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

Pancreatectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02617979
• Other study ID #: 201511067
• Status: Terminated
• Phase: N/A
• Start date: July 20, 2016
• Est. completion date: April 8, 2020

Study information

• Verified date: May 2020
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 91
• Est. completion date: April 8, 2020
• Est. primary completion date: April 4, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pancreatectomy

Intervention

Other:
• SAFECARE at Home customized lessons

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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

External Links

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