RCT: Impact of Preop Video on Patient Preparedness for Surgery
Impact of Preoperative Patient Education Video on Patient Preparedness After Sacrocolpopexy: A Single Blind Randomized Controlled Trial
This is a single-blind, randomized (1:1 allocation), stratified, single-parallel clinical trial at one institution evaluating the use of a preoperative patient education video as an adjunct to preoperative counseling on patient-centered outcomes.
The aim of this study is to determine the impact of a preoperative patient educational video as an adjunct to the routine preoperative visit on patients' preparedness for surgery, perception of time spent with their healthcare team, and ultimately their satisfaction after surgery. The aim of this video is not to limit the doctor patient interaction (as all patients will still be granted their pre-allotted 30 minute visit with the physician regardless of their intervention allocation) but rather to augment the visit with additional educational information in an attempt to optimize the visit.
Objective:
A. Primary Aim(s):
• To determine if patients feel more prepared for surgery with addition of preoperative patient education video
B. Secondary Aim(s):
- To determine if addition of preoperative patient education video correlates with improved patient satisfaction after surgery
- To determine if patients' perception of time spent with healthcare team in preparation for surgery increases with addition of patient educational video
- To determine if actual patient-physician time spent counseling differs between groups
- To determine if patient preparedness is correlated with objective surgical outcomes
- To determine if patient preparedness is correlated with patient symptom improvement scores after surgery
Hypothesis:
The addition of a preoperative patient education video enhances patient preparedness for surgery, increases perception of the amount of time patients spend with healthcare team, and improves patient satisfaction.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Florida
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Tampa, Florida, 미국, 33606
- University of South Florida Urogynecology clinic
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Women >18 scheduled to undergo either a laparoscopic or robotic-assisted sacrocolpopexy
- It is acceptable if concomitant procedures such as suburethral slings or additional vaginal repairs are planned
- English speaking
- Willing and able to provide written and informed consent
Exclusion Criteria:
- Women <18
- Not scheduled to undergo either a laparoscopic or robotic-assisted sacrocolpopexy
- Non-English speaking
- Unable or unwilling to provide written and informed consent
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Preop Video
This arm will watch an instructional video in addition to their normal preoperative visit with the physician.
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Patients will watch preoperative instructional video
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간섭 없음: No video
This arm will receive only the normal preoperative visit with the physician without the additional video
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
patients' preparedness for surgery
기간: prior to surgery (baseline)
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patients' feelings of preparedness for surgery as determined by a preoperative patient preparedness questionnaire for pelvic surgery
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prior to surgery (baseline)
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Patient preparedness for surgery
기간: 2 week postop visit
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patients' feelings of preparedness for surgery as determined by a postoperative patient preparedness questionnaire for pelvic surgery
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2 week postop visit
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
patient satisfaction
기간: 2 weeks postop
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patient satisfaction as determined by completion of an adapted postoperative satisfaction questionnaire
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2 weeks postop
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perception of time
기간: prior to surgery (baseline)
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patients' perception of time spent with healthcare team
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prior to surgery (baseline)
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Actual facetime spent
기간: prior to surgery (baseline)
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Actual facetime spent between physician and patient during preoperative counseling session measured in minutes
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prior to surgery (baseline)
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QOL
기간: 2 weeks postop
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Completion of validated condition specific QOL measures (ie. the Patient Global Impression of Improvement [PGI-I])
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2 weeks postop
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POPQ
기간: 2 weeks postop
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Objective measures of success will be determined using the Pelvic organ prolapse quantification (POPQ to quantify prolapse)
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2 weeks postop
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Patient satisfaction
기간: prior to surgery (baseline)
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patient satisfaction as determined by completion of an adapted preoperative satisfaction questionnaire
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prior to surgery (baseline)
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공동 작업자 및 조사자
수사관
- 수석 연구원: Kristie Greene, MD, University of South Florida
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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