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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12610001055099
Ethics application status
Approved
Date submitted
29/11/2010
Date registered
1/12/2010
Date last updated
2/09/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Development and feasibility testing of a "consumer questions" program to increase health literary and empower consumers to participate in decisions about their health.
Scientific title
Development and feasibility testing of a "consumer questions" program to increase health literary and empower consumers to participate in decisions about their health.
Secondary ID [1] 253201 0
Nil
Universal Trial Number (UTN)
Trial acronym
Consumer Questions Program (CQP) Health literacy/empowerment Project
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Women's health 258732 0
Contraception 258733 0
Medical checks for reproductive organs 258734 0
Condition category
Condition code
Reproductive Health and Childbirth 258884 258884 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This trial will be conducted in two stages:

Stage 1: Development of the Consumer Questions Program (CQP). This is the intervention which will be tested in Stage 2.

Participants:
a) Clinical staff focus groups (health professionals and clinic staffs at Family Planning NSW
b) Consumer focus groups (clients at Family Planning NSW)
Outcome: thematic analysis to identify themes and sub-themes within the data (audio-records transcriptions)

Stage 1 will take 1-4 months

Stage 2: A feasibility Study. Testing of the intervention: The Consumer Questions Program.

The Consumer Questions Program (CQP) to train consumers to use the consumer questions. The program includes providing participants with four components:
i) a 2-5 min CQP DVD
ii) a consultation summary sheet
iii) a consumer questions reminder card
iv) a CQP pamphlet, including website address to access the DVD and the supporting information online


The intervention will be delivered once to participants by a research officer/nurse when they attend the clinic. Client participants will complete questionnaires for data collection at 3 time points. Prior to consultation (T1), immediately post consultation ( T2) and 2 weeks post consultation (T3)

Participants:
a) Clinical staff (health professionals and clinic staff) at Family Planning NSW
b) Clients at Family Planning NSW


Primary outcomes will be measured from participants' report:
a) proportion of client participants who report asking the questions in the consultation
b) qualitative data about the experience of asking the questions and use of the information obtained from the doctor as a result of asking the questions.

Secondary outcomes:
c) proportion of clients who report viewing the CQP video
d) Proportion of clients who report accessing the online information
e) length of consultation
f) access to study online resource monitored by URL address hits
g) qualitative data from the health professional log books
h) data from the consultation summary sheets completed by client participants.


We anticipate Stage 2 will take 5 months to complete all data collection and analysis.
Intervention code [1] 257679 0
Other interventions
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259740 0
Proportion of patients who report asking the questions in the consultation as measured by participants' reports
Timepoint [1] 259740 0
Immediately after the consultation
Primary outcome [2] 259741 0
Qualitative data about the experience of asking the questions and use of the information obtained from the doctor as a result of asking the questions as measured by participants' report
Timepoint [2] 259741 0
Immediately after the consultation
Secondary outcome [1] 266485 0
Proportion of participants who report viewing the CQP video as measured by participants' report
Timepoint [1] 266485 0
Immediately after the consultation and two weeks after the consultation
Secondary outcome [2] 266486 0
Proportion of participants who report accessing the online information as measured by participants' report
Timepoint [2] 266486 0
Immediately after the consultation and two weeks after the consultation
Secondary outcome [3] 266487 0
Length of consultation (collected by FPNSW from an automated system)
Timepoint [3] 266487 0
Immediately after the consultation
Secondary outcome [4] 266488 0
Access to study online resource monitored by URL address hits
Timepoint [4] 266488 0
To be collected progressively throughout the study
Secondary outcome [5] 266489 0
Qualitative data from the health professional log books
Timepoint [5] 266489 0
To be collected progressively throughout the study
Secondary outcome [6] 266490 0
Data from the consultation summary sheets completed by client participants
Timepoint [6] 266490 0
Immediately after the consultation

Eligibility
Key inclusion criteria
1) Women aged equal to or older than 18 years
2) English language fluency
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Clients who require an interpreter will not be eligible

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258154 0
Charities/Societies/Foundations
Name [1] 258154 0
The Foundation of Informed Medical Decision Making Inc.
Address [1] 258154 0
40 Court street
Suite 200
Boston
MA 02108
Country [1] 258154 0
United States of America
Primary sponsor type
Individual
Name
Dr Heather Shepherd
Address
CeMPED
School of Public Health (DO2)
University of Sydney
Sydney NSW 2006
University of Sydney, School of Public Health
Country
Australia
Secondary sponsor category [1] 257318 0
Individual
Name [1] 257318 0
Associate Professor Alexandra Barratt
Address [1] 257318 0
Centre for Medical Psychology & Evidence-based Decision-making
School Of Public Health
Edward Ford Building, A27
University of Sydney
Sydney NSW 2006
University of Sydney
Country [1] 257318 0
Austria
Secondary sponsor category [2] 257319 0
Individual
Name [2] 257319 0
Dr Deborah Bateson
Address [2] 257319 0
Family Planning NSW
328-336 Liverpool Road
Ashfield NSW 2131
Family Planning NSW
Country [2] 257319 0
Australia
Secondary sponsor category [3] 257320 0
Individual
Name [3] 257320 0
Mrs Karen Carey
Address [3] 257320 0
Unit 6, 168 Mounts Bay Rd
West Perth WA 6005
GSB Consulting and Communications Pty Ltd
Country [3] 257320 0
Australia
Secondary sponsor category [4] 257321 0
Individual
Name [4] 257321 0
Associate Professor Lyndal Trevena
Address [4] 257321 0
A27 - Edward Ford Building
School of Public Health
The University of Sydney
Sydney NSW 2006
Country [4] 257321 0
Australia
Secondary sponsor category [5] 257322 0
Individual
Name [5] 257322 0
Mr Kevin McGeechan
Address [5] 257322 0
Sydney School of Public Health
Edward Ford Building ( A27)
University of Sydney NSW 2006
Country [5] 257322 0
Australia
Secondary sponsor category [6] 257323 0
Individual
Name [6] 257323 0
Professor Chris del Mar
Address [6] 257323 0
Faculty of Health Sciences
Bond University
Gold Coast QLD 4229
Country [6] 257323 0
Australia
Secondary sponsor category [7] 257324 0
Individual
Name [7] 257324 0
Professor Phyllis Butow
Address [7] 257324 0
CeMPED, School of Psychology
Griffith Taylor Building (A19)
University of Sydney
Sydney NSW 2006
Country [7] 257324 0
Australia
Other collaborator category [1] 251694 0
Individual
Name [1] 251694 0
Dr Edith Weisberg
Address [1] 251694 0
Family Planning NSW
328- 336 Liverpool Road
Ashfield NSW 2131
Country [1] 251694 0
Australia
Other collaborator category [2] 251695 0
Individual
Name [2] 251695 0
Professor Vikki Entwistle
Address [2] 251695 0
Professor of Values in Health Care
Social Dimensions of Health Institute
Universities of Dundee and St Andrews
11 Airlie Place
Dundee Scotland DD1 4HJ
United Kingdom
Country [2] 251695 0
United Kingdom
Other collaborator category [3] 251696 0
Individual
Name [3] 251696 0
Professor Ronald Epstein
Address [3] 251696 0
Family Medicine Research Programs
University of Rochester School of Medicine & Dentistry
1381 South Avenue
Rochester New York 14620
USA
Country [3] 251696 0
United States of America
Other collaborator category [4] 251697 0
Individual
Name [4] 251697 0
Professor Martin Tattersall
Address [4] 251697 0
Blackburn Building (D06)
University of Sydney NSW 2006
Country [4] 251697 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260130 0
Family Planning Association Ethics Committee (EC00120)
Ethics committee address [1] 260130 0
Family Planning NSW
328-336 Liverpool Road
Ashfield NSW 2131
Ethics committee country [1] 260130 0
Australia
Date submitted for ethics approval [1] 260130 0
19/10/2010
Approval date [1] 260130 0
28/10/2010
Ethics approval number [1] 260130 0
R2010-09
Ethics committee name [2] 260131 0
The University of Sydney Human Research Ethics Committee (EC00145)
Ethics committee address [2] 260131 0
Level 6, Jane Foss Russell Building - G02
City Road, Darlington Campus
The University of Sydney
NSW 2006
Ethics committee country [2] 260131 0
Australia
Date submitted for ethics approval [2] 260131 0
26/11/2010
Approval date [2] 260131 0
Ethics approval number [2] 260131 0

Summary
Brief summary
Aims
To explore the feasibility and implementation issues of a program to train consumers to use simple consumer questions to enhance their understanding and decision-making in a clinical consultation.

Specific aims
i) To develop and produce a program to train and support consumers to use consumer questions (the Consumer Questions Program CQP) to elicit information for decision making and to integrate this information with their personal preferences, and;
ii) To test the feasibility of consumers using this program in FPNSW consultations.

Research questions
The effects of the program results on:
1) consumers' knowledge of the questions
2) consumers' understanding of when and why they might want to ask the questions
3) consumers' willingness to ask the questions in the consultation
4) consultation processes, particularly in consultation length and complexity
Health professionals' reactions to the questions will also be examined.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31965 0
Dr Heather Shepherd
Address 31965 0
Surgical Outcomes Research Centre (SOuRCe)
Royal Prince Alfred Hospital
Sydney Local Health District
Camperdown
NSW 2050
Country 31965 0
Australia
Phone 31965 0
+61 2 9515 3203
Fax 31965 0
Email 31965 0
heather.shepherd@sydney.edu.au
Contact person for public queries
Name 15212 0
Dr Dr Heather Shepherd
Address 15212 0
Surgical Outcomes Research Centre (SOuRCe)
Royal Prince Alfred Hospital
Sydney Local Health District
Camperdown
PO Box M157
NSW 2050
Country 15212 0
Australia
Phone 15212 0
+61 2 9515 3203
Fax 15212 0
+61 2 95153222
Email 15212 0
heather.shepherd@sydney.edu.au
Contact person for scientific queries
Name 6140 0
Dr Dr Heather Shepherd
Address 6140 0
Surgical Outcomes Research Centre (SOuRCe)
Royal Prince Alfred Hospital
Sydney Local Health District
Camperdown
PO Box M157
NSW 2050
Country 6140 0
Australia
Phone 6140 0
+61 2 95153203
Fax 6140 0
+61 2 95153222
Email 6140 0
heather.shepherd@sydney.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary