NCT03126565

Brief 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. The investigators want to see whether the CareSage system is effective in helping to identify hospital admissions which can be prevented.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
370

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 24, 2017

Completed
25 days until next milestone

Study Start

First participant enrolled

May 19, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 16, 2019

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2019

Completed
Last Updated

September 1, 2020

Status Verified

August 1, 2020

Enrollment Period

1.9 years

First QC Date

April 14, 2017

Last Update Submit

August 29, 2020

Conditions

Multimorbidity

Outcome Measures

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

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

    9 months after study enrollment

Secondary Outcomes (11)

  • Emergency Transport use

    9 months after study enrollment

  • 30-, 90- and 180- day readmissions

    9 months after study enrollment

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

    9 months after study enrollment

  • Total medical expenses attributable to the avoidable admissions

    9 months after study enrollment

  • Mortality rates

    9 months after study enrollment

  • +6 more secondary outcomes

Study Arms (2)

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.

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.

Interventions

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

Group A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Partners Healthcare at Home

Waltham, Massachusetts, 02451, United States

Location

Related Publications (1)

  • 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.

    PMID: 29743156DERIVED

Study Officials

  • Kamal Jethwani, MD, MPH

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dermatologist

Study Record Dates

First Submitted

April 14, 2017

First Posted

April 24, 2017

Study Start

May 19, 2017

Primary Completion

April 16, 2019

Study Completion

November 30, 2019

Last Updated

September 1, 2020

Record last verified: 2020-08

Locations

US(1)