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

5 juni 2020 bijgewerkt door: Ottawa Hospital Research Institute

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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Werkelijk)

184

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1Y4E9
        • The Ottawa Hospital

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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)

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
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.
Ander: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Patient Knowledge
Tijdsspanne: 1 day
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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Anxiety
Tijdsspanne: 1 day
Measured using the Short Form State-Trait Anxiety Inventory
1 day
Patient Experience
Tijdsspanne: 1 day
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
Patient Acceptability
Tijdsspanne: 1 day
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
Clinician Change in Management
Tijdsspanne: 1 day
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
Clinician Acceptability
Tijdsspanne: 1 day
Clinician acceptability of the application assessed using a likert scale (strongly disagree to strongly agree or no opinion).
1 day
Feasibility
Tijdsspanne: Through study completion for all participants, an average of one year
Proportion of patients for whom a risk score can be calculated
Through study completion for all participants, an average of one year
Feasibility
Tijdsspanne: Through study completion for all participants, an average of one year
Proportion of missing data.missing data.
Through study completion for all participants, an average of one year
Hospital Length of Stay
Tijdsspanne: Indexed Hospitalization, an average of 5 days
Hospital LOS in patients with an expected length of stay greater than the 75th procedure specific percentile
Indexed Hospitalization, an average of 5 days

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Ottawa Hospital Research Institute

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

26 april 2018

Primaire voltooiing (Werkelijk)

18 juli 2019

Studie voltooiing (Werkelijk)

18 juli 2019

Studieregistratiedata

Eerst ingediend

11 januari 2018

Eerst ingediend dat voldeed aan de QC-criteria

30 januari 2018

Eerst geplaatst (Werkelijk)

5 februari 2018

Updates van studierecords

Laatste update geplaatst (Werkelijk)

9 juni 2020

Laatste update ingediend die voldeed aan QC-criteria

5 juni 2020

Laatst geverifieerd

1 juni 2020

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • 20170737-01H

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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