MultimorbidityNCT03126565
Evaluation of the Philips Lifeline CareSage Risk Assessment System
A study testing Lifeline CareSage Flagging in people with Multimorbidity, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multimorbidity
- What is being tested?
- Lifeline CareSage Flagging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 370 participants
- Where
- 1 siteUnited States
- Study dates
- 19 May 2017to 30 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Partners Healthcare at Home
Waltham, Massachusetts, 02451
About this study
Official title: Evaluating the Impact of an Integrated Risk Assessment System (Philips Lifeline Personal Emergency Response Service) on Healthcare Utilization
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.
Read the detailed description
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.
- Conditions
- Multimorbidity
- Being tested
- Lifeline CareSage Flagging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifeline CareSage FlaggingOther
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
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | This group will include a cohort of 185 participants who will be monitored by the CareSage risk assessment platform. Tailored interventions, using a Stepped-Care Approach, will be targeted to patients flagged as high risk for emergency transport during the 6-month intervention period. Receives: Other: Lifeline CareSage Flagging |
| Group B | No intervention | This group will include a cohort of 185 participants where study staff will not see if patients are flagged by the CareSage risk assessment platform as being at high or low risk for emergency transport during the 6-month intervention period. Patients will continue to receive care as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
To assess the impact of the CareSage risk assessment platform and tailored PHH intervention on the 90- and 180- day ED visits.
Measured: 9 months after study enrollment
Secondary outcomes (11)
Emergency Transport use
Patient usage of emergency transport
Measured: 9 months after study enrollment
30-, 90- and 180- day readmissions
Data pertaining to the 30-day readmissions will be collected in the intervention period (6 months).
Measured: 9 months after study enrollment
Total number of avoidable hospital admissions using Center for Medicare and Medicaid Services (CMS) criteria
Total number of avoidable hospital admissions
Measured: 9 months after study enrollment
Total medical expenses attributable to the avoidable admissions
Total medical expenses attributable to the avoidable admissions
Measured: 9 months after study enrollment
Mortality rates
Patient deaths
Measured: 9 months after study enrollment
Time to readmission
Length of time before patient was readmitted.
Measured: 9 months after study enrollment
Patient quality of life
This outcome will be assessed using a validated questionnaire- Short-form 12 version 2 (SF-12v2)
Measured: 9 months after study enrollment
Patient satisfaction with the service
Patient and provider satisfaction with the service will be evaluated using a Satisfaction survey designed specifically for this study
Measured: 9 months after study enrollment
Patient leakage
Number of patients who have been admitted to hospitals outside of the Partners network will be assessed by patient self-disclosure at close-out
Measured: 9 months after study enrollment
PLL switch rate from No to Yes-Payment at the end of the study.
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
Measured: 9 months after study enrollment
Total number of hospital admissions assessed by reviewing the medical record
Total number of hospital admissions for participants
Measured: 9 months after study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2017
- Study start19 May 2017
- Primary completion16 Apr 2019
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MultimorbidityStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 370 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Philips Healthcare
- Responsible party
- Principal investigator, Joseph C. Kvedar, Massachusetts General Hospital
- Investigators
- Kamal Jethwani, MD, MPH, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03126565
- Sponsor's protocol ID
- 2017P000195
- Status last verified
- Aug 2020
- First submitted
- 14 Apr 2017
- Last updated
- 1 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Palacholla RS, Fischer NC, Agboola S, Nikolova-Simons M, Odametey S, Golas SB, Op den Buijs J, Schertzer L, Kvedar J, Jethwani K. Evaluating the Impact of a Web-Based Risk Assessment System (CareSage) and Tailored Interventions on Health Care Utilization: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2018 May 9;7(5):e10045. doi: 10.2196/10045.
PubMed 29743156
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of an Integrated Risk Assessment System (Philips Lifeline Personal Emergency Response Service) on Healthcare Utilization
- ClinicalTrials.gov ID
- NCT03126565
- Acronym / sponsor ID
- 2017P000195
- Conditions
- Multimorbidity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 370 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Philips Healthcare
- Study start
- 19 May 2017 (actual)
- Primary completion
- 16 Apr 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 24 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Lifeline CareSage FlaggingThis group will include a cohort of 185 participants who will be monitored by the CareSage risk assessment platform. Tailored interventions, using a Stepped-Care Approach, will be targeted to patients flagged as high risk for emergency transport during the 6-month intervention period. |
| Group B | No intervention | –This group will include a cohort of 185 participants where study staff will not see if patients are flagged by the CareSage risk assessment platform as being at high or low risk for emergency transport during the 6-month intervention period. Patients will continue to receive care as usual. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifeline CareSage FlaggingPatients 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 | Other | Group A |
Primary outcome
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.
11 secondary outcomes
Emergency Transport use
Time frame: 9 months after study enrollment
30-, 90- and 180- day readmissions
Time frame: 9 months after study enrollment
Total number of avoidable hospital admissions using Center for Medicare and Medicaid Services (CMS) criteria
Time frame: 9 months after study enrollment
Total medical expenses attributable to the avoidable admissions
Time frame: 9 months after study enrollment
Mortality rates
Time frame: 9 months after study enrollment
Time to readmission
Time frame: 9 months after study enrollment
Patient quality of life
Time frame: 9 months after study enrollment
Patient satisfaction with the service
Time frame: 9 months after study enrollment
Patient leakage
Time frame: 9 months after study enrollment
PLL switch rate from No to Yes-Payment at the end of the study.
Time frame: 9 months after study enrollment
Total number of hospital admissions assessed by reviewing the medical record
Time frame: 9 months after study enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2020.
- Derived from this study: PubMed 29743156Palacholla RS, Fischer NC, Agboola S, Nikolova-Simons M, Odametey S, Golas SB, Op den Buijs J, Schertzer L, Kvedar J, Jethwani K. Evaluating the Impact of a Web-Based Risk Assessment System (CareSage) and Tailored Interventions on Health Care Utilization: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2018 May 9;7(5):e10045. doi: 10.2196/10045.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kamal Jethwani, MD, MPH principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifeline CareSage Flagging in people with Multimorbidity, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03126565, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2020.