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Completed

NCT Number: NCT03126565

Evaluation of the Philips Lifeline CareSage Risk Assessment System

This study is being done to evaluate the impact of a system called CareSage. The CareSage system is a technology that uses clinical data to monitor, identify and target care to patients at risk of being transported to the hospital. The investigators want to see whether the CareSage system is effective in helping to identify hospital admissions which can be prevented.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Partners Healthcare at Home

Waltham, Massachusetts, 02451, United States

About this study

The growing elderly population and rising rates of costly chronic disease have led to the development of preventative homecare management opportunities to improve health outcomes and reduce the number of patients who enter costly inpatient care. Partners HealthCare at Home (PHH) is a preventative homecare management system which offers general care as well as specialized services to help patients and their loved ones manage chronic conditions at home. Such continuity of care is achieved through a multidisciplinary clinical team and the integration of telemonitoring into the patient's care plan.

The Philips Lifeline Personal Emergency Response Service (PERS), a wearable button device worn on the wrist or as a pendant, is a telemonitoring device available to patients receiving care through PHH. When the patient presses the button, the patient is immediately connected with a Lifeline response agent. Philips Lifeline (PLL) has developed CareSage, a predictive analytics engine that combines continuous monitoring with predictive analytics. The clinical interface (CareSage platform) helps care teams monitor the patient's calculated risk scores for emergency transport. The algorithm used by this integrated risk assessment system was originally developed after studying a large cohort of the PERS subscribers (N = ~600,000). In Phase 1 of this study the algorithm was validated among a cohort (N = 3,335) of PHH patients to predict emergency transports in this population (AUC = .76).

In Phase 2 of this study, the investigators will conduct a prospective, randomized trial of 370 patients to assess the effect of the risk assessment CareSage platform and PHH tailored interventions on the rate of readmissions, quality of life, and the overall cost of medical care. The investigators hypothesize that a multidisciplinary intervention approach could significantly reduce the healthcare resource utilization in patient at high risk for hospitalization. The intervention will flag those patients at the highest risk for hospital transport, alert the patient's care team that an intervention may be needed, thereby targeting care at high risk patients who are most likely to get readmitted. By predicting which patients are at high risk of hospital transport which may lead to hospitalization, targeting interventions at those patients and engaging patients with their care team, the investigators hope to reduce readmissions, hospital days, and rates of mortality in high risk patients.

The goal of this 2-arm randomized controlled study is to assess the impact of the CareSage risk assessment platform on 90- and 180-day Emergency Department (ED) visits in a cohort of PHH patients. All patients will receive the PERS device and be followed for a total of 9 months, including an initial 3-month observation period and followed by a 6-month intervention period. At the beginning of the observation period (baseline), enrolled patients will be randomized into 2 groups: the Intervention Group or the Control Group. During the observation period the CareSage algorithm will calibrate using patient data (both groups) collected during this interval from the PERS device. Then, during the intervention period, patients in the intervention group will be actively monitored by the CareSage algorithm and will receive tailored PHH interventions if flagged as being at high risk for emergency transport. Patients in the control group will receive care as usual during the intervention period. All data collected during the study will be used to further strengthen the CareSage algorithm developed in the Phase I of this study.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Aged 18 years or older
  • Receiving care from Partners Healthcare at Home (PHH)
  • Total healthcare costs fall within the middle 51st-95th percentile of patients seen at Partners Healthcare from fiscal year 2016

Exclusion criteria

  • Currently on admission in a hospital facility with planned discharge to a long-term-care facility or Skilled Nursing Facilities (SNFs).
  • Severe dementia, Alzheimer's or other serious psychiatric illness (severe anxiety disorder or psychosis).
  • Enrolled in the Integrated Care Management Program (iCMP) program.
  • Continued telemonitoring (TM) support extending into the 6 months of study period post the observation period of 3 months.
  • PHH patients with pacemakers and other implanted devices

Treatment and study plan

Lifeline CareSage Flagging

Other

Patients in the intervention group will receive active monitoring by the CareSage risk assessment platform and clinical interface, including nurse triage calls and tailored PHH interventions. Beginning at month 4, the CareSage algorithm will assess patients' risk for emergency transport every 30 days. Patients identified as high risk will receive nurse triage calls and, depending on their needs, tailored care according to a stepped-care approach. The principal goals will be to reinforce the patients' education, ensure compliance with medications and diet, and identify recurrent symptoms amenable to treatment on an outpatient basis to avoid readmissions

Primary outcomes

  1. Number of participants who visit the emergency department 90 and 180 days after the three month observational period and assessed by reviewing the medical records

    Time frame: 9 months after study enrollment

    To assess the impact of the CareSage risk assessment platform and tailored PHH intervention on the 90- and 180- day ED visits.

Secondary outcomes

  1. Emergency Transport use

    Time frame: 9 months after study enrollment

    Patient usage of emergency transport

  2. 30-, 90- and 180- day readmissions

    Time frame: 9 months after study enrollment

    Data pertaining to the 30-day readmissions will be collected in the intervention period (6 months).

  3. Total number of avoidable hospital admissions using Center for Medicare and Medicaid Services (CMS) criteria

    Time frame: 9 months after study enrollment

    Total number of avoidable hospital admissions

  4. Total medical expenses attributable to the avoidable admissions

    Time frame: 9 months after study enrollment

    Total medical expenses attributable to the avoidable admissions

  5. Mortality rates

    Time frame: 9 months after study enrollment

    Patient deaths

  6. Time to readmission

    Time frame: 9 months after study enrollment

    Length of time before patient was readmitted.

  7. Patient quality of life

    Time frame: 9 months after study enrollment

    This outcome will be assessed using a validated questionnaire- Short-form 12 version 2 (SF-12v2)

  8. Patient satisfaction with the service

    Time frame: 9 months after study enrollment

    Patient and provider satisfaction with the service will be evaluated using a Satisfaction survey designed specifically for this study

  9. Patient leakage

    Time frame: 9 months after study enrollment

    Number of patients who have been admitted to hospitals outside of the Partners network will be assessed by patient self-disclosure at close-out

  10. PLL switch rate from No to Yes-Payment at the end of the study.

    Time frame: 9 months after study enrollment

    The PLL switch rate from No to Yes-Payment will be evaluated at the end of the study by using the billing accounts from Phillips

  11. Total number of hospital admissions assessed by reviewing the medical record

    Time frame: 9 months after study enrollment

    Total number of hospital admissions for participants

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Philips Healthcare

Registry information

Official study title

Evaluating the Impact of an Integrated Risk Assessment System (Philips Lifeline Personal Emergency Response Service) on Healthcare Utilization

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 24, 2017
Registry last updated
Sep 1, 2020

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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