Improving Mental and Physical Health and Decreasing Hospital Readmission After Pancreatectomy Through Enhanced Patient and Caregiver Education and Engagement
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|ClinicalTrials.gov Identifier: NCT02617979|
Recruitment Status : Terminated (Patients are receiving detailed packet from department and do not feel they need to go online for additional support.)
First Posted : December 1, 2015
Last Update Posted : May 15, 2020
|Condition or disease||Intervention/treatment||Phase|
|Pancreatectomy||Other: SAFECARE at Home customized lessons||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||91 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Improving Mental and Physical Health and Decreasing Hospital Readmission After Pancreatectomy Through Enhanced Patient and Caregiver Education and Engagement|
|Actual Study Start Date :||July 20, 2016|
|Actual Primary Completion Date :||April 4, 2019|
|Actual Study Completion Date :||April 8, 2020|
Experimental: Arm 1: SAFECARE at Home
Other: SAFECARE at Home customized lessons
No Intervention: Arm 2: Standard of Care
-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 [ Time Frame: 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.
- Effect of the SAFECARE at Home program as measured by the number of follow-up visits [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02617979
|United States, Missouri|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|Principal Investigator:||Ryan C Fields, M.D.||Washington University School of Medicine|