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

NCT03890471 | Completed

• 1 other identifier: 2018120057
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Prolapse; Stress Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

• Surgical preparedness

  Patient Preparedness Questionnaire, Modified Preparedness for Colorectal Cancer Surgery Questionnaire

  Baseline

Secondary Outcomes (3)

• Surgical satisfaction

  Will be measured at postoperative visit 4-8 weeks after surgery.

• Patient-reported outcomes

  Will be measured at baseline and at the postoperative visit 4-8 weeks after surgery.

• Cost-effectiveness

  Will be measured at baseline and at the postoperative visit 4-8 weeks after surgery.

Study Arms (2)

Preoperative telephone call

EXPERIMENTAL

Patients will receive routine preoperative counseling in the clinic plus a provider initiated telephone call 3 days before surgery.

Behavioral: Preoperative telephone call three days before surgery

No preoperative telephone call

NO INTERVENTION

Patients will receive routine preoperative counseling in the clinic.

Interventions

Preoperative telephone call three days before surgery BEHAVIORAL

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.

Preoperative telephone call

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (2)

Seton Midtown Medical Tower

Austin, Texas, 78705, United States

Location

Pelvic Floor Integrated Practice Unit at the University of Texas Health Austin

Austin, Texas, 78712, United States

Location

Related Publications (1)

• Halder GE, Guo F, Harvie H, White AB, Caldwell L, Giles DL, Bilagi D, Rogers RG. Cost Effectiveness of Additional Preoperative Telephone Call to Increase Surgical Preparedness: Analysis of a Randomized Clinical Trial. Int Urogynecol J. 2024 Mar;35(3):527-536. doi: 10.1007/s00192-023-05719-7. Epub 2024 Jan 8.

  PMID: 38189853 DERIVED

MeSH Terms

Conditions

Prolapse; Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms

Study Officials

• Rebecca Rogers, MD

  Tenured Processor, Department of Women's Health at UT Austin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator, FPMRS Fellow

Model Details: We will conduct a randomized controlled trial comparing a provider-initiated preoperative telephone call plus usual clinic counseling to usual clinic counseling alone in women planning pelvic reconstructive surgery for SUI and/or POP.

Study Record Dates

• First Submitted: March 11, 2019
• First Posted: March 26, 2019
• Study Start: June 5, 2019
• Primary Completion: May 11, 2020
• Study Completion: May 11, 2020
• Last Updated: October 6, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)