An interventional study of SAFECARE at Home customized lessons in Pancreatectomy, sponsored by Washington University School of Medicine. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-05-15.
Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Supportive care
The study of readmission is in its infancy in the surgical world, and there are no prospective studies, to the investigators' knowledge, evaluating the efficacy of interventions on preventing readmission following pancreatectomy. Undoubtedly, patients and their caregivers will play a key role in any useful intervention to reduce readmission. Therefore, the investigators' approach is to target perioperative education and engagement of patients and their caregivers in the postoperative recovery of pancreatectomy patients.
Washington University School of Medicine is the lead sponsor of 1,795 studies on the registry; 270 are open to participants now.
Of its 330 completed or terminated interventional studies of FDA-regulated products, 216 (65%) have results posted.
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Inclusion Criteria:
* Patients randomized to the intervention arm will be assigned a username and password to access a SAFECARE at Home account via the internet. They will also be emailed a link to the site with their username and password. * The investigators have worked directly with SAFECARE at Home to create customized lessons for patients undergoing pancreatectomy. These lessons are comprehensive and encompass preoperative preparation as well as postoperative recovery and care. This includes videos, printed material, web-based material, and modules that focus on the pre-treatment, treatment, and follow-up care of patients undergoing surgery for pancreatic cancer. * All patients will receive standard pre- and post-operative instructions and care. This will include verbal education about the procedure by the surgeon as well as standard educational patient handouts, which are routinely provided preoperatively to pancreatectomy patients.
Other: SAFECARE at Home customized lessons
-All patients will receive standard pre- and post-operative instructions and care. This will include verbal education about the procedure by the surgeon as well as standard educational patient handouts, which are routinely provided preoperatively to pancreatectomy patients.
Efficacy of the SAFECARE at Home program as measured by readmission rate
-The investigators hypothesize that the SAFECARE at HOME program intervention will reduce readmission by half (i.e. from 22% to 11%). The investigators will include a total of 225 evaluable patients in the study, randomized in a 2:1 ratio (i.e. 2 patients in the SAFECARE arm for every 1 patient in the standard of care arm). The designed sample size will allow 80% at a 1-sided alpha=0.1 to detect a 50% decrease in 30-day readmission.
Time frame: 30 days
Effect of the SAFECARE at Home program as measured by the number of follow-up visits
-Follow-up visits include emergency room visits, urgent care visits, unscheduled surgeon office visits, and office calls.
Time frame: Through 30 day post-discharge
Comparison of quality of life between SAFECARE at Home patients and patients who received standard post-operative care and education as measured by SF-36
-The quality of life as measured by SF-36 (overall and sub-scales) will be summarized using descriptive statistics for each arm and compared by two-way ANOVA for repeated measurement data. The Short Form (36) Health Survey (SF-36) is a 36-item, patient-reported survey of patient health. -The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability.
Time frame: Up to 6 months post-discharge
Plan to share: No
This study is terminated, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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