Telehealth Postop Follow up RCT

NCT ID: NCT03791697

Last Updated: 2019-01-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 142 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-09
• Study Completion Date: 2019-07-31

Brief Summary

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.

Detailed Description

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.

Conditions

Patient Satisfaction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Telephone Group

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.

Group Type: ACTIVE_COMPARATOR

Telehealth 2 week postoperative visit

Intervention Type: OTHER

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)

In Person Clinic Visit Group

For the patient randomized into the clinic group, the clinic visit will entail questions about common postoperative complications (including fever, nausea/vomiting, pain, urinary symptoms, constipation, etc.). As per usual, vital signs and a focused physical examination will be completed at the clinic visit. All clinic visits will be performed by an FPRMS fellow and/or attending physician

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Telehealth 2 week postoperative visit

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)

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of South Florida

OTHER

Sponsor Role: collaborator

Jackson, Elisha

OTHER

Sponsor Role: lead

Responsible Party

Elisha Jackson

Physician-Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elisha J Jackson, MD

Role: PRINCIPAL_INVESTIGATOR

University of South Florida Morsani School of Medicine

Locations

University of Florida Health

Tampa, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Elisha J Jackson, MD

Role: CONTACT

elisha.jackson815@gmail.com

8166860222

Facility Contacts

Elisha Jackson, MD

Role: primary

elisha.jackson815@gmail.com

816-686-0222

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Telehealth Study

Identifier Type: -

Identifier Source: org_study_id