Elective Surgical ProceduresNCT03422133
A Patient-oriented Risk Communication Tool to Improve Patient Experience, Knowledge and Outcomes After Elective Surgery
An observational study of Elective Surgical Procedures, run by Ottawa Hospital Research Institute at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Elective Surgical Procedures
- What is being tested?
- Patient-oriented, personalized risk communication eHealth application
- How many people
- 201 participants
- Where
- 1 siteCanada
- Study dates
- 26 Apr 2018to 18 Jul 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: We will recruit all consenting adults aged 18 or older seen in the Pre-Admission Unit prior to major elective, non-cardiac, inpatient surgery at The Ottawa Hospital.
Who may be able to join
- English or French speaking
- Major elective, non-cardiac inpatient surgery
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the detailed 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.
- Conditions
- Elective Surgical Procedures
- Being tested
- Patient-oriented, personalized risk communication eHealth application
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient-oriented, personalized risk communication eHealth applicationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Pre-Implementation Phase | Participants in this group (before the eHealth app is implemented in the PAU) will be English or French speaking patients, aged 18 and older, scheduled for major non-cardiac elective surgery. Patients will be recruited using standardized procedures, and process and outcome measures will be recorded using the same tools and methods in both study phases to decrease the risk of measurement and selection bias. | |
| Post-Implementation Phase | Participants in this group (after the eHealth app is implemented in the PAU) will be English or French speaking patients, aged 18 and older, scheduled for major non-cardiac elective surgery. Receives: Other: Patient-oriented, personalized risk communication eHealth application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Knowledge
Change in patient knowledge of their risk profile from before their Preadmission Unit (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 [(questions correct/total questions)*100], scale scores will range from 0 to 100 (0=all questions incorrect, 100=all questions correct). A question was marked as correct if the patient's self-estimated risk and their model estimated risk were within the same range categoryHigher scores indicate higher levels of knowledge.
Measured: 1 day
Secondary outcomes (7)
Anxiety
Measured using the Short Form State-Trait Anxiety Inventory: at baseline and after the consultation using the short form State-Trait Anxiety Inventory, which is normalized to a 100-point scale. Scores can range from 20 to 80. Higher scores indicate greater levels of anxiety. Specifically, scores below 40 suggest minimal anxiety, while scores equal to or greater than 40 are considered clinically significant, indicating that the individual may be experiencing a heightened level of anxiety that could require further attention.
Measured: 1 day
Patient Satisfaction- Likelihood to Recommend
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) as recommended by the Institute for Healthcare Improvement's Triple Aim measurement guide.The value of the intervention will be defined using a patient-perceived equation as proposed by Morgan et al.
Measured: 1 day
Patient Acceptability- Ease of Use
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). The number of participants who find the application easy to use or very easy to use (gave a 1 or 2 on the likert scale) will be reported.
Measured: 1 day
Clinician Change in Management
Likelihood to change management will be measured using a 5-point scale, (1 strongly agree and 5 being strongly disagree) to change the management of the patient after reviewing the information provided by the personalized risk calculator. The number of participants that indicated that they strongly or moderately agreed (gave a score of 1 or 2 on the likert scale) that the application would lead to them making a change in anesthetic management will be reported.
Measured: 1 day
Clinician Acceptability
Clinician acceptability of the application will be assessed using a 5-point likert scale (strongly disagree, moderately disagree, moderately agree, strongly agree or no opinion). The number of participants that strongly or moderately agreed that the personalized risk profiles were clear and unambiguous will be reported.
Measured: 1 day
Proportion of Patients for Whom a Risk Score Can be Calculated
The proportion of patients for whom a risk score could be calculated - the number of participants who were able to have a risk score calculated out of the total sample will be reported (the number of participants who were able to provide the data required to calculate their personalized risk scores successfully using the application out of the total number of participants).
Measured: Through study completion for all participants, an average of one year
Proportion of Missing Data From the Patient-centered Health Questionnaire
Proportion of missing data from the patient-centered health questionnaire - the number of participants with missing data for the patient-centered health questionnaire that is used to calculate risk out of the total sample will be reported.
