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Mobile Cardiovascular Risk Service Trial (mCVRS)

2018년 10월 9일 업데이트: Elizabeth A Chrischilles, University of Iowa

Design and Testing of a Mobile Cardiovascular Risk Service With Patient Partners

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.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (실제)

80

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 미국
    • Iowa
      • Iowa City, Iowa, 미국, 52242
        • University of Iowa
      • Sioux City, Iowa, 미국, 51105
        • Siouxland Community Health Center

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

55년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 건강 서비스 연구
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
다른: 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.
다른: 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.
다른: 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.
활성 비교기: 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.
다른: 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.
다른: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Mean number of days on which a patient interacts with the cardiovascular risk service (using either mobile app or web-site)
기간: 4 months post enrollment
Mean number of days on which a patient interacts with the cardiovascular risk service (using either mobile app or web-site)
4 months post enrollment
Mean number of contacts with a pharmacist
기간: 4 months post enrollment
Mean number of contacts with a pharmacist
4 months post enrollment

2차 결과 측정

결과 측정
측정값 설명
기간
Guideline Adherence score calculated on the subset of guidelines amenable to intervention during the 4 month intervention
기간: 4 months post enrollment
Guideline Adherence score calculated on the subset of guidelines amenable to intervention during the 4 month intervention
4 months post enrollment

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

University of Iowa

수사관

  • 수석 연구원: Elizabeth Chrischilles, PhD, University of Iowa

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2017년 9월 1일

기본 완료 (실제)

2018년 8월 31일

연구 완료 (실제)

2018년 8월 31일

연구 등록 날짜

최초 제출

2017년 3월 10일

QC 기준을 충족하는 최초 제출

2017년 3월 10일

처음 게시됨 (실제)

2017년 3월 16일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2018년 10월 11일

QC 기준을 충족하는 마지막 업데이트 제출

2018년 10월 9일

마지막으로 확인됨

2018년 10월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 201603819

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

Public use data sets will be created and made available to other investigators in a timely manner. Data will only be provided in the form of fully HIPAA-de-identified datasets. Data sets will be carefully reviewed to make sure that information such as age and gender cannot be used to gather additional information that could potentially identify individual subjects. All categorical demographic variables will be collapsed into categories large enough so that combinations of demographic categories for age, gender or area of residence will have 10 or more individuals in each cell. The investigators plan to create SAS datasets in transport format and provide data dictionaries describing the contents of each dataset. Investigators requesting access to the data will be asked to complete a data sharing agreement.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

미국에서 제조되어 미국에서 수출되는 제품

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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