eHealth Blood Pressure Control Program (Rhode Island)

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Summary:

Health Information Technology (IT) can enable patient-centered care and the overall quality of care by exchanging health information data between the patient’s home and the medical office. Hypertension represents an ideal condition to test this model of patient-centered eHealth enabled care because hypertension is common, largely treated by primary care physicians, and, when uncontrolled is associated with significant morbidity and mortality.          

This pilot study compared the use of home blood pressure monitoring (HBPM) to a health IT enabled eHealth blood pressure (BP) system of care that integrated HBPM into a provider’s electronic medical record (EMR) via a Web portal. The project took place at a community-based safety-net hospital where a “high-tech” solution was thought to problematic due to a digital divide. A digital divide occurs when some patients do not have the opportunities or skills to enable them to benefit from digital resources. As such, a patient navigator-training program was developed as part of the study in order to assist patients with a “high-tech/high-touch” approach to HBPM.           

The specific aims of this project were to:

  • Develop and refine a Web-based patient-centered decision support system for BP control using an iterative, user-centered design process so that it meets standards of feasibility and acceptability for patient navigators and participants.
  • Determine the appropriate and acceptable patient motivators (i.e., engaging content, social media, and incentives) leading to use of the eHealth BP control program (BP device, personal health record, Web portal, patient navigator).
  • Develop and begin to field-test a patient navigator-training program, a manual of procedures for the patient navigators, and a measure of patient navigator adherence to the training manual.
  • Test the functionality, security, and fidelity of the secure data exchange between the HBPM device, personal health record, Web-based portal, and EMR interface engine in both test and live (enterprise) environments.
  • Determine the degree of adoption by participants of the four intervention components (HBPM, personal health record, Web portal, patient navigator).
  • Estimate the effect sizes of the four-component program relative to the three-component program with regard to patient activation, self-care activities, medication adherence, reduced clinical inertia, and improved BP control with implementation of the eBP control program.

Ninety percent of the enrolled patients (n=28) were able to upload BP readings to the Web portal. Approximately half of the patients required some technological support in order to use the system. The percentage of controlled patients at the first research visit was 46 percent, which increased to 65 percent at the final research visit. When the patient navigator was engaged, 75 percent of all recruited patients were controlled.          

The project team concluded that integration of a HBPM program in primary care settings is feasible and accepted by patients, providers, and the health care team. The program appeared to be effective in controlling BP in previously uncontrolled patients. Although the existence of a digital divide is a barrier, this study showed that the use of a patient navigator appears to be able to overcome this.

eHealth Blood Pressure Control Program - 2012

Summary Highlights

  • Principal Investigator: 
  • Funding Mechanism: 
    RFA: HS08-269: Exploratory and Developmental Grant to Improve Health Care Quality Through Health Information Technology (R21)
  • Grant Number: 
    R21 HS 018238
  • Project Period: 
    September 2009 – September 2012
  • AHRQ Funding Amount: 
    $299,967
  • PDF Version: 
    (PDF, 177.32 KB)

Summary: Researchers at Memorial Hospital of Rhode Island designed a two-phase study of the feasibility and acceptability of an e-health model for the treatment of hypertension. The study, the eHealth Blood Pressure (eBP) Control Program, integrated electronic medical records (EMRs) and personal health records (PHRs) with monitoring devices through a Web portal that connected patients to their medical team. The goal of the project was to obtain the necessary pilot data for a randomized clinical trial of the eBP Control Program.

The program strived to improve patients’ blood pressure (BP) control by increasing medication adherence and reducing clinical inertia. It also sought to improve patient education, collaborative self-management support, and care coordination. In Phase 1 of the study, the research team developed and field-tested a PHR, a BP self-management Web portal, and training materials for a patient navigator. Additionally, the team integrated a home BP monitoring (HBPM) device into the PHR. During Phase 2, the team enrolled patients with uncontrolled BP to test the program. For the first 3 months of Phase 2, all patients used a single component of the intervention program: HBPM. After 3 months, the participants were randomized to the three-component program (HBPM + PHR + Web portal) or the three-component program plus a patient navigator.

