Clinical trial NCT06320002: Communication Intervention for Fecal Ostomy Surgery
Official title: Improving Biopsychosocial Outcomes With a Communication Intervention for Patients Undergoing Fecal Ostomy Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Surgery
Colostomy Stoma
Ileostomy - Stoma
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2024-03-20
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: In this study the investigators will evaluate the acceptability of a communication intervention for fecal ostomy surgery (CI-oSurg) to address the needs of adults who are undergoing fecal ostomy surgery. The investigators will recruit 24 patients and 4 clinicians (surgical nurses, wound ostomy nurses). At least half of patients are 65 years or older to understand the unique needs of older adults recovering from fecal ostomy surgery that might impact intervention acceptability. Questionnaires will be administered at two time-points for patient participants: upon study start and 4 weeks after exposure to the intervention.

Detailed description: In this study the investigators are trying to understand the feasibility and acceptability of a psychologically informed communication guide for fecal ostomy Surgery with the overall goal of improving biopsychosocial outcomes of patients undergoing fecal ostomy surgery.

An estimated 100,000 people in the US undergo fecal ostomy surgery (colostomy or ileostomy) each year, frequently to address severe symptoms (i.e., obstruction, perforation, and incontinence) due to colorectal cancer, diverticulitis, and pelvic floor dysfunction. Complication rates after fecal ostomy surgery are high (up to 37%) with negative effects on patient and family quality of life. Surgeons do not traditionally identify and address health outcomes patients with serious illness prioritize when making treatment decisions, such as caregiver burden, loss of independence and psychosocial function. Communicating this information is key to address patient anxiety when facing major surgery and ensure caregiver preparedness among patients and families considering fecal ostomy surgery.

Current surgical guidelines support the use of preoperative communication and education interventions to improve psychosocial adjustment after fecal ostomy surgery based on expert opinion. However, little evidence exists evaluating the impact of communication interventions or content needs of patients undergoing fecal ostomy surgery or their family. Despite these guidelines, a recent study notes that inadequate ostomy education remains a frequent concern among patients undergoing fecal ostomy surgery. Furthermore, patients' perception of inadequate education is associated with poor emotional, social, and marital outcomes after surgery. There is a critical need to address this deficit in communication quality between patients undergoing fecal ostomy surgery, their family, and surgical care providers. Our guiding hypothesis is that development of a Communication Intervention for fecal ostomy Surgery (CI-oSurg) is acceptable to patients and clinicians, and will ultimately reduce patient distress and improve quality of life.

Eligibility criteria: Inclusion Criteria:

1. Age 18 or older
2. English fluency and literacy
3. Patient planned to undergo elective fecal ostomy surgery

Exclusion Criteria:

1. Deemed inappropriate by the surgery team
2. Unable to provide consent due to severe cognitive impairment or physiologic status (septic shock/intubated)

Primary outcomes:
measure: Intervention Acceptability
timeFrame: 4 weeks after the intervention
Secondary outcomes:
measure: Intervention Usability
timeFrame: 4 weeks after intervention use
Other outcomes:
measure: Emotional Distress
timeFrame: baseline and 4 weeks after intervention
measure: World Health Organization Brief quality of life evaluation
timeFrame: baseline and 4 weeks after intervention
measure: Hospital Anxiety and Depression Scale
timeFrame: baseline and 4 weeks after intervention
measure: Therapy Evaluation Form
timeFrame: baseline and 4 weeks after intervention
measure: Client Satisfaction Questionnaire
timeFrame: baseline and 4 weeks after intervention
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References: