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

NCT ID: NCT02617979

Last Updated: 2020-05-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 91 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-20
• Study Completion Date: 2020-04-08

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

SAFECARE at Home customized lessons

Intervention Type: OTHER

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

SAFECARE at Home customized lessons

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ryan C Fields, M.D.

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Countries

United States

Related Links

http://www.siteman.wustl.edu

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

Other Identifiers

201511067

Identifier Type: -

Identifier Source: org_study_id