Telephone Intervention to Increase Patient Preparedness and Satisfaction Trial (TIPPS): A Randomized Control Trial

Stress Urinary Incontinence Clinical Trial

— TIPPS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03890471
• Other study ID #: 2018120057
• Status: Completed
• Phase: N/A
• Start date: June 5, 2019
• Est. completion date: May 11, 2020

Study information

• Verified date: October 2020
• Source: University of Texas at Austin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: May 11, 2020
• Est. primary completion date: May 11, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• At least 18 years of age

• Speak and read English: Only English-speaking women will be allowed to participate because the questionnaires used in the study are validated only in English and Swedish; they are not validated in other languages.

• Planned surgery for pelvic organ prolapse and/or stress urinary incontinence

Exclusion Criteria:

• Less than 18 years of age

• Do not read or speak English

• Unable to participate in a telephone call (dementia, hard of hearing, deaf)

• Scheduled for surgery in 3 days or less

Related Conditions & MeSH terms

• Prolapse
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Behavioral:
• Preoperative telephone call three days before surgery
Patients will receive a provider-initiated telephone call three days before surgery. In order to standardize counseling across providers, each provider will use a telephone script addressing the following components: Purpose of the surgery, alternatives to the surgery, surgical benefits, surgical risk (such as infection, bleeding, injury to other organ systems), potential surgical complications (such as mesh erosion, voiding dysfunction, urinary retention requiring indwelling catheter), bowel complaints (such as nausea, vomiting, constipation, diarrhea), and postoperative expectations (such as Foley management, pain management, activity restrictions, and diet. The following ERAS-specific components will be incorporated into the counseling: management of chronic medical conditions, cessation of alcohol and tobacco, and daily exercise until surgery. Questions from patients and total counseling time will be recorded.

Locations

Country	Name	City	State
United States	Pelvic Floor Integrated Practice Unit at the University of Texas Health Austin	Austin	Texas
United States	Seton Midtown Medical Tower	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas at Austin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical preparedness	Patient Preparedness Questionnaire, Modified Preparedness for Colorectal Cancer Surgery Questionnaire	Baseline
Secondary	Surgical satisfaction	Decision Regret Scale and Satisfaction with Decision Scale, Scale of 1-5, Scoring consists of reversing the scores of the 2 negatively phrased items, then taking the mean of the 5 items (range, 1-5).	Will be measured at postoperative visit 4-8 weeks after surgery.
Secondary	Patient-reported outcomes	Pelvic Floor Distress Inventory - 20	Will be measured at baseline and at the postoperative visit 4-8 weeks after surgery.
Secondary	Cost-effectiveness	The European Quality of Life-5 Dimensions	Will be measured at baseline and at the postoperative visit 4-8 weeks after surgery.