Measured: Through study completion for all participants, an average of one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start26 Apr 2018
- Primary completion18 Jul 2019
- Study completion18 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Elective Surgical ProceduresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03422133
- Sponsor's protocol ID
- 20170737-01H
- Status last verified
- Sep 2024
- First submitted
- 11 Jan 2018
- Last updated
- 18 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hladkowicz E, Yachnin D, Boland L, Wilson K, McKinnon A, Hawrysh K, Hawrysh T, Bell C, Atkinson K, van Walraven C, Taljaard M, Thavorn K, Stacey D, Yang H, Pysyk C, Moloo H, Manuel D, MacDonald D, Lavallee LT, Gagne S, Forster AJ, Bryson GL, McIsaac DI. Evaluation of a preoperative personalized risk communication tool: a prospective before-and-after study. Can J Anaesth. 2020 Dec;67(12):1749-1760. doi: 10.1007/s12630-020-01809-y. Epub 2020 Sep 15.
PubMed 32929659
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Patient-oriented Risk Communication Tool to Improve Patient Experience, Knowledge and Outcomes After Elective Surgery
- ClinicalTrials.gov ID
- NCT03422133
- Acronym / sponsor ID
- 20170737-01H
- Conditions
- Elective Surgical Procedures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- 26 Apr 2018 (actual)
- Primary completion
- 18 Jul 2019 (actual)
- Study completion
- 18 Jul 2019 (actual)
- First posted
- 5 Feb 2018 (actual)
- Results
- Posted 18 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-Implementation Phase | – | –Participants in this group (before the eHealth app is implemented in the PAU) will be English or French speaking patients, aged 18 and older, scheduled for major non-cardiac elective surgery. Patients will be recruited using standardized procedures, and process and outcome measures will be recorded using the same tools and methods in both study phases to decrease the risk of measurement and selection bias. |
| Post-Implementation Phase | – | Other: Patient-oriented, personalized risk communication eHealth applicationParticipants in this group (after the eHealth app is implemented in the PAU) will be English or French speaking patients, aged 18 and older, scheduled for major non-cardiac elective surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- We will recruit all consenting adults aged 18 or older seen in the Pre-Admission Unit prior to major elective, non-cardiac, inpatient surgery at The Ottawa Hospital.
Key inclusion criteria (2 listed)
- English or French speaking
- Major elective, non-cardiac inpatient surgery
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient-oriented, personalized risk communication eHealth applicationThe 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. | Other | Post-Implementation Phase |
Primary outcome
Patient Knowledge
Time frame: 1 day
Change in patient knowledge of their risk profile from before their Preadmission Unit (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 [(questions correct/total questions)*100], scale scores will range from 0 to 100 (0=all questions incorrect, 100=all questions correct). A question was marked as correct if the patient's self-estimated risk and their model estimated risk were within the same range categoryHigher scores indicate higher levels of knowledge.
7 secondary outcomes
Anxiety
Time frame: 1 day
Patient Satisfaction- Likelihood to Recommend
Time frame: 1 day
Patient Acceptability- Ease of Use
Time frame: 1 day
Clinician Change in Management
Time frame: 1 day
Clinician Acceptability
Time frame: 1 day
Proportion of Patients for Whom a Risk Score Can be Calculated
Time frame: Through study completion for all participants, an average of one year
Proportion of Missing Data From the Patient-centered Health Questionnaire
Time frame: Through study completion for all participants, an average of one year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32929659Hladkowicz E, Yachnin D, Boland L, Wilson K, McKinnon A, Hawrysh K, Hawrysh T, Bell C, Atkinson K, van Walraven C, Taljaard M, Thavorn K, Stacey D, Yang H, Pysyk C, Moloo H, Manuel D, MacDonald D, Lavallee LT, Gagne S, Forster AJ, Bryson GL, McIsaac DI. Evaluation of a preoperative personalized risk communication tool: a prospective before-and-after study. Can J Anaesth. 2020 Dec;67(12):1749-1760. doi: 10.1007/s12630-020-01809-y. Epub 2020 Sep 15.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Elective Surgical Procedures, run by Ottawa Hospital Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Knowledge (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03422133, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2024.