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Trial registered on ANZCTR
Registration number
ACTRN12619000180112
Ethics application status
Approved
Date submitted
22/01/2019
Date registered
7/02/2019
Date last updated
7/02/2019
Date data sharing statement initially provided
7/02/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
Addressing the Issue of High Attenders in General Practice: Developing a Team Approach to Care
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Scientific title
Addressing the Issue of High Attenders in General Practice:Developing a Team Approach to Care to Improve the Appropriateness of High Attending Patients’ Care
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Secondary ID [1]
297152
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Nil known
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Universal Trial Number (UTN)
U1111-1220-0153
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Patients with complicated health needs who attend GP practice frequently
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Condition category
Condition code
Public Health
309814
309814
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0
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Health service research
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The study aims to address the issue of high attenders in General Practice by developing and putting in place systematic team practice strategies to improve the appropriateness of these patients’ care and reduce attendance rates. The Medical Corner Doctors practice research team will identify the demographics, health issues and consultation types of the top 20 attenders at Medical Corner Doctors Medical Practice, 237 High St, Rangiora. These top 20 attenders will be invited to be participants in the study via a letter containing information about the study. Those that agree to take part will be invited to a preliminary no fee consultation with one of our two study nurses from the research team at which they will be given any further information that they require and then asked for informed consent. At this interview the nurse will establish the patient’s health goals which will form the basis of their Personalised Care Plan (PCP). The form used will be a modified version of the care plan template available at healthnavigator.org.nz
The patient’s General Practitoner (GP) will do a case review looking at their clinical record, classifications and medications. The GP and the study nurse will then meet to complete a Practice management plan (PMP) which could include the following strategic interventions depending on patient need:
• A medication review by the pharmacist and provision of a yellow card listing medications and their actions
• An Acute Plan (AP) if the patient has recurrent acute exacerbations of a condition eg COPD requiring emergency treatment or hospitalisation.
• Provision of self-medication for exacerbations of conditions where clinically safe and appropriate eg recurrent uncomplicated UTI
• Advanced Care Planning (ACP) if considered appropriate for end of life planning.
• Care coordination by the practice nurse to provide better support in the community.
• Referral for counselling if anxiety or depression is considered a co-factor in their high attendance rates.
The study nurse will follow up with the patient to get informed consent to implement the strategies chosen and to complete the PCP and other plans as appropriate.
The twenty patients enrolled in the study will be identified on the practice management software in the patient’s alerts as: High Attenders Study (HAS)
When an HAS patient phones the practice he/she will be triaged by one of the study nurses. The patient will be assigned to the most clinically appropriate intervention:
• Telephone advice by the nurse - may involve guiding use of their PCP or AP
• Telephone advice by their own GP
• A timely appointment with their own GP for non-urgent or semi-acute problems
• For acute problems a same day appointment with preferably their own GP preceded by nurse triage on arrival.
These interventions will be put in place for a period of one year and delivered by the Medical Corner Doctors practice team. The study will include an evaluation of the effectiveness of the strategies that have been put in place by collecting qualitative data in the form of conducting interviews with some high attenders to the practice after a six month period. The purpose of the interviews is to gauge patients' views about the new strategies and to further refine the new strategies as a result of these findings. Further evaluation in the form of telephone interviews with participants will take place after 12 months.
The Lead Investigator will carry out three monthly audits of the interventions put in place for each patient by their GP/study nurse team to ensure consistency and appropriateness of clinical care in line with the aims of the study. Any clinical concerns raised by this audit will be addressed at the weekly meeting of the Management team at Medical Corner Doctors which consists of the Lead Investigator, GP director, Practice Manager and Nurse Team leader.
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Intervention code [1]
313422
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Other interventions
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Appropriateness of care will be assessed through patient self-review via the semi-structured interviews with participants.
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Assessment method [1]
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Timepoint [1]
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Developmental evaluation of new strategies used after a period of 6 and 12 months through semi-structured interviews with participants
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Secondary outcome [1]
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The number of consultations each participant had with GPs in the year previous to the intervention will be compared with the number of consultations each participant had with GPs at the end of the intervention using the new team approach strategies. This will be assessed through data-linkage to medical records.
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Assessment method [1]
365997
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Timepoint [1]
365997
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Baseline data showing attendance rates will be compared with attendance rates after 12 months of the new strategies
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Eligibility
Key inclusion criteria
For the purpose of this study high attenders are defined as the patients aged 16 and over who have attended the highest number of face to face consultations, as identified through patient records, with any General Practitioner at Medical Corner Doctors over the preceding two years. The top ranked twenty high attenders who agree to take part in the study will be the participants.
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Minimum age
16
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
None
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
This is a small General Practice study involving the top twenty frequent attenders at our medical centre over the preceding two years. Interventions through a team approach will be put in place. Analysis of whether this approach has improved outcomes for this group of patients will be by semi-structured face to face interviews with five of the identified high attenders after six months. A further evaluation will be carried out by a telephone interview at the end of the study at 12 months as well as analysis of data around change of attendance rates from baseline . There are no statistical assumptions and evaluation will be observational rather than statistically analysed. The number of participants involved in the study is manageable for our practice research team
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/03/2019
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Actual
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Date of last participant enrolment
Anticipated
1/04/2019
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Actual
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Date of last data collection
Anticipated
1/04/2020
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Actual
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Sample size
Target
20
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
21218
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New Zealand
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State/province [1]
21218
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Canterbury
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Funding & Sponsors
Funding source category [1]
301707
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Charities/Societies/Foundations
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Name [1]
301707
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Royal NZ College of General Practitoners
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Address [1]
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level 4 50 Customhouse Quay
PO Box 10440
Wellington 6143
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Country [1]
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New Zealand
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Primary sponsor type
Individual
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Name
Dr Nigel Tapper
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Address
Medical Corner Doctors
237 High Street
Rangiora 7400
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Country
New Zealand
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Secondary sponsor category [1]
301452
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None
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Name [1]
301452
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Address [1]
301452
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Country [1]
301452
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
302426
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Southern Health and Disability Ethics Committee
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Ethics committee address [1]
302426
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c/o Ministry Of Health
133 Molesworth street
PO Box 5013
Wellington 6011
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Ethics committee country [1]
302426
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New Zealand
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Date submitted for ethics approval [1]
302426
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05/09/2018
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Approval date [1]
302426
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21/12/2018
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Ethics approval number [1]
302426
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18/STH/186
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Summary
Brief summary
Title: Addressing the Issue of High Attenders in General Practice: Developing a Team Approach
Objectives
• To put in place systematic team practice strategies to improve the appropriateness of high attending patients’ care and to reduce attendance rates.
• To evaluate the effectiveness of the strategies that have been put in place by collecting qualitative data in the form of conducting interviews with some high attenders to the practice to gauge their views about the appropriateness of the new strategies, and quantitative data in the form of looking at any changes in attendance rates and consultation types.
• To further refine the new strategies as a result of these findings.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Nigel Tapper
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Address
90202
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Medical Corner Doctors
237 High Street
Rangiora 7400
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Country
90202
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New Zealand
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Phone
90202
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+6433137819
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Fax
90202
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+6433137861
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Email
90202
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[email protected]
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Contact person for public queries
Name
90203
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Dr Nigel Tapper
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Address
90203
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Medical Corner Doctors
237 High Street
Rangiora 7400
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Country
90203
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New Zealand
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Phone
90203
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+6433137819
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Fax
90203
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+6433137861
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Email
90203
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[email protected]
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Contact person for scientific queries
Name
90204
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Dr Nigel Tapper
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Address
90204
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Medical Corner Doctors
237 High Street
Rangiora 7400
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Country
90204
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New Zealand
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Phone
90204
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+6433137819
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Fax
90204
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+6433137861
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Email
90204
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
No identifying data regarding participants will be made public to protect patient confidentiality
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
1138
Study protocol
376786-(Uploaded-31-01-2019-10-52-23)-Study-related document.docx
1139
Informed consent form
Participant information sheet and consent form
376786-(Uploaded-22-01-2019-19-28-35)-Study-related document.docx
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.
Download to PDF