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

NCT ID: NCT03809468

Last Updated: 2020-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-16

Study Completion Date

2020-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Abnormal Uterine Bleeding

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

control

Routine follow up of a clinic visit at 1-2 weeks postop, and 6-8 weeks postop.

Group Type NO_INTERVENTION

No interventions assigned to this group

study

phone call follow up instead of clinic visit follow up at 1-2 weeks, followed by 6-8 week clinic follow up

Group Type EXPERIMENTAL

phone call follow up

Intervention Type OTHER

instead of a clinic visit, patients will be randomized to a phone call

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

phone call follow up

instead of a clinic visit, patients will be randomized to a phone call

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* women undergoing minimally invasive hysterectomy

Exclusion Criteria

* patients without adequate phone or transportation access
* patients with concern for underlying malignancy
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The Cleveland Clinic

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pamela Frazzini Padilla

Role: PRINCIPAL_INVESTIGATOR

Cleveland Clinic Florida

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Cleveland Clinic Florida

Weston, Florida, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

FLA 18-095

Identifier Type: -

Identifier Source: org_study_id