Improving Mental and Physical Health and Decreasing Hospital Readmission After Pancreatectomy Through Enhanced Patient and Caregiver Education and Engagement

ID: NCT02617979
Status: Recruiting
Phase: N/A
Start Date: July 20, 2016
First Submitted: November 18, 2015
Last Updated: February 23, 2018
Results: N/A
Sponsors & Collaborators: Washington University School of Medicine
Location: United States
Conditions: Pancreatectomy
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Study Description

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.

Detailed Description

Condition or disease Intervention/treatment Phase

Pancreatectomy

Other: SAFECARE at Home customized lessons
Other Names
N/A

Tracking Information

First Submitted DateNovember 18, 2015
Last Update Posted DateFebruary 23, 2018
Actual Start DateJuly 20, 2016
Anticipated Completion DateJanuary 31, 2019
Actual Primary Completion DateJune 30, 2018
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • 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.

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • 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.

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleImproving Mental and Physical Health and Decreasing Hospital Readmission After Pancreatectomy Through Enhanced Patient and Caregiver Education and Engagement
Official TitleImproving Mental and Physical Health and Decreasing Hospital Readmission After Pancreatectomy Through Enhanced Patient and Caregiver Education and Engagement
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.

Detailed Description

Study TypeInterventional
Study PhaseN/A
Estimated Enrollment
225
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
None (Open Label)
Primary Purpose
Supportive Care
Conditions
Pancreatectomy
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Other: SAFECARE at Home customized lessons

Other Names
Study Groups/Cohorts
Arm 1: SAFECARE at Home
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.

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.

Study Arms
Experimental Arm 1: SAFECARE at Home
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

Arm Intervention/Treatment
Experimental Arm 1: SAFECARE at Home
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

Recruitment Information

Recruitment Status:Recruiting
Enrollment225
Completion DateJanuary 31, 2019
Eligibility Criteria: 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.
GenderAll
Age18 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Listed Location Countries
United States

Administrative Information

NCT Number:NCT02617979
Other Study ID Numbers
201511067
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
Washington University School of Medicine
Collaborators
Not Available
Investigators
Principal Investigator
Ryan C Fields, M.D.
Washington University School of Medicine