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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02543190
Acronym
SWIFT
Enrollment
100
Registered
2015-09-07
Start date
2014-10-31
Completion date
2016-11-11
Last updated
2017-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colectomy, Colorectal Surgery, Ileostomy

Keywords

Care Transition, Readmission, Rehospitalization

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)

Interventions

BEHAVIORALcompliance surveillance and improvement strategy

External monitor to ensure compliance with an educational protocol.

Sponsors

Colon and Rectal Surgery Associates, Ltd.
CollaboratorOTHER
University of Minnesota
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Caregiver, Outcomes Assessor)

Masking description

Care provider did not know study assignment. Reviewer for primary outcomes did not know study assignment

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Readmission to the hospital30 days after hospital discharge

Secondary

MeasureTime frameDescription
Index length-of-stayIndex length-of-stayTime from surgical date to hospital discharge
Emergency room visit30 days after hospital dischargeEmergency room visits for any reason 30 days after surgery
Patient satisfaction3-6 months after surgeryS-CAHPS
Readmission due to dehydration or acute renal failure30 days after hospital dischargeDehydration by clinician assessment, acute renal failure defined as elevation in creatinine to \>2 mg/dl, or oliguria/anuria
Post-discharge follow up phone call30 days after hospital dischargeNurse, physician, or physician-assistant documentation of phone call to the patient that describes monitoring of ileostomy output volume
Total hospital-length-of-stay30 days after hospital dischargeTotal hospital length of stay for any reason after surgery

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026