A Video-Based Communication Intervention for Fecal Ostomy Surgery (CI-oSurg): Protocol for Open Pilot Testing to Improve Intervention Acceptability and Feasibility.

IF 1.4 Q3 HEALTH CARE SCIENCES & SERVICES JMIR Research Protocols Pub Date : 2024-11-15 DOI:10.2196/60575

Christy Elaine Cauley, Atziri Rubio, Mary Brindle, Zara Cooper, Ana-Maria Vranceanu, Christine S Ritchie

{"title":"A Video-Based Communication Intervention for Fecal Ostomy Surgery (CI-oSurg): Protocol for Open Pilot Testing to Improve Intervention Acceptability and Feasibility.","authors":"Christy Elaine Cauley, Atziri Rubio, Mary Brindle, Zara Cooper, Ana-Maria Vranceanu, Christine S Ritchie","doi":"10.2196/60575","DOIUrl":null,"url":null,"abstract":"Background: Approximately 100,000 patients undergo fecal ostomy operations annually across the United States. This patient population experiences high surgical complication rates and poor biopsychosocial outcomes. Surgical teams are not trained to address the psychosocial needs that often arise during recovery after fecal ostomy surgery.Objective: This study aims to refine and establish the acceptability and usability of the Communication Intervention for fecal ostomy Surgery (CI-oSurg), a web-based communication intervention aimed at reducing distress among patients recovering from ostomy surgery.Methods: We describe the proposed study design, methodology, and training protocol. We will conduct an open pilot (n=24 patients and n=8 clinicians) of video-based training to first identify the level and types of distress patients are experiencing. Next, patients will view web videos that address frequent challenges faced by ostomy patients, considering practical management and emotional and adaptation concerns. Qualitative one-to-one semistructured interviews will be conducted with participants to explore the acceptability and feasibility of the program and refine the intervention and study procedures.Results: This study has been approved by the Mass General Brigham Institutional Review Board. Study funding has been obtained, and recruitment is planned for the fall of 2024.Conclusions: Through this study, we will refine CI-oSurg, a web-based communication intervention focused on reducing distress after ostomy surgery, to improve intervention acceptability and usability. These improvements will allow us to establish the usability and acceptability of the intervention before efficacy testing to determine the ability of this intervention to reduce distress after fecal ostomy surgery.Trial registration: ClinicalTrials.gov NCT06320002; https://clinicaltrials.gov/study/NCT06320002.International registered report identifier (irrid): PRR1-10.2196/60575.","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"13 ","pages":"e60575"},"PeriodicalIF":1.4000,"publicationDate":"2024-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"JMIR Research Protocols","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.2196/60575","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"HEALTH CARE SCIENCES & SERVICES","Score":null,"Total":0}

引用次数: 0

Abstract

Background: Approximately 100,000 patients undergo fecal ostomy operations annually across the United States. This patient population experiences high surgical complication rates and poor biopsychosocial outcomes. Surgical teams are not trained to address the psychosocial needs that often arise during recovery after fecal ostomy surgery.

Objective: This study aims to refine and establish the acceptability and usability of the Communication Intervention for fecal ostomy Surgery (CI-oSurg), a web-based communication intervention aimed at reducing distress among patients recovering from ostomy surgery.

Methods: We describe the proposed study design, methodology, and training protocol. We will conduct an open pilot (n=24 patients and n=8 clinicians) of video-based training to first identify the level and types of distress patients are experiencing. Next, patients will view web videos that address frequent challenges faced by ostomy patients, considering practical management and emotional and adaptation concerns. Qualitative one-to-one semistructured interviews will be conducted with participants to explore the acceptability and feasibility of the program and refine the intervention and study procedures.

Results: This study has been approved by the Mass General Brigham Institutional Review Board. Study funding has been obtained, and recruitment is planned for the fall of 2024.

Conclusions: Through this study, we will refine CI-oSurg, a web-based communication intervention focused on reducing distress after ostomy surgery, to improve intervention acceptability and usability. These improvements will allow us to establish the usability and acceptability of the intervention before efficacy testing to determine the ability of this intervention to reduce distress after fecal ostomy surgery.

Trial registration: ClinicalTrials.gov NCT06320002; https://clinicaltrials.gov/study/NCT06320002.

International registered report identifier (irrid): PRR1-10.2196/60575.

查看原文

微信好友朋友圈 QQ好友复制链接

本刊更多论文

基于视频的粪便造口手术沟通干预（CI-oSurg）：公开试点测试协议，提高干预的可接受性和可行性。

背景：美国每年约有 10 万名患者接受造瘘手术。这类患者的手术并发症发生率高，生物心理社会效果差。手术团队没有接受过培训，无法满足粪便造口手术后恢复期间经常出现的社会心理需求：本研究旨在完善和确定粪便造口手术沟通干预（CI-oSurg）的可接受性和可用性，这是一种基于网络的沟通干预，旨在减少造口手术后恢复期患者的痛苦：我们将介绍拟议的研究设计、方法和培训方案。我们将对基于视频的培训进行公开试点（24 名患者和 8 名临床医生），首先确定患者所经历的痛苦程度和类型。接下来，患者将观看针对造口患者经常面临的挑战的网络视频，考虑实际管理、情感和适应问题。将对参与者进行一对一半结构化定性访谈，以探讨该计划的可接受性和可行性，并完善干预措施和研究程序：本研究已获得 Mass General Brigham 机构审查委员会的批准。研究经费已经到位，计划于 2024 年秋季进行招募：通过这项研究，我们将改进 CI-oSurg（一种基于网络的交流干预措施，主要用于减轻造口手术后的痛苦），以提高干预措施的可接受性和可用性。这些改进将使我们能够在疗效测试前确定干预措施的可用性和可接受性，以确定该干预措施能否减轻造口手术后的痛苦：ClinicalTrials.gov NCT06320002; https://clinicaltrials.gov/study/NCT06320002.International 注册报告标识符 (irrid)：PRR1-10.2196/60575。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文去求助

来源期刊