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Improving Safety of Transitions to Skilled Nursing Care Using Videoconferencing (ECHO-CT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03832257
Recruitment Status : Recruiting
First Posted : February 6, 2019
Last Update Posted : June 4, 2020
Sponsor:
Collaborators:
Brown University
Hebrew SeniorLife
Information provided by (Responsible Party):
Lewis Lipsitz, Beth Israel Deaconess Medical Center

Tracking Information
First Submitted Date  ICMJE February 3, 2019
First Posted Date  ICMJE February 6, 2019
Last Update Posted Date June 4, 2020
Actual Study Start Date  ICMJE September 30, 2018
Estimated Primary Completion Date August 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 4, 2019)
30-Day Readmission Rates [ Time Frame: 30-Days ]
Number of hospital readmissions over 30 day period among participating SNF sites
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 4, 2019)
  • Health Care Utilization [ Time Frame: up to 90 days ]
    Includes average length of stay in the facility
  • Incidence of Adverse Clinical Conditions [ Time Frame: 30 Days ]
    From the MDS (variable codes in parentheses), including rates of dehydration (J1550C), internal bleeding (J1550D), falls (J1800), anti-psychotic medication use (N0400A), delirium (C1300), surgical wound infections (I2500 and M1040E), pressure ulcers (M0210), and uncontrolled pain (J0850).
  • Health Care Cost [ Time Frame: 30-days ]
    Total 30-day Medicare costs for fee-for-service patients.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Improving Safety of Transitions to Skilled Nursing Care Using Videoconferencing
Official Title  ICMJE AHRQ Health Services Research Projects: Making Health Care Safer in Ambulatory Care Settings and Long Term Care Facilities
Brief Summary This prospective cohort study seeks to determine if the ECHO-CT program, a healthcare videoconferencing program, can improve clinical outcomes while reducing cost and resource utilization when expanded to a community hospital setting. Data will be analyzed on the facility level and patient level.
Detailed Description

ECHO-Care Transitions is a healthcare outreach program utilizing videoconferencing technology to improve the quality and efficiency of care transitions for medically-complex elderly patients by connecting post-acute care facilities that receive BIDMC patients with a multidisciplinary BIDMC team that sends these patients following discharge. This case-control study seeks to determine if ECHO-CT can improve clinical outcomes and reduce cost and resource utilization during transitions of care in both an academic (BIDMC Boston) and community (BIDMC Needham) hospital.

Our prospective cohort study of the ECHO-CT intervention will take place in the two Boston-area hospitals, one providing tertiary care and one community-based care, in which the outcomes of patients transferred to Skilled Nursing Facilities (SNFs) associated with these hospitals will be compared to those transferred to SNFs from similar hospitals in New England. We will also be comparing outcomes from individual patients enrolled in the ECHO program to matched controls. Using a national database available from the Brown University Center for Gerontology and Healthcare Research, the outcomes of Medicare beneficiaries residing in SNFs that are participating in ECHO-CT will be compared to those in the comparison group using a difference-of-difference analytic approach. Analyses will be adjusted for potential confounders as appropriate.

In this study, the investigators also plan to measure satisfaction as well as process, utilization, cost and patient safety outcomes to determine best practices for implementing the program at a community hospital and affiliated SNFs.

Data will be obtained from the following sources:

  1. Protected health information (PHI) from resident assessment data, as well as Medicare claims and enrollment data to be obtained via a data use agreement (DUA) with the Centers for Medicare and Medicaid Services (CMS) by the Brown University Center for Gerontology and Health Care Research during years 2-3 of the study to include the following:

    1. The resident Minimum Data Set Resident Assessment (MDS) assessments. The MDS has nearly 400 data elements including cognitive function, communication/hearing problems, physical functioning, continence, psycho-social well-being, mood state, activity and recreation, diagnoses, health conditions, nutritional status, oral/dental status, skin conditions, special treatments, and medication use. The assessments are done for all patients admitted to Medicare and Medicaid certified SNFs, including enrollees in both traditional Medicare and Medicare Advantage. These data will already be housed at Brown University,Brown has an active DUA to obtain quarterly pulls of the population of MDS assessments .
    2. Medicare claims which will be used to ascertain 30-day costs, re-hospitalizations, and use of other medical services by Medicare fee for service (FFS) patients admitted to the SNFs. The data also include diagnosis fields to ascertain comorbidities.
    3. Medicare enrollment file includes demographic information such as sex and race, dates of birth and death, and various indicators of Medicare/Medicaid eligibility, Part D eligibility, and Medicare Advantage enrollment.
    4. BIDMC will collect and share ECHO-CT participating patient's social security number and health insurance claims number with Brown University. Their clinical information will be matched with control patients from the Medicare claims data to show study effect on 30-day costs, re-hospitalizations rate and patient length of stay.
  2. In addition to aggregates derived from above, facility level data will come from the Certification and Survey Provider Enhanced Reporting (CASPER) data, which are publicly available and based upon facility surveys for Medicare/Medicaid certification. They will be used in addition to data from "Nursing Home Compare and the Long Term Care: Facts on Care in the US (LTCFocus.org) websites to describe the SNFs.
  3. Intervention-specific data: Project-specific quality improvement data derived from questionnaires, staff satisfaction surveys, and structured meeting minutes will be designed and evaluated by BIDMC and Hebrew Senior Life

    1. SNF Satisfaction: Every 6 months the investigators will send a satisfaction questionnaire to the hospitals and SNFs participating in ECHO-CT to assess their views of the ECHO-CT sessions, the value of time spent, feelings of empowerment, inter-professional relationships, learning, and recommendations. All answers to the survey questions will be kept strictly confidential. This information will be used to improve the content and organization of the sessions and to develop tools for dissemination (Aim 3). The investigators will develop the satisfaction questionnaire during the first 6 months of the project, building upon our previous survey experience and literature review. Metrics to quantify the quality of transitional care will be derived from the work of Coleman et al.3 and incorporated into the questionnaire. Survey design and evaluation will be conducted by the outcome evaluation group under the leadership of Dr. Thomas Travison at Hebrew SeniorLife's Institute for Aging Research.
    2. Process assessment: The investigators will keep attendance logs to assess adherence to the ECHO-CT intervention and its changes over time. Any consistent decline in staff attendance for 2 or more weeks will be followed up by phone calls to assess barriers to participation and corrective actions will be taken. These may include changing to a more convenient time, identifying other providers who can attend instead, contacting facility administrators or medical directors for their support, and providing incentive gifts or continuing education credits In addition, during each ECHO-CT session, the hospital based team will inquire about unexpected outcomes or issues that arose during the transition process, including those related to patients already discussed. This element will allow for an ongoing technology-enabled learning platform and continuous quality improvement mechanism over the course of the proposed project. The value of the video-conferencing approach is that it creates a mutually trusting learning community in which "all teach and all learn."
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Acute Disease
Intervention  ICMJE
  • Other: ECHO CT Intervention
    weekly video conference between hospitalist and skilled nursing facilities
  • Other: Matched Non-Participating Facilities
    Matched Non-Participating Facilities
Study Arms  ICMJE
  • Experimental: ECHO CT Intervention
    Weekly video conference between hospitalist at Beth Israel and skilled nursing facilities.
    Intervention: Other: ECHO CT Intervention
  • Matched Non- Participating Facilities
    Matched non-participating facilities
    Intervention: Other: Matched Non-Participating Facilities
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 3, 2019)
800
Original Estimated Enrollment  ICMJE
 (submitted: February 4, 2019)
20
Estimated Study Completion Date  ICMJE August 31, 2021
Estimated Primary Completion Date August 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Facility Inclusion Criteria:

  • SNF receives approximately the middle third of referral volume (approx. 20-100 referrals/ average 40 per year)
  • SNF not so highly engaged with acute hospital that their patients are less likely to benefit from the intervention.
  • SNF affiliated with BIDMC Boston or BIDMC Needham

Facility Exclusion Criteria:

  • Has not recently participated in ECHO CT
  • Do not send anyone to ECHO CT training
  • Clinicians are unwilling to make a commitment to attend at least 75% of video conferences

Patient Selection:

ECHO-CT Group:

Inclusion Criteria: Patients that were discharged from BIDMC and admitted to skilled nursing facilities that are participating in ECHO-CT between April 2019 and March 2021.

Exclusion Criteria: Patients discharged from a hospital other than BIDMC. Patients admitted to a skilled nursing facility that is not participating in ECHO-CT.

Control Group:

Inclusion Criteria: Patients from skilled nursing facilities not participating in ECHO.

Exclusion Criteria: Patients discharged from BIDMC to one of our participating SNFs during the study period of April 2019- March 2021

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lewis Lipsitz, MD 617-971-5318 Lipsitz@hsl.harvard.edu
Contact: Lauren Junge-Maughan 617- 632-8699 ljunge-m@bidmc.harvard.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03832257
Other Study ID Numbers  ICMJE 2018P000457
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Lewis Lipsitz, Beth Israel Deaconess Medical Center
Study Sponsor  ICMJE Beth Israel Deaconess Medical Center
Collaborators  ICMJE
  • Brown University
  • Hebrew SeniorLife
Investigators  ICMJE Not Provided
PRS Account Beth Israel Deaconess Medical Center
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP