Clinical trial NCT02543190: System-Wide Improvement for Transitions After Surgery: The SWIFT Post op Program
Official title: System-Wide Improvement for Transitions After Surgery: The SWIFT Post op Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colectomy
Colorectal Surgery
Ileostomy
Keywords: Care Transition
Readmission
Rehospitalization
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: Colon and Rectal Surgery Associates, Ltd.
First posted: 2015-09-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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)

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.

Primary outcomes:
measure: Readmission to the hospital
timeFrame: 30 days after hospital discharge
Secondary outcomes:
measure: Patient satisfaction
timeFrame: 3-6 months after surgery
measure: Index length-of-stay
timeFrame: Index length-of-stay
measure: Emergency room visit
timeFrame: 30 days after hospital discharge
measure: Total hospital-length-of-stay
timeFrame: 30 days after hospital discharge
measure: Readmission due to dehydration or acute renal failure
timeFrame: 30 days after hospital discharge
measure: Post-discharge follow up phone call
timeFrame: 30 days after hospital discharge
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota Medical Center -Fairview
state: Minnesota
city: Saint Paul
country: United States
facility: Colon and Rectal Surgery Associates
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Mary R Kwaan, MD
role: PRINCIPAL_INVESTIGATOR
References: