Telehealth Postop Follow up RCT

Jackson, Elisha

Status: Unknown

Conditions: Patient Satisfaction

Treatments: Other: Telehealth 2 week postoperative visit

Study type: Interventional

Funder types: Other

Identifiers

NCT03791697

Telehealth Study

Details and patient eligibility

About

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.

Full 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.

Enrollment: 142 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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142 participants in 2 patient groups

Telephone Group

Active Comparator group

Description:

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.

Treatment:

Other: Telehealth 2 week postoperative visit

In Person Clinic Visit Group

No Intervention group

Description:

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