Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000105246
Ethics application status
Approved
Date submitted
19/12/2017
Date registered
23/01/2018
Date last updated
3/12/2020
Date data sharing statement initially provided
30/05/2019
Date results information initially provided
30/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of Quality Incentive Payments in General Practice
Scientific title
A cluster randomised trial of an outcomes-based funding model in Australian General Practice to improve quality of care
Secondary ID [1] 293643 0
Nil known
Universal Trial Number (UTN)
U1111-1206-7884
Trial acronym
EQuIP-GP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Quality of general practitioner care 306185 0
Condition category
Condition code
Public Health 305112 305112 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study aims to evaluate the impact of an outcomes-based funding and service delivery model in Australian General Practice, comprising targeted practice incentives for enrolment with a preferred provider, longer consultations, same day access and structured follow-up after hospitalisation, on quality of care, health service utilisation and related costs for patients at increased risk of hospitalisation. The impact of the intervention will be compared to usual care, provided in the control group. If implementation of the intervention does not occur as planned at the practice level, usual care will be provided by default in the intervention group.

The outcomes-based funding will be calculated and provided to intervention practices at the end of the 12 month trial. The funding components are listed below. EQUiP-GP incentive structure:

The EQUiP-GP study investigates the impact of an alternate, outcomes based funding model that provides incentives linked to the quality of primary care provision by GPs.
Incentive payments are paid proportional to expected health system cost savings that result from improved quality of GP care. Thus, incentives are not fixed and enable continuous quality improvement to be rewarded.

Specifically, quality improvement incentive payments are made proportional to expected cost savings associated with the reduction of potentially unnecessary care (e.g. prescribing, diagnostic imaging and pathology), an increase in relational continuity for patients and the reduction of avoidable hospitalisation.

These continuous incentive payments are policy relevant and health system scalable for either health system budget neutrality (payments conservatively equate to downstream cost savings) or cost savings (expected cost savings are shared between GP payments and health system).
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Enrolment minimum requirement: enrolment of older patients (>65), patients with chronic and/or complex conditions (18-65 years) and patients aged < 16 years
Payment structure – study enrolment and data payments
$20 per patient sign on
Maximum payment: $20 per patient; $1000 for 50 patients
COMMENT: Sign on $20/Pt and total for sign on and all data collection points $200/pt, $10,000 per practice

Process minimum requirement: three patient encounters / year for enrolled older patients and patients with chronic and/or complex ambulatory care sensitive conditions

Quality improvement incentive 1: Increased length of consultations linked to quality improvement with reduced unnecessary care for enrolled older patients and patients with chronic/ complex ambulatory care sensitive conditions

Incentive structure: Payment of up to $2 per additional minute ($3 for Concession Card Holders) for consultation time in excess of an average 15 minutes across enrolled older and chronic conditions patients. Payment is up to $250 per patient ($7500 across 30 patients) on a sliding scale conditional on extent to which meet a 25% reduction in a composite measure of prescribing, diagnostic imaging and pathology ordering across this patient population in12 months of trial compared with 12 months preceding trial.
Maximum payment: $250 per older and chronic patient, $7500 for 30 patients. This equates per patient to up to an additional 125 minutes (83 minutes for concession card holder) where this contributes to an average consultation time above 15 minutes across the elderly and chronic condition trial population in additional supported consultation times per patient.

