NCT03890471: TIPPS

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

Completed NA Last updated 6 October 2020

What this trial tests

NA trial testing Preoperative telephone call three days before surgery in Prolapse in 150 participants. Completed in 11 May 2020.

Timeline

5 June 2019

Primary endpoint
11 May 2020

11 May 2020

Quick facts

Lead sponsor	University of Texas at Austin
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	150
Start date	5 June 2019
Primary completion	11 May 2020
Estimated completion	11 May 2020
Sites	2 locations across United States

Drugs / interventions tested

• Preoperative telephone call three days before surgery

Conditions studied

• Prolapse — all drugs for Prolapse →
• Stress Urinary Incontinence — all drugs for Stress Urinary Incontinence →

Sponsor

University of Texas at Austin

Who can join

18 and older, female only, with Prolapse or Stress Urinary Incontinence. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. A telehealth intervention to increase patient preparedness for surgery: a randomized trial.
   Halder GE, White AB, Brown HW, Caldwell L, et al · · 2022 · cited 12× · PMID 34028575 · DOI 10.1007/s00192-021-04831-w
2. Cost Effectiveness of Additional Preoperative Telephone Call to Increase Surgical Preparedness: Analysis of a Randomized Clinical Trial.
   Halder GE, Guo F, Harvie H, White AB, et al · · 2024 · cited 1× · PMID 38189853 · DOI 10.1007/s00192-023-05719-7