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Trial registered on ANZCTR


Registration number
ACTRN12620000194965
Ethics application status
Approved
Date submitted
5/02/2020
Date registered
19/02/2020
Date last updated
19/02/2020
Date data sharing statement initially provided
19/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Patient Directed Discharge Letter (PADDLE): A novel approach to improve patient knowledge, satisfaction and outcomes
Scientific title
Patient Directed Discharge Letter (PADDLE): A novel approach to improve patient knowledge, satisfaction and outcomes
Secondary ID [1] 298593 0
PADDLE
Universal Trial Number (UTN)
NA
Trial acronym
PADDLE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
acute coronary syndrome

 313434 0
pneumonia
 313435 0
Type I diabetes

 313436 0
atrial fibrilllation 316262 0
heart failure 316263 0
Chronic obstructive pulmonary disease 316264 0
Pulmonary embolism 316265 0
pyelonephritis 316266 0
cellulitis 316267 0
Hyponatraemia 316268 0
Type II diabetes 316269 0
treatment for thyroid cancer 316270 0
Condition category
Condition code
Cardiovascular 311872 311872 0 0
Other cardiovascular diseases
Respiratory 311873 311873 0 0
Other respiratory disorders / diseases
Metabolic and Endocrine 311875 311875 0 0
Other endocrine disorders
Public Health 314547 314547 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomised (1:1) to a standard hospital discharge letter or both a standard hospital discharge letter AND a patient directed discharge letter (PADDLE) tailored to their individual situation and explained to them face to face by their physician.
Standard hospital discharge letters are written to the patient's GP. This letter describes the patient's hospital presentation, diagnosis, treatments and recommendations. The letter includes details of investigations and results, and is written using medical terminology for the doctor. All patients receive this standard letter at discharge.
The patient directed discharge letter (PADDLE) is written using lay person's language and focuses on 4 headings: reasons the patient came into hospital, important tests and results, treatment received, and recommendations for when the patient goes home. Information is tailored to each patient's care and includes recommendations for follow up after discharge eg lifestyle changes, further testing, further contact with Health Professionals. Completing this PADDLE letter will take approximately 5 minutes.
The PADDLE letter is written and explained to the patient at the bedside by their treating doctor. This explanation will take approximately 10-15 minutes.
Intervention code [1] 314852 0
Behaviour
Comparator / control treatment
Control group receive the standard hospital discharge letter.
Control group
Active

Outcomes
Primary outcome [1] 320538 0
Knowledge:
Global knowledge score, calculated as a sum of scores of the 4 domains; 1. reasons for admission and diagnosis, 2. tests performed, 3. treatments received and 4. follow up plan and recommendations. This is a composite outcome.
Timepoint [1] 320538 0
Participant's knowledge of the 4 domains will be will be assessed at week 1 follow up telephone call assessed by a study-specific questionnaire.
Primary outcome [2] 322866 0
Satisfaction:
Satisfaction with hospital care and preparedness for discharge as assessed by study specific questionnaire. This is a composite outcome.
Timepoint [2] 322866 0
Participant's level of satisfaction will be assessed 1 week post-discharge using a study-specific questionnaire.
Primary outcome [3] 322869 0
Adherence to post-discharge recommendations
Timepoint [3] 322869 0
Adherence to post-discharge recommendations will be assessed 1 week post-discharge by study-specific questionnaires. We have 92% power to detect a 30% difference in adherence using a Likert scale (1-5) (average 4.3 versus 3.0 [SD 3.0]) with our proposed sample size (120 PADDLE versus 120 Control subjects).


Secondary outcome [1] 380077 0
Satisfaction:
Satisfaction with hospital care and preparedness for discharge as assessed by study specific questionnaire. This is a composite outcome.
Timepoint [1] 380077 0
Satisfaction with hospital care and preparedness for discharge - at discharge using a study-specific questionnaire.
Participants receiving a PADDLE letter will be assessed at discharge using additional study specific questionnaires to determine satisfaction with the PADDLE letter.
Utilisation of the PADDLE letter will be assessed at 1 week post-discharge.
Secondary outcome [2] 380078 0
Adherence to post-discharge recommendations
Timepoint [2] 380078 0
Adherence will be assessed using study specific questionnaires 1 week post-discharge using participant's self-report. Point score expressed as percentage will be calculated based on participant responses 1 week post-discharge compared with discharge summary.
Secondary outcome [3] 380173 0
Re-hospitalisations
Timepoint [3] 380173 0
Re-hospitalisations will be assessed at 1 week and 6 months post-discharge using study specific questionnaires and confirmed by Medicare data linkage. Medical Benefits Schedule and Pharmaceutical Benefits Scheme claims usage through Medicare Australia will be collected to ascertain use of medical services and prescribed pharmaceuticals.
Note: Re-hospitalisation is listed as a secondary outcome, because the ANZCTR site allows only 3 primary outcomes. We will use re-hospitalisation at 6 months post-discharge as a primary outcome measure. Re-hospitalisation at 1 week and Pharmaceutical Benefits Claim usage will be secondary endpoints.
Secondary outcome [4] 380296 0
Knowledge:
A secondary knowledge endpoint is the individual score for domain; 1: . reasons for admission and diagnosis. This will be assessed by a study-specific questionnaire..

Timepoint [4] 380296 0
Participant's knowledge of the reasons for admission and diagnosis will be assessed 1 week post-discharge by a study-specific questionnaire.
Secondary outcome [5] 380297 0
Knowledge:
A secondary knowledge endpoint is the individual score for domain; 2: . tests performed . This will be assessed by a study-specific questionnaire..

Timepoint [5] 380297 0
Participant's knowledge of tests performed will be assessed 1 week post-discharge by a study-specific questionnaire.
Secondary outcome [6] 380298 0
Knowledge:
A secondary knowledge endpoint is the individual score for domain; 3: treatments received. This will be assessed by a study-specific questionnaire..
Timepoint [6] 380298 0
Participant's knowledge of treatments received will be assessed 1 week post-discharge by a study-specific questionnaire.
Secondary outcome [7] 380299 0
Knowledge:
A secondary knowledge endpoint is the individual score for domain 4: follow-up plan and recommendations . This will be assessed by a study-specific questionnaire..
Timepoint [7] 380299 0
Participant's knowledge of the follow-up plan and recommendations will be assessed 1 week post-discharge by a study-specific questionnaire.

Eligibility
Key inclusion criteria
Participants are eligible for the study if the current hospital admission is due to:
1. Admitted to hospital with one of the following as a primary diagnosis
a. A cardiac diagnosis of acute coronary syndrome (ACS), or heart failure (HF), or atrial fibrillation (AF)
b. A respiratory diagnosis of pneumonia, or pulmonary embolus (PE), or chronic obstructive pulmonary disease (COPD)
c. A general medicine diagnosis of pneumonia, or pyelonephritis, or cellulitis
d. An endocrine diagnosis of Type I diabetes, or Type II diabetes, or treatment for thyroid cancer or hyponatraemia
2. Age greater than or equal to 18 years of age
3. Able to provide written informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Participant has life expectancy of less than 6 months
2. Participant is being discharged to a nursing home or is unable to self-manage activities of daily living (ADLs)
3. At discretion of investigator

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
concealled allocation by interactive web-based randomisation system (IWRS)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation by site and health condition
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
NA
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Primary analysis will be comparison of outcomes between groups at study time points (discharge, 1 week and 6 months following discharge) using parametric and non-parametric between group analysis techniques as appropriate, controlling for any differences between groups on baseline characteristics

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
24/02/2020
Actual
Date of last participant enrolment
Anticipated
10/06/2021
Actual
Date of last data collection
Anticipated
10/02/2022
Actual
Sample size
Target
240
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 14087 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [2] 14088 0
Ryde Hospital - Eastwood
Recruitment hospital [3] 14089 0
North Shore Private Hospital - St Leonards
Recruitment postcode(s) [1] 26878 0
2065 - St Leonards
Recruitment postcode(s) [2] 26879 0
2122 - Eastwood

Funding & Sponsors
Funding source category [1] 303135 0
Charities/Societies/Foundations
Name [1] 303135 0
HCF Research Foundation
Country [1] 303135 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
HCF Research Foundation
Address
The Hospitals Contribution Fund of Australia Ltd
HCF Research Foundation
GPO BOX 4242
Sydney, NSW 2001
Country
Australia
Secondary sponsor category [1] 303133 0
None
Name [1] 303133 0
Address [1] 303133 0
Country [1] 303133 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303684 0
Northern Sydney Local Health District Human Research Ethics Committee (NSLHD HREC)
Ethics committee address [1] 303684 0
Ethics committee country [1] 303684 0
Australia
Date submitted for ethics approval [1] 303684 0
30/04/2019
Approval date [1] 303684 0
28/01/2020
Ethics approval number [1] 303684 0
2019/STE13311

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94482 0
Prof Geoffrey Tofler
Address 94482 0
5A Cardiology Clinical Administration
Level 5 Acute Services Building
Royal North Shore Hospital St Leonards NSW 2065
Country 94482 0
Australia
Phone 94482 0
+61 2 94631514
Fax 94482 0
+61 2 94632053
Email 94482 0
geoffrey.tofler@health.nsw.gov.au
Contact person for public queries
Name 94483 0
Jill Dent
Address 94483 0
5A Cardiology Clinical Administration
Level 5 Acute Services Building
Royal North Shore Hospital St Leonards NSW 2065
Country 94483 0
Australia
Phone 94483 0
+61 2 94632425
Fax 94483 0
+61 2 94632053
Email 94483 0
jill.dent@health.nsw.gov.au
Contact person for scientific queries
Name 94484 0
Geoffrey Tofler
Address 94484 0
5A Cardiology Clinical Administration
Level 5 Acute Services Building
Royal North Shore Hospital St Leonards NSW 2065
Country 94484 0
Australia
Phone 94484 0
+61 2 94631514
Fax 94484 0
+61 2 94632053
Email 94484 0
geoffrey.tofler@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The study is not designed for data sharing


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.