Scenario: A practice enrolled 10 non-concessional and 20 concession card holding older/chronic/complex patients. The average consultation time for 60 consults (6 per patient) beyond 15 minutes consultations for non-concessional patients at the end of the trial was 30 minutes. The average consultation time for 100 consults (5 per patient) for concessional card holders was 35 minutes. Across these populations the practice achieved a 20% reduction in pharmaceutical prescriptions, pathology and diagnostic imaging.
The average time in excess of an average consultation time of 15 minutes was 15 minutes for non-concessional and 20 minutes for concessional patients.
Hence, the maximum payments for non-concessional card holders is 6 consults x 15 min excess x $2/min =$180 or $1800 for 10 patients. This is not capped as less than $250 per patient. The maximum payment per patient for concessional card holders is 5 consults x 20 min excess x $3/min =$300 per patient. This is capped at $250 per patient and hence $5000 for 20 concession card holder patients. The total maximum payment across concession and non-concession card holders is $6800.
Now as the practice achieved 80% of target 25% reduction , the practice overall receives: $6800 x 80% =$5480.
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Quality improvement incentive 2: proportion of enrolled patients <16 years seen on same day (where appropriate) exceeding 70%
Process minimum requirement: 70% of enrolled patients <16 years seen on same day (where appropriate)
Incentive structure: sliding scale of additional payment from $0 to maximum $30 per patient with 70% up to
100% enrolled patients <16 years seen on same day
COMMENT: $30 proportional to expected cost savings from improved continuity for at risk of under-16 patients
Maximum payment: $30 per enrolled patient < 16 years, $600 for 20 patients

Quality improvement incentive 3: proportion enrolled chronic / complex patients (18-65 years) and patients >65 years within one week post hospital discharge exceeding 70%
Process minimum requirement: 70% of enrolled patients seen <1 week post hospital discharge
Performance indicator: proportion of enrolled patients seen <1 week post hospital discharge
Incentive structure: sliding scale of additional payment from $0 to maximum $30 with 70% up to
100% of enrolled patients seen <1 week post hospital discharge exceeding minimum of 70%
Maximum payment: $90 per enrolled patient, $2700 for 30 patients
COMMENT: Only for chronic / complex patients or over 65 patients (< 16 years old should be accounted for in same day incentive)
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Quality improvement incentive 4: Potentially avoidable hospital admissions (PAH) chronic / complex patients (18-65 years) and > 65 years
Performance indicator: rate of PAHs for enrolled older / chronic or complex patients in last 12 months of trial compared with 12 months preceding trial (after adjustment for age, sex, and socioeconomic status measured by Index of Relative Socioeconomic Disadvantage)
Incentive structure: sliding scale of additional payment from $0 to maximum $200 with 0 to 40+% reduction in PAH rate in last 12 months of trial compared with 12 months preceding trial (after adjustment for age, sex and socioeconomic status measured by Index of Relative Socioeconomic Disadvantage)
Maximum Payment: $200 per enrolled patient with 40% reduction achieved; $6000 for 30 patients
_______________________________________________________________________________
Quality improvement incentive 5: Potentially avoidable hospital admissions < 16 yo
Performance indicator: rate of PAHs for < 16 yos in last 12 months of trial compared with 12 months preceding trial (after adjustment for age, sex and socioeconomic status measured by Index of Relative Socioeconomic Disadvantage)
Incentive structure: sliding scale of additional payment from $0 to maximum $60 with 0 to 40+% reduction in PAH rate in last 12 months of trial compared with 12 months preceding trial (after adjustment for age, sex and socioeconomic status measured by Index of Relative Socioeconomic Disadvantage)
Maximum Payment: $60 per enrolled patient with 40% reduction achieved; $1200 for 30 patients
COMMENT: Max $150 with 100% reduction modified to maximum $60 with 40% reduction

Each intervention practice will be facilitated in the uptake of the intervention by 3 x 2 hour sessions with a trial facilitator, conducted at two monthly intervals at the intervention practices over the first 6 months of the trial. These sessions will include:

1. Training in the trial procedures
2. Discussion of potential alterations to practice procedures to facilitate the trial procedures
3. Access to educational and quality improvement resources to inform practice changes

Trial facilitators will monitor adherence to the intervention as they will observe, discuss, troubleshoot and report on trial progress at each site. Adherence to trial procedures is also monitored by quarterly in-practice data audits.
Intervention code [1] 299902 0
Prevention
Intervention code [2] 299903 0
Treatment: Other
Intervention code [3] 299904 0
Behaviour
Comparator / control treatment
The control group will receive usual care. Usual care is routine care provided to patients in the Australian general practice setting. In the study, usual care may include a whole person approach to care where it is assumed the GP manages diagnostic and therapeutic activities as well as coordination, referral, advocacy and clinical teamwork. An average consultation lasts approx 10-15 minutes and patients may request and pre-book a longer consult if desired. Usual care may or may not provide continuity with the same GP at each consultation. Usual care includes the provision of GP Management Plans and Team Care Arrangements for patients with chronic and complex care. Patient charges in the usual care control group will follow existing arrangements with rebates available as per the Medicare Benefits Schedule.
Control group
Active

