Trial Outcomes & Findings for A Patient-oriented Risk Communication Tool to Improve Patient Experience, Knowledge and Outcomes After Elective Surgery (NCT NCT03422133)
NCT ID: NCT03422133
Last Updated: 2024-11-18
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
201 participants
Primary outcome timeframe
1 day
Results posted on
2024-11-18
Participant Flow
Participant milestones
| Measure |
Pre-Implementation Phase
Participants in this group (before the eHealth app is implemented in the Preadmission Unit (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 Preadmission Unit (PAU)) will be English or French speaking patients, aged 18 and older, scheduled for major non-cardiac elective surgery.
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 National Surgical Quality Improvement Program (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.
|
|---|---|---|
|
Overall Study
STARTED
|
104
|
97
|
|
Overall Study
COMPLETED
|
90
|
93
|
|
Overall Study
NOT COMPLETED
|
14
|
4
|
Reasons for withdrawal
| Measure |
Pre-Implementation Phase
Participants in this group (before the eHealth app is implemented in the Preadmission Unit (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 Preadmission Unit (PAU)) will be English or French speaking patients, aged 18 and older, scheduled for major non-cardiac elective surgery.
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 National Surgical Quality Improvement Program (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.
|
|---|---|---|
|
Overall Study
Ineligible procedure, data error, patient declined because of timing, MD not consented
|
14
|
4
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Pre-Implementation Phase
n=90 Participants
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
n=93 Participants
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.
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.
|
Total
n=183 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57 years
STANDARD_DEVIATION 14 • n=90 Participants
|
64 years
STANDARD_DEVIATION 11 • n=93 Participants
|
61 years
STANDARD_DEVIATION 13 • n=183 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=90 Participants
|
34 Participants
n=93 Participants
|
82 Participants
n=183 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=90 Participants
|
59 Participants
n=93 Participants
|
101 Participants
n=183 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
BMI
|
30 kg/m2
STANDARD_DEVIATION 8 • n=90 Participants
|
30 kg/m2
STANDARD_DEVIATION 6 • n=93 Participants
|
30 kg/m2
STANDARD_DEVIATION 7 • n=183 Participants
|
PRIMARY outcome
Timeframe: 1 dayChange 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.
Outcome measures
| Measure |
Pre-Implementation Phase
n=90 Participants
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
n=93 Participants
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.
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.
|
|---|---|---|
|
Patient Knowledge
|
32.2 score on a scale
Standard Deviation 28.5
|
53 score on a scale
Standard Deviation 33.1
|
SECONDARY outcome
Timeframe: 1 dayMeasured 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.
Outcome measures
| Measure |
Pre-Implementation Phase
n=90 Participants
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
n=93 Participants
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.
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.
|
|---|---|---|
|
Anxiety
|
36.3 score on a scale
Standard Deviation 11.6
|
29.4 score on a scale
Standard Deviation 11.6
|
SECONDARY outcome
Timeframe: 1 dayPatient 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.
Outcome measures
| Measure |
Pre-Implementation Phase
n=90 Participants
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
n=93 Participants
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.
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.
|
|---|---|---|
|
Patient Satisfaction- Likelihood to Recommend
|
7.9 score on a scale
Standard Deviation 2.5
|
8.9 score on a scale
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: 1 dayPopulation: Participant feedback was not obtained for the pre-implementation phase as the app was not used.
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.
Outcome measures
| Measure |
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
n=93 Participants
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.
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.
|
|---|---|---|
|
Patient Acceptability- Ease of Use
|
0 Participants
|
87 Participants
|
SECONDARY outcome
Timeframe: 1 dayPopulation: The app was not used in the pre-implementation phase, therefore we did not obtain feedback from clinicians in the first phase.
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.
Outcome measures
| Measure |
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
n=56 Participants
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.
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.
|
|---|---|---|
|
Clinician Change in Management
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 1 dayPopulation: The app was not used in the pre-implementation phase, therefore we did not obtain feedback from clinicians in the first phase.
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.
Outcome measures
| Measure |
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
n=56 Participants
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.
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.
|
|---|---|---|
|
Clinician Acceptability
|
—
|
51 Participants
|
SECONDARY outcome
Timeframe: Through study completion for all participants, an average of one yearPopulation: The app was not used in the pre-implementation phase, therefore this is not applicable to the first phase.
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).
Outcome measures
| Measure |
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
n=93 Participants
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.
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.
|
|---|---|---|
|
Proportion of Patients for Whom a Risk Score Can be Calculated
|
0 Participants
|
93 Participants
|
SECONDARY outcome
Timeframe: Through study completion for all participants, an average of one yearPopulation: The app was not used in the pre-implementation phase, therefore this is not applicable to the first phase.
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.
Outcome measures
| Measure |
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
n=93 Participants
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.
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.
|
|---|---|---|
|
Proportion of Missing Data From the Patient-centered Health Questionnaire
|
0 Participants
|
0 Participants
|
Adverse Events
Pre-Implementation Phase
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Post-Implementation Phase
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place