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

Colorectal Surgery Clinical Trial

— SWIFT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02543190
• Other study ID #: 1408M52923
• Status: Completed
• Phase: N/A
• First received: September 3, 2015
• Last updated: December 27, 2017
• Start date: October 2014
• Est. completion date: November 11, 2016

Study information

• Verified date: December 2017
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 11, 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colectomy
• Colorectal Surgery
• Ileostomy

Intervention

Behavioral:
• compliance surveillance and improvement strategy
External monitor to ensure compliance with an educational protocol.

Locations

Country	Name	City	State
United States	University of Minnesota Medical Center -Fairview	Minneapolis	Minnesota
United States	Colon and Rectal Surgery Associates	Saint Paul	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute	Colon and Rectal Surgery Associates, Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Readmission to the hospital		30 days after hospital discharge
Secondary	Patient satisfaction	S-CAHPS	3-6 months after surgery
Secondary	Index length-of-stay	Time from surgical date to hospital discharge	Index length-of-stay
Secondary	Emergency room visit	Emergency room visits for any reason 30 days after surgery	30 days after hospital discharge
Secondary	Total hospital-length-of-stay	Total hospital length of stay for any reason after surgery	30 days after hospital discharge
Secondary	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
Secondary	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