STUDY PROTOCOL Open Access

Efficacy and cost-effectiveness of acommunity-based model of care for olderpatients with complex needs: a studyprotocol for a multicentre randomisedcontrolled trial using a stepped wedgecluster designIrina Kinchin1,2* , Susan Jacups1,2,3, Jennifer Mann4, Rachel Quigley4,5, Desley Harvey4,6, Christopher M. Doran1

and Edward Strivens4,5

Abstract

Background: Community-dwelling older persons with complex care needs may deteriorate rapidly and requirehospitalisation if they receive inadequate support for their conditions in the community.

Intervention: A comprehensive, multidimensional geriatric assessment with care coordination was performed in acommunity setting—Older Persons ENablement And Rehabilitation for Complex Health conditions (OPEN ARCH).

Objectives: This study will assess the acceptability and determine the impact of the OPEN ARCH intervention onthe health and quality of life outcomes, health and social services utilisation of older people with multiple chronicconditions and emerging complex care needs. An economic evaluation will determine whether OPEN ARCH is cost-effective when compared to the standard care.

Methods/design: This multicentre randomised controlled trial uses a stepped wedge cluster design with repeatedcross-sectional samples. General practitioners (GPs; n ≥ 10) will be randomised as ‘clusters’ at baseline using simplerandomisation. Each GP cluster will recruit 10–12 participants. Data will be collected on each participant at 3-monthintervals (− 3, 0, 3, 6 and 9 months). The primary outcome is health and social service utilisation as measured byEmergency Department presentations, hospital admissions, in-patient bed days, allied health and community supportservices. Secondary outcomes include functional status, quality of life and participants’ satisfaction. Cost-effectiveness ofthe intervention will be assessed as the change to cost outcomes, including the cost of implementing the interventionand subsequent use of services, and the change to health benefits represented by quality adjusted life years.

Discussion: The results will have direct implications for the design and wider implementation of this new model ofcare for community-dwelling older persons with complex care needs. Additionally, it will contribute to the evidencebase on acceptability, efficacy and cost-effectiveness of the intervention for this high-risk group of older people.

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* Correspondence: i.kinchin@cqu.edu.au1Centre for Indigenous Health Equity Research and School of Health, Medicaland Applied Sciences, CQUniversity, Cairns, QLD, Australia2The Cairns Institute, James Cook University, Cairns, QLD, AustraliaFull list of author information is available at the end of the article

© The Author(s). 2018 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, andreproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link tothe Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver(http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

Kinchin et al. Trials (2018) 19:668 https://doi.org/10.1186/s13063-018-3038-0

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Trial registration: Australian New Zealand Clinical Trials Registry, ACTRN12617000198325p. Registered on 6 February2017.

Keywords: Model of care, Comprehensive geriatric assessment, Integrated care, Effectiveness, Cost utility analysis,OPEN ARCH, Complex care needs, Elderly, Quality of life

BackgroundThe Australian healthcare system experiences significantdemand in health service utilisation due to an aging popu-lation coupled with more complex health conditions [1].Complex health conditions are the leading cause of illness,disability and death in Australia, accounting for 90% of alldeaths in 2011 [1]. Hospitalisation for many complex con-ditions is preventable, yet they remain the most commonhospital admission category [1].Community-dwelling older patients with complex

health needs may deteriorate rapidly and face hospitalisa-tion if their conditions are poorly managed or poorly coor-dinated in the community. Once hospitalised, these oftenfrail individuals may face excessively long hospital stays,which in turn increase their risk of hospital-acquiredinfections, delirium, falls and cognitive decline [2]. Theybecome more dependent and may require permanentplacement in a residential aged care facility, rather thanreturning home as a self-caring individual. It is not un-usual for such patients to be hospitalised without greatacute need.Strong evidence suggests that older people will have bet-

ter health outcomes if appropriate preventative care isprovided in the community and early in the trajectory ofthe person’s illness [2]. In 2009 the National Health andHospital Reform Commission (the Commission) recom-mended major changes to the health service delivery forpatients with complex needs [3]. Of central interest areolder people with interrelated medical, functional and psy-chosocial issues, increased risk of functional deteriorationand unplanned institutional care. The Commission rein-forced the task to expand specialist services in the com-munity to address the needs of older people [3]. Severalsuch models of care have been developed. In comprehen-sive geriatric assessment, such as the geriatric evaluationand management (GEM) model of care, an interdisciplin-ary team of healthcare professionals assesses an olderperson’s medical, functional, psychosocial, nutritional andenvironmental needs [4]. This interdisciplinary team cre-ates a comprehensive plan of care that is communicatedto the person’s physician. The model demonstrats a multi-disciplinary, coordinated solution designed to facilitatecare transition and improve health outcomes for olderpeople with multidimensional health needs [4].Published programmes utilising the GEM in Australia

