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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
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
Secondary ID [1] 297152 0
Nil known
Universal Trial Number (UTN)
U1111-1220-0153
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients with complicated health needs who attend GP practice frequently 311194 0
Condition category
Condition code
Public Health 309814 309814 0 0
Health service research

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 313422 0
Other interventions
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 318773 0
Appropriateness of care will be assessed through patient self-review via the semi-structured interviews with participants.
Timepoint [1] 318773 0
Developmental evaluation of new strategies used after a period of 6 and 12 months through semi-structured interviews with participants
Secondary outcome [1] 365997 0
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.
Timepoint [1] 365997 0
Baseline data showing attendance rates will be compared with attendance rates after 12 months of the new strategies

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.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

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)
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 design features
Phase
Not Applicable
Type of endpoint/s
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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2019
Actual
Date of last participant enrolment
Anticipated
1/04/2019
Actual
Date of last data collection
Anticipated
1/04/2020
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 21218 0
New Zealand
State/province [1] 21218 0
Canterbury

Funding & Sponsors
Funding source category [1] 301707 0
Charities/Societies/Foundations
Name [1] 301707 0
Royal NZ College of General Practitoners
Country [1] 301707 0
New Zealand
Primary sponsor type
Individual
Name
Dr Nigel Tapper
Address
Medical Corner Doctors
237 High Street
Rangiora 7400
Country
New Zealand
Secondary sponsor category [1] 301452 0
None
Name [1] 301452 0
Address [1] 301452 0
Country [1] 301452 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302426 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 302426 0
Ethics committee country [1] 302426 0
New Zealand
Date submitted for ethics approval [1] 302426 0
05/09/2018
Approval date [1] 302426 0
21/12/2018
Ethics approval number [1] 302426 0
18/STH/186

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

Contacts
Principal investigator
Name 90202 0
Dr Nigel Tapper
Address 90202 0
Medical Corner Doctors
237 High Street
Rangiora 7400
Country 90202 0
New Zealand
Phone 90202 0
+6433137819
Fax 90202 0
+6433137861
Email 90202 0
ntapper@gmail.com
Contact person for public queries
Name 90203 0
Nigel Tapper
Address 90203 0
Medical Corner Doctors
237 High Street
Rangiora 7400
Country 90203 0
New Zealand
Phone 90203 0
+6433137819
Fax 90203 0
+6433137861
Email 90203 0
ntapper@gmail.com
Contact person for scientific queries
Name 90204 0
Nigel Tapper
Address 90204 0
Medical Corner Doctors
237 High Street
Rangiora 7400
Country 90204 0
New Zealand
Phone 90204 0
+6433137819
Fax 90204 0
+6433137861
Email 90204 0
ntapper@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No identifying data regarding participants will be made public to protect patient confidentiality


What supporting documents are/will be available?




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.