Mobile Cardiovascular Risk Service Trial

NCT ID: NCT03081871

Last Updated: 2018-10-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-01
• Study Completion Date: 2018-08-31

Brief Summary

Risk factors for cardiovascular disease are poorly controlled even for patients who frequently visit their physician, leading to large numbers of preventable cardiovascular events such as heart attacks and strokes. Research from integrated healthcare systems suggests that risk factors can be controlled better and treatment strategies for cardiovascular disease can be markedly improved by using a centralized cardiovascular risk service (CVRS) managed by pharmacists. The investigators are confident that a pharmacist-managed mHealth CVRS can become a strategy in un-integrated healthcare settings to markedly reduce cardiovascular events in the United States.

Detailed Description

Cardiovascular disease (CVD) causes 2,200 deaths in Americans every day with one death every 39 seconds. There is evidence that these deaths can be prevented with better risk factor management, however, many risk factors remain uncontrolled. The Patient-Centered Medical Home (Medical Home) which includes self-management, personalized health records and team-based care, has been proposed as a strategy to reduce these gaps in care delivery. Several Cochrane reviews and meta-analyses have found evidence that adding pharmacists to the primary care team improves risk factor control and physician adherence to guidelines. Managed care organizations have found that a centralized cardiovascular risk service (CVRS) managed by pharmacists can reduce mortality. A gap in the literature is that it is not known whether a comprehensive CVRS model would be implemented in typical office practices in un-integrated settings. Simultaneously, systematic reviews of mobile health (mHealth) trials including disease management apps have found no trial that has incorporated communication with a pharmacist and this lack of evidence is a major gap in the mHealth literature.

The objective of this application is to develop and test a mobile app enabled, pharmacist managed CVRS for disseminating and implementing evidence-based guidelines in practice. In addition to developing the app with patients as design partners, the investigators will conduct a multi-center individually randomized study nested within an ongoing NIH trial in medical offices with large geographic, racial and ethnic diversity. The study team will randomize 100 patients from primary care offices to mHealth CVRS (mobile app + web site + pharmacist) or to CVRS only (web site + pharmacist) of whom 55 will be from racial/ethnic minorities. The central hypothesis is that the mHealth CVRS designed with patients as partners will be implemented and significantly improve patient engagement, leading to improved CVD guideline adherence using the Get with The Guidelines and Guideline Advantage metrics. The rationale for this proposed study is that a novel mHealth model that improves secondary prevention of CVD with pharmacist assistance will lead to broader adoption by health systems throughout the US.

The primary Aim is: to examine the feasibility of mHealth technology to disseminate evidence-based risk reduction guidelines in a prospective randomized controlled trial among diverse primary care offices. The investigators postulate that system engagement (primary hypothesis) and adherence to guidelines for secondary prevention of CVD (secondary hypothesis) will be significantly greater in patients randomized to the mHealth intervention compared to the control group.

This study is expected to produce the following outcomes: unique mobile app features that complement the standard CVRS, increased engagement with a CVRS and increased achievement of guideline-concordant therapy.

Conditions

Cardiovascular Diseases; Personal Health Records; Pharmaceutical Care; Mobile Apps

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Web and mobile app access

Subjects will have access to both the mobile and web-app versions of the study Personal Health Record to communicate with the study pharmacist and enter and track their health data.

Group Type: EXPERIMENTAL

Pharmacist-led cardiovascular risk service (CVRS)

Intervention Type: OTHER

CVRS pharmacists will access the study database including patient baseline information obtained from the medical record and patient entered data to make their assessments and recommendations to onsite physicians and onsite clinical pharmacists and individualize their communication with patients. The intervention will provide patient-centered counseling and education to improve medication adherence, lifestyle modifications and/or smoking cessation. The CVRS pharmacist does not make changes to therapy independently but, rather, provides the physicians and on-site pharmacists with action plans and status updates about adherence to Guideline metrics, which should markedly reduce the gaps in guideline-concordant therapy that place patients at risk for CVD events.

