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Trial registered on ANZCTR


Registration number
ACTRN12611001284954
Ethics application status
Approved
Date submitted
12/12/2011
Date registered
15/12/2011
Date last updated
28/10/2024
Date data sharing statement initially provided
28/10/2024
Date results provided
28/10/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effectiveness of a clinical practice change intervention in increasing, on a health service wide basis, community health clinician adherence to preventive care guidelines.
Scientific title
The effectiveness of a clinical practice change intervention in increasing, on a health service wide basis, community health clinician adherence to preventive care guidelines; a multiple baseline trial.
Secondary ID [1] 273573 0
Nil
Universal Trial Number (UTN)
U1111-1126-3465
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Clinician delivery of preventive care 279369 0
Poor nutrition 279370 0
Alcohol overconsumption 279371 0
Physical inactivity 279372 0
Smoking 279377 0
Condition category
Condition code
Public Health 285557 285557 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A 12 month multi-strategic clinical practice change intervention will be implemented including:

-Local opinion leaders and consensus processes:
Oversight and corporate support of the intervention will be via a purpose specific Taskforce involving health service executives. To increase intervention adherence, consensus for the model of preventive care will be sought and formalised through the development of a Preventive care policy, applicable to all clinicians. An Aboriginal Advisory group will be established to provide oversight regarding the cultural appropriateness of the intervention. At the facility level, consultation with managers and clinicians will be undertaken.

-Enabling clinical and management organisational systems; patient mediated intervention:
The electronic medical record system, utilised across all sites within the area health service to record care provided by clinicians will be modified to standardise: client eligibility for risk assessment, brief advice and referral; prompt clinician delivery of preventive care; provide assessments and suggestions for provision of brief advice based on age; record the provision of each form of care; enable the production of an automated tailored letter for clients’ general practitioner and such a letter for the client; and enable the generation of preventive care delivery performance reports for health service managers. A hard copy preventive care checklist will be provided to facilitate care provision and recording for use in home visits.

-Clinician and manager educational meetings; educational outreach visits and academic detailing; and client and clinician practice change resources:

-Clinician and manager educational meetings:
The Health District Population Health service will provide current clinicians with competency based online training. The modular training will take approximately two hours in total, involve didactic and quiz based components, and will address the model of preventive care, the standards of delivery for each aspect of preventive care, and how to record care delivery in the electronic medical record. New clinicians will attend such training as a component of new staff orientation procedures.

All managers will be required to complete two hours of face to face training regarding leadership of the initiative and the conduct of performance audit and feedback.

-Educational outreach visits and academic detailing
Practice change support officers will be allocated to each community health facility to facilitate implementation of practice change strategies and clinician provision of preventive care. The support officers will provide a minimum of one face to face visit per month during the intervention period and fortnightly telephone support for managers to support the implementation and maintenance of the intervention.

-Clinician practice change resources:
An email helpline, an internet site that includes all clinician support resources (e.g. referral forms, hardcopy assessment tool for home visits, electronic medical records data entry guide), a clinician resource pack (also containing these support resources), and referral resources will be provided. Managers and clinicians will be provided with newsletters, tips and updates sheets, and a workstation reminder to prompt and provide additional information and solutions to problems.

-Audit and feedback:
Monthly performance reports describing the prevalence of clinician preventive care provision will be provided to managers via email. The reports will provide information regarding care delivery at the individual service, facility, and larger administrative unit levels. Feedback and advice regarding care delivery performance will be provided by the support officers.

-Community promotion:
General practice (GP) organisations will be regularly briefed regarding the initiative, and articles describing the intervention will be published in GP newsletters.

To increase awareness of the initiative among clients and community members general community and Aboriginal-focused media releases will be issued at the commencement of the initiative in each facility. A series of posters and an Aboriginal community brochure will be disseminated by health facilities to further promote awareness of the initiative.
Intervention code [1] 283874 0
Lifestyle
Intervention code [2] 283875 0
Prevention
Intervention code [3] 283876 0
Early detection / Screening
Comparator / control treatment
A multiple baseline design will be implemented. Prior to the implementation of the intervention in each group of facilities, usual preventive care practice change strategies will be utilised in the comparison sites.

Intervention strategies will be applied for each group when each groups’ intervention period commences. Prior to this, usual preventive care based on individual clinician discretion will be implemented. Such care is likely to vary by type of care (assess, advice, referral), type of risk and individual clinician as no existing network-wide policies, protocols or systems guide the provision of such care.
Control group
Active

Outcomes
Primary outcome [1] 286119 0
Clinician provision of recommended preventive care (risk assessment, brief advice, and referral) for each of four chronic disease health risk behaviours (smoking, inadequate fruit and vegetable consumption, risky alcohol use, and inadequate physical activity)as self-reported by clients via computer-assisted telephone interviews.

