Pancreatectomy
Conditions
Brief summary
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.
Interventions
OTHERSAFECARE at Home customized lessons
Sponsors
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Scheduled for major pancreatectomy (i.e., pancreaticoduodenectomy, total pancreatectomy, or a distal pancreatectomy). * At least 18 years of age. * Able to read and understand English (the SAFECARE at Home program is only implemented in English) * Has internet access. * Knowledge of the internet and how to use web-based programs. * Not pregnant or breastfeeding. * Able to understand and willing to sign an IRB-approved written informed consent document.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of the SAFECARE at Home program as measured by readmission rate | 30 days | -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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of the SAFECARE at Home program as measured by the number of follow-up visits | Through 30 day post-discharge | -Follow-up visits include emergency room visits, urgent care visits, unscheduled surgeon office visits, and office calls. |
| 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 | Up to 6 months post-discharge | -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. |
Countries
United States
Outcome results
None listed