Appendectomy, LaparoscopicNCT03258177
Virtual Visits (Utilization of Virtual Care in Postoperative Patients to Improve the Patient Experience)
A study testing Virtual Visit in people with Appendectomy, Laparoscopic and Cholecystectomy, Laparoscopic, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The purpose of this study is to implement and evaluate postoperative virtual care visits for patients who undergo a laparoscopic appendectomy, laparoscopic cholecystectomy, or robotic cholecystectomy. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Appendectomy, Laparoscopic, Cholecystectomy, Laparoscopic, Cholecystectomy, Robotic
- What is being tested?
- Virtual Visit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 460 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Aug 2017to 10 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing to comply with all study procedures and be available for the duration of the study
- English speaking
- Able to read
- Have an email address
- Scheduled to undergo a laparoscopic appendectomy, laparoscopic cholecystectomy or robotic cholecystectomy OR have undergone an unplanned (urgent or emergent) laparoscopic appendectomy, laparoscopic cholecystectomy, or robotic cholecystectomy
- Have surgery performed by a surgeon at either Carolinas Medical Center-Main or Carolinas Medical Center- Mercy who provides emergency general surgery clinical coverage
- Live in North Carolina or South Carolina
Who cannot join
- Unable to complete a virtual visit (due to lack of appropriate technology, necessary technology skills, other);
- Medical condition, laboratory finding, or physical exam finding that precludes participation (patients at high risk for complications, particularly those with perforated appendicitis, patients with active cocaine abuse)
- Postoperative length of stay greater than or equal to 4 days
- Discharged with drains that need to be removed at a postoperative visit
- Admitted from or discharged to assisted living facility, skilled nursing facility, or location other than home
- Have chronic pain for which the participant takes narcotic medication
Trial locations and contacts
1 site in 1 country.
United States1 site
Atrium Health- Carolinas Medical Center
Charlotte, North Carolina, 28203
About this study
Official title: Utilization of Virtual Care in Postoperative Patients to Improve the Patient Experience
The purpose of this study is to implement and evaluate postoperative virtual care visits for patients who undergo a laparoscopic appendectomy, laparoscopic cholecystectomy, or robotic cholecystectomy. The investigators aim to better understand whether postoperative virtual care visits will not result in a greater composite measure of the occurrence of hospital encounters within Atrium Health (AH) for the 30 days following surgery than standard in-person clinic care. The investigators also aim to better understand whether postoperative virtual care visits provide time and cost savings, and provide equal or improved patient satisfaction and convenience.
Read the detailed description
Participants will be randomized to complete either a postoperative follow-up visit using virtual care technology or by attending a standard in-person visit at the clinic. The virtual visit uses a camera-enabled device and internet access to provide live access to the medical professional. Surveys to assess patient satisfaction and convenience will be administered by email on the day of the postoperative follow-up visit. Additional information including demographics, hospital encounters within 30 days of surgery, length of time of the follow-up visit, travel cost and time, whether additional follow-up care is required, and complications after surgery will be collected to evaluate postoperative virtual care visits. Subject participation in the study will end after follow-up care is complete or at 30 days, whichever occurs last.
