N/A N=103 Randomized Other

Visits Versus Telephone Calls for Postoperative Care

Satisfaction · Postoperative Complications · Pelvic Floor Disorder

Bottom Line

View on ClinicalTrials.gov: NCT02891187 ↗

Enrolled (actual)

103

Serious AEs

6.0%

Results posted

Nov 2024

Primary outcome: Primary: Patient Satisfaction — 43; 42; 43; 45 participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Telephone follow-up (Behavioral); Outpatient Clinic Visits (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: University of New Mexico
Primary completion: Jan 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Patient Satisfaction	43; 42; 43; 45; 40; 44	—
SECONDARY Adverse Events	15; 11	—

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.

Eligibility Criteria

Inclusion Criteria

Subjects ≥ 18 years of age
Women undergoing surgery for a pelvic floor disorder
Able to give informed consent
Has a reliable phone number for contact postoperatively
Able to speak and understand English or Spanish. Spanish forms will be submitted after initial review of English materials.

Exclusion Criteria

Any patient whose physician decides medical necessity for the patient to have postoperative follow-up in the clinic
Unable to give written informed consent
Does not have a reliable phone number
Inability to speak and understand either English or Spanish. As noted above, Spanish forms will be submitted after initial review of English materials.
Those who specifically request postoperative clinic visits
Pregnant patients

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02891187). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.