Telehealth Postop Follow up RCT

Jackson, Elisha142 enrolled

Overview

A randomized controlled trial that will evaluate whether telephone two-week postoperative follow up visits are an acceptable and safe alternative to traditional face-to-face-clinic two-week postoperative visits.

This is a two group, parallel randomized non-inferiority clinical trial at one institution evaluating telephone postoperative visits as non-inferior in patient satisfaction, patient preference, and patient safety, when compared with clinic postoperative visits. This protocol was written in accordance with CONSORT (Consolidated Standards of Reporting Trials) guidelines 2011.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

142

Conditions

Patient Satisfaction

Interventions

Telehealth 2 week postoperative visitOTHER

The patient randomized into the telephone follow up group, will be contacted, at the pre-scheduled date and time, by the urogynecology clinic nurse. The nurse will utilize a scripted series of postoperative questions, which are consistent with questions asked during our standard postoperative clinic visits. Vital signs and physical examination will be deferred for the patients in the telephone follow up group. Any patient responses that are not consistent with a usual postoperative course will be escalated to an in person visit. However, these patients will remain in the group, to which they were originally randomized, for research analysis purposes. (Intent to treat)

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Women \>18 desiring surgical management of prolapse or incontinence * English speaking * Willing and able to provide written and informed consent without assistance from medical surrogate or interpreter * Immediate access to telephone services (landline, mobile phone, office phone) Exclusion Criteria: * Women \<18 * Non-English speaking * Unwilling and unable to provide written and informed consent without assistance from surrogate or interpreter * Hearing impairment * No access to telephone services (landline, mobile phone, office phone) * Grade 3 complication- a complication requiring surgical, endoscopic, or radiological intervention. \[3\] * Patient who did not attend any postoperative follow up visit

Locations (1)

University of Florida Health

Tampa, Florida, United States

RECRUITING

Outcomes

Primary Outcomes

Patient Satisfaction (questionnaire)

Comparison of patient satisfaction as determined by completion of a non-validated, treatment non-specific satisfaction questionnaire between the two groups.

Time frame: Survey will be provided at the six-week follow up visit.

Secondary Outcomes

Patient safety (adverse events)

• Comparison of adverse events and Emergency Department (ED) visits between the two groups. Will be determined by reviewing the patient's record to identify adverse events as defined below

Time frame: Postoperative period up to 6 weeks

Time Spent (post op telephone follow up compared to clinic follow up [minutes])

• Actual time spent on phone call during postoperative telephone follow up compared to time spent in clinic follow up measured in minutes.

Time frame: Calculated from time spent at the two week follow up visit

Central Contacts

Elisha J Jackson, MD

CONTACT

8166860222 elisha.jackson815@gmail.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.