Ignite Creation Date:
2024-05-06 @ 7:45 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06124716
Status:
RECRUITING
Last Update Posted:
2024-03-25
First Post:
2023-11-06
Brief Title:
Collaboration Oriented Approach to Controlling High Blood Pressure
Sponsor:
Oregon Health and Science University
Organization:
Oregon Health and Science University
Study Overview
Official Title:
Collaboration Oriented Approach to Controlling High Blood Pressure
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COACH
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 nations 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 ACCAHA 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 studys 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
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 ACCAHA 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 studys 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None