Telehealth Follow-Up for Surgery

Recruiting at 3 trial locations

Overseen By Edward L Jones, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Eastern Colorado Health Care System

Disqualifiers: Permanent sutures, wound vacuum, others

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

Compensation: Varies

Number of Visits: 1

3000 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on telehealth follow-up after surgery, so it's best to consult with the trial coordinators or your doctor for guidance on your medications.

What data supports the effectiveness of the treatment Telehealth follow-up for surgery?

Research shows that telehealth follow-up after surgery can increase patient access to care and reduce complications, especially for those in remote areas. Studies have found that telehealth monitoring can improve health outcomes and patient satisfaction, while also saving time and resources compared to traditional in-person visits. ^{1 2 3 4 5}

Is telehealth follow-up after surgery safe?

Research suggests that telehealth follow-up after surgery, such as for inguinal hernia repair, is generally safe, with studies evaluating safety through measures like readmission and complication rates. However, high-quality evidence is still limited, and more studies are needed to fully confirm its safety across different surgeries. ^{1 4 5 6 7}

How does telehealth follow-up differ from traditional postoperative care?

Telehealth follow-up after surgery is unique because it allows patients to have their postoperative check-ups remotely, often via phone or video calls, instead of in-person visits. This approach can save patients time and travel, increase access to care, and make better use of healthcare resources by reducing the need for physical clinic visits. ^{1 4 5 8 9}

What is the purpose of this trial?

Background: A quarter of US Veterans reside in rural communities and are significantly older than their urban counterparts. Providing timely access to care is especially important in this older, independent and medically complex cohort. Virtual care, by phone or video, has improved access to care in non-surgical specialties; however, its utilization in surgery is less than 10% and has continued to decline after the COVID pandemic. Recent studies in surgical patients have demonstrated no difference in missed adverse events, emergency department visits or readmissions; but these data are limited to routine, low-risk procedures in large, urban centers. Routine telehealth for low and high-complexity surgery could be of particular benefit to rural patients by reducing travel challenges, costs, improving scheduling flexibility and reinforcing independence. The hypothesis is that routine telehealth follow-up for elective surgical procedures, of all complexity, will provide equivalent outcomes and improved patient satisfaction and access in comparison to face-to-face follow-up. Significance: VA Integrated Service Network (VISN) 19 is the largest geographic region in the VA system and includes four intermediate/complex VA Medical Centers (VAMC) serving rural and urban patients across 10 states. Almost 4000 unique patients are seen annually at these 4 centers resulting in 2600 operations and over 16,000 patient encounters. Another 2500 unique patients are referred to community care (CC) at a cost of over $5 million in FY23. Improving access through telehealth in this largely rural VISN will positively impact Veterans and reduce community care expenditures in addition to improving patient and provider satisfaction. Innovation \& Impact: There are currently no funded or published randomized trials evaluating the efficacy of telehealth in providing postoperative surgical care to rural patients. The proposal will provide robust, Level 1 data confirming the safety of postoperative telehealth care. In addition, the investigators will provide the only evaluation of both the patient and provider experience in rural, surgical telehealth care. They will leverage the largest geographic region, VISN19, to ensure broad applicability of findings to rural and urban Veterans. Specific Aims: Aim 1: Evaluate the safety of postoperative telehealth in rural and urban Veterans. Aim 2: Evaluate the usability and patient satisfaction of telehealth in comparison to in-person postoperative follow-up. Aim 3: Evaluate the usability and provider satisfaction of telehealth in comparison to in-person follow-up. Methodology: Patients undergoing elective general surgical procedures (both inpatient and outpatient) at four VA medical centers (Denver, CO; Oklahoma City, OK; Muskogee, OK; Salt Lake City, UT) in VISN 19 will be randomized to post-operative follow-up in person or via telehealth. Patients who discharge with drains or wound vacuum therapy, permanent suture or staples will be excluded. Aim 1: 30-day morbidity, missed adverse events (complications that may have been recognized with in-person follow-up), 30-day mortality, 30-day readmission, and 30-day ED visits will be compared evaluated to determine safety of telehealth follow-up. Aim 2: Post-operative surveys at 6 weeks after surgery will quantify acceptability of telehealth follow-up via the standardized Telehealth Usability Questionnaire; satisfaction and usability will be compared via the Consumer Assessment of Healthcare Providers and Systems Outpatient and Ambulatory Surgery survey (S-CAHPS) between the groups. Patients will also be characterized by baseline demographics, distance to nearest facility, socioeconomic vulnerability and procedure type to further define optimal cohorts for future telehealth participation and implementation. Aim 3: Usability and satisfaction for Providers will be determined by self-developed survey. Bi-monthly responses will be recorded to define trends and optimize future implementation. Next Steps/Implementation: If safe and acceptable to patients and providers, standardization for telehealth follow-up after surgery can be implemented nation-wide to improve access to care and satisfaction.

Eligibility Criteria

This trial is for US Veterans undergoing elective general or surgical oncology procedures, who can participate in follow-ups via telehealth. It's not suitable for those with permanent sutures, wound vacuums, staples, or drains needing removal in person.

Inclusion Criteria

I am scheduled for or have had surgery related to cancer.

Exclusion Criteria

I have devices like sutures or drains from surgery that need a doctor to remove them.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo elective general surgical procedures

1 day

1 visit (in-person)

Postoperative Follow-up

Participants are randomized to follow-up in person or via telehealth to evaluate safety and satisfaction

6 weeks

Bi-monthly visits (virtual or in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Telehealth follow-up

Trial Overview The study tests if postoperative follow-up through telehealth is as safe and satisfying as in-person visits for both rural and urban veterans after surgery. Participants are randomly chosen to have either virtual or face-to-face check-ups.

Participant Groups

Group I: Telehealth Experimental Treatment 1 Intervention

Patients will follow-up via phone after surgery

Group II: In-Person Active Control 1 Intervention

Patients will follow-up in-person after surgery

Who Is Running the Clinical Trial?

VA Eastern Colorado Health Care System

Lead Sponsor

Trials

55

Recruited

26,200+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Identification of postoperative care amenable to telehealth. [2018]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Results of Telehealth Electronic Monitoring for Post Discharge Complications and Surgical Site Infections following Arterial Revascularization with Groin Incision. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Outpatient visits versus telephone interviews for postoperative care: a randomized controlled trial. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Telephone follow-up by a midlevel provider after laparoscopic inguinal hernia repair instead of face-to-face clinic visit. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Implementation of a Telephone Postoperative Clinic in an Integrated Health System. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Telehealth Follow-Up After Inguinal Hernia Repair in Veterans. [2023]

7. Australia pubmed.ncbi.nlm.nih.gov

Telemedicine versus face-to-face follow up in general surgery: a randomized controlled trial. [2023]

8. India pubmed.ncbi.nlm.nih.gov

Telephone follow-up: an extension of the surgical outpatient department. [2015]

9. England pubmed.ncbi.nlm.nih.gov

Telephone consultations in place of face to face out-patient consultations for patients discharged from hospital following surgery: a systematic review. [2023]