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OpenTrials
Completed

NCT Number: NCT01360203

Better Effectiveness After Transition - Heart Failure

The purpose of this study is to compare the effect of implementing wireless remote monitoring combined with structured telephone monitoring, versus current care, on variation in rehospitalization among older patients hospitalized with heart failure at six medical centers.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Davis, Davis, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients hospitalized at any of the six medical centers who are being actively treated for heart failure.

Exclusion criteria

  • patients who have previously received a transplant, are being evaluated for a transplant, or who are on the wait list for a transplant,
  • patients who are enrolled or enrolling in hospice, or are expected to expire shortly after discharge,
  • patients with dementia,
  • patients who are admitted from a skilled nursing facility (SNF), or who we anticipate will be discharged to a long term stay in a SNF,
  • patients who do not have a working land line phone or reliable cell service,
  • patients on chronic dialysis,
  • patients who cannot identify a usual source of care (free clinic is acceptable) and who will not be assigned a provider upon discharge,
  • patients with the following cardiovascular conditions: patients with valvular disorders requiring surgical intervention (except for those with incidental valvular disease, who will be included), acute myocardial infarction (except for those with demand ischemia, who will be included), percutaneous coronary intervention
  • patients expected to enroll in hospice or expire after discharge,
  • patients who are unable to use the intervention equipment (e.g., unable to stand on the weight scale), or who are otherwise unable to comply with the intervention

Treatment and study plan

Structured Telephone / Remote Outpatient Monitoring

Other

During their hospitalization, patients will receive education on their condition and will be taught to use a wireless remote monitoring device that they will use from home on a daily basis for six months following hospital discharge. Patients will receive structured telephone phone calls from a centralized call center nurse at least once a week for the first month post-discharge, and monthly for the remainder of the six month study period. Patients may receive additional calls depending upon the information gathered during the scheduled call center phone calls and/or their health status as ascertained by the data (weight, heart rate, blood pressure, answers to general health and heart failure-related questions) transmitted daily by the wireless remote monitoring device.

Other names: Care Transition Intervention, Care Transitions Intervention, Structured Telephone Monitoring, Remote Monitoring

Primary outcomes

  1. 180 day rehospitalization rate

    Time frame: at 180 days post-discharge

    Patient self-report in response to telephone survey, combined with administrative claims data of rehospitalization for any cause

Secondary outcomes

  1. 7 day mortality rate

    Time frame: within 7 days post-discharge

    Mortality during the study period. Next of kin will be contacted in the event the patient has expired to verify death and date of death.

  2. Change in quality of Life

    Time frame: as an inpatient, within 7 days post-discharge, and at 30 and 180 days post-discharge

    Quality of life scores will be measured using standardized questionnaires, and data captured during enrollment will be compared with data captured during three post-discharge phone calls

  3. 30 day mortality rate

    Time frame: at 30 days post-discharge

    Mortality during the study period. Next of kin will be contacted in the event the patient has expired to verify death and date of death.

  4. 180 day mortality rate

    Time frame: at 180 days post-discharge

    Mortality during the study period. Next of kin will be contacted in the event the patient has expired to verify death and date of death.

  5. 30 day rehospitalization rate

    Time frame: at 30 days post-discharge

    Patient self-report in response to telephone survey, combined with administrative claims data of rehospitalization for any cause

  6. 7 day rehospitalization rate

    Time frame: within 7 days post-discharge

    Patient self-report in response to telephone survey, combined with administrative claims data of rehospitalization for any cause

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • Cedars-Sinai Medical Center
  • University of California, Davis
  • University of California, Irvine
  • University of California, San Diego
  • University of California, San Francisco

Registry information

Official study title

Variations in Care: Comparing Heart Failure Care Transition Intervention Effects

Acronym: BEAT-HF

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
May 25, 2011
Registry last updated
May 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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