Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000226808
Ethics application status
Approved
Date submitted
13/06/2019
Date registered
4/03/2021
Date last updated
24/02/2022
Date data sharing statement initially provided
4/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Can an integrated care service (ED PainPATH) improve the value of care for people with chronic pain frequently attending NSW Emergency Departments?
Scientific title
Effect of an integrated care service (ED PainPATH) on the frequency of presentation to NSW Emergency Departments by people with chronic pain
Secondary ID [1] 297992 0
Nil
Universal Trial Number (UTN)
U1111-1231-8975
Trial acronym
ED PainPATH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Pain 312414 0
Condition category
Condition code
Emergency medicine 310976 310976 0 0
Other emergency care
Anaesthesiology 311693 311693 0 0
Pain management
Public Health 311706 311706 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants enrolled in the study will be randomly allocated to either the care coordination intervention group or the usual care control group.

When a participant is allocated to the intervention group, a referral will be made to the Care Coordination Service, for a Care Coordinator to be assigned and to contact the patient to offer care coordination support.

The established care coordination services of the LHD will be used to provide this intervention. The established model of care will be used for the study, with the addition of specific Pain Management Skills Training being provided to the Care Coordinators to enable them to more effectively provide support to study participants.

The care coordination intervention is a clinical service provided by Registered Nurses (CNS2) for people with complex care needs requiring integration of their care. It enables integration of the care team (the patient, their carer and their health and social care providers) in the delivery of required care and support.

It is a time-limited service, requiring review at 3 months to confirm that needed integrated care and supports are in place, and that the patient and their carer are able to effectively self-manage, prior to discharge from the care coordination service intervention. If further care integration is required the patient can receive an additional 3-month intervention period.

Key components of the Care Coordination intervention include:
1. Face-to face baseline consultation at the participant's home, involving completion of a comprehensive clinical assessment. This is anticipated to take between 60-120 minutes in addition to travel time and time for documentation and liaison.
2. Regular (initially weekly then progressing to 'when required') face-to face or telephone
consultations aimed at identifying the patients’ care needs and developing a care management plan in consultation with the patient, carer and their healthcare providers. The plan is provided to the patient, uploaded into the patient’s eMR and shared with the patient's General Practitioner (GP). This is anticipated to take between 30-60 minutes but would reduce over time.
3. Care navigation support to assist patients in the identification of health and social care providers, booking of appointments and if required attending key consultations (either face-to-face or via telehealth). Time duration will depend upon the need for travel plus the time in preparation and attendance at the consultation. This would normally reduce as the plan is established but for some patients may need to continue to enable maintenance of their situation.
4. Assisting liaison between GP, hospital, specialists and relevant health/non-health providers. The time spent on this will vary from week to week and the number of healthcare providers involved. The time spent on this is likely to be higher earlier on and may initially require up to 120 minutes. This will reduce once the plan is established.
5. Supporting patients to identify goals and encouraging chronic pain self-management. This would be undertaken during the initial and subsequent sessions.
6. Providing health coaching with the aim to empower patients to feel more confident managing their chronic pain as they work towards achieving their health care goals. This would be provided during the initial and subsequent sessions.
7. Referral to chronic pain specific Multidisciplinary Team services and other services as needed. This would be provided during the initial and subsequent sessions.

Fidelity of the intervention will be monitored and evaluated by the research team using the Patient Assessment of Chronic Illness Care (PACIC) tool aimed at assessing the extent to which participants received care coordination and self-management support (implementation fidelity). In addition, qualitative data / narratives will assess whether contextual (patient, clinician or organisational) factors influenced implementation of the care coordination pathway for people with chronic pain.
Intervention code [1] 314218 0
Prevention
Intervention code [2] 314728 0
Treatment: Other
Comparator / control treatment
Participants randomly allocated to the control group will continue to receive usual care within the Local Health District including all hospital inpatient services, outpatient services and primary and community health support. The services provided by their local GP and other health professionals will remain unchanged.

Participants will receive usual care when presenting to the Emergency Department including prescription of analgesia and further blood investigation/imaging as required, for management of their chronic pain and other health comorbidities.
Control group
Active

Outcomes
Primary outcome [1] 319778 0
Change in frequency of ED presentations as assessed by data linkage to hospital medical records
Timepoint [1] 319778 0
The frequency of ED presentations over the 12 months prior to identification will be compared to the frequency of ED presentations 12 months after identification.
Secondary outcome [1] 369513 0
Change in pain and pain interference as measured by the Brief Pain Inventory (BPI)
Timepoint [1] 369513 0
At baseline, and then post-enrolment at 6 and 12 months in-study follow-up
Secondary outcome [2] 369514 0
Change in the extent the person believes they can manage their pain as measured by the Pain Self-efficacy Questionnaire (PSEQ)
Timepoint [2] 369514 0
At baseline, and then post-enrolment at 6 and 12 months in-study follow-up
Secondary outcome [3] 389296 0
Change in patient confidence to self-manage assessed by the Health Confidence Score (HCS)
Timepoint [3] 389296 0
At baseline, and then post-enrolment at 6 and 12 months in-study follow-up
Secondary outcome [4] 389297 0
Change in patient reported experience as assessed by an ED Patient Experience Survey which is based on the Bureau of Health Information (BHI) Patient Survey ED (abridged to 10 items)
Timepoint [4] 389297 0
At baseline, and then post-enrolment at 6 and 12 months in-study follow-up
Secondary outcome [5] 389298 0
The incremental cost per additional quality adjusted life year (QALY) gained in the intervention group compared to the control group.

AQoL-8D will be used as the utility measure and costs calculated on health services utilised including the care coordination intervention, ED attendance, hospital admissions and community care.

Linked data to obtain costs will be obtained from CHeReL (MLK and external databases) and Services Australia (MBS/PBS).
Timepoint [5] 389298 0
The cost over 12 months after identification in the intervention cohort compared to control.

AQoL-8D will be measured at baseline, and then post-enrolment at 6 and 12 months in-study follow-up.
Secondary outcome [6] 389300 0
Qualitative data / narratives obtained from patients, clinicians and health managers (via focus groups, interviews and open-text survey responses) to examine:
- ED PainPATH experience (positive and negative) and feasibility of undertaking the intervention.
- ED PainPATH acceptability (relevant to potential for adoption), adverse experiences and effect on subpopulations (Aboriginal people, those with mental health or drug and alcohol concerns).
- Implementation fidelity (identification, triage, engagement, Care Plan implementation, broad healthcare engagement and complaints arising).
Timepoint [6] 389300 0
Cumulative data will be assessed at the completion of the study
Secondary outcome [7] 391281 0
Data from study recruitment and participation records and care coordination records to examine:
- Study recruitment and retention rates
- Care coordination access and completion rates (Reasons for non-access and dropout)
Timepoint [7] 391281 0
Cumulative data will be assessed at the completion of the study
Secondary outcome [8] 391282 0
Quantitative data from RCT and observational cohort to examine:
- Factors affecting patient participation in the care coordination trial

Patient reported survey data collected during the study will be used to determine which factors are associated with participation in the RCT or observational cohort. Survey data will include demographics, pain (e.g. PSEQ) and health management (e.g. PAM-13) and health services received (e.g. PACIC). The number of ED Presentations will be extracted from local utilisation data.
Timepoint [8] 391282 0
Cumulative data will be assessed at the completion of the study
Secondary outcome [9] 391283 0
Qualitative data from interviews with care coordination staff who received skills training, their case workbooks, video recordings of care delivery, the objective structured clinical examination (OSCE), diary entries, care coordination records to examine:
- Care coordination staff’s acceptability, views and experiences about the pain management skills training and its delivery in the context of care coordination
- ED PainPATH experience (positive and negative) and feasibility of undertaking the intervention
- ED PainPATH acceptability (relevant to potential for adoption), adverse experiences, and effect on subpopulations (Aboriginal people, those with mental health or drug and alcohol concerns)
- Implementation fidelity (identification, triage, engagement, Care Plan implementation, broad healthcare engagement and complaints arising)
Timepoint [9] 391283 0
Cumulative data will be assessed at the completion of the study
Secondary outcome [10] 391284 0
Change in Patient Assessment of Chronic Illness Care (PACIC) data from surveys to assess:
- The extent to which participants received care coordination and self-management support (implementation fidelity)
Timepoint [10] 391284 0
The PACIC will be collected at baseline, 6 and 12 months
Secondary outcome [11] 391286 0
Change in the frequency of unhelpful treatments and investigations undertaken in the intervention cohort compared to control.

Unhelpful treatments and investigations may include certain medications (e.g. opioids) and repeat investigations (CT scans, blood tests). Data will be obtained from NSW Ministry linked datasets, PBS and MBS.
Timepoint [11] 391286 0
The frequency over the 12 months prior to identification will be compared to the frequency 12 months after identification
Secondary outcome [12] 406771 0
Change in patient enablement (ability to self-manage their illness) assessed by the Patient Enablement Instrument (PEI)
Timepoint [12] 406771 0
At baseline, and then post-enrolment at 6 and 12 months in-study follow-up

Eligibility
Key inclusion criteria
18-65 years
Presented to an ED greater than or equal to 7 times in the prior twelve months
Chronic pain related diagnosis, based on review of clinical records guided by previous 4 years of ICD-10-AM / SNOMED CT diagnosis codes of ED presentations
Non-cancer chronic pain of greater than or equal to 3 months
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Postoperative patients, antenatal care, acute conditions with time-limited interventions, palliative care and cancer pain, patients on renal dialysis and chemotherapy
• Currently being supported by a care coordination/management service/intervention
• Currently being supported by a NSW Ministry of Health Leading Better Value Care (LBVC) initiative, such as Osteoporosis Refracture Prevention (ORP) service and Osteoarthritis Chronic Care Program (OACCP).

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation involves contacting the holder of the allocation schedule who is "off-site" or at central administration site. The person undertaking randomisation will be a non-clinician removed from the care of the patient.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization sequence will be created by computer with a 1:1 allocation using random block sizes of 2 and 4.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Intention to treat and per-protocol analyses will be performed. A follow-up pre-post analysis of the intervention group only will be conducted to examine variables that moderate the magnitude of effect e.g. time from recruitment to implementation.

The primary outcome of number of ED attendances will be compared between the intervention and control groups at 12 months using generalised linear mixed (Poisson) models, while controlling for demographic variables. A sample size of 70 (35 in each group) would provide 80% power to detect a 25% difference in patients’ ED presentations over 12 months at a 5% level of statistical significance. We would require 44 patients in each group (a total of 88) to control for a 20% dropout. We do not anticipate loss to follow-up occurring for the primary outcome, as this data is not provided by the patient. Intention to treat and per-protocol analyses will be performed for the primary outcome.
The secondary (patient-reported) outcomes will be analysed in the same way but using linear mixed models.

Qualitative data collected during focus group and individual interviews with all key stakeholder groups will be recorded and transcribed for analysis. Data will be coded, categorised and themed using interpretative description, underpinned by critical realist theory.

Economic analysis
A within-study cost-utility analysis will be undertaken to determine the incremental cost per additional quality adjusted life year (QALY) gained in the intervention cohort over the control cohort. Utility will be calculated using AQoL-8D and costs will be calculated on health services utilised including the care coordination intervention, ED attendance and hospital admissions.

A within-study cost-benefit analysis will also be undertaken in relation to the cost and pain outcomes in the intervention cohort over the control cohort. Findings from this study will be weighted by state population and service use data to assess the costs and benefits of the provision of the care coordination intervention compared to usual care; scaled up to the state level if similar outcomes were achieved.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
31/03/2021
Actual
14/07/2021
Date of last participant enrolment
Anticipated
30/09/2022
Actual
Date of last data collection
Anticipated
31/03/2023
Actual
Sample size
Target
70
Accrual to date
16
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 13666 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [2] 13983 0
Hornsby Ku-ring-gai Hospital - Hornsby
Recruitment hospital [3] 13984 0
Ryde Hospital - Eastwood
Recruitment hospital [4] 13985 0
The Northern Beaches Hospital - Frenchs Forest
Recruitment postcode(s) [1] 26348 0
2065 - St Leonards
Recruitment postcode(s) [2] 32465 0
2077 - Hornsby
Recruitment postcode(s) [3] 32466 0
2122 - Eastwood
Recruitment postcode(s) [4] 32467 0
2086 - Frenchs Forest

Funding & Sponsors
Funding source category [1] 302460 0
Charities/Societies/Foundations
Name [1] 302460 0
The Trustee for Ernest Heine Family Foundation
Country [1] 302460 0
Australia
Primary sponsor type
Government body
Name
Northern Sydney Local Health District
Address
Chief Executive Officer
Northern Sydney Local Health District
Royal North Shore Hospital
Kolling Building, Level 14
10 Westbourne St
St Leonards NSW 2065
Country
Australia
Secondary sponsor category [1] 302535 0
None
Name [1] 302535 0
Address [1] 302535 0
Country [1] 302535 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303128 0
Northern Sydney Local Health District Human Research Committee
Ethics committee address [1] 303128 0
Ethics committee country [1] 303128 0
Australia
Date submitted for ethics approval [1] 303128 0
17/04/2019
Approval date [1] 303128 0
06/06/2019
Ethics approval number [1] 303128 0
2019/ETH08733

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

Contacts
Principal investigator
Name 92570 0
A/Prof Paul Wrigley
Address 92570 0
Pain Management Research Institute
Royal North Shore Hospital
Kolling Building, Level 13
3 Reserve Road
St Leonards NSW 2065
Country 92570 0
Australia
Phone 92570 0
+61 0413 187 772
Fax 92570 0
+61 2 9463 1050
Email 92570 0
[email protected]
Contact person for public queries
Name 92571 0
Paul Wrigley
Address 92571 0
Pain Management Research Institute
Royal North Shore Hospital
Kolling Building, Level 13
3 Reserve Road
St Leonards NSW 2065
Country 92571 0
Australia
Phone 92571 0
+61 0413 187 772
Fax 92571 0
+61 2 9463 1050
Email 92571 0
[email protected]
Contact person for scientific queries
Name 92572 0
Paul Wrigley
Address 92572 0
Pain Management Research Institute
Royal North Shore Hospital
Kolling Building, Level 13
3 Reserve Road
St Leonards NSW 2065
Country 92572 0
Australia
Phone 92572 0
+61 0413 187 772
Fax 92572 0
+61 2 9463 1050
Email 92572 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
Study patient self-reported data will be linked to NSW Health utilisation and costings datasets and Services Australia MBS & PBS datasets. In accordance with guidelines relating to this data linkage and Ethics approvals, sharing with third party researchers is not permitted.


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.