Telehealth Education Leveraging Electronic Transitions Of Care for COPD Patients (TELE-TOC)

TELE-TOC: Telehealth Education Leveraging Electronic Transitions Of Care for COPD Patients

Transitions of Care (TOC) between hospital, ambulatory, and home settings for high-risk, frequently hospitalized adults with chronic diseases, such as chronic obstructive pulmonary disease (COPD) are complex, costly, and vulnerable to safety threats and poor health outcomes. One potential solution to address this gap in care is the Transitional Care Model (TCM), which utilizes a patient-centered approach with in-home interventions; since in-person in-home visits are costly, using innovative telehealth, such as virtual visits via teleconferencing may be just as effective with greater feasibility, scalability, and sustainability, particularly in the post-COVID-19 era as has been seen the rapid expansion of these technologies. With a transdisciplinary team of experts from cognitive science, care transitions/handoffs, human factors engineering, design, implementation science, and health services research, the study team proposes to implement and evaluate via a randomized clinical trial the "TELE-TOC: Telehealth Education: Leveraging Electronic Transitions Of Care for COPD patients," intervention which includes a virtual visit, pharmacy-based, in-home intervention for COPD patients to improve medication use and patient outcomes among a population at high risk for readmission and medication safety events.

Study Overview

• Status: Not yet recruiting
• Conditions: COPD Exacerbation; Care Transitions
• Intervention / Treatment: Other: Virtual at Home Medication Reconciliation Visit(s); Behavioral: Virtual At Home Medication Education Visit(s); Other: COPD advanced practice nurse Inpatient Consult; Other: Inpatient Medication Reconciliation; Other: Post-discharge nurse 48 hour phone follow-up call; Other: Post-discharge follow-up advanced practice nurse outpatient visit

Detailed Description

Transitions of Care (TOC) for high-risk, frequently hospitalized adults with chronic diseases are complex, costly, and vulnerable to safety threats and poor health outcomes. Communication breakdowns, information lapses, and IT-induced unintended consequences can result in poor follow-up and medication non-adherence, both of which contribute to preventable readmissions or emergency room (ER) visits. The Transitional Care Model (TCM) aims to reduce such risks through a holistic, collaborative, patient-centered approach with in-home interventions. Prior to the coronavirus disease 2019 (COVID-19) pandemic, most in- home interventions relied on in-person visits, which can be cost-prohibitive and unsustainable. One potential sustainable and scalable solution is to use telehealth for in-home virtual visits; however, use of telehealth for post-discharge TOC interventions has not been routinely implemented. In the post-COVID-19 era, given the rapid expansion of telehealth, hospitals are well-positioned to initiate this virtual care. In-home virtual visits may be particularly promising for patients with chronic obstructive pulmonary disease (COPD), who are often hospitalized, have multiple comorbidities, and require intensive medication teaching due to rampant inhaler misuse. COPD affects more than 16 million US adults, many of whom are older, contribute ~$50 billion to healthcare costs annually, experience high rates of acute care revisits, often due to care coordination failures. For this reason, Medicare's Hospital Readmission Reduction Program (HRRP) aims to incentivize hospitals to implement TOC programs for increased quality and value of care for COPD patients. However, currently, such programs fall short of aligning with the full TCM. In-home interventions may be particularly salient for improving medication skills and outcomes for patients with COPD given rampant inhaler misuses, the effectiveness of in- hospital inhaler education, and evidence showing the need for inhaler education reinforcement post discharge. Thus, our trans-disciplinary team proposes to implement and evaluate "TELE-TOC: Telehealth Education: Leveraging Electronic Transitions Of Care for COPD patients," which seeks to integrate virtual, pharmacy-based, in-home visits for COPD patients within our hospital's existing COPD HRRP. The central hypotheses are that virtual visits with pharmacists will be feasible to implement and will result in improved medication use and outcomes among COPD patients at high risk for readmission. The investigator aims to iteratively design TELE-TOC using participatory study design and stakeholder input. The study team will then test the effectiveness of adding TELE-TOC virtual visits in a randomized controlled trial among COPD patients enrolled in the HRRP program. Lastly, the study team will develop a plan for a dissemination strategy and roadmap with national stakeholders to facilitate wide scale adoption of TELE-TOC nation wide.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Leah Traeger; Phone Number: 773-834-4489; Email: ltraeger@bsd.uchicago.edu
• Study Contact Backup: Name: Valerie G Press, MD, MPH; Phone Number: 7737025170; Email: vpress@bsd.uchicago.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago
      • Principal Investigator: Vineet M Arora, MD, MAPP
      • Principal Investigator: Valerie G Press, MD, MPH
      • Contact: Leah Traeger; Phone Number: 773-834-4489; Email: ltraeger@bsd.uchicago.edu
      • Contact: Valerie G Press, MD, MPH; Phone Number: 7737025170; Email: vpress@bsd.uchicago.edu
      • Principal Investigator: Joanna Abraham, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults 40 years or older
• Admitted to the hospital on a general inpatient ward with a COPD Exacerbation
• Enrolled/seen by our COPD Hospital Readmission Reduction Program

Exclusion Criteria:

