NCT02763202

Brief Summary

The purpose of this study is to better enhance transitions of care for the highest risk, complex patients, Carolinas HealthCare System (CHS) has designed an Integrated Practice Unit, called Transition Services (CHS-TS).CHS-TS aims to improve patient outcomes through innovative approaches that leverage analytics and technology, while bridging care coordination and communication gaps. During their hospitalization, CHS-TS patients enter into a transition pathway that includes the following key services: integrated access to medical, pharmacist, and specialty providers; access to CHS disease specific management programs; dedicated care management services delivered in home and at the clinic; lab and infusion services; palliative care consultations when appropriate; and paramedicine for 24 hour support. AIRTIGHT (Aiming to Improve Readmissions Through InteGrated Hospital Transitions) is a pragmatic, randomized quality improvement evaluation, which seeks to evaluate the effects of the role-out of CHS-TS services for patients at high risk for a 30-day readmission. AIRTIGHT will test the hypothesis that patients that receive care through CHS-TS will have a lower all cause, 30-day readmission rate than patients that receive usual care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,876

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2016

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

Study Start

First participant enrolled

February 8, 2016

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

March 3, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 5, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2017

Completed
Last Updated

April 27, 2022

Status Verified

February 1, 2018

Enrollment Period

12 months

First QC Date

March 3, 2016

Last Update Submit

April 20, 2022

Conditions

Keywords

transition of carepragmatic clinical trialtelemedicineemergency medical technician

Outcome Measures

Primary Outcomes (1)

  • 30-day all cause CHS readmission

    Index visit as defined by the Centers for Medicaid and Medicare Services (CMS) and inclusion of observation patients at any CHS facility

    30 days from index visit

Secondary Outcomes (4)

  • 30-day all cause CHS readmission

    30 days from index visit

  • Length of stay upon the index visit

    Length of stay upon the index visit, will be measured up to 1 month.

  • Length of stay upon the readmission visit

    Length of stay upon the first readmission after index visit, will be measured up to 1 month.

  • All cause, 60 and 90-day readmission rate

    60 and 90 days from index visit

Study Arms (2)

Usual Care Group

NO INTERVENTION

Participants assigned to the usual care group will continue have the current standard of care including any discharge services for example those usually arranged by case managers, hospitalists, and primary care physicians.

CHS-TS Group

EXPERIMENTAL

Participants assigned to the Carolinas Healthcare Services Transition Services (CHS-TS) group will be introduced to a patient navigator prior to discharge from the hospital and if interested enter the CHS-TS pathway that includes the following key services: integrated access to medical, pharmacist, and specialty providers; access to CHS disease specific management programs; dedicated care management services delivered in home and at the clinic; lab and infusion services; palliative care consultations when appropriate; and paramedicine for 24 hour support.

Other: CHS Transition Services

Interventions

The CHS Transition Services (CHS-TS) pathway includes the following seven components: (i) Introduction to CHS-TS process prior to discharge (ii) Hospital follow-up evaluation within 72 hours either in home with paramedicine or in the CHS-TS clinic (iii) Medication reconciliation by a pharmacist within 72 hours (iv) Weekly contact with care management team (v) Entry into the Heart Success Program if appropriate (vi) Access to 24/7 phone support, 24/7 paramedicine visits, and same day clinic scheduling (vii) Coordinated transition to the next appropriate care location after 30 days from time of discharge

CHS-TS Group

Eligibility Criteria

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

You may qualify if:

  • Classified as inpatient or observation as of (00:00), and
  • Predixion score ≥ 0.50, and
  • Carolinas Hospitalist Group is listed as the primary attending service or consulting service at CMC Main or Mercy campuses, and
  • Not discharged at the time of list generation.

You may not qualify if:

  • Randomized in the last 90 days into either the CHS-TS or to usual care
  • Not a North Carolina resident
  • Greater than 2.5 hour drive time from CMC to primary residence
  • Psychiatric diagnosis codes within the last 6 months including: Schizophrenia, Suicidal Ideation, Homicidal Ideation, or Psychosis (ICD10 - R45.851, R45.850, F20.x-F29.x)
  • Diagnosis of sickle cell anemia in the past year (ICD10 - D57)
  • Diagnosis of drug or alcohol dependence within the last 90 days (ICD10 - F10.2x, F11.2x, F12.2x, F13.2x, F14.2x, F16.2x, F18.2x, F19.2x)
  • Actively followed for a primary diagnosis of cancer (greater than 2 visits to CHS Cancer Center or on chemotherapy in last 2 months)
  • Hospitalized for greater than 72 hours
  • Residing in a facility prior to admission (example jail or skilled nursing facility)
  • Under the care of hospice prior to admission
  • Left Against Medical Advice\*
  • Disposition other than home (example skilled nursing facility or rehabilitation facility)\*
  • Disposition home with hospice\*
  • Heart Failure as a discharge diagnosis \*

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carolinas Medical Center

Charlotte, North Carolina, 28226, United States

Location

Related Publications (10)

  • Moore B, Levit K, Elixhauser A. Costs for Hospital Stays in the United States, 2012. 2014 Oct. In: Healthcare Cost and Utilization Project (HCUP) Statistical Briefs [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2006 Feb-. Statistical Brief #181. Available from http://www.ncbi.nlm.nih.gov/books/NBK259217/

    PMID: 25521003BACKGROUND
  • Weiss AJ, Elixhauser A. Overview of Hospital Stays in the United States, 2012. 2014 Oct. In: Healthcare Cost and Utilization Project (HCUP) Statistical Briefs [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2006 Feb-. Statistical Brief #180. Available from http://www.ncbi.nlm.nih.gov/books/NBK259100/

    PMID: 25506966BACKGROUND
  • Rennke S, Nguyen OK, Shoeb MH, Magan Y, Wachter RM, Ranji SR. Hospital-initiated transitional care interventions as a patient safety strategy: a systematic review. Ann Intern Med. 2013 Mar 5;158(5 Pt 2):433-40. doi: 10.7326/0003-4819-158-5-201303051-00011.

    PMID: 23460101BACKGROUND
  • Hansen LO, Young RS, Hinami K, Leung A, Williams MV. Interventions to reduce 30-day rehospitalization: a systematic review. Ann Intern Med. 2011 Oct 18;155(8):520-8. doi: 10.7326/0003-4819-155-8-201110180-00008.

    PMID: 22007045BACKGROUND
  • Jack BW, Chetty VK, Anthony D, Greenwald JL, Sanchez GM, Johnson AE, Forsythe SR, O'Donnell JK, Paasche-Orlow MK, Manasseh C, Martin S, Culpepper L. A reengineered hospital discharge program to decrease rehospitalization: a randomized trial. Ann Intern Med. 2009 Feb 3;150(3):178-87. doi: 10.7326/0003-4819-150-3-200902030-00007.

    PMID: 19189907BACKGROUND
  • Kansagara D, Chiovaro JC, Kagen D, Jencks S, Rhyne K, O'Neil M, Kondo K, Relevo R, Motu'apuaka M, Freeman M, Englander H. So many options, where do we start? An overview of the care transitions literature. J Hosp Med. 2016 Mar;11(3):221-30. doi: 10.1002/jhm.2502. Epub 2015 Nov 9.

    PMID: 26551918BACKGROUND
  • Kansagara D, Englander H, Salanitro A, Kagen D, Theobald C, Freeman M, Kripalani S. Risk prediction models for hospital readmission: a systematic review. JAMA. 2011 Oct 19;306(15):1688-98. doi: 10.1001/jama.2011.1515.

    PMID: 22009101BACKGROUND
  • Kripalani S, Theobald CN, Anctil B, Vasilevskis EE. Reducing hospital readmission rates: current strategies and future directions. Annu Rev Med. 2014;65:471-85. doi: 10.1146/annurev-med-022613-090415. Epub 2013 Oct 21.

    PMID: 24160939BACKGROUND
  • McWilliams A, Roberge J, Anderson WE, Moore CG, Rossman W, Murphy S, McCall S, Brown R, Carpenter S, Rissmiller S, Furney S. Aiming to Improve Readmissions Through InteGrated Hospital Transitions (AIRTIGHT): a Pragmatic Randomized Controlled Trial. J Gen Intern Med. 2019 Jan;34(1):58-64. doi: 10.1007/s11606-018-4617-1. Epub 2018 Aug 14.

  • McWilliams A, Roberge J, Moore CG, Ashby A, Rossman W, Murphy S, McCall S, Brown R, Carpenter S, Rissmiller S, Furney S. Aiming to Improve Readmissions Through InteGrated Hospital Transitions (AIRTIGHT): study protocol for a randomized controlled trial. Trials. 2016 Dec 19;17(1):603. doi: 10.1186/s13063-016-1725-2.

Study Officials

  • Andrew McWilliams, MD, MPH

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2016

First Posted

May 5, 2016

Study Start

February 8, 2016

Primary Completion

January 31, 2017

Study Completion

April 30, 2017

Last Updated

April 27, 2022

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations