Patient Satisfaction With Initial Phone Call Versus Office Visit Following Minimally Invasive Hysterectomy, a Randomized Controlled Trial.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03809468|
Recruitment Status : Enrolling by invitation
First Posted : January 18, 2019
Last Update Posted : February 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Abnormal Uterine Bleeding||Other: phone call follow up||Not Applicable|
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|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
No Intervention: control
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
Other: phone call follow up
instead of a clinic visit, patients will be randomized to a phone call
- patient satisfaction [ Time Frame: 6-8 weeks postop ]patient satisfaction scores
- phone calls and visits (unplanned) [ Time Frame: 6-8 weeks postop ]
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
|United States, Florida|
|Cleveland Clinic Florida|
|Weston, Florida, United States, 33331|
|Principal Investigator:||Pamela Frazzini Padilla||Cleveland Clinic Florida|