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A VIDEO-BASED COMMUNICATION INTERVENTION FOR FECAL OSTOMY SURGERY (CI-OSURG): RESULTS OF THE OPEN PILOT TESTING
Atziri Rubio-Chavez*1,2, Sevdenur Cizginer Konuk3,9, Mary E. Brindle2,4, Zara Cooper5,6,8, Ana-Maria Vranceanu7, Christine S. Ritchie9, Christy Cauley1,2,9
1Massachusetts General Hospital Department of Surgery, Boston, MA; 2Harvard T H Chan School of Public Health Ariadne Labs, Boston, MA; 3Massachusetts General Hospital, Division of Palliative Care and Geriatric Medicine, Department of Medicine, Boston, MA; 4University of Calgary Cumming School of Medicine, Department of Surgery, Calgary, AB, Canada; 5Brigham and Women's Hospital Department of Surgery, Boston, MA; 6Brigham and Women's Hospital Center for Surgery and Public Health, Boston, MA; 7Massachusetts General Hospital Department of Psychiatry, Boston, MA; 8Hinda and Arthur Marcus Institute for Aging Research, Boston, MA; 9Massachusetts General Hospital Mongan Institute, Boston, MA

Background
Approximately 100,000 U.S. patients undergo fecal ostomy surgery annually, often experiencing high complication rates and poor psychosocial outcomes. Patients report inadequate training in ostomy care and psychosocial support. Our aim is to design, test and refine a supportive care intervention to assist patients in adapting to life with a new fecal ostomy.

Methods
Open pilot clinical trial with 14 patients and 4 clinicians to evaluate a web-based training program (CI-oSurg). The study evaluated the intervention's utility, feasibility, acceptability and patient outcomes (i.e., distress levels and quality of life). Surgical clinician feedback on acceptability and usability was obtained through individual semi-structured qualitative interviews after viewing the intervention. The intervention was then refined and piloted with patients in three phases: 1) preoperative survey; 2) web-based video training on postoperative day 2-3; and 3) one-month follow-up survey and exit interview. Quantitative data was analyzed using descriptive statistics, qualitative data through rapid analysis.(Detailed protocol: DOI:10.2196/60575)

Results
Between March and April 2024, four surgical clinicians (two wound/ostomy nurses, one nurse practitioner, and one registered nurse) from a single academic surgical clinic provided feedback for the web-based intervention. They averaged 25 years of experience (SD 11.5), with 75% caring for more than 20 ostomy patients monthly. Suggestions included adding detailed ostomy appliance images, supply ordering instructions, guidance on positioning for emptying and changes, clearer advice on output reduction medications and dietary exclusions.

From May-November 2024, 14 of 19 eligible patients (73%) agreed to participate, aged 25-86 (median 58.5). Four patients (28%) were excluded due to no ostomy formation, and one (7%) withdrew due to technical challenges with digital content. Nine (65%) received the intervention, 45% via hospital tablets, 45% link to visualize in personal devices, or both (10%).

Preoperative data was complete for 7 participants (77%), postoperative for 6 (66%). Preoperative distress ranged 0-8 (median=2), mean QoL was 82.1, with 85% reporting ostomy concerns. Postoperative distress ranged 0-5 (median=3.5), mean QoL decreased to 66.6 after surgery, with 66% reporting concerns that contributed to distress. Mean intervention satisfaction was 8.3/10. Patients found the intervention short, simple, and useful, reinforcing nurses' teachings. They desired preoperative video access for care-partners and more details on daily ostomy care and nighttime appliance management.

Conclusion
Our web-based communication intervention was feasible, acceptable, and user-friendly. Future steps will focus on adapting it to better engage care-partners, especially for those with technology literacy challenges, and testing its effectiveness.


Table. CI-oSurg Open Pilot Clinical Trial Participant Characteristics
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