Preferred Method of Postoperative Follow Up After Pelvic Reconstructive Surgery. (Phone Call Versus Clinic Visit): A Non-Inferiority Randomized Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Patient Satisfaction
- Sponsor
- Jackson, Elisha
- Enrollment
- 142
- Locations
- 1
- Primary Endpoint
- Patient Satisfaction (questionnaire)
- Last Updated
- 7 years ago
Overview
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.
Investigators
Elisha Jackson
Physician-Fellow
Jackson, Elisha
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
Outcomes
Primary Outcomes
Patient Satisfaction (questionnaire)
Time Frame: Survey will be provided at the six-week follow up visit.
Comparison of patient satisfaction as determined by completion of a non-validated, treatment non-specific satisfaction questionnaire between the two groups.
Secondary Outcomes
- Patient safety (adverse events)(Postoperative period up to 6 weeks)
- Time Spent (post op telephone follow up compared to clinic follow up [minutes])(Calculated from time spent at the two week follow up visit)