Mobile access to study Personal Health Record

Intervention Type: OTHER

Only subjects assigned to the intervention arm will have access to the mobile app version of the study personal Health Record.

Web access to study Personal Health Record

Intervention Type: OTHER

Subjects assigned to both the intervention and control arms will have access to the standard website version of the study personal Health Record.

Web app only access

Subjects will have access to the web-app version of the study Personal Health Record (and not the mobile app version) to communicate with the study pharmacist and enter and track their health data.

Group Type: ACTIVE_COMPARATOR

Pharmacist-led cardiovascular risk service (CVRS)

Intervention Type: OTHER

CVRS pharmacists will access the study database including patient baseline information obtained from the medical record and patient entered data to make their assessments and recommendations to onsite physicians and onsite clinical pharmacists and individualize their communication with patients. The intervention will provide patient-centered counseling and education to improve medication adherence, lifestyle modifications and/or smoking cessation. The CVRS pharmacist does not make changes to therapy independently but, rather, provides the physicians and on-site pharmacists with action plans and status updates about adherence to Guideline metrics, which should markedly reduce the gaps in guideline-concordant therapy that place patients at risk for CVD events.

Web access to study Personal Health Record

Intervention Type: OTHER

Subjects assigned to both the intervention and control arms will have access to the standard website version of the study personal Health Record.

Interventions

Pharmacist-led cardiovascular risk service (CVRS)

CVRS pharmacists will access the study database including patient baseline information obtained from the medical record and patient entered data to make their assessments and recommendations to onsite physicians and onsite clinical pharmacists and individualize their communication with patients. The intervention will provide patient-centered counseling and education to improve medication adherence, lifestyle modifications and/or smoking cessation. The CVRS pharmacist does not make changes to therapy independently but, rather, provides the physicians and on-site pharmacists with action plans and status updates about adherence to Guideline metrics, which should markedly reduce the gaps in guideline-concordant therapy that place patients at risk for CVD events.

Intervention Type: OTHER

Mobile access to study Personal Health Record

Only subjects assigned to the intervention arm will have access to the mobile app version of the study personal Health Record.

Intervention Type: OTHER

Web access to study Personal Health Record

Subjects assigned to both the intervention and control arms will have access to the standard website version of the study personal Health Record.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Patients age 55 and older;

2. Owns and uses a smartphone;

3. Any ONE of the following guideline-related needs in the past 18 months:

1. Most recent encounter LDL >= 100 mg/dl

2. Most recent encounter BP > 140/90 mmHg (or > 150/90 for persons age 60+)

3. Most recent encounter not taking recommended post-stroke medications

4. Most recent encounter not taking recommended post-MI medications

5. Diabetics with most recent encounter not on ACE inhibitor or ARB blocker

6. Any patient with most recent A1c > 8.0%

7. Diabetics with no urine microalbumin screening, past 18 months

Exclusion Criteria

1. Non-English speaking (app available only in English for this study)

2. No encounter in the past 18 months (they may be receiving care elsewhere and guideline-related needs may not be reliably assessed) at the clinic itself

3. Most recent systolic BP >200 or diastolic BP > 110 mm Hg

4. Any history of significant hepatic disease, including cirrhosis, Hepatitis B or C infection, or laboratory abnormalities (serum ALT or AST > 3 times normal (either AST above 96 U/L or ALT above 99 U/L or total bilirubin > 2.0 mg/dl))

5. History of hemorrhagic stroke

6. Pulmonary hypertension

7. Stage 4 or metastatic cancer

8. Current nursing home residence or has plans to move to one within the next 12 months

9. Has plans to transfer care from the current clinic within the next 6 months

10. Inability to give informed consent or impaired cognitive function

11. Currently pregnant (females only)

12. Currently a prisoner

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Iowa

OTHER

Sponsor Role: lead

Responsible Party

Elizabeth A Chrischilles

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elizabeth Chrischilles, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Locations

University of Iowa

Iowa City, Iowa, United States

Siouxland Community Health Center

Sioux City, Iowa, United States

Countries

United States

Other Identifiers

201603819

Identifier Type: -

Identifier Source: org_study_id