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NCT Number: NCT06752031

Optimizing Care Transition Process for Older Colorectal Surgery Patients

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.

Recruiting

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

81 Highland Ave

Salem, Massachusetts, 01970, United States

Location status: Recruiting

Location contact

Sevdenur Cizginer, MD MPH

CONTACT

[email protected]

7813639283

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OSCAR-S Care Transition Model

Behavioral

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.

Primary outcomes

  1. Postdischarge 30-day readmission or death

    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.

Secondary outcomes

  1. Reach

    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.

  2. Fidelity

    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.

  3. Adoption

    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.

  4. Effectiveness - Patient Satisfaction

    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.

  5. Effectiveness - Postoperative Complications

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Sevdenur Cizginer

CONTACT

[email protected]

617-726-4600

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 30, 2024
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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