Clinical Trials Directory

Trials / Completed

CompletedNCT02543190

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
100 (actual)
Sponsor
University of Minnesota · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
BEHAVIORALcompliance surveillance and improvement strategyExternal monitor to ensure compliance with an educational protocol.

Timeline

Start date
2014-10-01
Primary completion
2016-06-01
Completion
2016-11-11
First posted
2015-09-07
Last updated
2017-12-29

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT02543190. Inclusion in this directory is not an endorsement.