Home Monitoring for Thoracic Surgery Patients

NCT04340960 | Completed

• 1 other identifier: CDHM:RCT
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Background and Importance: When patients transition from hospital to home following surgery, perceived complications or poorly controlled pain can result in emergency department visits and readmissions. Continuity of care after discharge has been shown to reduce ED visits and readmissions rates. Hence any improved method of extending the continuity of care in a patient's home may improve postoperative outcomes. For patients who are at risk, continuity of care with digital solutions offers a pathway to providing more education, influencing behaviour, and creating better outcomes. Care teams can understand what's going on with each patient daily or weekly, as opposed to sporadically through an office visit. Goals/Research Aims: Atrial fibrillation is one of the important complications after thoracic surgery, it is estimated to occur in 10.5% of patients. We will conduct a randomized controlled trial to test the use of a secured digital system to monitor vital signs and home-based ECG monitoring for 2 weeks after surgery in patients undergoing an elective thoracic surgical procedure at the London Health Sciences Centre \[LHSC\]. Specific objectives are to determine the feasibility of 30-day emergency department visits as the primary outcome, 30-day readmission rates, postoperative complications, in-hospital length of stay, pain scores, hospital case costing, societal costs, mortality, and patient satisfaction. Methods/Approaches/Expertise: This trial will be a single centre, assessor-blinded, parallel arm, randomized controlled trial. Participants will be recruited from patients scheduled for thoracic surgical procedures at LHSC. Patients will be randomized to either the Continuity of care with Digital Home Monitoring (CDHM) group or the control group. The control group will be provided with the usual post-operative care, and the CDHM group will be provided with access to self-help resources, digital monitoring and access to a clinical navigator for two weeks. All outcomes will be compared between the CDHM group and control group at the end of 4 weeks post-discharge, including out-of-pocket costs, travel costs and lost productivity. Expected Outcomes: The Ontario Hospital Association estimates the average cost of a one-day stay in an acute care hospital is $1,300. With digital monitoring and continuity of care, we expect to decrease visits and readmission rates by at least 50% and in-hospital length stay by at least one day. This is a feasibility study. We will follow the traffic light approach criteria for reporting feasibility outcomes: Feasible (green) 75-100%: all feasibility outcomes are met; no protocol modifications are needed; (2) Feasible with modification (amber) 50-75%: all feasibility outcomes are met or can be met with protocol modifications; (3) Not feasible (red) \<50%: even with protocol modifications, some feasibility outcome cannot be met.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (3)

• Trial Recruitment

  Number of patients recruited over the period of the study, a measure of study feasibility

  1 year

• Protocol adherence

  As collected on the Case Report Forms and loss-to-follow-up

  1 year

• Outcome data collection

  Data will be collected from the patient on the vitals and daily assessment on the video call.

  1 year

Secondary Outcomes (3)

• Patient satisfaction score

  30 days postoperatively

• Patient/caregiver experience

  30 days postoperatively

• 30 day ED visit; 30 day readmission rate; cost analysis etc

  30 days postoperatively

Study Arms (2)

Control Group

NO INTERVENTION

The control group will not be monitored with continuity of care. After this period, 30-day emergency department visits will be measured and compared between the two groups, along with 30-day readmission rates, in-hospital length of stay, mortality, quality of recovery 40 item scale (QoR-40), European Quality of Life 5 Dimensions (EQ5D), patient satisfaction score, and societal and hospital cost. No intervention will be administered.

Home Monitoring Group

EXPERIMENTAL

At the time of hospital discharge, the control group will be discharged without receipt of home monitoring, and the intervention group will receive a home monitoring kit with (NIBP (non-invasive blood pressure) and SPO2 (pulse oximetry) with instructions on how to use these devices. Patients in the intervention groups will receive digital communication for four weeks and have their NIBP, HR (heart rate), SPO2 and pain scores evaluated twice a day for two weeks.

Other: Home Monitoring

Interventions

Home Monitoring OTHER

Patients in this group will receive home monitoring for NIBP (non-invasive blood pressure), SPO2 (pulse oximetry), and pain scores. These will be monitored 4 times a day for 2 weeks following surgery.

