A randomised trial assessing the acceptability and effectiveness of providing generic versus tailored feedback about health risks for a high need primary care sample

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12614001205628
• Date of registration: 17/11/2014
• Prospective Registration: No
• Primary sponsor: University of Newcastle
• 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?
• Date of first enrolment: 06/02/2012
• Target sample size: 200
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12614001205628.aspx
• Study type: Interventional
• Study design: Purpose: Educational / counselling / training; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: Ms Natasha Noble

• Name: Ms Natasha Noble

Key inclusion & exclusion criteria

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

Exclusion criteria: Under 18yrs
Not attending for a GP appointment
Not physically or mentally able to give consent or complete the survey

Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Cardiovascular - Coronary heart disease

Cancer - Any cancer

Public Health - Health promotion/education

Cardiovascular disease;Cancer;
Cardiovascular disease
Cancer

Intervention(s)

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. Bot

Primary Outcome(s)

Effectiveness of tailored versus generic feedback as assessed by the number of participants who reported showing the feedback to their GP.[Exit survey conducted immediately after the participant's GP appointment. The exit survey was developed specifically for the study.]

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

Effectiveness of tailored versus generic feedback as assessed by the number of survey health risk topics that participants reported talking to their GP about.[Exit survey conducted immediately after the participant's GP appointment. The exit survey was developed specifically for the study.]

Secondary Outcome(s)

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

Secondary ID(s)

None

Source(s) of Monetary Support

NSW Health: Mental Health and Drug and Alcohol Research Grant

Ethics review

Status: Approved
Approval date:
Contact:

Aboriginal Health and Medical Research Council NSW Human Research Ethics Committee

Status: Approved
Approval date:
Contact:

University of Newcastle Human Research Ethics Committee