Results Summary and Professional Abstract

Results Summary

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Results Summary

What was the research about?

Many patients need surgery to treat cancer or heart problems. For patients ages 60 and older, surgery has an increased risk of a long hospital stay, a nursing home stay, or life not going back to normal. When deciding on surgery, patients may not ask their doctors about all the trade-offs that matter to them. As a result, patients can be unprepared for what life is like after surgery.

In this study, the research team wanted to learn whether having a list of questions to ask the surgeon helped improve discussions and decisions about surgery. The team compared older patients who received the list with patients who didn’t.

What were the results?

Patients who did and didn’t receive the list were the same or similar in

• The number or type of questions they asked surgeons
• How confident they felt when talking with surgeons
• How well they felt physically and mentally after treatment
• Feelings of regret about the treatment received

Who was in the study?

The research team recruited 446 patients ages 60 and older who were thinking about surgery for cancer or heart problems. Patients were receiving care from one of 40 surgeons working at five hospitals across the United States. Of these patients, 83 percent were white, 9 percent were black, 3 percent were Asian, and 1 percent were another race or didn’t select a race; 17 percent were Hispanic or Latino. The average age was 72, and 56 percent were men.

What did the research team do?

The research team assigned patients by chance to one of two groups based on when they saw their surgeon. In one group, patients received a brochure by mail. The brochure had 11 questions to ask a surgeon when thinking about surgery. The group also received a letter from their surgeon asking them to use the brochure during the next office visit. In the other group, patients didn’t receive the brochure or letter before the visit with their surgeon.

The research team recorded patients’ conversations with the surgeon to count the number and type of questions asked. After the visit, patients filled out a survey about how confident they felt during the talk. Six weeks after surgery, patients filled out a survey about how well they felt and about any feelings of regret after treatment. Patients who decided against surgery filled out the same survey three months after enrolling in the study.

Patients who had major surgery and their family members gave input throughout the study.

What were the limits of the study?

Only about half of patients in the first group read or used the list of questions. Results may differ if more patients used the list.

Future research could look at how surgeons could improve discussions about surgery for older patients.

How can people use the results?

Doctors can use the results when considering how to help older patients make decisions about surgery.

Professional Abstract

Professional Abstract

Objective

To compare the effectiveness of using a question prompt list for surgical decisions versus not using one on improving patient engagement in the decision-making process, patient well-being, and postoperative treatment regret

Study Design

Design Elements	Description
Design	Randomized time-dependent cluster randomized controlled trial
Population	446 patients ages 60 and older considering surgery for oncologic or vascular conditions with one of 40 surgeons at 5 medical centers across the United States
Interventions/ Comparators	Question prompt list Usual care
Outcomes	Number and type of questions asked during pre-surgical visit, patient-reported efficacy during interactions with physician, change in patient-reported well-being after treatment, patient-reported treatment regret
Timeframe	Up to 14 weeks of follow-up for study outcomes

This cluster-randomized stepped-wedge trial compared the effectiveness of a question prompt list versus usual care on improving patient engagement, well-being, and treatment regret for older patients considering surgery.

Researchers recruited 446 patients who were considering surgery for oncologic or vascular conditions and receiving care from 40 surgeons at five hospitals across the United States. Of these patients, 83% were white, 9% were black, 3% were Asian, 8% were another race, and 2% did not indicate a race; 17% were Hispanic or Latino. The average age was 72, and 56% were male.

Researchers randomized patients to one of two groups based on the timing of their visit with one of the participating surgeons. In the intervention group, patients received a brochure in the mail consisting of 11 questions to ask a surgeon when considering surgery. They also received a letter from their surgeon encouraging them to use the brochure during an upcoming surgical consultation. In the usual care group, patients did not receive a brochure or letter before their surgical consultation.

