Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000169246
Ethics application status
Approved
Date submitted
17/12/2017
Date registered
2/02/2018
Date last updated
30/01/2019
Date data sharing statement initially provided
30/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The ImPress study: Impact of a nurse-delivered intervention to identify primary care patients with hypertension and provide care directed at improving blood pressure
Scientific title
The ImPress study: Efficacy of a nurse-delivered intervention to identify primary care patients with hypertension and target care towards improved blood pressure control.
Secondary ID [1] 293381 0
None
Universal Trial Number (UTN)
Trial acronym
ImPress
Linked study record

Health condition
Health condition(s) or problem(s) studied:
high blood pressure 305787 0
Condition category
Condition code
Cardiovascular 305006 305006 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Pre intervention education for participating General Practice nurses (GPNs) will be provided prior to implementation. This will comprise of an all day workshop covering hypertension etiology, blood pressure management strategies, motivational interviewing techniques and Clinical Auditing Tool application. The research team facilitating the workshops have extensive skills and expertise in primary health care across clinical, academic and educational domains.
Following the assessment visit and study enrollment, patients will attend three face to face GPN appointments and two telephone consultations throughout intervention. All consultations will be underpinned by a person centred approach with the GPN utilising motivational interviewing techniques and the 5 As’ to build rapport, set goals and offer support for self-management. The 5 A's framework enables the GPN to structure visits through the following steps- Asses, Advise, Agree, Assist and Arrange.
The 3 face to face appointments will be conducted over a 6 month period, 1 hour in duration arranged at a mutually convenient time for the GPN and patient.
The GPN will provide 2 telephone calls no longer than 15 minutes in duration over the 6 month intervention period at a time convenient to the patient.
While the aim of first GPN consultation is to record baseline BP, biometric measures and lifestyle risks, this initial encounter is an opportunity to build rapport and shared understanding. Subsequent visits will focus on individualised action planning in partnership with the patient, goal setting and feedback on progress.
GPs contribution will involve medication optimisation in line with Australian hypertension guidelines (National Heart Foundation of Australia, 2016, Guideline for the diagnosis and management of hypertention in adults)
Templates to structure each nursing assessment will be uploaded to the practices computerised clinical files in Director or Best Practice .To streamline the data entry process, templates will have the capacity to pre-populate existing patient details. GPNs will be encouraged to collaborate with the participating General Practitioners (GP) to share information around the nursing care being provided. Patients participating in the intervention will keep a copy of their action plan which will be annotated at each visit. This will record their progress to date and ongoing goals.
Intervention code [1] 299803 0
Prevention
Intervention code [2] 299868 0
Lifestyle
Intervention code [3] 299869 0
Treatment: Other
Comparator / control treatment
GPNs in control practices will attend a three hour training session at the commencement of the study where they will be given information about study recruitment, instructions on using Clinical Auditing Tool (CAT) and data collection measures. Participating patients assigned to the control group will receive usual care from their GP and GPNs during the study period. GPNs from control group practices will receive the hypertension management education session and resources following the conclusion of the data collection.
The GPN will see the patient at initial eligibility assessment visit where the patient's BP will be recorded and surveys are completed, and patients are followed up at 6th and 12 month while the usual care is continued.
Control group
Active

Outcomes
Primary outcome [1] 304169 0
Blood pressure will be measured by Automated Office Blood Pressure Machine (AOBPM) using the Omron HEM 907 device with up to date calibration schedules as per National Heart Foundation guidelines (2016).
Timepoint [1] 304169 0
Primary timepoint will be at intervention completion, a time period of 6 months since beginning the intervention
Secondary outcome [1] 341365 0
Composite secondary outcome of Health behaviors recorded using combined self reported smoking status, alcohol use, physical activity and fruit and vegetable consumption based on questions from NSW Health Adult Health Survey, 2002 and ABS National Health Survey, 2001..
Timepoint [1] 341365 0
secondary timepoint will occur at 12th months post intervention commencement.
Secondary outcome [2] 341366 0
Body Mass Index, using National Heart Foundation guidelines (2016) measured with wall-mounted stadiometer and metric anatomical measuring tape.
Timepoint [2] 341366 0
12th months post intervention commencement.
Secondary outcome [3] 341367 0
Adherence to blood pressure treatment assessed using validated tools- Hill-Bone Compliance to High Blood Pressure Therapy Scale and The Morisky medication adherence scale (MMAS)
Timepoint [3] 341367 0
at 6th and 12th months post intervention completion

