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Mobile Cardiovascular Risk Service Trial (mCVRS)

9. oktober 2018 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

80

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

55 år til 99 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Helsetjenesteforskning
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Annen: 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.
Annen: 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.
Annen: 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.
Aktiv komparator: 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.
Annen: 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.
Annen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Mean number of days on which a patient interacts with the cardiovascular risk service (using either mobile app or web-site)
Tidsramme: 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
Tidsramme: 4 months post enrollment
Mean number of contacts with a pharmacist
4 months post enrollment

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Guideline Adherence score calculated on the subset of guidelines amenable to intervention during the 4 month intervention
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Iowa

Etterforskere

  • Hovedetterforsker: Elizabeth Chrischilles, PhD, University of Iowa

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. september 2017

Primær fullføring (Faktiske)

31. august 2018

Studiet fullført (Faktiske)

31. august 2018

Datoer for studieregistrering

Først innsendt

10. mars 2017

Først innsendt som oppfylte QC-kriteriene

10. mars 2017

Først lagt ut (Faktiske)

16. mars 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

11. oktober 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

9. oktober 2018

Sist bekreftet

1. oktober 2018

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 201603819

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

Ja

IPD-planbeskrivelse

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

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