Telemedicine for Post-Surgery Care

(RCT Pilot Trial)

Not currently recruiting at 2 trial locations

Overseen By Thaddeus Budelier, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Disqualifiers: Under 18, Non-elective surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 24 hours post-surgery

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if telemedicine can effectively support post-surgery care. Using a system called the Recovery Control Tower, doctors and nurses will remotely assist patient recovery after elective surgeries. The study focuses on improving communication and care efficiency between surgical teams and remote clinicians. Adults undergoing elective surgery at Barnes Jewish Hospital in St. Louis may be suitable candidates for this trial. As an unphased trial, it offers patients the opportunity to contribute to innovative healthcare solutions that could enhance recovery experiences for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this telemedicine protocol is safe for post-surgery care?

Research has shown that telemedicine tools, such as the Recovery Control Tower (RCT), are generally safe and easy to use. For instance, the Caregility iObserver app enables doctors to monitor patients remotely. This setup has proven to enhance patient safety and improve communication among healthcare providers.

Although specific safety data for the Recovery Control Tower is not yet available, similar technologies have been widely used without major safety issues. This study serves as a pilot, testing the safety and effectiveness of this technology in a new environment. Overall, existing telemedicine tools have a strong safety record for patient monitoring and facilitating communication among healthcare providers. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Recovery Control Tower (RCT) for post-surgery care because it leverages cutting-edge telemedicine technology to enhance patient recovery. Unlike traditional post-anesthesia care, which relies heavily on in-person interactions, the RCT uses AlertWatch® decision-support software and Caregility's iObserver for remote patient monitoring and two-way video communication. This setup allows clinicians to participate in real-time handoffs and stay updated on patients' recovery progress without being physically present. The RCT aims to streamline and potentially improve patient care, making recovery more efficient and personalized.

What evidence suggests that this telemedicine protocol is effective for post-surgery care?

Research has shown that telemedicine, such as the Recovery Control Tower (RCT) in this trial, can enhance post-surgery care. Participants will receive care through the RCT, where studies have found that virtual care boosts healthcare team efficiency and improves patient outcomes. With decision-support software and two-way video calls, doctors can monitor and assist patients remotely, ensuring necessary post-surgery care. Enhanced recovery plans, similar to those in telemedicine, have been shown to speed up recovery and increase patient satisfaction compared to standard care. Overall, these tools aim to help patients recover better and faster by keeping healthcare teams connected and informed. ^{2 4 6 7 8}

Who Is on the Research Team?

Michael S Avidan, MBBch

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for adults aged 18 and older who are scheduled for elective surgery at Barnes Jewish Hospital in St. Louis, Missouri. The study aims to include a diverse group of participants undergoing various surgical procedures.

Inclusion Criteria

I am an adult scheduled for elective surgery at Barnes Jewish Hospital.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Integration of telemedicine into the PACU environment with remote monitoring and decision support

Up to 24 hours post-surgery

Continuous monitoring during PACU stay

Follow-up

Participants are monitored for safety events and clinician interactions post-PACU

24 hours

Long-term follow-up

Assessment of PACU clinician satisfaction and overall study outcomes

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Recovery Control Tower

Trial Overview The trial is testing the 'Recovery Control Tower' which uses telemedicine in the Post-Anesthesia Care Unit (PACU). It's designed to see if this technology can improve efficiency and safety during recovery after surgery.

How Is the Trial Designed?

Group I: Recovery Control Tower (RCT) Experimental Treatment 1 Intervention

Clinicians in the RCT will remotely work with PACU clinicians to care for patients assigned to one of the two study bays. A version of AlertWatch® (AlertWatch, Ann Arbor, Michigan) decision-support software, customized for the PACU environment, will assist clinicians in the RCT to perform core PACU-related functions remotely. Caregility's iObserver, from the Caregility Cloud™ Virtual Care Platform, will be used for two-way video communication When feasible, RCT clinicians will join handoff activities from the OR to the PACU and discuss pertinent intraoperative events with clinical teams on the ground. RCT clinicians will document patient specific recovery tasks within AlertWatch to assist in tracking patient recovery progresses. RCT clinicians will be the initial point of contact for ongoing recovery care, such as order placements. The attending anesthesiologist in the RCT will assess patients' discharge readiness throughout their PACU stay.

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Published Research Related to This Trial

The study demonstrated that implementing a quality assurance (QA) program in store-and-forward telemedicine is feasible and effective, as it helped identify and resolve issues that could impact patient care in two networks over a 2-year period.

User feedback indicated that over 90% of referring doctors found the telemedicine advice beneficial, with about 20% reporting cost savings, highlighting the potential for QA to enhance both the quality of care and economic efficiency in telemedicine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experience with Quality Assurance in Two Store-and-Forward Telemedicine Networks. Wootton, R., Liu, J., Bonnardot, L., et al.[2022]

A 1-month telephone care program for 604 patients after trauma surgery significantly reduced emergency department visits, with an odds ratio of 1.8 for the control group, indicating that patients who received telephone support were less likely to seek emergency care.

The program was cost-effective, costing only 1.65 € per patient, suggesting that implementing such a program could be beneficial for both patient outcomes and healthcare budgets.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effect of a telephone care program after hospital discharge from a trauma surgery unit]. Herrera-Espiñeira, C., Rodríguez del Águila, Mdel M., Navarro Espigares, JL., et al.[2016]

The pilot post-operative telephone service at Bumley General Hospital provided valuable insights into patient recovery, including the incidence of post-operative problems and pain management, by following up with patients the day after discharge.

Feedback from the audit allowed hospital staff to identify areas for improvement and set new standards for patient care, enhancing the overall quality of post-operative support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A day surgery post-operative telephone call line. Heseltine, K., Edlington, F.[2004]

The pilot study involving 233 patients showed that a telemedicine program (eClinic) for postoperative care is safe and effective, with similar rates of readmission and complications compared to traditional in-person visits (tClinic).

Patients reported high satisfaction with the eClinic, with 85% wanting to use it again, and the program significantly reduced visit times from 145 minutes to just 14 minutes, enhancing overall efficiency and potentially increasing healthcare revenue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot Study to Evaluate the Safety, Feasibility, and Financial Implications of a Postoperative Telemedicine Program. Nikolian, VC., Williams, AM., Jacobs, BN., et al.[2019]

In a study of 39 patients who had parathyroidectomy, using TeleHealth for postoperative visits was effective, with no reported surgical complications, demonstrating its safety and efficacy.

TeleHealth significantly reduced travel distance by an average of 119 miles per patient, resulting in an average cost savings of $357.00, highlighting its financial benefits for both patients and the healthcare system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telemedicine--an efficient and cost-effective approach in parathyroid surgery. Urquhart, AC., Antoniotti, NM., Berg, RL.[2022]

A randomized controlled trial involving 123 patients showed that telemedicine follow-up after uncomplicated general surgeries is safe, with no significant differences in complication rates compared to face-to-face follow-ups.

Patient satisfaction was high, with 40% of telemedicine patients reporting high satisfaction and 60% reporting very high satisfaction, while consultation times were significantly shorter for telemedicine (10.5 minutes) compared to in-person visits (15.9 minutes).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telemedicine versus face-to-face follow up in general surgery: a randomized controlled trial. Fink, T., Chen, Q., Chong, L., et al.[2023]

Telemedicine is revolutionizing surgical education and practice by enabling the transmission of images, audio, and video, which enhances training and interactivity among medical specialties.

Current applications of telemedicine in surgery include teaching, diagnostic assistance, and remote consultations, with promising future developments like telementoring and telesurgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Telemedicine applied to surgery]. Sézeur, A.[2009]

A survey of 346 veterans revealed that half preferred telemedicine for postoperative follow-up, indicating a significant demand for remote visits that could enhance convenience, especially for those traveling long distances.

The study suggests that telemedicine could offer advantages over traditional face-to-face appointments, but further research is needed to assess patient and surgeon acceptance and to monitor for any delays in identifying postoperative complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telemedicine for postoperative visits at the Minneapolis VA Medical Center. Results of a needs assessment study. Stypulkowski, K., Uppaluri, S., Waisbren, S.[2022]

This study aims to evaluate the effectiveness of a telemedicine center in enhancing patient monitoring and safety in the post-anesthesia care unit (PACU) by comparing outcomes before and after its implementation over a six-month period.

Key outcomes will include the time taken to determine patient readiness for discharge, as well as the ability to detect physiological issues and manage emergencies, which could lead to improved patient care and reduced complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol for a proof-of-concept observational study evaluating the potential utility and acceptability of a telemedicine solution for the post-anesthesia care unit. Budelier, TP., King, CR., Goswami, S., et al.[2021]

In a study comparing 34 patients using telemedicine follow-up to 44 patients with traditional follow-up, the telemedicine group had significantly fewer unscheduled clinic visits (3 vs. 14) and in-clinic calls (6 vs. 40), indicating its effectiveness in reducing unnecessary postoperative healthcare interactions.

Patients who received telemedicine follow-up reported higher satisfaction with their postoperative care compared to those who did not, suggesting that telemedicine can enhance patient experience after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of telemedical applications in postoperative follow-up after total joint arthroplasty. Sharareh, B., Schwarzkopf, R.[2022]

A mobile, low-bandwidth telemedicine platform successfully enabled real-time postoperative visits at patients' homes, demonstrating feasibility with no technical issues reported during the study involving 11 patients who had laparoscopic procedures.

Patients expressed high satisfaction with the home visits, rating their experience an average of 4.8 out of 5, while the time required for these remote evaluations was comparable to traditional office visits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the effectiveness of portable low-bandwidth telemedical applications for postoperative followup: initial results. Rosser, JC., Prosst, RL., Rodas, EB., et al.[2019]

The Anesthesiology Control Tower is a telemedicine-based system designed to enhance intra-operative clinical support, aiming to improve patient outcomes in perioperative care through evidence-based practices.

Usability testing will be conducted in two phases, focusing on both individual components and overall integration, to ensure the system is effective and user-friendly before being evaluated in a randomized controlled clinical trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anesthesiology Control Tower: Feasibility Assessment to Support Translation (ACT-FAST)-a feasibility study protocol. Murray-Torres, TM., Wallace, F., Bollini, M., et al.[2022]

A pilot study involving 20 colorectal surgery patients demonstrated that a real-time surveillance system using wireless health technology can effectively monitor postoperative health status, with a compliance rate of 63% over 265 patient days.

The system not only captured essential health data and patient-reported outcomes but also enhanced the patient-surgeon relationship, suggesting that remote monitoring could improve communication, patient satisfaction, and potentially reduce readmissions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wireless Technology to Track Surgical Patients after Discharge: A Pilot Study. Dawes, AJ., Reardon, S., Chen, VL., et al.[2022]

Citations

1. withpower.com withpower.com/trial/phase-elective-surgeries-9-2023-1a323

Telemedicine for Post-Surgery Care (RCT Pilot Trial) What data supports the effectiveness of the treatment Recovery Control Tower in the clinical trial Telemedicine for Post-Surgery Care? Research shows that ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11213997/

Outcomes reported in randomised trials of surgical ... The objective of this scoping review was to systematically map outcomes and assessment tools used in trials of surgical prehabilitation.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06190730

REmote Symptom COllection to improVE postopeRative Care This study aims to investigate the possibility of utilizing Voice-Assisted Remote Symptom Monitoring System (VARSMS) to alleviate some of these challenges.

4. caregility.com caregility.com/

Caregility: Bedside Virtual Care Solutions At Caregility, we help healthcare providers seamlessly scale virtual care and AI at the point of care to reinforce bedside teams, drive efficiency, and improve ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1878124125000309

Enhanced recovery pathways improve early outcomes and ... ERAS pathways improved most functional outcomes after surgery when compared to standard care. In the first postoperative week, patients showed better ...

6. caregility.com caregility.com/caregility-cloud-virtual-care-platform/applications/iobserver/

iObserver Telehealth Application Caregility's iObserver telehealth application supports remote observation of up to 12 patients in any location on a single monitor.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7113803/

Postoperative Remote Automated Monitoring and Virtual ... This trial, underway, is designed to examine the effectiveness of postoperative RAM and virtual hospital-to-home recovery support on health ...

8. healthrecoverysolutions.com healthrecoverysolutions.com/vision-to-virtual-2021

Vision to Virtual 2021 View these resources from Caregility: iObserver Data Sheet · Caregility Overview · Caregility and Epic Integration. Learn more about how Caregility can help you ...