Eligibility
Key inclusion criteria
• Active patients according to the Royal College of General Practitioners definition; attending the practice 3 or more times in the last 2 years.
• Diagnosis of hypertension, are at high risk of a CVD event and have uncontrolled hypertension. This study defines uncontrolled hypertension in line with the Heart Foundation Guidelines; office BP >140/90 mmHg. High CVD risk is defined as calculated 5 year absolute CVD risk >15% or the presence of cardiovascular disease as per National Vascular Disease Prevention Alliance (NVDPA) guide.
Minimum age
45 Years
Maximum age
74 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals who are unable to read and comprehend health information in the English Language.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
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
The sample size calculation for this RCT has been conducted under the supervision of the UOW Statistical Consulting Service. Intra-cluster correlation coefficients and design effects for the outcome measures of systolic BP, diet score, physical activity score and BMI have been calculated using data from the HIPs study. The calculation is based on a between person standard deviation of 8mmHg. This is a compromise between the high effect (14mmHg) seen in the pilot study and the clinically significant difference of 5mmHg which would overly inflate the sample size. The pilot study has demonstrated that 10 participants per practice is achievable and feasible within the available resources.
Therefore, the calculation has considered a cluster size of 10 and an intra-cluster correlation coefficient of 0.063. Using these figures, 154 participants across 15 practices would be required. However, allowing for 30% dropout / loss to follow up, a total sample of 200 patients across 20 practices will be sought. At this sample size, the study will also be sufficiently powered to detect a clinically significant difference in diet score (0.6 units), physical activity score (0.8 units) and BMI (2 units) and a difference of 2 in the Morisky medication adherence scale.
Post Intervention, data will be entered into SPSS Version 21 and checked for completeness and data entry errors. Subsequently, the data will be examined for differences between primary (BP) and secondary (BMI, medication adherence and health behaviours) outcomes. Variables between patients will be explored within and across practices. The intra-cluster correlation coefficient, or the measure of relatedness between the data will be calculated and published to aid future research. Given the high level analysis required, assistance will be sought from the UOW Statistical Consulting Service throughout the project.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/02/2018
Actual
1/10/2018
Date of last participant enrolment
Anticipated
31/12/2019
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
36
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 298007 0
University
Name [1] 298007 0
University of Wollongong
Country [1] 298007 0
Australia
Primary sponsor type
Individual
Name
Professor Elizabeth Halcomb
Address
University of Wollongong
Northfields Ave, Wollongong NSW 2522
Country
Australia
Secondary sponsor category [1] 297072 0
Individual
Name [1] 297072 0
Professor Nick Zwar
Address [1] 297072 0
University of Wollongong
Northfields Ave, Wollongong NSW 2522
Country [1] 297072 0
Australia
Secondary sponsor category [2] 297344 0
Individual
Name [2] 297344 0
Dr Susan McInnes
Address [2] 297344 0
University of Wollongong
Northfields Ave, Wollongong NSW 2522
Country [2] 297344 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299043 0
Human Research Ethics Committee
Ethics committee address [1] 299043 0
University of Wollongong
Northfields Ave, Wollongong NSW 2522
Ethics committee country [1] 299043 0
Australia
Date submitted for ethics approval [1] 299043 0
Approval date [1] 299043 0
24/10/2017
Ethics approval number [1] 299043 0
2017/412

Summary
Brief summary
This project will comprise of a randomised control trial (RCT). The hypothesis will be tested by randomly allocating participants into two groups; the ImPress intervention and a control group. Clinical differences between these groups will be assessed at 6 and 12 months follow-up.
The primary goal of conducting this trial is to evaluate if the ImPress intervention is more effective than usual care in achieving optimal blood pressure control, medication adherence, behavioural risk factors and body mass index in general practice.
Randomisation will occur at a practice level and data will be collected by the GPN at baseline, six and twelve months when patients attend the practice.
A total sample of 200 patients across 20 practices will be sought. .Once Practices have been recruited, participating GPNs will conduct a structured electronic search of the practice medical record database to identify a list of eligible patients. Following the assessment visit and study enrollment, patients will attend three face to face GPN appointments and two telephone consultations throughout intervention. All consultations will be underpinned by a person centred approach with the GPN utilising motivational interviewing techniques and the 5 As’ to build rapport, set goals and offer support for self-management. While the aim of first GPN consultation is to record baseline BP, biometric measures and lifestyle risks, this initial encounter is an opportunity to build rapport and shared understanding. Subsequent visits will focus on individualised action planning in partnership with the patient, goal setting and feedback on progress.
Templates to structure each nursing assessment will be uploaded to the practices computerised clinical files in Director or Best Practice. GPNs will be encouraged to collaborate with the participating GP(s) to share information around the nursing care being provided.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 79094 0
Mrs Catherine Stephen
Address 79094 0
University of Wollongong
Northfields Ave, Wollongong NSW 2522
Country 79094 0
Australia
Phone 79094 0
+61410348651
Fax 79094 0
Email 79094 0
[email protected]
Contact person for public queries
Name 79095 0
Mrs Catherine Stephen
Address 79095 0
University of Wollongong
Northfields Ave, Wollongong NSW 2522
Country 79095 0
Australia
Phone 79095 0
+61410348651
Fax 79095 0
Email 79095 0
[email protected]
Contact person for scientific queries
Name 79096 0
Prof Elizabeth Halcomb
Address 79096 0
University of Wollongong
Northfields Ave, Wollongong NSW 2522
Country 79096 0
Australia
Phone 79096 0
+61242213784
Fax 79096 0
Email 79096 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Researchers may decide to update this field at a future date


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.