Perioperative Post-Prostatectomy Incontinence Home Telehealth Program

围手术期前列腺切除术后失禁家庭远程医疗计划

• 批准号: 9928732
• 负责人: KATHRYN Larsen BURGIO
• 金额: --
• 依托单位: BIRMINGHAM VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-10-01 至 2019-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9928732
• 关键词: Adherence; Affect; Age; Back; Bladder Control; Cancer Survivor; Caring; Catheters; Chronic; Client satisfaction; Clinic; Clinic Visits; Clinical; Clinical Trials; Consultations; Control Groups; Cost Savings; Counseling; Data; Databases; Development; Devices; Discipline; Economic Burden; Education; Effectiveness; Electronic Mail; Emotional; Exercise; Extravasation; Famous Persons; Funding; Health Status; Healthcare Systems; Home environment; Hospitals; Incontinence; International; Intervention; Knowledge; Learning; Life; Malignant neoplasm of prostate; Measures; Medical; Medical center; Muscle; Nursing Homes; Odors; Operative Surgical Procedures; Outcome; Outcome Measure; Participant; Patient Education; Patient Monitoring; Patients; Pelvic Floor Muscle; Pelvic floor structure; Perception; Perioperative; Perioperative Care; Persons; Pilot Projects; Population; Postoperative Period; Privacy; Probability; Procedures; Prostate; Prostate Cancer therapy; Prostatectomy; Protocols documentation; Quality of life; Questionnaires; Radical Prostatectomy; Randomized; Randomized Controlled Trials; Reading; Rehabilitation therapy; Reporting; Research; Secure; Severities; Site; Skin Care; Study Section; Surveys; Symptoms; Techniques; Technology; Telephone Interviews; Testing; Time; Training; Training Programs; Translations; United States; Urinary Incontinence; Urine; Urology; Veterans; Work; base; cancer surgery; care coordination; cost effective; efficacy testing; empowered; evidence base; experience; fourth grade; health related quality of life; improved; indexing; instrument; men; novel; prevent; primary outcome; programs; psychosocial; public health relevance; research and development; rural setting; satisfaction; secondary outcome; skills; telehealth; tool; treatment group; urinary

DESCRIPTION (provided by applicant): Telehealth is the use of medical information exchanged from one site to another via electronic communications to improve patients' health status. Telehealth has been shown to be an effective means to deliver care to veterans in rural settings or in VA Medical Centers without expertise in specific disciplines. The VA Care Coordination / Home Telehealth (CCHT) Program has been highly successful with implementing patient education and monitoring programs using home messaging units for a wide variety of chronic and subacute conditions with over 300,000 veterans receiving care through CCHT in FY2010. Prostate cancer treatment, particularly radical prostatectomy, results in persistent incontinence that in patient surveys is significant enough to require long-term use of pads in 1 of 3 of men undergoing surgery. Although several randomized, controlled trials of perioperative pelvic floor muscle training have shown that it reduces duration and severity of post-operative incontinence for men undergoing prostate cancer surgery, most men do not receive this training because of lack of specially trained therapists. This study will test an evidence-based perioperative pelvic floor muscle training program that has been adapted to telehealth format and pilot tested in a recently completed Rehab R&D-funded pilot/developmental trial in a randomized, controlled manner to determine if this training can be effectively delivered to veterans using home messaging units. Content is delivered in daily 10-minute sessions written at a 4th grade reading level. Each session ends with a fun fact, often about a famous person with successfully treated prostate cancer. In our pilot study, veterans reported that the home messaging units were easy to set up and use, that they appreciated receiving the training in the privacy of their homes, enjoyed the interactive style of the learning experience, and felt better prepared to deal with incontinence and empowered with new knowledge and skills to help themselves. The control group will also receive the telehealth device, but without the pelvic floor muscle training component to control the use of technology. Content for both groups will include general perioperative care; wetness, odor and skin care management; and outcome measures. Only the treatment group will receive the pelvic floor muscle training which is started preoperatively and then continued postoperatively along with bladder control strategies - actively using muscles to prevent leakage, and adherence tips, prompts, and measures. All outcome measures will be obtained using validated instruments administered via the home telehealth device, another novel part of the study. Data are transmitted nightly to a secure VA database as they are in the CCHT program. The primary outcome measure will be time to continence which is extremely important to the veteran who wants to recover bladder control as soon as possible after surgery, and is the outcome in most clinical incontinence trials. Other outcome measures include scores on a validated health-related quality of life tool specific to prostate cancer survivors; pad use; a measure of the impact of incontinence on daily activities, several other condition-specific quality of life measures, and three validated global patient ratings of efficacy and satisfaction, as perceived by the veteran. Primary analysis will be intent-to-treat, using the Kaplan-Meier procedure and log rank test for time to continence and multiple regression, controlling for baseline for the other variables. A qualitative analysis will also be done, with veterans completing an in-person or telephone interview concerning their experience with the telehealth program. If demonstrated efficacious, the program could be rapidly disseminated across VA through the Care Coordination / Home Telehealth Program so that all veterans undergoing radical prostatectomy can have evidenced-based perioperative pelvic floor muscle training and improved continence outcomes.

描述(由申请人提供)： 远程医疗是通过电子通信将医疗信息从一个地点交换到另一个地点，以改善患者的健康状况。远程保健已被证明是向农村环境中的退伍军人或在没有特定学科专业知识的退伍军人医疗中心提供护理的有效手段。退伍军人事务部护理协调/家庭远程健康(CCHT)计划在实施患者教育和监测计划方面取得了巨大成功，该计划使用家庭消息单元针对各种慢性和亚急性疾病，2010财年有超过300,000名退伍军人通过CCHT接受护理。前列腺癌治疗，特别是根治性前列腺癌切除术，会导致持续性大小便失禁，根据患者调查，这种情况非常严重，需要在三分之一的手术患者中长期使用PADS。尽管几项关于围术期盆底肌肉训练的随机对照试验表明，对于接受前列腺癌手术的男性来说，盆底肌肉训练可以减少术后大小便失禁的持续时间和严重程度，但大多数男性没有接受这种训练，因为缺乏受过专门培训的治疗师。这项研究将测试一种循证的围术期盆底肌肉训练计划，该计划已适应远程医疗模式，并在最近完成的康复研发资助的试点/发育试验中以随机、受控的方式进行试点测试，以确定这种训练是否可以有效地使用家庭信息单元提供给退伍军人。内容每天10分钟，以四年级阅读水平写作。每一次会议都以一个有趣的事实结束，通常是关于一位成功治疗前列腺癌的名人。在我们的试点研究中，退伍军人报告说，家庭通讯设备易于设置和使用，他们感谢在家中的隐私中接受培训，享受学习体验的互动风格，并感觉更好地准备应对大小便失禁，并被赋予新的知识和技能来帮助自己。对照组还将接受远程保健装置，但不使用盆底肌肉训练组件来控制技术的使用。两组的内容将包括一般围手术期护理；湿气、气味和皮肤护理管理；以及结果衡量标准。治疗组术前开始盆底肌训练，术后继续配合膀胱控制策略--积极运用肌肉防止渗漏，并给予坚持的提示、提示和措施。所有结果测量将使用通过家庭远程医疗设备管理的经过验证的仪器来获得，这是研究的另一个新部分。数据每晚被传输到安全的退伍军人管理局数据库，就像它们在CCHT计划中一样。主要的结果衡量标准将是可控时间，这对希望手术后尽快恢复膀胱控制的退伍军人来说极其重要，也是大多数临床大小便失禁试验的结果。其他结果测量包括前列腺癌幸存者特定的有效健康相关生活质量工具的分数；垫子的使用；大小便失禁对日常活动的影响的测量；其他几种特定条件的质量 三个有效的全球患者的疗效和满意度评级，如退伍军人所认为的。主要分析将是意向治疗，使用Kaplan-Meier程序和对可控时间和多元回归的对数等级检验，对其他变量的基线进行控制。还将进行定性分析，让退伍军人完成关于他们在远程医疗计划中的经历的面对面或电话采访。如果证明有效，该计划可以通过护理协调/家庭远程保健计划在退伍军人事务部迅速传播，以便所有接受根治性前列腺切除术的退伍军人能够在围手术期进行基于证据的盆底肌肉训练，并改善可控结果。