• Patients younger than 40 years of age
• Currently in the intensive care unit

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TELE-TOC plus Usual Care; Patients randomized to this arm will receive the TELE-TOC intervention as well as the standard COPD care via the institution's COPD readmission reduction program.	Other: Virtual at Home Medication Reconciliation Visit(s); Patients will have their medications reviewed by the TELE-TOC interventionalist, a member of the pharmacy team (anticipated); Other Names: Virtual At Home Medication Reconciliation; Behavioral: Virtual At Home Medication Education Visit(s); Patients will be provided with inhaler education by the TELE-TOC interventionalist, a member of the pharmacy team (anticipated); Other Names: Virtual At Home Inhaler Education; Other: COPD advanced practice nurse Inpatient Consult; Patients will receive a COPD consult by an advanced practice nurse as part of standard of care; Other Names: Inpatient consult; Other: Inpatient Medication Reconciliation; Patients will have their medications reviewed by member(s) of the clinical care team as part of standard of care; Other: Post-discharge nurse 48 hour phone follow-up call; Patients will receive a post-discharge nurse 48 hour phone follow-up call as part of standard of care; Other: Post-discharge follow-up advanced practice nurse outpatient visit; Patients will be scheduled for a 1-2 week post-discharge visit with the COPD advanced practice nurse as part of standard of care
Active Comparator: Usual Care; Patients randomized to this arm will receive standard COPD care via the institution's COPD readmission reduction program.	Other: COPD advanced practice nurse Inpatient Consult; Patients will receive a COPD consult by an advanced practice nurse as part of standard of care; Other Names: Inpatient consult; Other: Inpatient Medication Reconciliation; Patients will have their medications reviewed by member(s) of the clinical care team as part of standard of care; Other: Post-discharge nurse 48 hour phone follow-up call; Patients will receive a post-discharge nurse 48 hour phone follow-up call as part of standard of care; Other: Post-discharge follow-up advanced practice nurse outpatient visit; Patients will be scheduled for a 1-2 week post-discharge visit with the COPD advanced practice nurse as part of standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correct inhaler technique 30 days post discharge	Correct inhaler technique within 30 days post-discharge compared to baseline technique in hospital based on standardized checklists (<75% correct steps = misuse)	30 days post discharge
Reach of the TELE-TOC intervention	Proportion of patients receiving at home inhaler education within 1-2 weeks post discharge	1-2 weeks post discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30 day revisits	proportion of patients with any emergency department visit and/or re-hospitalization within 30 days of index admission	30 -days
90 day revisits	proportion of patients with any emergency department visit and/or re-hospitalization within 90 days of index admission	90 -days
180 day revisits	proportion of patients with any emergency department visit and/or re-hospitalization within 180 days of index admission	180 -days
Medication errors	Proportion of patients with medication errors at TELE-TOC visit medication reconciliation	Within 30 days
COPD Symptoms option 1	Evaluation of COPD symptoms using COPD Assessment Test (CAT)	Within 30 days
COPD Symptoms option 2	Evaluation of COPD symptoms using the modified medical Research Council Scale (mmRC) [Scale = 0 to 4; 0 (better) = Breathlessness only on strenuous exercise; 4 (worse)= too breathless to leave the house or breathless when dressing or undressing]	Within 30 days

Collaborators and Investigators

• Sponsor: University of Chicago
• Collaborators: Washington University School of Medicine; Agency for Healthcare Research and Quality (AHRQ); COPD Foundation; Society of Hospital Medicine; Hospital Medicine Reengineering Network (HOMERuN); The American Telemedicine Association
• Investigators: Principal Investigator: Valerie G Press, MD, MPH, University of Chicago

Publications and helpful links

General Publications

• Jencks SF, Williams MV, Coleman EA. Rehospitalizations among patients in the Medicare fee-for-service program. N Engl J Med. 2009 Apr 2;360(14):1418-28. doi: 10.1056/NEJMsa0803563. Erratum In: N Engl J Med. 2011 Apr 21;364(16):1582.
• Naylor MD, Aiken LH, Kurtzman ET, Olds DM, Hirschman KB. The care span: The importance of transitional care in achieving health reform. Health Aff (Millwood). 2011 Apr;30(4):746-54. doi: 10.1377/hlthaff.2011.0041.
• Locke ER, Thomas RM, Woo DM, Nguyen EHK, Tamanaha BK, Press VG, Reiber GE, Kaboli PJ, Fan VS. Using Video Telehealth to Facilitate Inhaler Training in Rural Patients with Obstructive Lung Disease. Telemed J E Health. 2019 Mar;25(3):230-236. doi: 10.1089/tmj.2017.0330. Epub 2018 Jul 17.
• Thomas RM, Locke ER, Woo DM, Nguyen EHK, Press VG, Layouni TA, Trittschuh EH, Reiber GE, Fan VS. Inhaler Training Delivered by Internet-Based Home Videoconferencing Improves Technique and Quality of Life. Respir Care. 2017 Nov;62(11):1412-1422. doi: 10.4187/respcare.05445. Epub 2017 Jul 18.
• Press VG, Au DH, Bourbeau J, Dransfield MT, Gershon AS, Krishnan JA, Mularski RA, Sciurba FC, Sullivan J, Feemster LC. Reducing Chronic Obstructive Pulmonary Disease Hospital Readmissions. An Official American Thoracic Society Workshop Report. Ann Am Thorac Soc. 2019 Feb;16(2):161-170. doi: 10.1513/AnnalsATS.201811-755WS.

Helpful Links

• Contextual Frameworks for Research on the Implementation of Complex System Interventions
• Society of Hospital Medicine COPD Implementation Guide
• Centers for Medicare and Medicaid Services Hospital Readmission Reduction Program (HRRP)

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: May 10, 2023
• First Submitted That Met QC Criteria: May 31, 2023
• First Posted (Actual): June 9, 2023

Study Record Updates

• Last Update Posted (Actual): November 30, 2023
• Last Update Submitted That Met QC Criteria: November 29, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Medication Adherence; Medication reconciliation; Medication education
• Other Study ID Numbers: IRB21-1325

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Pending ethical approvals and data sharing allowances may be able to provide de-identified data to other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No