Specific Aims:

  • Develop and refine a Web-based patient-centered decision support system for BP control using an iterative, user-centered design process so that it meets standards of feasibility and acceptability for patient navigators and participants. (Achieved)
  • Determine the appropriate and acceptable patient motivators (i.e., engaging content, social media, and incentives) leading to use of the eHealth BP control program (BP device, PHR, Web portal, patient navigator). (Achieved)
  • Develop and begin to field-test a patient navigator training program, a manual of procedures for the patient navigators, and a measure of patient navigator adherence to the training manual. (Achieved)
  • Test the functionality, security, and fidelity of the secure data exchange between the HBPM device, PHR, Web-based portal, and EMR interface engine in both test and live (enterprise) environments. (Achieved)
  • Determine the degree of adoption by participants of the four intervention components (HBPM, PHR, Web portal, patient navigator). (Achieved)
  • Estimate the effect sizes of the four-component program relative to the three-component program with regard to patient activation, self-care activities, medication adherence, reduced clinical inertia, and improved BP control with implementation of the eBP control program. (Achieved)

2012 Activities: A total of 28 participants were recruited through letters sent to the homes of potentially eligible patients. Additionally, a ‘pop-up’ alert in the EMR flagged potentially eligible patients. Thirteen patients were randomized to the patient navigator arm; 12 to the no patient-navigator arm; and three dropped out before randomization. Of patients who were randomized, 20 completed the study and five dropped out after randomization. Reasons for drop-out included loss to followup and technical issues with the BP cuff. In some instances, the BP cuff did not properly fit patients, which led to an error message. The investigators discussed this issue with the BP cuff vendor, who is receptive to making modifications to future versions of the cuff. As patients progressed through the study, the research team assisted them with any technical issues. The patient navigators were trained in motivational interviewing and met in-person or by phone with patients on a monthly basis. Fidelity assessment was based upon regular meetings with a behavioral psychologist reviewing audio recordings from the navigators’ meetings with patients and discussing how to handle new or difficult situations. The meetings also offered an opportunity to ensure conformity to the study protocol, including ensuring that peer navigators continued proper communication with the patients’ care team, offered instrumental support in the use of the system, and provided emotional support to patients while being careful not to suggest clinical advice. Finally, after all patients completed the study, the research team analyzed the data collected during the study.

Due to initial challenges with participant recruitment, Dr. Eaton used a 1-year no-cost extension. As last reported in the AHRQ Research Reporting System, project progress was on track and budget spending was on target. This project was completed in September 2012.

Impact and Findings: The team prepared for the quantitative analysis by maintaining a study database and cleaning the data throughout the data collection process. An analysis plan was developed to compare the BP of patients randomized to the peer navigator and Web site study arm to patients with Web site access only. The key finding from that analysis was that BP control increased over time. The percent of patients with controlled BP increased from 46.4 percent at the start of the study to 65.0 percent at the end of the study, for an overall 18.6 percent improvement. The results of this feasibility study will be used to inform a randomized controlled trial, including the sample-size calculations, barriers and facilitators of adoption, and the features that had the strongest impact on improving BP control among patients with hypertension.

The results of the patient exit interviews indicated that study participants believe this was an important study, liked meeting with the patient navigator, and would recommend the eBP Control Program to a friend or family member. Participants reported frequent use of the BP tracking feature of the PHR. While participants were aware of the other resources on the Web site, they did not access them frequently. The positive results for patient experience suggest that the eBP control program is acceptable and feasible.

Target Population: Adults, Hypertension, Low Literacy, Medically Underserved, Safety Net

Strategic Goal: Develop and disseminate health IT evidence and evidence-based tools to support patient-centered care, the coordination of care across transitions in care settings, and the use of electronic exchange of health information to improve quality of care.

Business Goal: Knowledge Creation

eHealth BP Control Program - 2011

Summary Highlights

  • Principal Investigator: 
  • Funding Mechanism: 
    RFA: HS08-269: Exploratory and Developmental Grant to Improve Health Care Quality Through Health Information Technology (R21)
  • Grant Number: 
    R21 HS 018238
  • Project Period: 
    December 2009 - September 2012
  • AHRQ Funding Amount: 
    $299,967
  • PDF Version: 
    (PDF, 192.13 KB)

Summary: Researchers at Memorial Hospital of Rhode Island have designed a two-phase study of the feasibility and acceptability of an e-health model for the treatment of hypertension. The study, the eHealth Blood Pressure (eBP) Control Program, integrates electronic medical records (EMRs) and personal health records (PHRs) with monitoring devices through a Web portal that connects patients to their medical team. The goal of the project is to obtain the necessary pilot data for a randomized clinical trial of the eBP Control Program.

The program strives to improve patients' blood pressure (BP) control by increasing medication adherence and reducing clinical inertia. It also seeks to improve patient education, collaborative self-management support, and care coordination. In phase one of the study, the research team developed and field-tested a PHR, a BP self-management Web portal, and training materials for a patient navigator. Additionally, the team integrated a home blood pressure monitoring (HBPM) device into the PHR. During phase two, the team will enroll 30 patients with uncontrolled BP. For the first 3 months of phase two, all 30 patients will use a single component of the intervention program: HBPM. After 3 months, the participants will be randomized to the three-component program (HBPM + PHR + Web portal) or the three-component program plus a patient navigator.

Specific Aims:

  • Develop and refine a Web-based patient-centered decision support system for BP control using an iterative, user-centered design process so that it meets standards of feasibility and acceptability for patient navigators and participants. (Achieved)
  • Determine the appropriate and acceptable patient motivators (i.e., engaging content, social media, and incentives) leading to use of the eHealth BP control program (BP device, PHR, Web portal, patient navigator). (Ongoing)
  • Develop and begin to field-test a patient navigator training program, a manual of procedures for the patient navigators, and a measure of patient navigator adherence to the training manual. (Achieved)
  • Test the functionality, security, and fidelity of the secure data exchange between the HBPM device, PHR, Web-based portal, and EMR interface engine in both test and live (enterprise) environments. (Achieved)
  • Determine the degree of adoption by participants of the four intervention components (HBPM, PHR, Web portal, patient navigator). (Ongoing)
  • Estimate the effect sizes of the four-component program relative to the three-component program with regard to patient activation, self-care activities, medication adherence, reduced clinical inertia, and improved BP control with implementation of the eBP control program.(Upcoming)

2011 Activities: The open trial of the eBP Control Program was underway. Beginning in 2010, participants were recruited through letters sent to the homes of potentially eligible patients. Additionally, a 'pop-up' alert in the EMR flagged potentially eligible patients. By December 2011, 28 patients had been enrolled. Thirteen patients were randomized to the patient navigator arm; 12 to the no patient-navigator arm; and three dropped out before randomization. Of patients who were randomized, 13 completed the study, seven continue to participate in the study, and five dropped out after randomization. Reasons for drop out included loss to follow-up and technical issues with the BP cuff. In some instances, the BP cuff did not properly fit patients, which led to an error message. Dr. Eaton discussed this issue with the BP cuff vendor, who is receptive to making modifications to future versions of the cuff. As patients progress through the study, the research team assists them with any technical issues. A few patients, for example, did not have the technical literacy to setup the required software, so the research team helped guide them through the process.

The patient navigators continue to meet regularly with a clinical psychologist to discuss questions and concerns related to patient interactions. During these meetings, the peer navigators and the clinical psychologist review the audio recordings from the navigators' meetings with patients and discuss how to handle new or difficult situations. The meetings also offer an opportunity to ensure fidelity to the study protocol, including ensuring that the peer navigators provide emotional support while being careful not to offer clinical advice.

As last self-reported in the AHRQ Research Reporting System, project progress and activities are on track and project spending is roughly on target.

Preliminary Impact and Findings: Preliminary results from patient exit interviews indicate that study participants believe this is an important study, that participants liked meeting with the patient navigator, and that they would recommend the eBP Control Program to a friend or family member. Participants reported frequent use of the BP tracking feature of the PHR. While participants were aware of the other resources on the Web site, those did not access them frequently. Dr. Eaton is writing a manuscript that summarizes these results.

Target Population: Adults, Hypertension, Low Literacy, Medically Underserved, Safety Net

Strategic Goal: Develop and disseminate health IT evidence and evidence-based tools to support patient- centered care, the coordination of care across transitions in care settings, and the use of electronic exchange of health information to improve quality of care.

Business Goal: Knowledge Creation

eHealth BP Control Program - 2010

Summary Highlights

  • Principal Investigator: 
  • Funding Mechanism: 
    RFA: HS08-269: Exploratory and Developmental Grant to Improve Health Care Quality through Health Information Technology (R21)
  • Grant Number: 
    R21 HS 018238
  • Project Period: 
    December 2009 – November 2011
  • AHRQ Funding Amount: 
    $299,967
  • PDF Version: 
    (PDF, 589.67 KB)


Target Population: Adults, Hypertension, Low Literacy, Medically Underserved, Safety Net

Summary: Memorial Hospital of Rhode Island has designed a two-phase study of the feasibility and acceptability of an e-health model for the treatment of hypertension. The study, the eHealth Blood Pressure (eBP) Control Program, integrates electronic medical records (EMRs) and personal health records (PHRs) with monitoring devices through a Web portal that connects patients to their medical team. The goal of the project is to obtain the necessary pilot data for a randomized practical clinical trial of the eBP Control Program.