Researchers audio recorded the surgical consultation to count the number and type of questions patients asked. Patients also filled out a survey immediately after the visit to gauge their self-efficacy for obtaining information from the surgeon. Patients who underwent surgery completed a survey about well-being and treatment regret six weeks post-surgery. Patients who did not have surgery completed the survey 12–14 weeks after enrollment.

A group of older patients who had undergone major surgery and their family members helped create study materials, recruit study patients, interpret data, and share results.

Results

The two groups did not differ significantly in number or type of questions asked during the surgical consultation, or in patients’ well-being, treatment regret, or reported self-efficacy during interactions with physicians (all p<0.05).

Limitations

Only about half of patients in the intervention group read or used the list of questions, which may have affected the results.

Conclusions and Relevance

In this study, the list of questions did not improve older patients’ engagement in the decision-making progress, patient well-being, or patient regret about treatment.

Future Research Needs

Future research could examine how surgeon behavior can improve patient participation in decision making.

More on this Project  

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 suggested that a more-narrow interpretation of the results was warranted. In particular, they recommended this because it appeared that less than half of the participants in the intervention arm of the study actually viewed the question prompt list (QPL) before talking with their surgeons and because a sizeable portion of patients did not talk with their surgeons at all before surgery. The reviewers noted that while this study did not demonstrate the efficacy of QPLs, other studies were more positive. The researchers agreed that their study lacked power to detect small effects of their intervention, but they did not want to state that they failed to see a greater effect because of the size of their study. The researchers noted it was also possible that the intervention did not work because surgeons dominated or controlled discussions so much that patients were not able to have their questions or concerns addressed. The researchers said their conclusions were specifically about their intervention, not whether QPLs in general are promising.
• The reviewers asked about the questionnaire chosen to measure patient concerns and well-being, noting that it seemed like an odd choice since the questionnaire measures changes in how a concern is rated, but the “most pressing concern” that is being rated can change. The researchers said that in hindsight they would not have used this questionnaire as their primary measure of patient well-being. The researchers explained that their patient and family advisors were clear that their most pressing problem with preoperative communication was feeling blindsided by treatments postoperatively. Since there is no measurement for being blindsided, the researchers explained, they chose the questionnaire they chose because it allowed patients and families to identify and rate their own concerns rather than rate concerns that researchers had defined in advance. The researchers said this outcome measure turned out to be confusing because patients and families specified a large range of concerns. The researchers added that they plan to conduct another analysis to describe the range of concerns patients and families expressed, which they feel will be helpful to surgeons.
• The reviewers asked for more details on missing data. The researchers said the rate of missing data was low and occurred randomly, rather than being concentrated in particular groups. Given the low rate of missing data, the researchers said they felt no need to make inferences about the missing data. The reviewers challenged this response, pointing out that the researchers used a complete case analysis, where they only included participant data in analyses where the data were complete. The researchers added a statement to their limitations that there were cases of substantial missing data for some measures, leading them to use the less stringent analysis strategy. 

Conflict of Interest Disclosures

View the COI disclosure form.

Project Details

Principal Investigator

Margaret L. Schwarze, MD, MPP

Project Status

Completed; PCORI Public and Professional Abstracts, and Final Research Report Posted

Project Title

Navigating High Risk Surgery: Empowering Older Adults to Ask Questions that Inform Decisions about Surgical Treatment

Board Approval Date

September 2015

Project End Date

December 2020

Organization

University of Wisconsin-Madison

Year Awarded

2015

State

Wisconsin

Year Completed

2020

Project Type

Research Project

Health Conditions  

Multiple/Comorbid Chronic Conditions

Intervention Strategies

Other Health Services Interventions
Training and Education Interventions

Populations

Individuals with Multiple Chronic/co-morbid Conditions
Low Income
Older Adults

Funding Announcement

Communication and Dissemination Research

Project Budget

$2,162,854

DOI - Digital Object Identifier

10.25302/10.2020.CDR.150227462

Study Registration Information

HSRP20162026

NCT02623335