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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03809468
Other study ID # FLA 18-095
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 16, 2019
Est. completion date June 30, 2020

Study information

Verified date October 2020
Source The Cleveland Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Patients will be randomized to clinic or telephone follow up after outpatient TLH. surveys will document patient satisfaction.


Description:

This is a randomized controlled trial looking at patient satisfaction with a 1-2 week postoperative visit versus phone call after minimally invasive hysterectomy. Patients will be screened, enrolled, consented, and randomized during the preoperative office encounter, which usually takes place 30 days prior to their scheduled surgery. Patients randomized to the study group (1-2 week postoperative phone call) will be given a time and date when to expect the postoperative phone call. Patients randomized to the control arm will receive a standard postoperative visit appointment 7-21 days after surgery. Patients in both arms will receive postoperative discharge instructions advising when to contact our office and when to present to the emergency room with certain complaints. The patients in the study arm will have instructions reinforcing that they will be contacted with a postoperative phone call instead of a visit initially; however, patients in both arms will have a postoperative visit 6-8 weeks following surgery. After surgery, patients randomized to the study arm will receive the phone call at 7-14 days post-op. The physician performing the phone call will be a minimally invasive gynecology fellow in our practice. The provider will use a script to review all of the typical review of systems and pertinent postoperative functioning questions typically reviewed and documented in our postoperative visit. They will also review the surgical pathology at this time. This conversation will be documented in our electronic medical record. Patients randomized to the control arm will undergo typical office visit at 7-21 days postop. Patients in both arms will have postoperative office visits at 6-8 weeks postop, and will complete a survey at that time. The survey is a modified version of the SCAHPS survey to assess patient satisfaction with the surgical experience. There will also be some questions about the patients' attitudes towards the number and timing of postoperative visits.


Recruitment information / eligibility

Status Completed
Enrollment 68
Est. completion date June 30, 2020
Est. primary completion date June 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria: - women undergoing minimally invasive hysterectomy Exclusion Criteria: - patients without adequate phone or transportation access - patients with concern for underlying malignancy

Study Design


Related Conditions & MeSH terms


Intervention

Other:
phone call follow up
instead of a clinic visit, patients will be randomized to a phone call

Locations

Country Name City State
United States Cleveland Clinic Florida Weston Florida

Sponsors (1)

Lead Sponsor Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary patient satisfaction patient satisfaction scores 6-8 weeks postop
Secondary phone calls and visits (unplanned) 6-8 weeks postop
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