System-Wide Improvement for Transitions After Surgery: The SWIFT Post op Program

NCT02543190 | Completed

• 1 other identifier: 1408M52923
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

Short-term post-operative complications after colon and rectal surgery present a known major clinical and financial burden for patients and hospitals. Focused efforts to reduce readmissions after colorectal surgery is one potentially high-yield and broad approach to address this problem since post- operative complications are the strongest predictor of readmissions. We focus on decreasing readmissions after ileostomy surgery by using a previously published intervention that prevents dehydration in the outpatient setting and decreases acute renal failure complications. We plan to introduce the SWIFT post op program for ileostomy patients at one academic and two community hospitals which are part of a single health care system, and to then randomize patients to usual care in the setting of this new program versus an aggressive compliance surveillance and improvement strategy (CSIS) strategy using study personnel. Our primary study outcome is all-cause 30-day readmission, and our secondary outcomes include patient satisfaction (CAHPS scores) and a cost-benefit analysis. We seek to create a partnership between colorectal surgeons, inpatient nurse managers and wound ostomy continence nurses (WOCN) at the three sites, linking them with outpatient nurse practitioners and physician's assistants at the respective colorectal surgery clinics who facilitate care-transition after hospital discharge.

Conditions

Colectomy; Colorectal Surgery; Ileostomy

Keywords

Care Transition; Readmission; Rehospitalization

Outcome Measures

Primary Outcomes (1)

• Readmission to the hospital

  30 days after hospital discharge

Secondary Outcomes (6)

• Patient satisfaction

  3-6 months after surgery

• Index length-of-stay

  Index length-of-stay

• Emergency room visit

  30 days after hospital discharge

• Total hospital-length-of-stay

  30 days after hospital discharge

• Readmission due to dehydration or acute renal failure

  30 days after hospital discharge

Study Arms (2)

compliance surveillance

EXPERIMENTAL

* Prospective audits by study personnel * Call from the clinic nurse practitioner or physician's assistant within 7 days of discharge to administer a screening questionnaire to identify patients at risk of dehydration. Study personnel will ensure this phone call is made.

Behavioral: compliance surveillance and improvement strategy

Usual Care

NO INTERVENTION

educational session at the start of the study

Interventions

compliance surveillance and improvement strategy BEHAVIORAL

External monitor to ensure compliance with an educational protocol.

compliance surveillance

Eligibility Criteria

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

You may qualify if:

• Patients who are scheduled or who undergo ileostomy alone or as part of a multiple procedure operation
• patients who have had an ileostomy in the past are eligible
• patients who have an ileostomy to address a recent surgical complication are eligible

You may not qualify if:

• Patients who have an ileostomy already in place immediately prior to the procedure (ie. revision, transposition, or parastomal hernia procedures
• patients on dialysis
• patients who require chronic TPN, IVF, or have short gut
• non-English speaking patients who do not have easy access to an appropriate interpreter.

Sponsors & Collaborators

• University of Minnesota: lead
• Colon and Rectal Surgery Associates, Ltd.: collaborator

Study Sites (2)

University of Minnesota Medical Center -Fairview

Minneapolis, Minnesota, 55455, United States

Location

Colon and Rectal Surgery Associates

Saint Paul, Minnesota, 55114, United States

Location

Study Officials

• Mary R Kwaan, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Care provider did not know study assignment. Reviewer for primary outcomes did not know study assignment
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2015
• First Posted: September 7, 2015
• Study Start: October 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: November 11, 2016
• Last Updated: December 29, 2017

Record last verified: 2017-12

Locations

US (2)