have shown promising results, including the Victorian

Hospital Admission Risk Program, which reported 35%fewer Emergency Department (ED) attendances, 52%fewer admissions and 41% fewer days in hospital [5]. Simi-larly, the Reengineered Hospital Discharge Program [6],Better Outcomes for Older Adults Through Safe Transi-tions and State Action on Avoidable Re-hospitalisationsprogrammes have shown improvements in reducing hos-pital readmissions and hospital utilisation such as lengthof stay [7]. The Geri-FITT model of care which involves a‘floating interdisciplinary geriatric team’ to providecontinuity of care through developing and facilitatingtransitional care plans and educating patients and careproviders about geriatric care principles has demonstratedimproved quality care transitions and greater patient satis-faction [8].The most similar study to the one proposedhere was the ‘Patients First Model of Care’, which targetedpeople over 55 years old who frequently presented to theED or were at risk of presenting to the ED. This studyinvolved a comprehensive needs assessment by acommunity-based care facilitator, with care coordinationand facilitation of access to a suite of services including al-lied health therapies where required. Findings from thiscommunity coordinated study reported a 27.9% reductionin hospital admissions and a 19.2% reduction in bed dayswithout increasing overall costs to the health system [9].Recent research on care transitions of older people

across acute, sub-acute and primary care identified under-utilisation of the GEM model in a community setting innorth-eastern Australia [4]. In this region, an integratedmodel of comprehensive geriatric assessment, care coord-ination and rehabilitation is currently only available forhospital in-patients, with no preventative services availableto prolong independent community living. Furthermore,sub-acute services for community-dwelling older personsare found to be fragmented; the access to health pathwaysis unclear, potentially leading to a perverse incentive forhospital admissions to access in-patient geriatric services.This trial aims to address the gap by delivering and

evaluating a comprehensive, multidimensional geriatricassessment with care coordination in a community set-ting. The Older Persons ENablement And Rehabilitationfor Complex Health conditions (OPEN ARCH) model ofcare evolved from an initial study that explored patientwell-being post hospitalisation [10]. That completedstudy examined patients’ transition back to primaryhealthcare and their access to allied health and social

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support services within the community [10]. Thiscurrent OPEN ARCH intervention builds on previousresearch [4, 10] and extends the service to preventativeservice delivered in a community setting; it creates a dir-ect path from a general practitioner (GP) to acommunity-based geriatrician-led Healthy Ageing Clinicfor comprehensive interdisciplinary assessment and careplanning. The OPEN ARCH intervention will facilitatetimely access to primary healthcare, including alliedhealth services and social supports within the commu-nity. It is envisaged that the OPEN ARCH interventionwill delay health decline by increasing individualcapacity, when supported by a team of communityhealthcare professionals, who monitor and manage thecommunity-dwelling complex older patients within thecommunity. Such coordinated care support is expectedto reduce the likelihood of the aforementioned cascadeof events that leads to hospitalisation, and eventual lossof independence following hospital discharge.

ObjectivesThe objective of the study is to assess the acceptability ofthe OPEN ARCH intervention and its impact on the healthand quality of life outcomes, health and social services util-isation of older people with multiple chronic conditionsand emerging complex care needs. An economic evaluationwill determine whether OPEN ARCH is cost-effective whencompared to the standard care. In particular, this study willaddress the following research questions:

� Does the OPEN ARCH intervention result inreduced hospital care demand as measured byEmergency Department (ED) presentations, hospitaladmissions and in-patient bed days?

� Does the OPEN ARCH intervention result inreduced functional decline and dependency, andenable patients to live in the community for longer?

� Does the OPEN ARCH intervention result in animproved quality of life for participants?

� Is the OPEN ARCH intervention considered byparticipants to be an acceptable model of care?

� Is the OPEN ARCH intervention a cost-effectivemeans to achieving better health and quality of lifeoutcomes for at-risk older persons when comparedto standard care?

MethodsThe items in this study protocol comply with the Stand-ard Protocol Items: Recommendations for InterventionalTrials (SPIRIT) checklist (see the SPIRIT Checklist andfigure in Additional file 1 and Fig. 1) [11, 12]. Adherenceto SPIRIT allows transparency and completeness of thetrial protocol for the benefit of investigators, trial

participants, research ethics committees and other keystakeholders [11].

Study settingThe study will be conducted at two sites in Far NorthQueensland (Australia): Cairns and Kuranda. Cairns is aregional centre on the north-east coast of Australia witha population of 160,285, of whom 11.6% are over the ageof 65 years [13]. Kuranda is a rural community adjacentto Cairns in the north-west with a population of 4684, ofwhom 16.4% are over the age of 65 years [14].

Trial designA multicentre, randomised controlled trial using a steppedwedge cluster design with repeated cross-sectional sampleswill be utilised to measure participants’ acceptability of themodel, health outcomes, services utilisation and economicviability of the OPEN ARCH intervention (see Fig. 2).The stepped wedge design allows all participants to re-

ceive the intervention, which is the preferred method-ology for studies where the intervention is predicted todo more good than harm [15]. It allows patients to actas their own controls and detect trends and changesassociated with time [15, 16].

Recruitment of general practitionersThe OPEN ARCH intervention builds on a successfulcollaboration between Cairns and Hinterland and Hos-pital and Health Service clinicians with local GP prac-tices. Individual GPs with an interest in geriatrics will beapproached via clinical and professional networks to par-ticipate in the study. A minimum of 10 GPs within theCairns area (urban) and the Cairns Hinterland region(rural) will be approached to participate in the study.The project manager will conduct informed consent forthe GP to participate.

Randomisation of general practitionersAll recruited GPs will be randomised as ‘clusters’ atbaseline using simple randomisation [17]. Such clusterrandomisation allows control for the ‘between GPs vari-ance’. A minimum of two clusters (two GPs) will becommencing the intervention at each step, as per therecommendations of Barker et al. [16], to ensure thatthe intervention effect estimator maintains the nominal5% significance level and is reasonably unbiased. Allclusters will ultimately receive the intervention for thesame length of time.

StaffingFor the purposes of this study, the following staffing willbe recruited: a project manager, who will facilitate GPengagement, patient recruitment and consent, data col-lection, data management and reporting; a community-

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embedded specialist in geriatric medicine to provide com-prehensive geriatric assessments and management plans atthe GPs’ rooms; and two community-based care coordina-tors (enablement officers), who will facilitate access tohealthcare services, social supports and self-management

options. These positions are solely community embed-ded, designed to coordinate hospital-based specialistgeriatric and other primary care services, such as so-cial care services, allied health and rehabilitationservices.

Fig. 1 Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) figure of the Older Persons ENablement And Rehabilitation forComplex Health conditions (OPEN ARCH) intervention

Fig. 2 Schematic of the study design. Adapted from Hemming et al. [38]

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Participants’ eligibility criteriaSample sizeBird et al. [5] reported suitable comparative outcomesfrom a similar study. Following the stepped wedge studydesign with repeated cross-sectional samples recommen-dations of Barker et al. [16] and the applied parametersof Bird et al. [5], at least two clusters will be randomisedat each step to ensure the nominal 5% significance level.Bird et al. [5] reached statistical significance using ANO-VAs and t tests over three measures: ED presentations,hospital admissions and bed days. Pre verses post im-provement for these three measures was 10%, 25% and18% respectively. Following consultations with clinicaland statistical experts, a conservative effect size acrossED and in-patient services utilisation of 9%, a 10%intra-cluster correlation and between-cluster variationsof 30% were assumed for the current study. The inter-vention will be staged in steps, each with at least twoclusters/GPs, totalling a minimum of 10 GPs (clusters),who will each recruit 10–12 participants to the study.Allowing for 25% censoring, a sample size of 120 partici-pants will be required, which will provide 80% power todetect a 9% difference (effect size) in service utilisationwith statistical significance at the 5% level. The studydesign incorporates the effects of ‘time’. Sample sizecalculations were performed using the stepped wedgecommand in STATA 15 [18].

