Electronic Reporting of Symptoms After Surgery

NCT02700256 | Completed DMC

• 1 other identifier: 15-315
• Study Type: observational
• Target: 135
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of this pilot study is to find out if patients are willing to self-report symptoms in the first 5 days following discharge, or when they leave the hospital after "ambulatory surgery" ("ambulatory surgery" is when the patient has surgery and then goes home within 24 hours).

Conditions

Patients Scheduled to Undergo Surgery on the Gynecology Service

Keywords

surgery; 15-315

Outcome Measures

Primary Outcomes (1)

• number of patients who respond to the survery

  A patient will be deemed a "responder" if they complete at least 5 of the 8 symptom items on at least 3 days postoperatively. The symptom assessment method will be deemed successful if 32 of the 50 patients respond.

  up to 5 days after surgery

Study Arms (1)

Patients undergoing a procedure

Patients will be asked to complete a baseline survey after enrollment. After surgery, enrollees who opt for the email/online access will receive an email upon discharge with a link to the WebCore site. Email will be sent at 9 am on postoperative day (POD) 2 to the email address the patient provided at consent. On post-operative days 2 through 6 the patient will be asked to complete a symptom inventory, they will receive an email with a link to the WebCore website, where they will be able to complete that day's survey. Enrollees who opt for the automated phone calls will complete their surveys via Interactive Voice Response (IVR), which will be automatically set-up to call the patient at 9 am on POD 2. Patients will complete phone surveys daily for 5 days. If the first phone call does not connect to the patient, a second phone call will be made at 10:00am. If the second call is unsuccessful a third \& final call for that day will be placed at 11:00am.

Behavioral: survey

Interventions

survey BEHAVIORAL

All patients will submit a baseline survey following enrollment onto study. After successful completion of the AXR or 24-hour discharge pathway, the consented patient will be contacted by email or telephone for 5 days following discharge from surgery.

Patients undergoing a procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled to undergo surgery on the Gynecology service through the AXR program or are discharged within 24-hours of surgery with internet access or a phone number will be recruited from the Rockefeller Outpatient Pavilion in the GYN Surgery Clinic.

You may qualify if:

• The patients must be undergoing surgery for an indication tracked within the Gynecologic AXR program or have an expected postoperative discharge within 24 hours of surgery. These surgical procedures typically include: minimally invasive hysterectomy or radical hysterectomy, salpingo-oophorectomies \[mentioned above\], and minimally invasive staging procedures.
• The patient must have a phone number or an email address.
• The patient must be willing to self-report postoperative symptoms over an automated phone system or via an online platform.
• The patient must speak and read fluent English.

You may not qualify if:

• Non-English speaking patients
• Patients unwilling to provide contact information (email or phone number)

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (5)

Memoral Sloan Kettering Cancer Center

Basking Ridge, New Jersey, United States

Location

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Westchester

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Rockville Centre

Rockville Centre, New York, 11570, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Oliver Zivanovic, MD, PhD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2016
• First Posted: March 7, 2016
• Study Start: December 4, 2015
• Primary Completion: October 21, 2019
• Study Completion: October 21, 2019
• Last Updated: November 4, 2019

Record last verified: 2019-11

Locations

US (5)