- Being tested
- Virtual Visit
- Keywords
- Virtual Visits, Telehealth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual VisitOther
Participants will be given information about how to enroll in virtual care. Participants will use their own camera-enabled device with internet connection to see and speak to the medical professional in real-time and complete the virtual follow-up visit.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Visit Group | Experimental | Participants assigned to the virtual visit group will receive a virtual visit as their postoperative follow-up visit. Receives: Other: Virtual Visit |
| Standard In-person Group | No intervention | Participants assigned to the standard in-person group will receive an in-person follow-up visit as their postoperative follow-up visit. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite measure of the occurrence of hospital encounters
composite measure of the occurrence of hospital encounters for the 30 days following surgery including all-cause and any-site inpatient, observational, and emergency department visits within Carolinas HealthCare System
Measured: from date of surgery until the date of 30 days after surgery
Secondary outcomes (7)
Postoperative follow-up visit time length in minutes
total time of postoperative follow-up visit in minutes
Measured: date of follow-up visit, approximately 14 days after date of surgery
Patient satisfaction score
self-reported patient satisfaction rating for follow-up visit assessed by survey
Measured: date of follow-up visit, approximately 14 days after date of surgery
Patient convenience score
self-reported patient convenience rating for follow-up visit assessed by survey
Measured: date of follow-up visit, approximately 14 days after date of surgery
Rate of postoperative follow-up
percent of patients who receive a postoperative follow-up visit
Measured: date of follow-up visit, approximately 14 days after date of surgery
Rate of postoperative no-shows
percent of scheduled postoperative follow-up appointments in which patients do not complete
Measured: date of follow-up visit, approximately 14 days after date of surgery
Patient travel time to clinic in minutes
total patient travel time from home to postoperative follow-up clinic in minutes
Measured: date of follow-up visit, approximately 14 days after date of surgery
Patient cost savings in dollars
Patient gas cost savings for travel from home to postoperative follow-up clinic
Measured: date of follow-up visit, approximately 14 days after date of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2017
- Study start18 Aug 2017
- Primary completion10 Apr 2020
- Study completion10 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Appendectomy, LaparoscopicStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 460 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- American College of Surgeons
- Responsible party
- Sponsor
- Investigators
- Caroline Reinke, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03258177
- Sponsor's protocol ID
- IRB00082477
- Other IDs
- 07-17-14E
- Status last verified
- Sep 2021
- First submitted
- 20 Aug 2017
- Last updated
- 10 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Harkey K, Connor CD, Wang H, Kaiser N, Matthews BD, Kelz R, Reinke CE. View from the Patient Perspective: Mixed-Methods Analysis of Post-Discharge Virtual Visits in a Randomized Controlled Trial. J Am Coll Surg. 2021 Nov;233(5):593-605.e4. doi: 10.1016/j.jamcollsurg.2021.07.688. Epub 2021 Sep 9.
PubMed 34509613Harkey K, Kaiser N, Zhao J, Hetherington T, Gutnik B, Matthews BD, Kelz RR, Reinke CE. Postdischarge Virtual Visits for Low-risk Surgeries: A Randomized Noninferiority Clinical Trial. JAMA Surg. 2021 Mar 1;156(3):221-228. doi: 10.1001/jamasurg.2020.6265.
PubMed 33439221
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilization of Virtual Care in Postoperative Patients to Improve the Patient Experience
- ClinicalTrials.gov ID
- NCT03258177
- Acronym / sponsor ID
- IRB00082477
- Keywords
- Virtual Visits, Telehealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 460 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- American College of Surgeons
- Study start
- 18 Aug 2017 (actual)
- Primary completion
- 10 Apr 2020 (actual)
- Study completion
- 10 May 2020 (actual)
- First posted
- 23 Aug 2017 (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.
The purpose of this study is to implement and evaluate postoperative virtual care visits for patients who undergo a laparoscopic appendectomy, laparoscopic cholecystectomy, or robotic cholecystectomy. The investigators aim to better understand whether postoperative virtual care visits will not result in a greater composite measure of the occurrence of hospital encounters within Atrium Health (AH) for the 30 days following surgery than standard in-person clinic care. The investigators also aim to better understand whether postoperative virtual care visits provide time and cost savings, and provide equal or improved patient satisfaction and convenience.
Detailed description
Participants will be randomized to complete either a postoperative follow-up visit using virtual care technology or by attending a standard in-person visit at the clinic. The virtual visit uses a camera-enabled device and internet access to provide live access to the medical professional. Surveys to assess patient satisfaction and convenience will be administered by email on the day of the postoperative follow-up visit. Additional information including demographics, hospital encounters within 30 days of surgery, length of time of the follow-up visit, travel cost and time, whether additional follow-up care is required, and complications after surgery will be collected to evaluate postoperative virtual care visits. Subject participation in the study will end after follow-up care is complete or at 30 days, whichever occurs last.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Visit Group | Experimental | Other: Virtual VisitParticipants assigned to the virtual visit group will receive a virtual visit as their postoperative follow-up visit. |
| Standard In-person Group | No intervention | –Participants assigned to the standard in-person group will receive an in-person follow-up visit as their postoperative follow-up visit. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Willing to comply with all study procedures and be available for the duration of the study
- English speaking
- Able to read
- Have an email address
- Scheduled to undergo a laparoscopic appendectomy, laparoscopic cholecystectomy or robotic cholecystectomy OR have undergone an unplanned (urgent or emergent) laparoscopic appendectomy, laparoscopic cholecystectomy, or robotic cholecystectomy
Key exclusion criteria (6 listed)
- Unable to complete a virtual visit (due to lack of appropriate technology, necessary technology skills, other);
- Medical condition, laboratory finding, or physical exam finding that precludes participation (patients at high risk for complications, particularly those with perforated appendicitis, patients with active cocaine abuse)
- Postoperative length of stay greater than or equal to 4 days
- Discharged with drains that need to be removed at a postoperative visit
- Admitted from or discharged to assisted living facility, skilled nursing facility, or location other than home
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 |
|---|---|---|
| Virtual VisitParticipants will be given information about how to enroll in virtual care. Participants will use their own camera-enabled device with internet connection to see and speak to the medical professional in real-time and complete the virtual follow-up visit. | Other | Virtual Visit Group |
Primary outcome
Composite measure of the occurrence of hospital encounters
Time frame: from date of surgery until the date of 30 days after surgery
composite measure of the occurrence of hospital encounters for the 30 days following surgery including all-cause and any-site inpatient, observational, and emergency department visits within Carolinas HealthCare System
7 secondary outcomes
Postoperative follow-up visit time length in minutes
Time frame: date of follow-up visit, approximately 14 days after date of surgery
Patient satisfaction score
Time frame: date of follow-up visit, approximately 14 days after date of surgery
Patient convenience score
Time frame: date of follow-up visit, approximately 14 days after date of surgery
Rate of postoperative follow-up
Time frame: date of follow-up visit, approximately 14 days after date of surgery
Rate of postoperative no-shows
Time frame: date of follow-up visit, approximately 14 days after date of surgery
Patient travel time to clinic in minutes
Time frame: date of follow-up visit, approximately 14 days after date of surgery
Patient cost savings in dollars
Time frame: date of follow-up visit, approximately 14 days after date of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.
- Derived from this study: PubMed 34509613Harkey K, Connor CD, Wang H, Kaiser N, Matthews BD, Kelz R, Reinke CE. View from the Patient Perspective: Mixed-Methods Analysis of Post-Discharge Virtual Visits in a Randomized Controlled Trial. J Am Coll Surg. 2021 Nov;233(5):593-605.e4. doi: 10.1016/j.jamcollsurg.2021.07.688. Epub 2021 Sep 9.
- Derived from this study: PubMed 33439221Harkey K, Kaiser N, Zhao J, Hetherington T, Gutnik B, Matthews BD, Kelz RR, Reinke CE. Postdischarge Virtual Visits for Low-risk Surgeries: A Randomized Noninferiority Clinical Trial. JAMA Surg. 2021 Mar 1;156(3):221-228. doi: 10.1001/jamasurg.2020.6265.
- Individual participant dataSharing planned: No
Related trials for Appendectomy, Laparoscopic
Active, not recruiting
Efficacy of Laparoscopic-Assisted TAP Block in Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Blockades Neuromuscular
Not yet recruitingObservational study
Preoperative Gastric Volume and PONV in Pediatric Appendectomy Cases
Postoperative Nausea and Vomiting
Not yet recruiting
Comparative Study Between Laparoscopic and Open Appendectomy of Complicated Appendicitis
Appendicitis, Perforated Appendicitis
Recruiting
Feasibility and Safety of a Pediatric ERAS Protocol for Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Acute Appendicitis
Not yet recruitingPhase 3
Piperacillin/Tazobactam Versus Ceftriaxone and Metronidazole for Children With Perforated Appendicitis
Appendicitis Perforated, Appendectomy, Laparoscopic
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. This study is not recruiting at the moment.
Caroline Reinke, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Visit in people with Appendectomy, Laparoscopic and Cholecystectomy, Laparoscopic, run by Wake Forest University Health Sciences at 1 site 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 7 inclusion and 6 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: finished, as of the sponsor's last update on 10 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite measure of the occurrence of hospital encounters (time frame: from date of surgery until the date of 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03258177, which also lists 2 linked publications.
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 10 Aug 2022.