Participant recruitmentThe treating GP, enrolled in the study, will select patientsbased on set eligibility criteria. The GP will discuss thestudy with individual patients and invite them to provideverbal consent to be contacted by the project manager tofurther discuss the project. The project team will arrangea time to meet with interested participants to discuss theOPEN ARCH intervention and study requirements, invit-ing them to provide informed consent for inclusion in thestudy. Participants who do not wish to provide consentfor inclusion in the OPEN ARCH intervention may stillaccess specialist geriatric assessment via the existingCairns Hospital Outpatient referral pathway, but they willnot be offered access to the OPEN ARCH communitycare coordination or a geriatric assessment at their GPpractices.Participation in this study is voluntary. Patient par-

ticipants will be informed that they can withdraw atany time without giving a reason and that refusal toparticipate will not have any impact on their currentor future access to geriatric or GP services. If re-quested by the participant, any information they mayhave provided will be withdrawn from the study. It isnot anticipated that GPs will withdraw their consentto participate in the study. However, should a GPmove their practice or retire, their patient participants

will also be withdrawn from the study and they willnot be invited to participate in any further data col-lection. Routine geriatric assessments will still beavailable to all patients via the usual outpatient refer-ral system and any links with services initiated by en-ablement officers may continue independently of theOPEN ARCH intervention.

Inclusion criteriaTo be eligible to enter the study, participants must meetthe following criteria:

� A community-dwelling older person with chronicconditions and complex care needs, defined as hav-ing multiple morbidities or a social situation thatrequires the attention of multiple healthcareproviders or facilities,○ who is 70 years or older for non-Aboriginaland Torres Strait Islander participants, or 50 yearsor older for Aboriginal and Torres Strait Islanderparticipants; or○ who is younger than the previous age criteriabut has documented chronic or complex age-related conditions (previously only associated witholder persons), such as early-onset dementia orarthritis, or another condition.

Exclusion criteria

� Residents of residential aged care facility or nursinghomes.

� Currently receiving specialist geriatricianintervention and/or care coordination, such as theTransition Care Program.

Intervention and comparisonThe OPEN ARCH intervention has two components:fast-track specialist geriatric assessment via a community-based referral to a geriatrician in local GP practices; and anenablement service offering coordination and implementa-tion of health and social care services customised to patientneed in the community. The OPEN ARCH interventionwill be delivered within primary healthcare. Patients whoare deemed eligible by GP screening evaluation and meetinclusion criteria will be invited to provide informedconsent.During the first interview and assessment, the geriatri-

cian will provide an in-depth, standardised comprehensivegeriatric assessment (CGA), a multi-dimensional, interdis-ciplinary process used to quantify an older individual’smedical, psychosocial and functional capabilities, includ-ing diagnosis, identification of problems, goal-setting andforming an individualised comprehensive managementplan for holistic treatment, rehabilitation, support and

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follow up [19]. Alternatively, if the participant is unable toattend the assessment at the practice, a geriatrician willoffer a home visit. The type and number of referrals toprimary allied healthcare professionals and communitysupport services will be determined by individual clinicalneeds and delivered in the community (GP, allied healthpractice or community health centre) or at home. Exam-ples of allied health services that will be offered include:occupational therapy, physiotherapy, dietetics and socialwork. Community social support services such as personalcare assistance, meals and domestic assistance will be ar-ranged through My Aged Care and community healthproviders.Upon completion of the initial interview and assess-

ment, the geriatrician and enablement officer will meetwith GP via face-to-face case conferencing, to completethe CGA with recommendations. The following Medi-care Benefits Schedule (MBS) items will be available toGPs to claim: Item Numbers 735, 739 and 743 [20].Based on the CGA recommendations, the enablement

officer will meet with participants to develop individualcare plans. The enablement officer, who is an advancedhealth professional specialising in aged care, will furthercoordinate the participant’s community care by linkingthem with existing services. Although a registered clin-ician, their role is not to provide discipline specific ser-vices, but rather to draw on existing public, private andnon-government allied health, nursing and social sup-port services available in the community to facilitatecare coordination goals. All participants will continueto consult with their GPs for usual medical care.The baseline (pre-intervention or standard care) level of

service provision for older patients includes referrals tothe Cairns Hospital Outpatient clinic without multidiscip-linary care coordination or referral to teams, such as theAged Care Assessment Team.