Outcomes
Primary outcome [1] 304277 0
Change in the mean score of the Primary Care Assessment Tool continuity scale.
Timepoint [1] 304277 0
Baseline at commencement of intervention and 12 months post commencement of intervention
Primary outcome [2] 304278 0
Hospitalisation rates as assessed by linked hospital data.
Timepoint [2] 304278 0
Comparison of 12 months prior to the commencement of the intervention with the 72 months following commencement of the intervention.
Secondary outcome [1] 341479 0
Hospital presentations as assessed by patient report.
Timepoint [1] 341479 0
Comparison of 12 months prior to the commencement of the intervention with the 12 months following commencement of the intervention.
Secondary outcome [2] 341480 0
Hospital presentations as assessed by linked hospital data.
Timepoint [2] 341480 0
Comparison of 12 months prior to the commencement of the intervention with 12, 36 and 72 months following commencement of the intervention.
Secondary outcome [3] 341481 0
Prescription rates assessed by practice Electronic Health Record (EHR) data.
Timepoint [3] 341481 0
Comparison of 12 months prior to the commencement of the intervention with the 12 months following commencement of the intervention.
Secondary outcome [4] 341482 0
Prescription rates assessed by linked Pharmaceutical Benefits Scheme data.
Timepoint [4] 341482 0
Comparison of 12 months prior to the commencement of the intervention with 12, 36 and 72 months following commencement of the intervention.
Secondary outcome [5] 341483 0
Pathology test rates assessed by EHR data.
Timepoint [5] 341483 0
Comparison of 12 months prior to the commencement of the intervention with the 12 months following commencement of the intervention.
Secondary outcome [6] 341484 0
Pathology test rates assessed by linked Medicare data.
Timepoint [6] 341484 0
Comparison of 12 months prior to the commencement of the intervention with 12, 36 and 72 months following commencement of the intervention.
Secondary outcome [7] 341485 0
Medical imaging rates assessed by EHR data.
Timepoint [7] 341485 0
Comparison of 12 months prior to the commencement of the intervention with the 12 months following commencement of the intervention.
Secondary outcome [8] 341486 0
Medical Imaging rates assessed by linked Medicare data.
Timepoint [8] 341486 0
Comparison of 12 months prior to the commencement of the intervention with 12, 36 and 72 months following commencement of the intervention.
Secondary outcome [9] 341487 0
Specialist consultation rates assessed by linked Medicare data.
Timepoint [9] 341487 0
Comparison of 12 months prior to the commencement of the intervention with the 12 months following commencement of the intervention.
Secondary outcome [10] 341488 0
Specialist consultation rates assessed by linked Medicare data.
Timepoint [10] 341488 0
Comparison of 12 months prior to the commencement of the intervention with 12, 36 and 72 months following commencement of the intervention.
Secondary outcome [11] 341489 0
Proportion of patients aged < 16 years seen same day as requested assessed by parent / patient report.
Timepoint [11] 341489 0
Comparison of 12 months prior to the commencement of the intervention with the 12 months following commencement of the intervention.
Secondary outcome [12] 341490 0
Proportion of patients aged 18-65 years with chronic conditions, or aged > 65 years, seen within 1 week of hospital discharge assessed patient report.
Timepoint [12] 341490 0
Comparison of 12 months prior to the commencement of the intervention with the 12 months following commencement of the intervention.
Secondary outcome [13] 341491 0
Number of consultations assessed by EHR data.
Timepoint [13] 341491 0
Comparison of 12 months prior to the commencement of the intervention with the 12 months following commencement of the intervention.
Secondary outcome [14] 341492 0
Number of medications in medication list assessed by EHR data.
Timepoint [14] 341492 0
Comparison of 12 months prior to the commencement of the intervention with the 12 months following commencement of the intervention.
Secondary outcome [15] 341493 0
Number of total prescriptions assessed by EHR data.
Timepoint [15] 341493 0
Comparison of 12 months prior to the commencement of the intervention with the 12 months following commencement of the intervention.
Secondary outcome [16] 341494 0
Health related quality of life assessed by EQ-5D-5L questionnaire.
Timepoint [16] 341494 0
Baseline at commencement of the intervention and at 12 months following commencement of the intervention.
Secondary outcome [17] 341495 0
Mortality assessed by linked Deaths registry data.
Timepoint [17] 341495 0
At 12, 36 and 72 months following commencement of the intervention.
Secondary outcome [18] 341496 0
Cost-effectiveness assessed by joint cost and effect distributions on the cost-effectiveness plane (two strategy comparisons), cost-disutility plane (multiple strategy comparisons) and relevant summary measures. Summary measures are determined by aims of the health economic analysis which are to calculate:
- Net benefit and cost-effectiveness acceptability curves for the two strategy comparison
- Expected net loss curves and frontiers for multiple strategy comparisons
- Expected net loss panes and surfaces and multiple domain of effect comparisons.
Timepoint [18] 341496 0
At 12, 36 and 72 months following commencement of the intervention.
Secondary outcome [19] 344943 0
Hospitalisation rates as measured by EHR
Timepoint [19] 344943 0
Comparison of 12 months prior to the commencement of the intervention with the 12 months following commencement of the intervention.
Secondary outcome [20] 344944 0
Proportion of patients aged 18-65 years with chronic conditions, or aged > 65 years, seen within 1 week of hospital discharge assessed by EHR.
Timepoint [20] 344944 0
Comparison of 12 months prior to the commencement of the intervention with the 12 months following commencement of the intervention.

