Communication Intervention for Fecal Ostomy Surgery

Surgery Clinical Trial

— CI-oSurg  

Official title:

Improving Biopsychosocial Outcomes With a Communication Intervention for Patients Undergoing Fecal Ostomy Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06320002
• Other study ID #: 2023P003564
• Status: Recruiting
• Phase: N/A
• Start date: March 18, 2024
• Est. completion date: August 30, 2024

Study information

• Verified date: March 2024
• Source: Massachusetts General Hospital
• Contact: Christy Cauley, MD, MPH
• Phone: 6177268129
• Email: ccauley[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. completion date: August 30, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Colostomy Stoma
• Ileostomy - Stoma
• Surgery

Intervention

Behavioral:
• Communication Intervention for fecal ostomy surgery
This is a educational video-based supportive intervention to address practical skills and adaptation to life with a fecal ostomy

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Emotional Distress	Exploratory outcome of Distress reported by patients from 0-10	baseline and 4 weeks after intervention
Other	World Health Organization Brief quality of life evaluation	There are 26 questions with scores ranging from 1-5. For 23 questions higher score is better and for 3 questions a lower score is better.	baseline and 4 weeks after intervention
Other	Hospital Anxiety and Depression Scale	This survey has 14 questions with scores ranging from 1-4. A higher score is better.	baseline and 4 weeks after intervention
Other	Therapy Evaluation Form	This survey has 6 questions with scores ranging from 1-9. A higher score is better.	baseline and 4 weeks after intervention
Other	Client Satisfaction Questionnaire	This survey has 8 questions with scores ranging from 1-4. A higher score is better.	baseline and 4 weeks after intervention
Primary	Intervention Acceptability	The intervention acceptability will be assessed by cognitive interviews with participants	4 weeks after the intervention
Secondary	Intervention Usability	The intervention usability will be assessed by cognitive interviews with participants	4 weeks after intervention use