Telehealth Education Leveraging Electronic Transitions Of Care for COPD Patients

COPD Exacerbation Clinical Trial

— TELE-TOC  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05897125
• Other study ID #: IRB21-1325
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: University of Chicago
• Contact: Leah Traeger
• Phone: 773-834-4489
• Email: ltraeger[@]bsd.uchicago.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 31, 2025
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Care Transitions
• COPD Exacerbation

Intervention

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)

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:
• COPD advanced practice nurse Inpatient Consult
Patients will receive a COPD consult by an advanced practice nurse as part of standard of care
• Inpatient Medication Reconciliation
Patients will have their medications reviewed by member(s) of the clinical care team as part of standard of care
• 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
• 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

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (7)

Lead Sponsor	Collaborator
University of Chicago	Agency for Healthcare Research and Quality (AHRQ), COPD Foundation, Hospital Medicine Reengineering Network (HOMERuN), Society of Hospital Medicine, The American Telemedicine Association, Washington University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	30 day revisits	proportion of patients with any emergency department visit and/or re-hospitalization within 30 days of index admission	30 -days
Secondary	90 day revisits	proportion of patients with any emergency department visit and/or re-hospitalization within 90 days of index admission	90 -days
Secondary	180 day revisits	proportion of patients with any emergency department visit and/or re-hospitalization within 180 days of index admission	180 -days
Secondary	Medication errors	Proportion of patients with medication errors at TELE-TOC visit medication reconciliation	Within 30 days
Secondary	COPD Symptoms option 1	Evaluation of COPD symptoms using COPD Assessment Test (CAT)	Within 30 days
Secondary	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

External Links

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