Data regarding acceptability of preventive care delivery will also be collected from the client interviews.
Timepoint [1] 286119 0
Cross-sectional measurements occurring continuously for all three facility groups for 54 months via telephone interviews. Comencing at the start of the baseline period for all groups, and continuing until 6 months after the completion of the 12 month intervention in the third group.
Primary outcome [2] 286137 0
As a secondary source of data of the primary outcome, provision of preventive care (risk assessment, brief advice, and referral) for each of four chronic disease health risk behaviours (smoking, inadequate fruit and vegetable consumption, risky alcohol use, and inadequate physical activity) will be self-reported by clinicians via computer-assisted telephone interviews.

The interview will also assess: clinicians perceived barriers to the provision of preventive care for the four individual risks, and the four risks simultaneously; the appropriateness, acceptability and utility of the preventive care elements; and the usefulness of the clinical practice change strategies implemented.
Timepoint [2] 286137 0
As a secondary source of data, telephone interviews will be undertaken prior to the baseline period for group 1 and immediately following the intervention for group 3 with randomly selected samples of clinicians from each facility group.
Secondary outcome [1] 295228 0
Nil
Timepoint [1] 295228 0
Nil

Eligibility
Key inclusion criteria
All adult clients who have at least one visit to a community health facility within the prior two weeks, and who meet the following inclusion criteria will be eligible to participate in the data collection: over 18 years of age; speak English; mentally and physically capable of completing an interview; not determined by clinician discretion as inappropriate to contact; not involved in another community health care focused survey; and not living in aged care facilities or gaol.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Clients seeing the following specific forms of services within their visit to the community health facility will be excluded: inpatient services, sexual assault, palliative care, genetics services, and child protection services (parents).

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Delineation of the three groups will be based on geographic and administrative boundaries, resulting in a varying number of non-randomly allocated facilities per group. Allocation of the three groups of community health facilities to order of intervention implementation (first, second, third) will not be random, but rather negotiated with service leaders and relevant staff.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
A multiple baseline design will be implemented. This will involve the sequential implementation of a 12 month practice change intervention in three groups of community health facilities. Prior to the implementation of the intervention in each group of facilities, usual preventive care practice change strategies will be utilised in the comparison sites.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
29/10/2009
Actual
29/10/2009
Date of last participant enrolment
Anticipated
Actual
27/06/2014
Date of last data collection
Anticipated
Actual
27/06/2014
Sample size
Target
13500
Accrual to date
Final
7091
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 284355 0
Other Collaborative groups
Name [1] 284355 0
Hunter Medical Research Institute (HMRI)
Country [1] 284355 0
Australia
Funding source category [2] 284356 0
Government body
Name [2] 284356 0
National Health and Medical Research Council - Partnership Grant
Country [2] 284356 0
Australia
Funding source category [3] 284357 0
Government body
Name [3] 284357 0
Population Health Hunter New England Local Health District
Country [3] 284357 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive
Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 283298 0
Government body
Name [1] 283298 0
Hunter New England Population Health
Address [1] 283298 0
Locked Bag 10
Wallsend NSW 2287
Country [1] 283298 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286316 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 286316 0
Ethics committee country [1] 286316 0
Australia
Date submitted for ethics approval [1] 286316 0
Approval date [1] 286316 0
20/08/2009
Ethics approval number [1] 286316 0
09/06/17/4.03
Ethics committee name [2] 286317 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [2] 286317 0
Ethics committee country [2] 286317 0
Australia
Date submitted for ethics approval [2] 286317 0
Approval date [2] 286317 0
30/06/2010
Ethics approval number [2] 286317 0
H-2010-1116

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

Contacts
Principal investigator
Name 33519 0
A/Prof John Wiggers
Address 33519 0
Hunter New England Population Health Locked Bag 10 Wallsend NSW 2287
Country 33519 0
Australia
Phone 33519 0
+61 2 4924 6247
Fax 33519 0
Email 33519 0
John.Wiggers@hnehealth.nsw.gov.au
Contact person for public queries
Name 16766 0
Associate Professor John Wiggers
Address 16766 0
Hunter New England Population Health
Locked Bag 10 Wallsend NSW 2287
Country 16766 0
Australia
Phone 16766 0
+61 2 4924 6247
Fax 16766 0
+61 2 4924 6048
Email 16766 0
John.Wiggers@hnehealth.nsw.gov.au
Contact person for scientific queries
Name 7694 0
Associate Professor John Wiggers
Address 7694 0
Hunter New England Population Health
Locked Bag 10 Wallsend NSW 2287
Country 7694 0
Australia
Phone 7694 0
+61 2 4924 6247
Fax 7694 0
+61 2 4924 6048
Email 7694 0
John.Wiggers@hnehealth.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
No additional documents have been identified.