Eligibility
Key inclusion criteria
Patient participants will include three groups:
a. Older patients (over 65 years); 15 per practice
b. Patients 18 - 65 years with chronic and/or complex ambulatory care sensitive conditions (COPD, diabetes, angina, cardiac failure, asthma); 15 per practice
c. Patients aged less than 16 years with increased risk of hospitalisation defined by previous high risk diagnosis (e.g. acute bronchiolitis, asthma, pneumonia, croup and vaccine preventable illness); 20 per practice
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Practice level:

If does not use compatible electronic health record software
If declines use of MedicineInsight data extraction program
If is participating in the Commonwealth Health Care Homes Trial
If is located outside of NSW, Victoria or Tasmania
If has been in business less than 1 year or intending to close within 2 years

Patient level:

Patients with significant cognitive impairment or distress

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 will involve contacting the holder of the allocation schedule who is “off-site” or at a central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be performed using minimisation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Cluster randomisation at practice level
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Allowing for four practices to drop out and an additional 25% participant attrition in remaining practices, the sample size will allow us to detect a change of 0.2 in the mean score of PCAT relational continuity scale (out of a total maximum of 4.0) for adult patients with 98% power.

With the same allowance for drop out and attrition, the trial is powered to detect a 40% reduction in PAHs by including the 5 years following the trial in comparison with the 12 months prior to the trial in a high risk population (assuming an annual PAH rate 7.5%) with 80% power.

Statistical analysis: using multi-level modelling methods to test for between-group (intervention vs. control) differences in the change in variables over the course of the study period.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/06/2018
Actual
15/07/2018
Date of last participant enrolment
Anticipated
31/12/2018
Actual
31/12/2018
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
1800
Accrual to date
Final
950
Recruitment in Australia
Recruitment state(s)
NSW,TAS,VIC

Funding & Sponsors
Funding source category [1] 298261 0
Other Collaborative groups
Name [1] 298261 0
Royal Australian College of General Practitioners
Country [1] 298261 0
Australia
Primary sponsor type
University
Name
University of Wollongong
Address
Northfields Avenue
Wollongong NSW 2522
Country
Australia
Secondary sponsor category [1] 297375 0
University
Name [1] 297375 0
University of Tasmania
Address [1] 297375 0
Launceston Clinical School
Locked Bag 1377
Launceston, TAS 7250
Country [1] 297375 0
Australia
Secondary sponsor category [2] 297376 0
University
Name [2] 297376 0
Monash University
Address [2] 297376 0
Scenic Boulevard
Clayton, Victoria 3800
Country [2] 297376 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299263 0
UOW & ISLHD Health and Medical Human Research Ethics Committee
Ethics committee address [1] 299263 0
University of Wollongong
Northfields Avenue
Wollongong NSW 2522
Ethics committee country [1] 299263 0
Australia
Date submitted for ethics approval [1] 299263 0
14/09/2017
Approval date [1] 299263 0
11/12/2017
Ethics approval number [1] 299263 0
2017/417

