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| ID | Type | Description | Link |
|---|---|---|---|
| 07-17-14E | Other Identifier | Atrium |
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| Name | Class |
|---|---|
| American College of Surgeons | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual Visit Group | Experimental | Participants assigned to the virtual visit group will receive a virtual visit as their postoperative follow-up visit. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Visit | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | from date of surgery until the date of 30 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative follow-up visit time length in minutes | total time of postoperative follow-up visit in minutes | date of follow-up visit, approximately 14 days after date of surgery |
| Patient satisfaction score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Caroline Reinke, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atrium Health- Carolinas Medical Center | Charlotte | North Carolina | 28203 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34509613 | Derived | 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. | |
| 33439221 | Derived |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jul 9, 2019 | Aug 5, 2022 | ICF_000.pdf |
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self-reported patient satisfaction rating for follow-up visit assessed by survey
| 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 | 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 | 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 | 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 | 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 | date of follow-up visit, approximately 14 days after date of surgery |
| Harkey 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. |