The program strives to increase medication adherence, reduce clinical inertia, and improve patients' BP control. In addition, the program also seeks to improve patient education, collaborative self management support, and care coordination. Phase 1 of the study will develop and field-test a PHR, a home BP monitoring (HBPM) device integrated into the PHR, a BP self-management Web portal, and training materials for a patient navigator. During Phase 2, the team will enroll 30 patients with uncontrolled BP. For the first 3 months of Phase 2, all 30 patients will only use a single component of the intervention program: HBPM. After 3 months the participants will be randomized to either the three-component program (HBPM + PHR + Web portal) or the four-component program (HBPM + PHR + Web portal + patient navigator).

Specific Aims:
  • Develop and refine a Web-based patient-centered decision support system for BP control using an iterative, user-centered design process so that it meets standards of feasibility and acceptability for patient navigators and participants. (Ongoing)
  • Determine the appropriate and acceptable patient motivators (i.e., engaging content, social media, and incentives) leading to use of the eHealth BP control program (BP device, PHR, Web portal, patient navigator). (Ongoing)
  • Develop and begin to field-test a patient navigator training program, a manual of procedures for the patient navigators, and a measure of patient navigator adherence to the training manual. (Ongoing)
  • Test the functionality, security, and fidelity of the secure data exchange between the HBPM device, PHR, Web-based portal, and EMR interface engine in both test and live (enterprise) environments. (Achieved)
  • Determine the degree of adoption by participants of the four intervention components (HBPM, PHR, Web portal, patient navigator) (Ongoing)
  • Estimate the effect sizes of the four-component program relative to the three-component program with regard to patient activation, self-care activities, medication adherence, reduced clinical inertia, and improved BP control with implementation of the e-Health BP control program. (Upcoming)

2010 Activities: In the first quarter of 2010 the patient navigator dashboard was finalized and the lead researchers have completed a training and reference manual for patient navigators on BP care management. Key points in the manual and training include the appropriate interpretation of HBPM results and the need to develop practice-wide decision rules on making timely changes in dosage, frequency of HBPM, and the addition of new BP medications to reduce clinical inertia. A document for adherence measures was prepared to provide guidance on what is an “acceptable” level of adherence for the procedures.

The team continued the development of several applications of the eBP Control Program. Beta testing was conducted by faculty and employees of the hospital and other collaborating partners. The project team noted that testing the system with developers, clinicians, study staff, and patients was very informative. Given the wide range of expertise and perspectives, the study staff was able to evaluate many aspects of the system including technical function, work flow, and end-user perspectives.

The open trial of the eBP Control Program is underway. Patients are recruited through letters sent to the home of potentially eligible patients and a ‘pop-up’ alert in the EMR. At the end of 2010, nine patients completed the telephone survey, participated in the first study visit, and enrolled in the study. To facilitate achieving the 30 patient enrollment goal, recruitment has been opened to additional care teams. Using information from the patients that are ultimately enrolled, the study team will assess which patient recruitment method was most effective.

Grantee's Most Recent Self-Reported Quarterly Status (as of December 2010): Progress is on track for this project and the budget is slightly underspent. The research team developed, tested and implemented the eBP Control Program. The study trial has been initiated.

Preliminary Impact and Findings: There are no findings to date for the project.

Strategic Goal: Develop and disseminate health IT evidence and evidence-based tools to support patient-centered care, the coordination of care across transitions in care settings, and the use of electronic exchange of health information to improve quality of care.

Business Goal: Knowledge Creation

eHealth Blood Pressure Control Program - Final Report

Citation:
Eaton C. eHealth Blood Pressure Control Program - Final Report. (Prepared by the Memorial Hospital of Rhode Island under Grant No. R21 HS018238). Rockville, MD: Agency for Healthcare Research and Quality, 2012. (PDF, 662.22 KB)

The findings and conclusions in this document are those of the author(s), who are responsible for its content, and do not necessarily represent the views of AHRQ. No statement in this report should be construed as an official position of AHRQ or of the U.S. Department of Health and Human Services.
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