Clinical trial NCT03791697: Telehealth Postop Follow up RCT
Official title: Preferred Method of Postoperative Follow Up After Pelvic Reconstructive Surgery. (Phone Call Versus Clinic Visit): A Non-Inferiority Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Patient Satisfaction
Keywords: Postoperative patient satisfaction
Lead sponsor: Jackson, Elisha
Sponsor class: OTHER
Collaborators: name: University of South Florida
First posted: 2019-01-03
Enrollment: 142
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eligible patients will be randomized to Arm1 or Arm2 (Telephone follow up or clinic follow up). Permuted block randomization with randomly varying block sizes will be used. Generation of allocation sequences will be performed using a random-number table.

The allocation sequence will be generated by our statistician who is neither responsible for patient recruitment or outcome assessment. Sequentially numbered opaque sealed envelopes will be used for concealment of treatment allocation.

It is not possible to mask clinical staff or participants, as they will be aware of the follow-up care that is being delivered over the telephone or in clinic. As such this is not a blinded study.
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Patient Satisfaction (questionnaire)
timeFrame: Survey will be provided at the six-week follow up visit.
Secondary outcomes:
measure: Patient safety (adverse events)
timeFrame: Postoperative period up to 6 weeks
measure: Time Spent (post op telephone follow up compared to clinic follow up [minutes])
timeFrame: Calculated from time spent at the two week follow up visit
Other outcomes:
Locations:
city: Tampa
country: United States
facility: University of Florida Health
state: Florida
Study officials:
affiliation: University of South Florida Morsani School of Medicine
name: Elisha J Jackson, MD
role: PRINCIPAL_INVESTIGATOR
References: