Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001205628
Ethics application status
Approved
Date submitted
4/10/2014
Date registered
17/11/2014
Date last updated
17/11/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised trial assessing the acceptability and effectiveness of providing generic versus tailored feedback about health risks for a high need primary care sample
Scientific title
Do high need primary care patients (those attending an Aboriginal Community Controlled Health Service) rate tailored health risk feedback provided before their GP appointment as more acceptable (in terms of easy to understand, relevant and will help improve health) than generic feedback, and is tailored feedback more effective in terms of being shown and discussed with the patient's GP than generic health risk feedback?
Secondary ID [1] 285436 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular disease 293194 0
Cancer 293195 0
Condition category
Condition code
Public Health 293470 293470 0 0
Health promotion/education
Cardiovascular 293562 293562 0 0
Coronary heart disease
Cancer 293563 293563 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants were invited by a Research Assistant (RA) to complete a health risk survey while waiting for their GP appointment. Immediately following completion of the survey (and also prior to their appointment), the RA provided participants with either tailored feedback (intervention group) or generic feedback (control group). The health risk survey was developed for the study and assessed the following risk factors: overweight (based on measured height and weight), and self reported: smoking, physical inactivity, inadequate fruit and vegetable intake, excess alcohol consumption, drug use, depression and under screening for blood pressure, cholesterol, diabetes and cervical, breast and colorectal cancer (according to age and gender). Survey items were drawn from previously validated measures or other national health surveys where possible. The survey took an average of 11 minutes to complete with the majority of participants completing the survey in less than 20 minutes. The tailored feedback was generated using study specific software and was based on individual survey responses, showing only those risk factors for which the participant was classified as at risk according to national guidelines or other cut offs. Tailored feedback showed the participant's current behaviour compared to that recommended in national guidelines. For example, for overweight participants, the tailored feedback displayed their current weight and a healthy weight for them (based on a BMI calculation of 25kg/m2). Generation and printing of the tailored feedback took approximately 2 minutes. Generic feedback included general guidelines covering all of the risk factors included in the survey, and was pre-printed and therefore provided to the participant immediately after survey completion. Both types of feedback also included simple advice about addressing health risks. For example, for weight, advice included tips for eating a healthy diet, doing more exercise, and advised talking to their GP for further help. All participants were instructed that they could show the feedback to their GP during their routine appointment if they wanted, and to ask their GP if they had any questions about the feedback. Participants had any remaining waiting time before their appointment to review the feedback. It was the choice of the participant and/or their GP about whether to discuss or take any other actions about the health risk feedback, including whether to schedule a follow-up appointment. Outcomes of the participant's appointment were assessed using an participant exit survey immediately following the participant's appointment with their GP. The exit survey took less than five minutes to complete.
Intervention code [1] 290364 0
Lifestyle
Intervention code [2] 290365 0
Behaviour
Intervention code [3] 290366 0
Prevention
Comparator / control treatment
All participants (control and intervention) completed the same health risk survey (as described above). Generic feedback was also provided by the Research Assistant immediately following completion of the survey and prior to the participant attending their GP appointment. As noted above, the generic feedback included current guidelines for all health risks included in the survey and simple advice for addressing these risk factors. Control group participants were also instructed that they could show the feedback to their GP during their routine appointment if they wanted, and to ask their GP if they had any questions about the feedback. It was the choice of the participant and/or their GP about whether to discuss or take any other actions about the health risk feedback, including whether to schedule a follow-up appointment. As for the intervention group, outcomes of the participant's appointment were assessed using an participant exit survey immediately following the participant's appointment with their GP.
Control group
Active

Outcomes
Primary outcome [1] 293289 0
Acceptability of the feedback to participants. Acceptability was assessed using 3 Likert-scale statements, with 3 response options (yes, no, not sure):
a) The feedback was easy to understand
b) The feedback was relevant to me
c) The feedback will help me improve my health
Timepoint [1] 293289 0
Exit survey conducted immediately after the participant's GP appointment. The exit survey was developed specifically for the study.
Primary outcome [2] 293290 0
Effectiveness of tailored versus generic feedback as assessed by the number of participants who reported showing the feedback to their GP.
Timepoint [2] 293290 0
Exit survey conducted immediately after the participant's GP appointment. The exit survey was developed specifically for the study.
Primary outcome [3] 293389 0
Effectiveness of tailored versus generic feedback as assessed by the number of survey health risk topics that participants reported talking to their GP about.
Timepoint [3] 293389 0
Exit survey conducted immediately after the participant's GP appointment. The exit survey was developed specifically for the study.
Secondary outcome [1] 310733 0
Effectiveness of the tailored versus generic feedback as assessed by the number of other actions taken by the participant's GP related to the survey health risks (e.g. gave lifestyle advice, made a follow up appointment etc).
Timepoint [1] 310733 0
Exit survey conducted immediately after the participant's GP appointment. The exit survey was developed specifically for the study.

Eligibility
Key inclusion criteria
Adults (18yrs+)
Attending Aboriginal Community Controlled Health Service for a general practice (GP) appointment
Mentally and physically able to give informed consent and complete a health risk survey
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Under 18yrs
Not attending for a GP appointment
Not physically or mentally able to give consent or complete the survey

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation was not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer software algorithm was used to randomise morning or afternoon GP appointment sessions to either the intervention or control condition. Participants were randomised according to appointment session such that all morning appointment participants were allocated to the same condition and all afternoon participants were allocated to the same condition. Computer software was run prior to each session to determine allocation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A sample size of 200 participants will allow the prevalence of agreement/disagreement with feedback acceptability statements to be estimated with +/- 6% precision. This sample size will also allow the detection of a mean increase in the number of topics discussed from 3 (control group) to 4 (intervention group) with 90% power at a significance level of 5%.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/12/2011
Actual
6/02/2012
Date of last participant enrolment
Anticipated
1/12/2012
Actual
5/09/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 8800 0
2470
Recruitment postcode(s) [2] 8801 0
2440

Funding & Sponsors
Funding source category [1] 290050 0
Government body
Name [1] 290050 0
NSW Health: Mental Health and Drug and Alcohol Research Grant
Country [1] 290050 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive
Callaghan
NSW 2308
Country
Australia
Secondary sponsor category [1] 288737 0
None
Name [1] 288737 0
Address [1] 288737 0
Country [1] 288737 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291756 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 291756 0
Ethics committee country [1] 291756 0
Australia
Date submitted for ethics approval [1] 291756 0
Approval date [1] 291756 0
19/08/2011
Ethics approval number [1] 291756 0
H-2011-0153
Ethics committee name [2] 291757 0
Aboriginal Health and Medical Research Council NSW Human Research Ethics Committee
Ethics committee address [2] 291757 0
Ethics committee country [2] 291757 0
Australia
Date submitted for ethics approval [2] 291757 0
Approval date [2] 291757 0
11/10/2011
Ethics approval number [2] 291757 0
806/11

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

Contacts
Principal investigator
Name 51874 0
A/Prof Christine Paul
Address 51874 0
Level 4 West
HMRI Building
School of Medicine and Public Health
University of Newcastle
University Drive
Callaghan NSW 2308
Country 51874 0
Australia
Phone 51874 0
+61 2 40420693
Fax 51874 0
Email 51874 0
[email protected]
Contact person for public queries
Name 51875 0
Natasha Noble
Address 51875 0
Level 4 West
HMRI Building
School of Medicine and Public Health
University of Newcastle
University Drive
Callaghan NSW 2308
Country 51875 0
Australia
Phone 51875 0
61 2 40420652
Fax 51875 0
Email 51875 0
[email protected]
Contact person for scientific queries
Name 51876 0
Natasha Noble
Address 51876 0
Level 4 West
HMRI Building
School of Medicine and Public Health
University of Newcastle
University Drive
Callaghan NSW 2308
Country 51876 0
Australia
Phone 51876 0
61 2 40420652
Fax 51876 0
Email 51876 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
EmbaseA randomised trial assessing the acceptability and effectiveness of providing generic versus tailored feedback about health risks for a high need primary care sample.2015https://dx.doi.org/10.1186/s12875-015-0309-7
N.B. These documents automatically identified may not have been verified by the study sponsor.