Visits Versus Telephone Calls for Postoperative Care (OPTIONs)
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|ClinicalTrials.gov Identifier: NCT02891187|
Recruitment Status : Completed
First Posted : September 7, 2016
Last Update Posted : December 13, 2018
|Condition or disease||Intervention/treatment||Phase|
|Satisfaction Postoperative Complications Pelvic Floor Disorder||Behavioral: Telephone follow-up Behavioral: Outpatient Clinic Visits||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Outpatient Visits Versus Telephone Interviews for Postoperative Care: A Randomized Controlled Trial|
|Actual Study Start Date :||September 2016|
|Actual Primary Completion Date :||January 2018|
|Actual Study Completion Date :||January 2018|
Active Comparator: Outpatient Clinic Visits
Outpatient clinic visits for postoperative care is currently the standard of care. Patients who undergo surgery for a pelvic floor disorder will be scheduled appointments in the outpatient clinic at 1-2 weeks, 6 weeks, and 3 months where they will be evaluated by a physician.
Behavioral: Outpatient Clinic Visits
Patients will return to the clinic at 1-2 weeks, 6 weeks, and 3 months
Active Comparator: Telephone Follow-up
Patients will be called instead of returning to clinic for postoperative care at 1-2 weeks, 6 weeks, and 3 months.
Behavioral: Telephone follow-up
Patients will be called for postoperative care at 1-2 weeks, 6 weeks, and 3 months
- Patient Satisfaction [ Time Frame: Preoperative until 3 months postoperative ]The objective is to compare patient satisfaction between women who present for clinic postoperative visits versus telephone follow-up. The investigators hypothesize that telephone calls will show non-inferior patient satisfaction when compared to clinic postoperative visits. The investigators will test the working hypothesis by using the approach of randomizing patients undergoing surgery for PFDs to either telephone follow-up or routine outpatient visits for their postoperative care and utilizing the S-CAHPS questionnaire preoperatively and 3 months postoperatively.
- Adverse Events [ Time Frame: 3 months postoperative ]The objective is to demonstrate telephone follow-up as both an effective and safe modality for postoperative care. The investigators hypothesize telephone calls and outpatient visits will not show a significant difference in adverse outcomes or patient outcomes for their pelvic floor dysfunction. Adverse events will be captured during the 3 months postoperative period for both groups in this study.
- Cost-effectiveness [ Time Frame: Preoperative to 3 months postoperative ]The objective is to determine the difference in cost-effectiveness between postoperative telephone follow-up versus outpatient visits from the patient and societal perspectives. The investigators hypothesize that telephone calls will be more cost-effective for both patients and society. This will be accomplished using detailed questionnaires and the European Quality of Life-5 Dimensions (EQ-5D)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02891187
|United States, New Mexico|
|University of New Mexico Health Sciences|
|Albuquerque, New Mexico, United States, 87131|
|Principal Investigator:||Rebecca G Rogers, MD||University of New Mexico|