that combines blood pressure control with relevant risk scores into an eCare Plan application and framework and implementing these patient-centered approaches in feasible, context-responsive, and effective ways. The investigators address scalability by helping organizations advance their use of patient-generated health data and patient-reported outcomes using standard implementation frameworks while producing CDS artifacts and implementation guides that can be leveraged to increase adoption beyond the work of this proposal. For interoperability, we use a standard-based, structured process that re-uses concept and value sets whenever possible while using robust techniques to develop new sets and make them available for future innovators.

To complete these goals, the study investigators leverage previous work in building standardized HBP value sets, logic, and a patient-facing FHIR tool. In this work, we have engaged in several collaborations, most notably with the CDS Connect Community, where we will upload all artifacts, but also with other AHRQ digital health efforts and with other large collaboratives, including the ACC/AHA and JNC8 guideline developers, the HL7 CPG-on-FHIR, and the eCare Planning project from NIDDK and AHRQ. The study investigators will use two frameworks to evaluate the implementation. First, adaptation in implementation science is both common and may be required for success; we explore the ways in which the 5 rights-the right information to the right person in the right intervention format through the right channel at the right time in workflow-can be adapted for key organizational needs while retaining fidelity to the goals. In addition, we consider a framework that combines usability with effectiveness for complex conditions by exploring concepts related to appropriate simplicity, prioritization, summarization, adjudication, and actionability to enhance CDS effectiveness for patient needs.

Thus, the study's specific aims are:

1. To refine and implement a patient-facing, adaptable Blood Pressure Control CDS system in 3 diverse settings, using implementation science and patient engagement to maximize effectiveness.
2. To evaluate the effectiveness of the application at lowering blood pressure employing a mixed methods design, with qualitative inquiry nested within a randomized controlled trial, secondary RE-AIM and social cognitive theory outcomes, and qualitative evaluation of implementations across sites.
3. To develop robust, sharable, interoperable mechanisms, leveraging collaborations and synthesis of the implementation experience to aid in further dissemination and implementations of patient-facing CDS.

Eligibility criteria: Inclusion Criteria:

* Adult patients aged 18-100 years old
* Patient receives care at a participating primary care clinic and has been seen in the last year
* Patient has high BP, defined as an average of 4 BPs \> 140 systolic or \> 90 diastolic (clinic) or \> 135 OR \> 85 (home)
* Patient is enrolled in online health portal
* Patient can communicate in English
* Patient has been recommended by their physician who thinks the patient would benefit from a home blood pressure monitoring program.

Exclusion Criteria:

* Patient is pregnant at the time of consent
* Patient who, in the opinion of the primary care clinician, has severe cognitive impairment
* Patient is on hospice care and/or has a life expectancy of less than 2 years
* Patient has end stage renal disease
* Patient for whom tight blood pressure control presents a greater risk, such as those with a history of adverse events from hypertension treatment (falls, dizziness, electrolyte disturbances, hypotension, active heart failure)
* Patient has any other disease or disorder that in the opinion of the investigator or the patient's primary care clinician, could put participants at risk and affect trial results, or hinder participation will exclude them from participating

Primary outcomes:
measure: Blood Pressure Control
timeFrame: Up to 6 months
Secondary outcomes:
measure: Reduction in Systolic and/or Diastolic Blood Pressure
timeFrame: Up to 6 months
measure: Demographic factors contributing to blood pressure control
timeFrame: Up to 6 months
measure: COACH Application System Usability Evaluation
timeFrame: Up to 6 months
measure: Participant report of health behaviors including Self Efficacy, Social Support, Outcome Expectations and Self-regulation
timeFrame: 2 months, 6 months
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri-Columbia
state: Missouri
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Oregon Health and Science University
name: David Dorr, MD, MS, FACMI, FAMIA
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Missouri-Columbia
name: Richelle Koopman, MD
role: PRINCIPAL_INVESTIGATOR
References: