Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000403639
Ethics application status
Approved
Date submitted
7/04/2014
Date registered
14/04/2014
Date last updated
14/04/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised controlled video vignette study on the effect different timing and lengths of discharge summaries have on the ability of general practitioners to identify ongoing problems in patients recently discharged from the hospital.
Scientific title
A randomised controlled video vignette study on the effect different timing and lengths of discharge summaries have on the ability of general practitioners to identify ongoing problems in patients recently discharged from the hospital.
Secondary ID [1] 284402 0
Nil
Universal Trial Number (UTN)
Trial acronym
Discharge Summary
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic and on-going medical problems 291586 0
Condition category
Condition code
Public Health 291964 291964 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All GPs commenced the study by viewing a five-minute video-recording of a monologue by an actor-patient as he might present to a GP after leaving the hospital. This was viewed online at the GPs’ own location. The actor described his ideas, concerns, and expectations about his current health. The issues described were drawn from the cases of several anonymous patients who were under the recent care of a general surgeon. The video was supplemented with case notes of medical, family, and drug history, which were provided to all GPs at the time of viewing the video. To optimise face validity, the monologue and case notes were reviewed by researcher-clinicians, including a surgeon, two GPs, and a pharmacist.
GPs assigned to groups A and C received a discharge letter at the time of viewing the video, while groups B and D received this letter one week later.
Intervention code [1] 289140 0
Other interventions
Comparator / control treatment
Control: Groups A and B received a short letter of 450 words , while Intervention: Groups C and D received a longer letter of 911 words.
Control group
Active

Outcomes
Primary outcome [1] 291870 0
Number of patient problems identified by the participants in each group. This is based on the number of problems identified from a predetermined list of patient problems as identified by the research team and then assessed from the responses to the survey from each participant by two independent researchers.
Timepoint [1] 291870 0
The GPs will complete the survey either immediately after viewing the video and discharge letter or immediately and again after receiving the delayed discharge letter.
Secondary outcome [1] 307703 0
No secondary outcomes planned.
Timepoint [1] 307703 0
Not applicable.

Eligibility
Key inclusion criteria
General practitioners or registrars working in Australia
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Non-general practitioners

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
GPs from seven Australian states and territories were recruited by the research team via email and personal contact. Organisations approached for recruitment included Australian Divisions of General Practice, which (at time of study) were geographically-defined organisations with comprehensive coverage of Australian GPs, university departments, research networks, and personal contacts. A total of 102 GPs agreed to participate in a series of video vignette studies. Following informed consent, GPs were provided with information via email on how to participate in the study.

Participating GPs were randomly assigned to one of four groups, A to D, by a computer-generated numbering system
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants were randomised on enrollment by a computer-generated numbering system.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Fisher’s exact test was used to determine group differences in: (1) the number of health problems identified after the video; and (2) GP ratings of timeliness, information content, and the utility of the short and long referral letters. Linear regression was used to determine group differences in the average number of health problems identified by the GPs. The full regression model included: the four GP groups; age; sex; country of graduation; years after graduation; years of GP experience; status as established GP or GP registrar (trainee); Fellowship status with the Royal Australian College of General Practitioners (FRACGP); the remoteness of their primary practice; the number of GPs at their primary practice; and status as a principal within their primary practice. Binary logistic regression models were used to determine: (1) the probability that the health problems would be identified; and (2) the influence of letter-length and demographic information. In addition to the aforesaid variables, a full binary logistic regression model included the health problems.

Regression models were constructed using both backwards elimination and forward selection. Variables with a p value of less than .05 were retained in the final model and reported, with the exception of the variable of intervention group, which remained in the model regardless of significance level. Stata version 12.1 (StataCorp LP, College Station, TX, USA) was used to perform the analyses. Multivariate regression models were adjusted for the lack of independence between individual GPs by estimating the clustered standard errors to account for intra-group correlation (vce option in Stata).

Given the influence of documented patient information on clinical judgement, groups A and C were anticipated to identify twice as many health problems, relative to groups B and D. For this reason, a sample of twenty GPs per group was deemed sufficient in this exploratory study to estimate the effect size of an immediate discharge letter within 95% confidence intervals ranging from 0-34%


Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/06/2011
Actual
1/06/2012
Date of last participant enrolment
Anticipated
2/09/2013
Actual
2/09/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 289049 0
University
Name [1] 289049 0
Curtin University
Country [1] 289049 0
Australia
Primary sponsor type
University
Name
curtin University
Address
GPO Box U1987
Perth, Western Australia 6845
Country
Australia
Secondary sponsor category [1] 287717 0
None
Name [1] 287717 0
Nil
Address [1] 287717 0
Country [1] 287717 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290846 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 290846 0
Ethics committee country [1] 290846 0
Australia
Date submitted for ethics approval [1] 290846 0
Approval date [1] 290846 0
23/05/2011
Ethics approval number [1] 290846 0
RD-13-11

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

Contacts
Principal investigator
Name 47570 0
Prof Moyez Jiwa
Address 47570 0
Curtin University,
GPO Box U1987
Perth, Western Australia 6845
Country 47570 0
Australia
Phone 47570 0
+ 61 8 9266 1768
Fax 47570 0
Email 47570 0
[email protected]
Contact person for public queries
Name 47571 0
Moyez Jiwa
Address 47571 0
Curtin University,
GPO Box U1987
Perth, Western Australia 6845
Country 47571 0
Australia
Phone 47571 0
+61 8 9266 1768
Fax 47571 0
Email 47571 0
[email protected]
Contact person for scientific queries
Name 47572 0
Moyez Jiwa
Address 47572 0
Curtin University,
GPO Box U1987
Perth, Western Australia 6845
Country 47572 0
Australia
Phone 47572 0
+61 8 9266 1768
Fax 47572 0
Email 47572 0
[email protected]

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
Dimensions AIA randomised trial deploying a simulation to investigate the impact of hospital discharge letters on patient care in general practice2014https://doi.org/10.1136/bmjopen-2014-005475
N.B. These documents automatically identified may not have been verified by the study sponsor.