Patient Satisfaction With Initial Phone Call Versus Office Visit Following Minimally Invasive Hysterectomy, a Randomized Controlled Trial.
Primary Purpose
Abnormal Uterine Bleeding
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
phone call follow up
Sponsored by
About this trial
This is an interventional other trial for Abnormal Uterine Bleeding focused on measuring patient satisfaction, hysterectomy, follow up
Eligibility Criteria
Inclusion Criteria:
- women undergoing minimally invasive hysterectomy
Exclusion Criteria:
- patients without adequate phone or transportation access
- patients with concern for underlying malignancy
Sites / Locations
- Cleveland Clinic Florida
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
control
study
Arm Description
Routine follow up of a clinic visit at 1-2 weeks postop, and 6-8 weeks postop.
phone call follow up instead of clinic visit follow up at 1-2 weeks, followed by 6-8 week clinic follow up
Outcomes
Primary Outcome Measures
patient satisfaction
patient satisfaction scores
Secondary Outcome Measures
phone calls and visits (unplanned)
Full Information
NCT ID
NCT03809468
First Posted
January 16, 2019
Last Updated
October 28, 2020
Sponsor
The Cleveland Clinic
1. Study Identification
Unique Protocol Identification Number
NCT03809468
Brief Title
Patient Satisfaction With Initial Phone Call Versus Office Visit Following Minimally Invasive Hysterectomy, a Randomized Controlled Trial.
Official Title
Patient Satisfaction With Initial Phone Call Versus Office Visit Following Minimally Invasive Hysterectomy, a Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
January 16, 2019 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
June 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Cleveland Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Patients will be randomized to clinic or telephone follow up after outpatient TLH. surveys will document patient satisfaction.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abnormal Uterine Bleeding
Keywords
patient satisfaction, hysterectomy, follow up
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control
Arm Type
No Intervention
Arm Description
Routine follow up of a clinic visit at 1-2 weeks postop, and 6-8 weeks postop.
Arm Title
study
Arm Type
Experimental
Arm Description
phone call follow up instead of clinic visit follow up at 1-2 weeks, followed by 6-8 week clinic follow up
Intervention Type
Other
Intervention Name(s)
phone call follow up
Intervention Description
instead of a clinic visit, patients will be randomized to a phone call
Primary Outcome Measure Information:
Title
patient satisfaction
Description
patient satisfaction scores
Time Frame
6-8 weeks postop
Secondary Outcome Measure Information:
Title
phone calls and visits (unplanned)
Time Frame
6-8 weeks postop
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
women undergoing minimally invasive hysterectomy
Exclusion Criteria:
patients without adequate phone or transportation access
patients with concern for underlying malignancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pamela Frazzini Padilla
Organizational Affiliation
Cleveland Clinic Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic Florida
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Patient Satisfaction With Initial Phone Call Versus Office Visit Following Minimally Invasive Hysterectomy, a Randomized Controlled Trial.
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