Postoperative Outcomes and Patient Satisfaction With Mayo Clinic Florida Care Hotel After Mastectomy and Tissue Expander Placement

Recruiting

• Conditions: Breast Carcinoma

• Registration Number: NCT06783179
• Lead Sponsor: Mayo Clinic

Brief Summary

This study evaluates the postoperative outcomes of patients who are admitted to the Mayo Clinic Florida Care Hotel after mastectomy and tissue expander placement. At Mayo Clinic Florida, patients receiving low risk surgeries are often admitted to the hospital overnight for observation. A new model of delivering patient care was created at the Mayo Clinic Florida coined the "Care Hotel." This is a temporal, voluntary accommodation that offers patients a comfortable environment to receive nursing care before or after hospital treatment with in-person daytime monitoring and 24-hour virtual tele-monitoring in a hotel setting. This study evaluates post operative complications in patients who underwent mastectomy followed by tissue expander reconstruction and were admitted to the Care Hotel for overnight observation compared to the standard hospital admission and those who are discharged home.

Detailed Description

PRIMARY OBJECTIVE:

I. To investigate post operative complications in patients who underwent mastectomy followed by tissue expander reconstruction and were admitted to the Care Hotel for overnight observation compared to the standard hospital admission and those who are discharged home.

OUTLINE: This is an observational study.

Patients have their medical records reviewed and may complete a survey on study.

Study Timeline

• Study Start: 2024-12-16
• Status Verified: 2025-01
• Study First Submitted: 2025-01-14
• Study First Submitted QC: 2025-01-17
• Last Update Submitted: 2025-01-17
• Study First Posted: 2025-01-20
• Last Update Posted: 2025-01-20
• Primary Completion: 2027-12-16
• Study Completion: 2027-12-16

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

• Women who underwent mastectomy followed by tissue expander reconstruction for breast cancer or high-risk gene mutation prophylaxis followed by immediate tissue expander reconstruction who are either admitted to the Care Hotel post operatively, discharge home or admitted to the hospital.

Exclusion Criteria

• Younger than 18 years old.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Complications	Up to 30 days	Recorded as incidence of hematoma, infection, readmission, and/or reoperation within 30 days of initial procedure.

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction	Up to 30 days	Assessed via voluntary survey given at first routine post operative visit to all patients who were admitted to the Care Hotel. The survey consists of 5 questions related to the Care Hotel Stay and one question related to pain level during the stay.. The 5 questions are answered on a scale ranging from 1-5 where 1=strongly disagree and 5=strongly agree, and the final questions is answered on a scale of 1-10 where 1=little pain and 10=worst pain ever experienced. There are also free-text sections for participants to indicate anything that impressed them about their experience with Care Hotel and/or anytihng that disappointed them about their experience.

Trial Locations

Locations (1)

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States