A Patient-oriented Risk Communication Tool to Improve Patient Experience, Knowledge and Outcomes After Elective Surgery

Elective Surgical Procedures Clinical Trial

Official title:

A Patient-oriented Risk Communication Tool to Improve Patient Experience, Knowledge and Outcomes After Elective Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03422133
• Other study ID #: 20170737-01H
• Status: Completed
• Start date: April 26, 2018
• Est. completion date: July 18, 2019

Study information

• Verified date: June 2020
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Many people have inpatient surgery each day. Most people will have no complications but some will have minor or serious complications. The risk of having complications can vary from one person to another depending on personal factors such as; age, medical conditions such as diabetes and whether someone smokes or takes certain medications.

The Investigators have learned that people want more information about their surgeries, both the general information about the risk for complications, but also more specific information about whether they are personally more or less likely to have complications. Patients are also interested in practical information such as how long they might stay in the hospital and what the recovery period will be like for them. Receiving more information can help decrease a person's level of anxiety about their surgery.

The Investigators are doing this study with the assistance of the mHealth Lab at The Ottawa Hospital (a team that develops simple technologies for managing health information). The Investigators will implement and evaluate a novel, innovative tablet-based, patient-oriented risk communication application to evaluate patient knowledge of their own surgical risk before and after their visit to the Pre-Admission Unit (PAU). The Investigators will also be exploring any potential levels of anxiety before and after the PAU visit, in addition to patient satisfaction with their PAU visit.

The Investigators hypothesize that it will: improve patient knowledge and experience, not increase anxiety, be acceptable to patients and clinicians, and will improve care efficiency for TOH surgical patients.

Description:

One and a half million Canadians have inpatient surgery every year, and many experience serious complications. Research shows that patient-specific risks are not routinely or effectively communicated to patients before surgery, despite the requirement for such information to be included as part of the informed consent process, and clear recommendations from best practice guidelines.

Mobile health technology can address this gap by engaging and empowering patients to provide their own health data to generate personalized risk estimates. Using a tablet-based platform, these risk estimates can then be communicated to patients in a format that is appealing and understandable. However, such an application and process do not exist.

The Investigators will address this knowledge gap through the development, implementation, and evaluation of a novel patient-oriented personalized preoperative risk communication eHealth application to empower patients, support shared decision making, and improve patient-centered outcomes. Development of this eHealth application will lead to an inclusively designed product tailored to the technology needs of elective surgery patients, who are typically older, and have limited technological expertise and comfort. The application will also be useful, in that it will communicate personalized risk estimates in a format consistent with best practices for risk communication to patients, and provide tools to engage shared discussions between patients and clinicians. Through implementation of the eHealth app, the Investigators will evaluate the effectiveness and value of personalized preoperative risk communication in improving knowledge, and satisfaction. The Investigators will also measure the acceptability of this process to patients and clinicians. Finally, the Investigators will test the feasibility of having a patient-oriented personalized risk communication application connect to the perioperative health system to identify high resource use patients prior to hospital admission.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 184
• Est. completion date: July 18, 2019
• Est. primary completion date: July 18, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• English or French speaking

• Major elective, non-cardiac inpatient surgery

Exclusion Criteria:

• Unable to communicate in English or French

• Unable to consent without a Substitute Decision Maker

• Scheduled for non-elective surgery

• Patients having same-day surgery (outpatient surgery)

Related Conditions & MeSH terms

• Elective Surgical Procedures

Intervention

Other:
• Patient-oriented, personalized risk communication eHealth application
The application features simple and consistent design, large well-lit buttons that tolerate tremor, and simple language. The process will be applied in preoperative clinics at The Ottawa Hospital (TOH), where patients will be asked to provide their personal health history through a series of questions already used on our TOH preoperative health screener. These values will then populate the NSQIP Universal Risk Calculator, which we have calibrated to TOH data, to generate personalized risks of mortality, serious complications, and hospital length of stay. These risk estimates will be communicated directly to the patient using absolute risk estimates represented pictorially (best practice for risk communication to patients). Risk estimates will also be provided to the patient's clinician.

Locations

Country	Name	City	State
Canada	The Ottawa Hospital	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Knowledge	Change in patient knowledge of their risk profile from before their PAU. The questionnaire will not test perceived knowledge, but will test factual items specifically related to the patient's personalized risk profile.The pre- and post-appointment knowledge scores will be normalized on a 100 point scale appointment to after.	1 day
Secondary	Anxiety	Measured using the Short Form State-Trait Anxiety Inventory	1 day
Secondary	Patient Experience	Patient experience will be assessed using a likelihood to recommend measurement based on a 10-point Likert scale (0 being not at all likely and 10 being extremely likely) to recommend the approach used to tell you about your surgical risk to a friend or family member)	1 day
Secondary	Patient Acceptability	Patient acceptability of the application will be assessed using a 5-point likert scale based on how easy it was to use (1 being the easiest and 5 being the hardest) and if they would be willing to use the application again in the future (1 being extremely willing and 5 being extremely unwilling).	1 day
Secondary	Clinician Change in Management	Likelihood to change management will be measured using a 5-point scale, acceptability using a 5-point likert scale (1 being extremely likely and 5 being extremely unlikely) to change the management of the patient after reviewing the information provided by the personalized risk calculator).	1 day
Secondary	Clinician Acceptability	Clinician acceptability of the application assessed using a likert scale (strongly disagree to strongly agree or no opinion).	1 day
Secondary	Feasibility	Proportion of patients for whom a risk score can be calculated	Through study completion for all participants, an average of one year
Secondary	Feasibility	Proportion of missing data.missing data.	Through study completion for all participants, an average of one year
Secondary	Hospital Length of Stay	Hospital LOS in patients with an expected length of stay greater than the 75th procedure specific percentile	Indexed Hospitalization, an average of 5 days