81 Highland Ave
Salem, Massachusetts, 01970, United States
Location status: Recruiting
NCT Number: NCT06752031
The goal of this study to test if a care transition intervention designed for older colorectal surgery patients would improve outcomes after discharge. It will assess the feasibility of the intervention.
Interested in participating?
Request Info65 year and older
All sexes
Interventional
Not applicable
Salem, Massachusetts, 01970, United States
Location status: Recruiting
The period following discharge poses particularly high risks for older colorectal surgery patients. Nearly a quarter of these patients are readmitted within a month of discharge due to a variety of issues including medication errors, surgical complications, imbalance in fluid or nutrition, or worsening of pre-existing chronic diseases.Recognizing the complex interplay of these factors, it isa more comprehensive approach is imperative to improve post- operative patient care. Geriatrics co-management programs incorporate interdisciplinary patient management approaches and geriatric principles to improve outcomes in older surgical patients.The OSCAR program is an integrated care model developed by geriatricians in collaboration with colorectal surgeons that combines geriatrics co-management with postoperative surgical care for older colorectal surgery patients. The care transition intervention (CTI) is a well-established care transition model that focuses on four domains at discharge: 1) medication self-management, 2) the personal health record, 3) timely primary care/specialty care follow-up, and 4) knowledge of red flags that indicate a worsening in condition. CTI involves interactions with a trained transition coach, both in-person visits and phone calls over four weeks. In this study, the goal is to bridge the gap between inpatient and post-discharge phases and mitigate the risk of hospital readmissions through adaptation and combination of the core components of a geriatric surgery core co-management (OSCAR) program with the core components of a care transition (CTI) program by applying an implementation research approach. By customizing OSCAR co-management model with the CTI intervention model, the investigators will leverage their strengths and, efficiently address the unique requirements of both patients and the healthcare environment. The investigators will conduct a pilot feasibility hybrid type I implementation effectiveness trial of OSCAR-S.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients and families in the intervention arm will receive touch points from the surgery nurse coach to support their care transition from hospital to home after surgery.
Time frame: 30 days
Composite incidence of all-cause hospital readmission or death within 30 days of discharge, measured by medical record review and hospital administrative data.
Time frame: 12 months
Percentage of eligible older colorectal surgery patients who are enrolled in the OSCAR-S intervention, measured by comparing enrollment logs against surgical case lists.
Time frame: 12 months
Continued adherence to the OSCAR-S protocol at 12 months, measured by a fidelity checklist (e.g., completion of required nurse coach touch points, red-flag education, follow-up scheduling) reviewed by study staff.
Time frame: 12 months
Percentage of eligible providers (surgeons, hospitalists, primary care physicians) who engage in at least one documented communication with the nurse coach during the patient's transition period, measured by electronic health record (EHR) audit logs.
Time frame: 30 days
Patient-reported satisfaction with the care transition process, measured by the Care Transitions Measure (CTM-3) total score (range 0-100; higher scores indicate better satisfaction). Higher scores indicate better (more positive) satisfaction with the care transition.
Time frame: 30 days
Incidence of postoperative complications (e.g., surgical site infection, ileus, dehydration) within 30 days of discharge, measured by medical record review using Clavien-Dindo classification (Grade I to V).
Contact information is provided by the study sponsor or research team.
Massachusetts General Hospital
Other
Optimization of Care and Recovery in Older Colorectal Surgery Patients: A Hybrid Effectiveness-Implementation Pilot Study Protocol
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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