Condition category
Not Applicable
Date applied
27/05/2020
Date assigned
05/06/2020
Last edited
05/06/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims:
Providing patients with adequate discharge instructions is an important task of healthcare professionals to ensure a safe discharge from hospital to home. If patients are not able to understand the information given to them on leaving the hospital they may risk becoming unwell and returning to the Emergency Department (ED). Multiple revisits to the ED by patients can put increased strains and costs on health services.

With the 'teach-back' method patients or proxies (such as caregivers), repeat back what they understand so that professionals can confirm that the patient has understood the information given and can correct any misunderstandings.

This study aims to test if using the teach-back method will reduce ED revisits, and if it increases patient knowledge retention of discharge instructions, improves self-management at home, and increases satisfaction with the provision of discharge instructions.

Who can participate?
All patients discharged from the ED to their home/residence (including assisted living facilities such as a senior home or an outpatient rehabilitation center)

What does the study involve?
The study involves the collection of data from patients discharged from the ED for four months before the introduction of the use of the teach-back method by healthcare staff. This will be compared to data collected over four months of the method being used. The investigators will look at how often patients have to return to the ED after they are discharged. Older adults (aged ≥70 years) who participate in the study will be invited to answer some further questions via telephone within 72 hours after ED discharge to collect information on how well they can recall instructions and self-manage at home, and how satisfied they were with the discharge instructions.

What are the possible benefits and risks of participating?
Possible benefits for the participants, particularly those receiving teach-back, are a better recall/comprehension of ED discharge instructions, a higher level of self-management post-discharge, and a reduced risk for an unplanned ED-revisit.

Where is the study run from?
Radboud University Medical Center Nijmegen (Netherlands)

When is the study starting and how long is it expected to run for?
March 2019 to December 2019

Who is funding the study?
This study was funded by the 'Affordable Better' (in Dutch: 'Betaalbaar Beter') quality improvement program of the Radboud University Medical Center (Netherlands) and the Dutch health insurer VGZ (Netherlands).

Who is the main contact?
Dr Gijs Hesselink
gijs.hesselink@radboudumc.nl

Trial website

Contact information

Type

Public

Primary contact

Dr Gijs Hesselink

ORCID ID

http://orcid.org/0000-0003-2532-0724

Contact details

Geert Grooteplein Zuid 22
Nijmegen
6525 GA
Netherlands
+31 243666264
gijs.hesselink@radboudumc.nl

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

Pre-post evaluation of the effects of teach-back of discharge instructions for patients in the ED on ED-revisits and patient-related outcomes

Acronym

Study hypothesis

Teach-back of discharge instructions for patients in the ED might reduce ED revisits, and improve patient knowledge retention of discharge instructions, self-management at home and satisfaction with the provision of discharge instructions.

Ethics approval

Approved 11/02/2019, the local medical ethical commission of the Radboud University Nijmegen Medical Centre (CMO region Arnhem-Nijmegen (Routenr 629), p/a Radboudumc, house post 628, P.O. box 9101,
6500 HB Nijmegen, The Netherlands; +31 24 361 3154; commissiemensgebondenonderzoek@radboudumc.nl), ref: 2019-5166

Study design

Single-center, single-arm, pre-post pilot interventional study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format. Available in Dutch language upon request.

Condition

Emergency Department (ED) visits

Intervention

Application of the teach-back method by Emergency Department (ED) professionals during the discharge conversation with patients or proxies (such as caregivers) in the ED.

Teach-back is a method whereby patients or proxies are asked to repeat back, in their own words or in demonstrations, the instructions that professionals provided them, so that comprehension of instructions can be confirmed, misunderstandings can be corrected and additional information can be provided if needed. The intervention lasts approximately 2-5 mins per patient. For a group of older participants aged over 75, there will be follow up via a structured telephone interview within 72 hours after ED discharge.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Emergency Department (ED) revisits within 7 days and within 8 to 30 days post-index visit assessed from the electronic medical record at 7 and 30 days

Secondary outcome measures

1. Older patient's knowledge retention of discharge instructions across five information domains assessed by comparing the written and observed ED discharge instructions at discharge to patient responses in a structured telephone interview within 72 h after ED discharge
2. Older patient's self-reported self-management of patients at home assessed by a structured telephone interview within 72 h after ED discharge
3. Older patient satisfaction with discharge instructions provided by professionals in the ED assessed by a structured telephone interview within 72 h after ED discharge

Overall trial start date

18/12/2018

Overall trial end date

01/12/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Discharged from the Emergency Department (ED) to home (home including outpatient assisted living facilities such as a senior home or a rehabilitation center)

Participant type

Patient

Age group

Mixed

Gender

Both

Target number of participants

600 (including a minimum of 120 patients aged 70 years and older)

Participant exclusion criteria

1. Unable to speak the Dutch language
2. Discharged to another medical facility or ward
3. Severe mental/cognitive impairment (e.g. advanced dementia) without being accompanied by a caregiver at the ED

Recruitment start date

01/03/2019

Recruitment end date

31/10/2019

Locations

Countries of recruitment

Netherlands

Trial participating centre

Radboud University Medical Center Nijmegen
Emergency Department Geert Grooteplein Zuid 22
Nijmegen
6525 GA
Netherlands

Sponsor information

Organisation

Radboud University Nijmegen Medical Centre

Sponsor details

Geert Grooteplein Zuid 22
Nijmegen
6525 GA
Netherlands
+31 243666264
stafsecretariaat@seh.umcn.nl

Sponsor type

Hospital/treatment centre

Website

https://www.radboudumc.nl/EN/Pages/default.aspx

Funders

Funder type

Hospital/treatment centre

Funder name

Radboud Universitair Medisch Centrum

Alternative name(s)

Radboudumc, Radboud University Medical Center, Radboud University Nijmegen Medical Center, RUNMC

Funding Body Type

private sector organisation

Funding Body Subtype

Universities (academic only)

Location

Netherlands

Funder name

VGZ

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We intend to publish the findings of this pilot study in an academic journal in 2020.

IPD sharing statement:
The original quantitative SPSS datasets generated during and/or analysed during the current study are available upon reasonable request from Gijs Hesselink (gijs.hesselink@radboudumc.nl). Datasets will contain individual de-identified data of participants who gave written consent.

Intention to publish date

01/10/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

05/06/2020: The following changes have been made: 1. The intervention type has been changed from "Other" to "Behavioural". 2. The overall trial end date has been changed from 02/11/2019 to 01/12/2019 and the plain English summary has been updated to reflect this change. 03/06/2020: Trial’s existence confirmed by Radboud University Nijmegen Medical Centre.