SurgeryNCT06210204
Improving Access to Surgical Care: Safety, Efficacy, and Satisfaction With Postoperative Telehealth
A study testing Telehealth follow-up in people with Surgery, run by VA Eastern Colorado Health Care System at 4 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery
- What is being tested?
- Telehealth follow-up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- 4 sitesUnited States
- Study dates
- Jan 2025to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing general surgery or surgical oncologic surgeries
Who cannot join
- patients with placement of permanent sutures, wound vacuum devices, staples or other wound devices or drains that would require in-person postoperative follow-up for removal
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites
Rocky Mountain Regional VAMC
Aurora, Colorado, 80045
Edward L Jones, MD, edward.jones1@va.gov
Eastern Oklahoma VAMC
Muskogee, Oklahoma, 74401
Stephen Bruns, MD, Stephen.Bruns@va.gov
Oklahoma CIty VAMC
Oklahoma City, Oklahoma, 73104
Senthil Sankaralingam, MD, senthil.sankaralingam@va.gov
Salt Lake City VAMC
Salt Lake City, Utah, 84148
William Peche, MD, william.peche@va.gov
About this study
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.
Read more
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.
- Conditions
- Surgery
- Being tested
- Telehealth follow-up
- Keywords
- telehealth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telehealth follow-upOther
Patients to follow-up via phone after surgery
| Study group | Role | What they receive |
|---|---|---|
| In-Person | No intervention | Patients will follow-up in-person after surgery |
| Telehealth | Experimental | Patients will follow-up via phone after surgery Receives: Other: Telehealth follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Missed Adverse Events
Complications that could have been identified with routine follow-up
Measured: 30 days
Patient Satisfaction
5-point Likert Scale
Measured: 6 weeks
Provider Satisfaction
5-Point Likert Scale
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study startJan 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Eastern Colorado Health Care System
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Edward Jones, VA Eastern Colorado Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06210204
- Sponsor's protocol ID
- SDR 24-021-1
- Status last verified
- Jan 2024
- First submitted
- 11 Dec 2023
- Last updated
- 18 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Given the multiple site locations, we are unable to share data without sharing information that can be used to identify individual Veterans and VA Medical Centers.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Access to Surgical Care: Safety, Efficacy, and Satisfaction With Postoperative Telehealth
- ClinicalTrials.gov ID
- NCT06210204
- Acronym / sponsor ID
- SDR 24-021-1
- Conditions
- Surgery
- Keywords
- telehealth
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- VA Eastern Colorado Health Care SystemUS federal agency
- Study start
- Jan 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 18 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| In-Person | No intervention | –Patients will follow-up in-person after surgery |
| Telehealth | Experimental | Other: Telehealth follow-upPatients will follow-up via phone after surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergoing general surgery or surgical oncologic surgeries
Key exclusion criteria (1 listed)
- patients with placement of permanent sutures, wound vacuum devices, staples or other wound devices or drains that would require in-person postoperative follow-up for removal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telehealth follow-upPatients to follow-up via phone after surgery | Other | Telehealth |
Primary outcome
Missed Adverse Events
Time frame: 30 days
Complications that could have been identified with routine follow-up
Patient Satisfaction
Time frame: 6 weeks
5-point Likert Scale
Provider Satisfaction
Time frame: 6 weeks
5-Point Likert Scale
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
- Individual participant dataSharing planned: No. Given the multiple site locations, we are unable to share data without sharing information that can be used to identify individual Veterans and VA Medical Centers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telehealth follow-up in people with Surgery, run by VA Eastern Colorado Health Care System at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Edward L Jones, MD (7207236462, edward.jones1@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Missed Adverse Events (time frame: 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2024.