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.
The VA serves disproportionately more men than any other health care system. Prostate cancer affects I in 6 men, usually men 50 years and older who comprise the majority of the veteran population served by the VA. Patient survey studies have shown that prostate cancer surgery results in long-term incontinence, sufficient to require pads, in up to 1of 3 of men undergoing surgery. Incontinence can be a physical, emotional, psychosocial and economic burden for the men affected. An intervention to improve urine control after prostate cancer surgery will have a particularly significant impact on the quality of life of the veteran populatio. Therapies that can reduce persistent incontinence, such as the evidence-based pelvic floor muscle training program proposed, are likely to result in cost-savings to the VA by reducing use of absorptive pads (provided to veterans by the VA) and by avoiding nursing home placement as these veterans age. Veterans successfully treated for incontinence will often tell you that you have given them their life back.
