Patient Satisfaction With Initial Phone Call Versus Office Visit Following Minimally Invasive Hysterectomy, a Randomized Controlled Trial.

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

Study Overview

• Status: Completed
• Conditions: Abnormal Uterine Bleeding
• Intervention / Treatment: Other: phone call follow up

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Weston, Florida, United States, 33331
      • Cleveland Clinic Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• women undergoing minimally invasive hysterectomy

Exclusion Criteria:

• patients without adequate phone or transportation access
• patients with concern for underlying malignancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: control; Routine follow up of a clinic visit at 1-2 weeks postop, and 6-8 weeks postop.
EXPERIMENTAL: study; phone call follow up instead of clinic visit follow up at 1-2 weeks, followed by 6-8 week clinic follow up	Other: phone call follow up; instead of a clinic visit, patients will be randomized to a phone call

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
patient satisfaction	patient satisfaction scores	6-8 weeks postop

Secondary Outcome Measures

Outcome Measure	Time Frame
phone calls and visits (unplanned)	6-8 weeks postop

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: Pamela Frazzini Padilla, Cleveland Clinic Florida

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 16, 2019
• Primary Completion (ACTUAL): June 30, 2020
• Study Completion (ACTUAL): June 30, 2020

Study Registration Dates

• First Submitted: January 16, 2019
• First Submitted That Met QC Criteria: January 16, 2019
• First Posted (ACTUAL): January 18, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 29, 2020
• Last Update Submitted That Met QC Criteria: October 28, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: patient satisfaction, hysterectomy, follow up
• Additional Relevant MeSH Terms: Pathologic Processes; Uterine Diseases; Hemorrhage; Uterine Hemorrhage
• Other Study ID Numbers: FLA 18-095

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No