Summary
Brief summary
This cluster randomised controlled trial aims to evaluate the impact of an outcomes based funding model in primary care practice. The model provides targeted practice incentives for patient enrolment with a preferred provider, longer consultations, same day access and structured follow-up after hospitalisation. The impact of the model on quality of care and health service utilisation for patients at increased risk of hospitalisation will be compared to usual care.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2286 2286 0 0
/AnzctrAttachments/374194-Review approval 11.12.2017.docx (Ethics approval)
Attachments [2] 2295 2295 0 0
/AnzctrAttachments/374194-Appendix KK Informal Practice Info Sheet V1 13.12.17.docx (Participant information/consent)
Attachments [3] 2296 2296 0 0
/AnzctrAttachments/374194-Appendix LL Informal Data Collection Info Sheet V1 14.12.2017.docx (Participant information/consent)
Attachments [4] 2521 2521 0 0
/AnzctrAttachments/374194-Appendix T Practice Information Sheet V8 CC logo 19.02.2018.docx (Participant information/consent)
Attachments [5] 2522 2522 0 0
/AnzctrAttachments/374194-Appendix U Practice Consent Form V8 CC logo 22.03.2018.docx (Participant information/consent)
Attachments [6] 2523 2523 0 0
/AnzctrAttachments/374194-Appendix O Patient Information Sheet- Intervention V5 CC logo 19.02.2018.docx (Participant information/consent)
Attachments [7] 2524 2524 0 0
/AnzctrAttachments/374194-Appendix Q Patient Consent Form INTERVENTION V5 logo CC 19.02.2018.docx (Participant information/consent)
Attachments [8] 2525 2525 0 0
/AnzctrAttachments/374194-Appendix N Patient Information Sheet Control V5 CC logo 19.02.2018.docx (Participant information/consent)
Attachments [9] 2526 2526 0 0
/AnzctrAttachments/374194-Appendix P Patient Consent Form CONTROL V5 CC logo 19.02.2018.docx (Participant information/consent)
Attachments [10] 2527 2527 0 0
/AnzctrAttachments/374194-APPENDIX AA Parent_Guardian Info Consent V4 CC logo 19.02.2018.docx (Participant information/consent)

Contacts
Principal investigator
Name 79834 0
Prof Andrew Bonney
Address 79834 0
School of Medicine
Level 1, Building 28
University of Wollongong
NSW 2522
Country 79834 0
Australia
Phone 79834 0
+61 2 4221 5819
Fax 79834 0
+61 2 4221 4341
Email 79834 0
abonney@uow.edu.au
Contact person for public queries
Name 79835 0
Ms Rebecca Thorne
Address 79835 0
School of Medicine
Level 1, Building 28
University of Wollongong
NSW, Australia 2522
Country 79835 0
Australia
Phone 79835 0
+61 2 4221 5992
Fax 79835 0
+61 2 4221 4341
Email 79835 0
beck@uow.edu.au
Contact person for scientific queries
Name 79836 0
Prof Andrew Bonney
Address 79836 0
School of Medicine
Level 1, Building 28
University of Wollongong
NSW, Australia 2522
Country 79836 0
Australia
Phone 79836 0
+61 2 4221 5819
Fax 79836 0
+61 2 4221 4341
Email 79836 0
abonney@uow.edu.au

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


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
SourceTitleYear of PublicationDOI
EmbaseEffectiveness of Quality Incentive Payments in General Practice (EQuIP-GP) cluster randomized trial: impact on patient-reported experience.2022https://dx.doi.org/10.1093/fampra/cmab157
N.B. These documents automatically identified may not have been verified by the study sponsor.