Results Summary
What was the research about?
Some patients may need an ostomy after they have surgery for cancer. An ostomy is a hole created in the abdomen to help clear stool or urine from the body. An ostomy bag attached to the body collects the waste. Educational programs about living with an ostomy can help patients manage their ostomy.
In this study, the research team looked at the use of telehealth, or remote care using phone or video, to make it easier for patients to attend an education program. The team compared two approaches on how well they improved patients’ confidence and ability to care for their ostomy:
- Usual care alone. Patients received a booklet about ostomy skin care and contact information for support groups. The research team suggested that patients see an ostomy nurse and have a follow-up visit with their surgeon.
- A telehealth program plus usual care. Along with usual care, patients received a workbook and set personal goals. Over five weeks, patients attended three telehealth sessions taught by an ostomy nurse and a peer coach with an ostomy. Patients used a tablet or computer to attend sessions. Caregivers took part in one session. Patients and caregivers completed a final session together.
What were the results?
At six months, patients receiving support through the two approaches didn’t differ in their:
- Confidence to manage and improve their health
- Feelings about their ability to do self-care activities
- Ostomy self-care knowledge
- Quality of life related to their ostomy
- Use of health care related their ostomy
Who was in the study?
The study included 167 adults receiving care at one of three health systems in California, Connecticut, and Pennsylvania. Among patients, 82 percent were White; 5 percent were African American; 5 percent were Asian; 4 percent were American Indian, Alaska Native, or more than one race; and 3 percent reported other race; 7 percent were Hispanic. Also, 46 percent were women.
What did the research team do?
The research team assigned patients and caregivers by chance to receive usual care with or without the telehealth program. Patients completed surveys and interviews at the start and end of the program, and again six months after the program ended. Surveys asked about knowledge, confidence, and ostomy self-care. Interviews asked about use of health care in the prior week.
People with ostomies, ostomy nurses, and telehealth specialists gave input on the program.
What were the limits of the study?
Patients receiving support through the two approaches differed in their education, income, and type of cancer. The research team took these differences into account, but it’s possible patients differed in other ways that may have affected the results. At six months, more people dropped out of the study than the team expected, mostly because of illness or death. As a result, it may have been hard to detect differences between the groups.
Future research could look at other ways to improve outcomes among patients with ostomies.
How can people use the results?
Health systems can use the results when considering ways to improve care for patients with ostomies.
Professional Abstract
Objective
To evaluate the effect of the Ostomy Self-Management Telehealth (OSMT) program on patient activation, self-efficacy, ostomy-related knowledge, and health-related quality of life among cancer survivors with ostomies
Study Design
| Design Element | Description |
|---|---|
| Study Design | Randomized controlled trial |
| Population | 167 cancer survivors over age 21 with colorectal, urological, gynecological, and other cancers who were at least 6 weeks post-surgery for creating an intestinal stoma |
| Interventions/ Comparators |
|
| Outcomes |
Primary: patient activation Secondary: self-efficacy, quality of life, ostomy-related knowledge, use of ostomy-related services including nurse visits, receiving a phone consultation, or receiving a physician consultation |
| Timeframe | 6-month follow-up for primary outcome |
In this randomized controlled trial, researchers compared the effect of a telehealth program plus usual care versus usual care alone in improving patient-reported outcomes and care utilization among cancer survivors with an ostomy.
Researchers randomized patients to one of two groups: the OSMT program plus usual care or usual care alone. Usual care included an educational booklet about ostomy skin care and contact information for ostomy support groups. Researchers encouraged patients to see a wound ostomy continence nurse (WOCN) and follow up with their surgeon about any problems. In the OSMT program, patients also received a workbook and set personal goals for participating in the program. Then, over five weeks, patients and caregivers participated in two-hour telehealth education sessions taught by a WOCN and a peer coach with an ostomy. Patients had three sessions, caregivers had one, then patients and caregivers completed a final joint session.
The study included 167 adults receiving care at one of three health systems in California, Connecticut, and Pennsylvania. Among patients, 82% were White; 5% were African American; 5% were Asian; 4% were American Indian, Alaska Native, or more than one race; and 3% reported other race; 7% were Hispanic. Also, 46% were female.
Patients completed surveys and interviews at the start and end of the program and then again six months after the program ended. Surveys asked about patient activation, self-efficacy, quality of life, ostomy-related knowledge, and family financial burden. Interviews asked about patients’ healthcare utilization in the prior week.
People with ostomies, WOCNs, and telehealth engineers gave input on the telehealth program.
Results
At six months, patients in the two groups did not differ significantly in patient activation, self-efficacy, quality of life, ostomy-related knowledge, or use of ostomy-related services.
Limitations
Patients randomly assigned to the two groups differed in the type of cancer they had and education and income levels. Although researchers controlled for these differences, it is possible that patients differed in other characteristics that may have affected the study results. After six months, the study had higher attrition than expected, primarily due to patient illness or death. The study may have been underpowered to detect meaningful differences between the groups.
Conclusions and Relevance
In this study, the OSMT program did not improve patient activation, self-efficacy, quality of life, ostomy-related knowledge, or use of ostomy-related services compared with usual care.
Future Research Needs
Future research could evaluate other ways to improve outcomes among patients with ostomies.
Final Research Report
View this project's final research report.
Journal Citations
Related Journal Citations
Peer-Review Summary
Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.
The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments.
Peer reviewers commented and the researchers made changes or provided responses. Those comments and responses included the following:
- The reviewers noted that the usual care comparison condition in the study seemed to be quite comprehensive and asked the researchers to describe how it compared to standard practice. The researchers agreed that the enhanced usual care condition may have provided more attention to participants than they would normally receive, and that even the contacts with participants to collect survey data could encourage them to seek additional community resources. The researchers added language to their study limitations about how the enhanced usual care condition might have reduced the potential comparative effectiveness of their experimental intervention.
- The reviewers stated that patients appeared to not be very involved in this study. The researchers explained that patients were very involved in the pilot study on which the full trial was based, were important in the curriculum development for the new intervention, and helped determine how it should be delivered to study participants.
- The reviewers asked the researchers to add more discussion about why the study failed to find a significant difference in patient activation between the experimental condition and the enhanced usual care condition. The researchers disagreed about whether the study could be viewed as having failed to find an effect, instead describing their results as not being as robust as they had hypothesized. The researchers suggested some reasons for this lack of significant results, such as problems with the matching strategy, lack of sufficient power to find an effect, and inappropriate timing of survey collection. The researchers added discussion of these possibilities to the report.
- The reviewers wondered whether the burden of the intervention, which included multiple meetings and surveys, affected the outcomes and led to the lower-than-anticipated comparative benefit. The researchers acknowledged that some potential participants may have declined participation because of the anticipated burden, but that most of the participants who started the intervention sessions completed them and did not complain about the burden of the study, and some lamented the end of the study sessions.
Conflict of Interest Disclosures
Project Information
Patient / Caregiver Partners
- The Trustees of the University of Pennsylvania
- City of Hope/Beckman Research Institute
- Yale University
Other Stakeholder Partners
- Ostomy Nurses:
- Nancy J. Tallman, RN, BSN, WOCN
- Lesley Hoffman, MSN, CNS, AOC
- Lucinda Pinchot, RN, BSN
- Peer Ostomates:
- Sue Reynolds
- Roger Iverson
- Frank Sova
- Marcie Felner
Key Dates
Study Registration Information
^Robert S. Krouse, MD, MS was affiliated with Arizona Board of Regents, University of Arizona when this study was initially funded.