Colorectal SurgeryNCT06752031
Optimizing Care Transition Process for Older Colorectal Surgery Patients
A study testing OSCAR-S Care Transition Model in people with Colorectal Surgery and Care Transition, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Colorectal Surgery, Care Transition, Older Adults (65 Years and Older)
- What is being tested?
- OSCAR-S Care Transition Model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Adult patients (>65 years old)
- Scheduled to undergo an elective colorectal surgery procedure
- Ability to provide informed consent
Who cannot join
- Emergent, non-elective colorectal procedures
- Non-English Speaking
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
81 Highland Ave
Salem, Massachusetts, 01970
Sevdenur Cizginer, MD MPH, 7813639283, scizginer1@mgh.harvard.edu
About this study
Official title: 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.
Read the 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.
- Being tested
- OSCAR-S Care Transition Model
- Keywords
- Colorectal surgery, Care transition, Older adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OSCAR-S Care Transition ModelBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| OSCAR-S Care Transition Model | Experimental | 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. Receives: Behavioral: OSCAR-S Care Transition Model |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (5)
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.
Measured: 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.
Measured: 12 months
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.
Measured: 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.
Measured: 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).
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2024
- Study start30 Oct 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal SurgeryStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevdenur Cizginer Konuk, MD, MPH, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06752031
- Sponsor's protocol ID
- K76AG078620-02
- Status last verified
- May 2026
- First submitted
- 18 Dec 2024
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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;12(1):58. doi: 10.1186/s40814-026-01796-9.
PubMed 41865059
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Care and Recovery in Older Colorectal Surgery Patients: A Hybrid Effectiveness-Implementation Pilot Study Protocol
- ClinicalTrials.gov ID
- NCT06752031
- Acronym / sponsor ID
- K76AG078620-02
- Keywords
- Colorectal surgery, Care transition, Older adults
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 30 Oct 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 30 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OSCAR-S Care Transition Model | Experimental | Behavioral: OSCAR-S Care Transition ModelThe 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Adult patients (>65 years old)
- Scheduled to undergo an elective colorectal surgery procedure
- Ability to provide informed consent
Key exclusion criteria (2 listed)
- Emergent, non-elective colorectal procedures
- Non-English Speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OSCAR-S Care Transition ModelPatients 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. | Behavioural | OSCAR-S Care Transition Model |
Primary outcome
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.
5 secondary outcomes
Reach
Time frame: 12 months
Fidelity
Time frame: 12 months
Adoption
Time frame: 12 months
Effectiveness - Patient Satisfaction
Time frame: 30 days
Effectiveness - Postoperative Complications
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Derived from this study: PubMed 41865059Yildiz 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;12(1):58. doi: 10.1186/s40814-026-01796-9.
- Individual participant dataSharing planned: No
Related trials for Colorectal Surgery
RecruitingPhase 1
Individual Response to Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Treatment of Peritoneal Carcinomatosis From Peritoneal Mesothelioma or Atypical Mesothelial Proliferation or From Ovarian, Colorectal, or Appendiceal Histologies
Peritoneal Mesothelioma, Peritoneal Carcinomatosis
RecruitingObservational study
Obtaining Solid Tumor Tissue From People Having Biopsy or Surgery for Certain Types of Cancer
Colorectal Neoplasms, Gastric Neoplasms
RecruitingObservational study
Evaluation for NCI Surgery Branch Clinical Research Protocols
Synovial Cell Cancer, Melanoma
Not yet recruitingObservational study
Cost-utility Evaluation of Cytoreductive Surgery With or Without Mitomycin-C Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Resectable Colorectal Peritoneal Metastases
Hyperthermic Intraperitoneal Chemotherap, Colorectal Cancer Metastatic
Not yet recruiting
T1 Colorectal Cancer After Local Excision: Decision Between Surgery and Active Surveillance (T1LDA Trial)
Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OSCAR-S Care Transition Model in people with Colorectal Surgery and Care Transition, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sevdenur Cizginer (617-726-4600, scizginer1@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postdischarge 30-day readmission or death (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06752031, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.