Home Monitoring Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient willing to provide informed consent
• Availability of a caregiver at the patient's home
• Wi-fi or cellular connectivity at the patient's home
• Undergoing elective segmentectomy, lobectomy, or pneumonectomy; VATS or open procedure and any thoracic foregut procedure like esophagectomy etc
• ASA III or lower
• Ability to comprehend and consent in English
• Patient or caregiver familiar/comfortable with the use of the technology like online banking

You may not qualify if:

• Unstable disease process preoperatively
• Patient requiring postoperative ICU admission
• Expected unstable disease process in the postoperative period

Sponsors & Collaborators

• Western University, Canada: lead

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

Related Publications (18)

• Book. All-Cause Readmission to Acute Care and Return to the Emergency Department. Ottawa, ON. Canadian Institute for Health Information. 2012 ISBN: 978-1-77109-040-7. :Available from: https://secure.cihi.ca/free_produc.

  BACKGROUND

• MOH. June 2019 report of the Premier's Council on Improving Healthcare and Ending Hallway Medicine: "Healthy Ontario: Building a Sustainable Health Care System.

  BACKGROUND

• Yang H, Dervin G, Madden S, Beaulé P, Gagné S, Crossan M, Fayad A, Wheeler K, Afagh M, Zhang T, Taljaard M. Post-Op Home Monitoring after Joint Replacement (POHM): A feasibility study. Innov Fund Prov Overs Comm Showc 2016; Toronto, ON Canada2016.

  BACKGROUND

• Cancer Care Council of Ontario. Unplanned Hospital Visits After Surgery. :Available from: http://www.csqi.on.ca/by_patient_j.

  BACKGROUND

• van Walraven C, Mamdani M, Fang J, Austin PC. Continuity of care and patient outcomes after hospital discharge. J Gen Intern Med. 2004 Jun;19(6):624-31. doi: 10.1111/j.1525-1497.2004.30082.x.

  PMID: 15209600 BACKGROUND

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  PMID: 28043480 BACKGROUND

• Young JM, Butow PN, Walsh J, Durcinoska I, Dobbins TA, Rodwell L, Harrison JD, White K, Gilmore A, Hodge B, Hicks H, Smith S, O'Connor G, Byrne CM, Meagher AP, Jancewicz S, Sutherland A, Ctercteko G, Pathma-Nathan N, Curtin A, Townend D, Abraham NS, Longfield G, Rangiah D, Young CJ, Eyers A, Lee P, Fisher D, Solomon MJ. Multicenter randomized trial of centralized nurse-led telephone-based care coordination to improve outcomes after surgical resection for colorectal cancer: the CONNECT intervention. J Clin Oncol. 2013 Oct 1;31(28):3585-91. doi: 10.1200/JCO.2012.48.1036. Epub 2013 Sep 3.

  PMID: 24002519 BACKGROUND

• Jeon JH, Kang CH, Kim HS, Seong YW, Park IK, Kim YT, Kim JH. Video-assisted thoracoscopic lobectomy in non-small-cell lung cancer patients with chronic obstructive pulmonary disease is associated with lower pulmonary complications than open lobectomy: a propensity score-matched analysis. Eur J Cardiothorac Surg. 2014 Apr;45(4):640-5. doi: 10.1093/ejcts/ezt460. Epub 2013 Sep 19.

  PMID: 24052605 BACKGROUND

• Cao C, Zhu ZH, Yan TD, Wang Q, Jiang G, Liu L, Liu D, Wang Z, Shao W, Black D, Zhao Q, He J. Video-assisted thoracic surgery versus open thoracotomy for non-small-cell lung cancer: a propensity score analysis based on a multi-institutional registry. Eur J Cardiothorac Surg. 2013 Nov;44(5):849-54. doi: 10.1093/ejcts/ezt406. Epub 2013 Aug 15.

  PMID: 23956268 BACKGROUND

• Bhave PD, Goldman LE, Vittinghoff E, Maselli J, Auerbach A. Incidence, predictors, and outcomes associated with postoperative atrial fibrillation after major noncardiac surgery. Am Heart J. 2012 Dec;164(6):918-24. doi: 10.1016/j.ahj.2012.09.004. Epub 2012 Oct 26.

  PMID: 23194493 BACKGROUND

• Garner M, Routledge T, King JE, Pilling JE, Veres L, Harrison-Phipps K, Bille A, Harling L. New-onset atrial fibrillation after anatomic lung resection: predictive factors, treatment and follow-up in a UK thoracic centre. Interact Cardiovasc Thorac Surg. 2017 Feb 1;24(2):260-264. doi: 10.1093/icvts/ivw348.

  PMID: 27803121 BACKGROUND

• Vaporciyan AA, Correa AM, Rice DC, Roth JA, Smythe WR, Swisher SG, Walsh GL, Putnam JB Jr. Risk factors associated with atrial fibrillation after noncardiac thoracic surgery: analysis of 2588 patients. J Thorac Cardiovasc Surg. 2004 Mar;127(3):779-86. doi: 10.1016/j.jtcvs.2003.07.011.

  PMID: 15001907 BACKGROUND

• Imperatori A, Mariscalco G, Riganti G, Rotolo N, Conti V, Dominioni L. Atrial fibrillation after pulmonary lobectomy for lung cancer affects long-term survival in a prospective single-center study. J Cardiothorac Surg. 2012 Jan 10;7:4. doi: 10.1186/1749-8090-7-4.

  PMID: 22233837 BACKGROUND

• Amar D, Zhang H, Leung DH, Roistacher N, Kadish AH. Older age is the strongest predictor of postoperative atrial fibrillation. Anesthesiology. 2002 Feb;96(2):352-6. doi: 10.1097/00000542-200202000-00021.

  PMID: 11818768 BACKGROUND

• Ayoub K, Habash F, Almomani A, Xu J, Marji M, Shaw-Devine A, Paydak H, Vallurupalli S. Long Term Risk of Recurrent Atrial Fibrillation and Ischemic Stroke after Post-Operative Atrial Fibrillation Complicating Cardiac and Non-Cardiac Surgeries. J Atr Fibrillation. 2018 Apr 30;10(6):1660. doi: 10.4022/jafib.1660. eCollection 2018 Apr.

  PMID: 29988296 BACKGROUND

• Gialdini G, Nearing K, Bhave PD, Bonuccelli U, Iadecola C, Healey JS, Kamel H. Perioperative atrial fibrillation and the long-term risk of ischemic stroke. JAMA. 2014 Aug 13;312(6):616-22. doi: 10.1001/jama.2014.9143.

  PMID: 25117130 BACKGROUND

• Yang H, Dervin G, Madden S, Beaule PE, Gagne S, Crossan ML, Fayad A, Wheeler K, Afagh M, Zhang T, Taljaard M. Postoperative Home Monitoring After Joint Replacement: Feasibility Study. JMIR Perioper Med. 2018 Sep 5;1(2):e10168. doi: 10.2196/10168.

  PMID: 33401364 BACKGROUND

• Nagappa M, Subramani Y, Yang H, Wood N, Querney J, Fochesato LA, Nguyen D, Fatima N, Martin J, John-Baptiste A, Nayak R, Qiabi M, Inculet R, Fortin D, Malthaner R. Enhancing Quadruple Health Outcomes After Thoracic Surgery: Feasibility Pilot Randomized Controlled Trial Using Digital Home Monitoring. JMIR Perioper Med. 2025 Feb 12;8:e58998. doi: 10.2196/58998.

  PMID: 39938882 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Blood Glucose Self-Monitoring

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Self-Testing; Self Care; Therapeutics; Investigative Techniques

Study Officials

• Yamini Subramani, MD

  Western University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 24, 2020
• First Posted: April 10, 2020
• Study Start: August 15, 2022
• Primary Completion: December 31, 2022
• Study Completion: January 31, 2023
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)