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

NCT03422133 | Completed Results

• 1 other identifier: 20170737-01H
• Study Type: observational
• Target: 201
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Elective Surgical Procedures

Outcome Measures

Primary Outcomes (1)

• 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.

  1 day

Secondary Outcomes (7)

• Anxiety

  1 day

• Patient Satisfaction- Likelihood to Recommend

  1 day

• Patient Acceptability- Ease of Use

  1 day

• Clinician Change in Management

  1 day

• Clinician Acceptability

  1 day

Study Arms (2)

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.

Other: Patient-oriented, personalized risk communication eHealth application

Interventions

Patient-oriented, personalized risk communication eHealth application OTHER

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.

Post-Implementation Phase

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• English or French speaking
• Major elective, non-cardiac inpatient surgery

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, K1Y4E9, Canada

Location

Related Publications (1)

• 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.

  PMID: 32929659 DERIVED

Limitations and Caveats

We could not perform an individual patient randomized trial as the risk of contamination was deemed to be very high (we were concerned that exposure to a patient randomized to the PREDICT app would bias the clinician to access an online risk calculator \[e.g., NSQIP online calculator\] when caring for subsequent patients randomized to the control condition). As the knowledge assessed comes from the app, this could bias our results in favour of the PREDICT app.

Results Point of Contact

• Title: Dr. Daniel McIsaac
• Organization: The Ottawa Hospital

dmcisaac@toh.ca

613-761-4940

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2018
• First Posted: February 5, 2018
• Study Start: April 26, 2018
• Primary Completion: July 18, 2019
• Study Completion: July 18, 2019
• Last Updated: November 18, 2024
• Results First Posted: November 18, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)