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

NCT02617979 | Terminated

• 1 other identifier: 201511067
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Effect of the SAFECARE at Home program as measured by the number of follow-up visits

  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

  Up to 6 months post-discharge

Study Arms (2)

Arm 1: SAFECARE at Home

EXPERIMENTAL

* 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 2: Standard of Care

NO INTERVENTION

-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.

Interventions

SAFECARE at Home customized lessons OTHER

Arm 1: SAFECARE at Home

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

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

Study Officials

• Ryan C Fields, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2015
• First Posted: December 1, 2015
• Study Start: July 20, 2016
• Primary Completion: April 4, 2019
• Study Completion: April 8, 2020
• Last Updated: May 15, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)