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

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.

Study Overview

• Status: Terminated
• Conditions: Pancreatectomy
• Intervention / Treatment: Other: SAFECARE at Home customized lessons

• Study Type: Interventional
• Enrollment (Actual): 91
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Up to 6 months post-discharge

Collaborators and Investigators

• Sponsor: Washington University School of Medicine

Publications and helpful links

Helpful Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2016
• Primary Completion (Actual): April 4, 2019
• Study Completion (Actual): April 8, 2020

Study Registration Dates

• First Submitted: November 18, 2015
• First Submitted That Met QC Criteria: November 30, 2015
• First Posted (Estimate): December 1, 2015

Study Record Updates

• Last Update Posted (Actual): May 15, 2020
• Last Update Submitted That Met QC Criteria: May 12, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 201511067

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No