Improving Biopsychosocial Outcomes of Older Adults Facing Fecal Ostomy Surgery

Project Summary. In this K76 proposal, I outline a comprehensive 5-year training program that will support my transition to independence as an emerging leader. The proposal focuses on development and rigorous testing of an intervention to improve integration of geriatric principles into surgical care of older adults undergoing fecal ostomy

surgery. This significant and innovative plan is directly tied to my training and career development goals. Background: Fecal ostomy surgery impacts biopsychosocial outcomes of older adults; however, surgeons are not trained to address geriatric needs that exist among this growing surgical patient population. Developing interventions for surgical teams

(i.e., surgeons, nurses, and medical assistants) to address geriatric needs when facing fecal ostomy surgery is an unexplored opportunity to improve biopsychosocial outcomes, including quality of life and functional independence, in this growing patient population. Specific aims and research design: I aim to develop the first version of the Geriatric

Assessment Strategy for Ostomy Management and Adaptation (GA-STOMA) intervention and methodology through 1:1 interviews with older adults 30-90 days after fecal ostomy surgery and care-partners when available (up to N=30) (Aim

1a), with additional input from focus groups of key clinical stakeholders (surgeons, geriatricians, surgical nurses, ostomy

nurses, nutritionists, physical therapists, and social workers) (N=6 focus groups, up to n=24 participants) (Aim 1b). Next,

I will examine usability and acceptability of GA-STOMA via an open pilot (N=16 participants) with exit interviews and pre-

post assessments. GA-STOMA intervention and methodology will be refined (Aim 2). Finally, I will evaluate feasibility of GA-STOMA in a single arm clinical trial (N=60 patients) at an outpatient surgical clinic following predetermined benchmarks with a run-in historical control (Aim 3). These findings will inform a hybrid efficacy/effectiveness cluster

randomized clinical trial of GA-STOMA through the R01 mechanisms to determine intervention impact on patient quality

of life. Training: My aims are supported by training goals to develop expertise in: 1) clinical geriatrics; 2) mixed-methods data integration to inform intervention development and refinement; 3) clinical trial methodology focusing on efficacy and effectiveness trials; and 4) leadership training. These training goals are support by 1) my expert mentorship team

led by my primary mentor Dr. Christine Ritchie (a geriatrician and palliative care physician with expertise in mixed- methods research and clinical trials), 2) a rich institutional environment (Massachusetts General Hospital and Harvard

Medical School), and 3) targeted coursework, scientific meetings and planned publications. Relevance to NIA: This K76 is

in line with NIA’s 2020-2025 Strategic Directions for Research Goal C, to “develop effective interventions to maintain

health, well-being, and function and prevent or reduce the burden of age-related diseases, disorders, and disabilities”.

Impact: As a surgeon-scientist and emerging leader with expertise in colorectal diseases I recognize the critical need to improve biopsychosocial outcomes among older adults facing surgery. Experiences gained through this proposal are foundational to my path to research independence as a national leader at the intersection of geriatrics and colorectal

surgery.