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

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ClinicalTrials.gov Identifier: NCT03809468
Recruitment Status : Enrolling by invitation
First Posted : January 18, 2019
Last Update Posted : February 7, 2019
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic

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

Condition or disease Intervention/treatment Phase
Abnormal Uterine Bleeding Other: phone call follow up Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Patient Satisfaction With Initial Phone Call Versus Office Visit Following Minimally Invasive Hysterectomy, a Randomized Controlled Trial.
Actual Study Start Date : January 16, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hysterectomy

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




Primary Outcome Measures :
  1. patient satisfaction [ Time Frame: 6-8 weeks postop ]
    patient satisfaction scores


Secondary Outcome Measures :
  1. phone calls and visits (unplanned) [ Time Frame: 6-8 weeks postop ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • women undergoing minimally invasive hysterectomy

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03809468


Locations
United States, Florida
Cleveland Clinic Florida
Weston, Florida, United States, 33331
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Pamela Frazzini Padilla Cleveland Clinic Florida

Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT03809468     History of Changes
Other Study ID Numbers: FLA 18-095
First Posted: January 18, 2019    Key Record Dates
Last Update Posted: February 7, 2019
Last Verified: January 2019

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by The Cleveland Clinic:
patient satisfaction, hysterectomy, follow up

Additional relevant MeSH terms:
Uterine Hemorrhage
Uterine Diseases
Genital Diseases, Female
Hemorrhage
Pathologic Processes