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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Cardiovascular disease

Cancer

Condition category

Condition code

Public Health

Health promotion/education

Cardiovascular

Coronary heart disease

Cancer

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]

Lifestyle

Intervention code [2]

Behaviour

Intervention code [3]

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]

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]

Exit survey conducted immediately after the participant's GP appointment. The exit survey was developed specifically for the study.

Primary outcome [2]

Effectiveness of tailored versus generic feedback as assessed by the number of participants who reported showing the feedback to their GP.

Timepoint [2]

Exit survey conducted immediately after the participant's GP appointment. The exit survey was developed specifically for the study.

Primary outcome [3]

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]

Exit survey conducted immediately after the participant's GP appointment. The exit survey was developed specifically for the study.

Secondary outcome [1]

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]

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?

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]

2470

Recruitment postcode(s) [2]

2440

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

NSW Health: Mental Health and Drug and Alcohol Research Grant

Address [1]

NSW Ministry of Health
Locked Mail Bag 961 North Sydney NSW 2059

Country [1]

Australia

Primary sponsor type

University

Name

University of Newcastle

Address

University Drive
Callaghan
NSW 2308

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Newcastle Human Research Ethics Committee

Ethics committee address [1]

University Drive
Callaghan
NSW 2308

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

19/08/2011

Ethics approval number [1]

H-2011-0153

Ethics committee name [2]

Aboriginal Health and Medical Research Council NSW Human Research Ethics Committee

Ethics committee address [2]

PO Box 1565
Strawberry Hills
NSW 2012

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

11/10/2011

Ethics approval number [2]

806/11

Summary

Brief summary

The purpose of this study was to assess the acceptability and effectiveness of providing real time tailored feedback, compared to generic feedback, to patients of Aboriginal Medical Services about their health behaviour risk factors. Participants could choose to show or discuss the feedback with their GP. The provision of tailored feedback to patients pre-consultation is designed to promote opportunities for both the patient and GP or health worker to consider the patient’s health risks and initiate actions to modify these risk factors. The study represents a novel approach to health promotion for the Indigenous population. Such an approach minimises the amount of time demanded of GPs and other clinic staff in screening for risk factors and potentially encourages the discussion of risk factors between the patient and GP, while also increasing the probability that patients are aware of their health status and are receptive to specific advice to from their GP. 

The acceptability of providing personalised feedback compared to generic feedback to patients on their self reported health risk behaviours, was assessed in terms participant assessment of the utility of the feedback and whether participants showed the feedback to their GP or otherwise used the feedback during their appointment; The effectiveness of personalised feedback compared to generic feedback was assessed in terms of increasing rates of discussion or action (such as referral or follow up appointment) on risk factors during the consultation between the GP and participant.

Trial website

n/a

Trial related presentations / publications

Noble N, Paul C, Carey M, Blunden S, Turner N. A randomised trial assessing the acceptability and effectiveness of providing generic versus tailored feedback about health risks for a high need primary care sample.  Drafted and ready for submission.

Public notes

Contacts

Principal investigator

Name

A/Prof Christine Paul

Address

Level 4 West
HMRI Building
School of Medicine and Public Health
University of Newcastle
University Drive
Callaghan NSW 2308

Country

Australia

Phone

+61 2 40420693

Fax

Chris.Paul@newcastle.edu.au

Contact person for public queries

Name

Natasha Noble

Address

Level 4 West
HMRI Building
School of Medicine and Public Health
University of Newcastle
University Drive
Callaghan NSW 2308

Country

Australia

Phone

61 2 40420652

Fax

Natasha.Noble@newcastle.edu.au

Contact person for scientific queries

Name

Natasha Noble

Address

Level 4 West
HMRI Building
School of Medicine and Public Health
University of Newcastle
University Drive
Callaghan NSW 2308

Country

Australia

Phone

61 2 40420652

Fax

Natasha.Noble@newcastle.edu.au

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

Source	Title	Year of Publication	DOI
Embase	A randomised trial assessing the acceptability and effectiveness of providing generic versus tailored feedback about health risks for a high need primary care sample.	2015	https://dx.doi.org/10.1186/s12875-015-0309-7

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically