Stress Urinary Incontinence Clinical Trial
Official title:
Telephone Intervention to Increase Patient Preparedness and Satisfaction Trial (TIPPS): A Randomized Control Trial Evaluating the Effect of Preoperative Telephone Calls on Patient Preparedness and Satisfaction in Urogynecologic Surgery
Surgical preparedness improves patient satisfaction and perioperative outcomes. In
urogynecology, interventions to increase preoperative patient preparedness have not been
adequately studied. Our objective is to evaluate the ability of preoperative
provider-initiated telephone calls to increase patient preparedness for surgery. The
investigators will conduct a randomized control trial comparing surgical preparedness between
provider-initiated telephone call three days before surgery plus usual preoperative
counseling versus usual preoperative counseling alone among women planning to undergo pelvic
reconstructive surgery as measured by the Preoperative Patient Questionnaire (PPQ) and the
Modified Preparedness for Colorectal Cancer Surgery Questionnaire (Modified PCSQ). Surgical
satisfaction, perioperative outcomes, and medical costs will be also be compared between the
two groups. Our hypothesis is that preoperative telephone calls will result in improved
surgical preparedness. This novel approach in preoperative counseling has the potential to
positively impact perioperative patient care.
The investigators will also conduct an ancillary qualitative study of sexually active women
undergoing pelvic reconstructive surgery who are enrolled in the randomized control trial.
This work will aim to describe the patient experience, concerns, and the quality of the first
sexual encounter following surgery. This ancillary study will lay the foundation for future
investigations into how to better counsel patients and discuss sexual activity after surgical
repair.
Increased surgical preparedness is linked to improved surgical satisfaction and
patient-reported outcomes. Interventions that increase preparedness for surgery are needed.
The impact of a provider-initiated preoperative telephone call on surgical preparedness is
unknown. The objectives of this study are to compare patient preparedness between women who
receive a preoperative provider-initiated telephone call plus the usual preoperative
counseling in the clinic versus usual preoperative counseling alone. The investigators
hypothesize that a provider initiated preoperative telephone call will increase surgical
preparedness and satisfaction, as well as improve perioperative outcomes. The investigators
will test our working hypothesis by using the approach of randomizing patients undergoing
surgery for SUI and/or POP to either a provider-initiated telephone call three days before
surgery plus usual preoperative counseling or usual preoperative counseling alone. The
rationale for this aim is that successful completion of the proposed research will contribute
a missing, fundamental element to our understanding of preoperative counseling. It is our
expectation that a preoperative telephone call three days before surgery will result in
improved surgical preparedness. Such a finding would be of importance because it would
provide evidence to support a novel method in preoperative counseling that positively impacts
patient care.
Patients enrolled in the ancillary sexual function study will be scheduled for one-on-one
telephone interview 2-4 months after surgery. Major themes of the interviews will be used to
better describe the patient experience of return to sexual activity after surgery.
The investigators are also planning on performing a cost analysis. A provider-initiated
telephone call before surgery requires the allocation of new resources that may result in
additional perioperative costs. However, if telephone calls improve perioperative outcomes,
an overall decrease in perioperative costs may be observed due to a decrease in direct and
non-direct costs. Direct costs are attributable to the use of a health care intervention or
illness and can be further classified in medical and non-medical costs. Medical care costs
include emergency room visits, hospital admissions, unplanned clinic visits, clinic telephone
calls. Non-medical costs include transportation, gas, and parking. Indirect costs include
lost wages for the patient or caregiver. The objective of aspect of the study is to determine
the difference in cost-effectiveness between women who receive a provider-initiated telephone
call 3 days before surgery plus the usual preoperative counseling in the clinic versus the
usual preoperative counseling alone from the patient and societal perspectives. The
investigators hypothesize that preoperative telephone calls will be more cost-effective for
both patients and society. The investigators will test our working hypothesis by using the
approach of resource costing method. It is our expectation that preoperative telephone calls
will improve perioperative outcomes resulting in overall cost to both the patient and society
that will compensate for the additional perioperative costs associated with a telephone call
before surgery.
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