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

NCT ID: NCT02543190

Last Updated: 2017-12-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2016-11-11

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.

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)

Conditions

Colectomy; Colorectal Surgery; Ileostomy

Keywords

Care Transition; Readmission; Rehospitalization

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

compliance surveillance and improvement strategy

Intervention Type: BEHAVIORAL

External monitor to ensure compliance with an educational protocol.

Usual Care

educational session at the start of the study

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

compliance surveillance and improvement strategy

External monitor to ensure compliance with an educational protocol.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

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

Sponsors

Colon and Rectal Surgery Associates, Ltd.

OTHER

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mary R Kwaan, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota Medical Center -Fairview

Minneapolis, Minnesota, United States

Colon and Rectal Surgery Associates

Saint Paul, Minnesota, United States

Countries

United States

Other Identifiers

1408M52923

Identifier Type: -

Identifier Source: org_study_id