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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Surgery; Colectomy; Ileostomy
• Intervention / Treatment: Behavioral: compliance surveillance and improvement strategy

Detailed Description

At the start of the study, inpatient and outpatient nurses, physicians and physicians assistants will be oriented to the intervention in the study and will be suggested that the intervention is standard of care based on the following study:

Nagle D, Pare T, Keenen E, Marcet K, Tizio S, Poylin V*. Ileostomy Pathway Virtually Eliminates Readmissions for Dehydration in New Ostomates. Diseases of the Colon and Rectum 2012; 55: 1266-1272.

The intervention patients will be subject to a compliance surveillance and intervention strategy (CSIS) administered by study personnel to encourage the following and persist with telephone calls if the following have not been achieved.

• Prospective audits by study personnel to check and encourage teaching in the clinic, teaching on the wards, and telephone follow up occurred.
• A self-assessment tool for patients and families to confirm understanding of the education materials.
• Coaching of inpatient nurses taking care of ileostomy patients by WOCN and/or the inpatient nurse champion
• Call from the clinic nurse practitioner or physician's assistant within 7 days of discharge to review the educational materials and administer a screening questionnaire to identify patients at risk of dehydration. In patients randomized to CSIS, study personnel will ensure this phone call is made.

The usual care arm will include no such surveillance.

The randomized study will be powered to detect a decrease in hospital readmission rates (all-cause) from 25% to 5%. Secondary outcomes include readmission due to dehydration and patient satisfaction (Surgical-CAHPS survey)

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota Medical Center -Fairview
    • Saint Paul, Minnesota, United States, 55114
      • Colon and Rectal Surgery Associates

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:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: compliance surveillance; 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; External monitor to ensure compliance with an educational protocol.
No Intervention: Usual Care; educational session at the start of the study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Readmission to the hospital	30 days after hospital discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction	S-CAHPS	3-6 months after surgery
Index length-of-stay	Time from surgical date to hospital discharge	Index length-of-stay
Emergency room visit	Emergency room visits for any reason 30 days after surgery	30 days after hospital discharge
Total hospital-length-of-stay	Total hospital length of stay for any reason after surgery	30 days after hospital discharge
Readmission due to dehydration or acute renal failure	Dehydration by clinician assessment, acute renal failure defined as elevation in creatinine to >2 mg/dl, or oliguria/anuria	30 days after hospital discharge
Post-discharge follow up phone call	Nurse, physician, or physician-assistant documentation of phone call to the patient that describes monitoring of ileostomy output volume	30 days after hospital discharge

Collaborators and Investigators

• Sponsor: University of Minnesota
• Collaborators: Colon and Rectal Surgery Associates, Ltd.
• Investigators: Principal Investigator: Mary R Kwaan, MD, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2014
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): November 11, 2016

Study Registration Dates

• First Submitted: September 3, 2015
• First Submitted That Met QC Criteria: September 3, 2015
• First Posted (Estimate): September 7, 2015

Study Record Updates

• Last Update Posted (Actual): December 29, 2017
• Last Update Submitted That Met QC Criteria: December 27, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Readmission; Rehospitalization; Care Transition
• Other Study ID Numbers: 1408M52923