Optimizing Care Transition Process for Older Colorectal Surgery Patients

Optimization of Care and Recovery in Older Colorectal Surgery Patients: A Hybrid Effectiveness-Implementation Pilot Study Protocol

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Surgery; Care Transition; Older Adults (65 Years and Older)
• Intervention / Treatment: Behavioral: OSCAR-S Care Transition Model

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sevdenur Cizginer; Phone Number: 617-726-4600; Email: scizginer1@mgh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Salem, Massachusetts, United States, 01970
      • Recruiting
      • 81 Highland Ave
      • Contact: Sevdenur Cizginer, MD MPH; Phone Number: 7813639283; Email: scizginer1@mgh.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult patients (>65 years old)
• Scheduled to undergo an elective colorectal surgery procedure
• Ability to provide informed consent

Exclusion Criteria:

• Emergent, non-elective colorectal procedures
• Non-English Speaking

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OSCAR-S Care Transition Model; The surgery nurse coach within the OSCAR-S model will provide touch points to patients and families to support their transition from hospital to home after surgery.	Behavioral: OSCAR-S Care Transition Model; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postdischarge 30-day readmission or death	Composite incidence of all-cause hospital readmission or death within 30 days of discharge, measured by medical record review and hospital administrative data.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adoption	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.	12 months
Reach	Percentage of eligible older colorectal surgery patients who are enrolled in the OSCAR-S intervention, measured by comparing enrollment logs against surgical case lists.	12 months
Fidelity	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.	12 months
Effectiveness - Patient Satisfaction	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.	30 days
Effectiveness - Postoperative Complications	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).	30 days

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital

Publications and helpful links

General Publications

• Yildiz F, Bartels SJ, Cauley C, Vrees M, Crabtree BF, Marcantonio ER, Ritchie CS, Hwabejire JO, Ricciardi R, Deiner SG, Cizginer S. Optimization of care and recovery in older colorectal cancer surgery patients: a hybrid effectiveness-implementation pilot study protocol. Pilot Feasibility Stud. 2026 Mar 21. doi: 10.1186/s40814-026-01796-9. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: December 18, 2024
• First Submitted That Met QC Criteria: December 20, 2024
• First Posted (Actual): December 30, 2024

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 8, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Colorectal surgery; Older adults; Care transition
• Other Study ID Numbers: K76AG078620-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No