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

Sponsor
The Cleveland Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT03809468
Collaborator
(none)
68
1
2
17.4
3.9

Study Details

Study Description

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
  • Other: phone call follow up
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
68 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 :
Jan 16, 2019
Actual Primary Completion Date :
Jun 30, 2020
Actual Study Completion Date :
Jun 30, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. patient satisfaction [6-8 weeks postop]

    patient satisfaction scores

Secondary Outcome Measures

  1. phone calls and visits (unplanned) [6-8 weeks postop]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • women undergoing minimally invasive hysterectomy
Exclusion Criteria:
  • patients without adequate phone or transportation access

  • patients with concern for underlying malignancy

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cleveland Clinic Florida Weston Florida United States 33331

Sponsors and Collaborators

  • The Cleveland Clinic

Investigators

  • Principal Investigator: Pamela Frazzini Padilla, Cleveland Clinic Florida

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT03809468
Other Study ID Numbers:
  • FLA 18-095
First Posted:
Jan 18, 2019
Last Update Posted:
Oct 29, 2020
Last Verified:
Oct 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by The Cleveland Clinic
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 29, 2020