CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 120 enrolled
Drug / intervention
Telephone follow-up +1 morebehavioral
Likely dose
Not stated in record
Key inclusion· 5
  • Age 18 years or older
  • Women undergoing surgery for a pelvic floor disorder
  • Able to give informed consent
  • Has a reliable phone number for contact postoperatively
Key exclusion· 6
  • Physician determines medical necessity for in-clinic postoperative follow-up
  • Unable to give written informed consent
  • Does not have a reliable phone number
  • Cannot speak and understand English or Spanish

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02891187
NCT02891187N/ACompleted

Outpatient Visits Versus Telephone Interviews for Postoperative Care: A Randomized Controlled Trial

University of New Mexico·interventional·Posted Sep 7, 2016·Updated Nov 1, 2024

In Brief

A clinical study evaluating Telephone follow-up and Outpatient Clinic Visits for Satisfaction and 2 related conditions. Completed, enrolled 120 participants across 1 site.

Detailed Summary

The OPTIONs study is a randomized controlled, non-inferiority study to evaluate postoperative care using outpatient clinic visits versus telephone calls for women undergoing surgery for pelvic floor disorders. The primary outcome is patient satisfaction using the Surgical-Consumer Assessment of Healthcare Providers and Systems (S-CAHPS) questionnaire provided by the Agency for Healthcare Research and Quality (AHRQ). Secondary outcomes include safety and cost analysis for patients' direct and indirect medical costs. Women who speak and understand either English or Spanish and planning to undergo an elective surgery for a pelvic disorder will be recruited. Baseline demographics, satisfaction, and cost analysis questionnaires will be acquired pre-operatively. Randomization will be assigned at the time of discharge from the hospital. Patients will either have scheduled clinic visits at 1-2 weeks, 6 weeks, and 3 months or telephone calls by a registered nurse at these same intervals. Questionnaires will be completed at 3 months for satisfaction and cost analysis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedSep 7, 2016
Enrollment StartSep 1, 2016
Primary CompletionJan 1, 2018
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 9.8 years ago

Interventions

Telephone follow-upbehavioral

Patients will be called for postoperative care at 1-2 weeks, 6 weeks, and 3 months

Outpatient Clinic Visitsbehavioral

Patients will return to the clinic at 1-2 weeks, 6 weeks, and 3 months