BlindingAs OPEN ARCH requires active involvement, itwould not be possible to blind participants or GPs(clusters), nor enablement officers or the project man-ager [15]. Participants and GPs will be required tomake an informed decision for consent, so they willhave full disclosure available prior to the consent. En-ablement officers providing clinical care will have fullknowledge of the participants’ health status through-out the study period. Similarly, the project manager,who will be required to enter the data, will remainun-blinded throughout the study. However, every at-tempt will be made to blind outcome assessors inorder to reduce information or ascertainment bias[21]. Directly asking outcome assessors which inter-vention they think was administered will judge thesuccess of blinding.

Clinical outcomesPrimary outcome measuresThe primary outcome is service utilisation including:Emergency Department (ED) presentations, hospital ad-missions, in-patient bed days, allied health and supportservices utilisation. Hospital and ED data will be ex-tracted from Queensland Health routinely collectedcomputerised patient activity records. The number andtype of appointments with the primary care physicianand community-based allied health, nursing and socialsupport services will be collated from medical clinic re-cords kept by the engagement officers. A purpose-builtdata input form will be used to collate health and sup-port service usage.

Secondary outcomes measuresSecondary outcomes will comprise: functional status asmeasured by the Functional Independence Measure [22]and Seniors at Risk (ISAR) screening tool [23]; quality oflife (QoL) as measured by EQ-5D-5L [24] and AQOL-8D[25]; and patient experience of the OPEN ARCH interven-tion collected via the PSQ-18 questionnaire [26]. The sec-ondary outcomes data collection will be shared betweenthe project manager and engagement officers.

Statistical methods to assess intervention effectThe primary outcome measures, including EmergencyDepartment (ED) presentations, hospital admissions,in-patient bed days, allied health and support servicesutilisation, will be analysed as panels between each cross-sectional time point of the stepped wedge design, compar-ing primary outcomes within and between clusters. Eachcross-section will include participants undertaking theintervention as well as those receiving standard care (pre--intervention component). In addition to assessing inter-vention effects, the stepped wedge design can also modelthe effects of time to determine whether the time of inter-vention (intervening early versus intervening late) impactsthe effectiveness of the intervention. Secondary outcomemeasures, including functional status, ISAR and QoLmeasures, will be compared for the pre versus post inter-vention periods, for each participant, and thus the partici-pants will act as their own control. Participants’experience of the OPEN ARCH intervention as measuredby the Likert scale responses will be analysed using de-scriptive statistics.Within-cluster and between-cluster variance, treat-

ment outcomes for intervention versus pre-intervention,across time, will be examined by applying a generalisedlinear mixed model (GLMM), as recommended for smallcluster designed stepped wedge studies [16]. GLMMmodels can be adjusted for unequal numbers withinclusters and cope with non-parametric data distribu-tions. Within the GLMM, primary and secondary

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outcomes will be assessed against time and interventionstatus, represented as fixed effects, while study clustersand clients will be represented in the model as randomeffects [16]. Secondary outcome analyses will include ttests (for continuous data), chi-square tests (for propor-tions) and GLMMs where applicable, to control fordemographic differences. All statistical tests will betwo-sided and performed using a 5% significance levelwith no adjustment for multiplicity. Data analysis will beperformed using STATA version 15 [18].

Economic evaluationThe economic research question is whether the OPENARCH intervention is cost-effective in reducing hospitalutilisation and enhancing health-related quality of lifewhen compared to the standard care. The perspectivefor the evaluation model will be a healthcare provider inthe Australian setting [27].Costs of the intervention will be incurred during the

CGA and management. The CGA and managementcosts include the average time with each participant ofdifferent personnel, such as a GP, community-embeddedspecialist in geriatric medicine and community-basedcare coordinator. Costs of consecutive ED presentations,hospital admissions and hospital length of stay will beincluded. The cost of the pre-intervention care will in-clude healthcare services utilisation before the initial GPconsultation and CGA. Trial initiation, patient accrualand pre-screening activities as well as research andevaluation costs will be recorded and reported separately[28, 29].Resources will be measured on a patient-specific basis

obtained from the purpose-built data input form collatedby the project manager from routinely collected compu-terised patient activity records and medical clinic re-cords, following informed consent processes. Utilisationof objective data is known to eliminate patient recall biasand reduce the amount of missing data [30]. The cost ofthe time will be derived from a log of time spent on dir-ect patient care activities. A top-down approach will beused to value resource use for capital and operatingcosts. Healthcare resource use data will be valued usingAustralian Independent Hospital Pricing Authoritystandard costs [31] reported in 2018 AUS$.QALYs will be generated using a multi-attribute utility in-

strument, the EuroQoL 5-Dimension (EQ-5D-5L) scale[24]. This standardised, five-item descriptive system and vis-ual analogue scale measures mobility, self-care, pain, usualactivities and anxiety, and contributes to a ‘utility’ score. TheAQOL-8D [32] instrument will be used to generate alterna-tive QALYs. The AQOL-8D consists of eight dimensions:physical, including independent living, senses and pain; andpsycho-social, including mental health, happiness,self-worth, coping and relationships. Utility weights for the

AQOL were generated using the time-trade-off techniqueand Australian population sample. Due to its robust psycho-metric properties, the AQOL is recommended for use in ep-idemiologic studies where health-related QoL and utilitydata are required from older populations [33]. The AQOLhas been used in Australian community older persons andIndigenous Australians studies [25].The time horizon of the economic analysis will incorp-

orate the lifetime of the cohort, through extrapolation ofquality-adjusted survival from the end of the study period.A discount rate of 5% per year will be applied to bothcosts and outcomes [34]. The difference in costs andQALYs, between the intervention and pre-interventionperiods, will be combined into the incremental cost-effect-iveness ratio (ICER) with valuations of the willingness topay for a marginal QALY to estimate the net monetarybenefits for a decision to adopt the intervention:

ICER ¼ CostInt−CostPre− int

QALYInt−QALYPre− int;

where CostInt(CostPre − int) and QALYInt (QALYPre − int) arethe mean cost and QALYs gained in the intervention (pre-intervention) periods, respectively. The maximum willing-ness to pay for a QALY will be assumed to beAUS$64,000 for the Australian setting [35]. The Markovstate transition process will be applied to model partici-pants’ probability of being readmitted to hospital, stayingin the community or dying [36]. Sensitivity analysis will beperformed to test variations in key parameters includingthe study perspective, the choice of the comparator andspecific cost impacts.

Frequency of analysesAll data will be collected at baseline ‘0’ with retrospect-ive collection for 3 months to time point ‘– 1’, followingevery 3 months of data collection, at time points ‘1’, ‘2’and ‘3’ (see Fig. 2), except for participants’ experiences,which will be collected at the end of the study period.

Ethical issuesThe human rights and dignity of the participants will beprotected in accordance with Australia’s National HealthMedical Research Council (NHMRC) guidelines [37].Participants will not receive any financial inducement toparticipate. Participants will be provided with contactdetails of the project team to enable them to address anypotential queries or concerns. Aboriginal and TorresStrait Islander participants will be offered the opportun-ity to have an Aboriginal and Torres Strait Islander Li-aison Officer or Health Worker present during theirCGA and care plan development. To conform to theData Protection and Freedom of Information Act, alldata will be stored securely and de-identified for the

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analysis. GPs will have access to the information relatedto the delivery of the study, including geriatric and en-ablement officer assessment, planning and progressnotes. These documents will be sent securely to the GPto be uploaded to the patient’s medical record. Addition-ally, as a specialist medical officer, the geriatrician willhave access to the GP medical notes into which they willwrite a summary of geriatric assessment, at the time ofclient appointment. All aspects of the assessment andpatient care planning will be discussed with the GP atthe case conference. Participants will be informed oftheir right to access their own results, and the overall re-sults of the research. No published material will containpatient identifiable information. Any complaints will besystematically recorded and acted upon in accordancewith NHMRC guidelines [37].

DiscussionThe OPEN ARCH intervention is based on the geriatricevaluation and management (GEM) model of care. It buildson previous work that explored patient experiences of transi-tions from the GEM service to primary healthcare [4]. Thissuccessful study noted, upon conclusion, that further im-provements to geriatric care could be made by offering earlyintervention and prevention through improved screeningand comprehensive assessment in primary care [10].Thus, this proposed OPEN ARCH study has been de-

signed to address the deficit identified within the originalhospital discharge model, through the provision of acommunity facing preventative care. By providing thecare in the community, condition deterioration can bedetected earlier and enable timely planning for perman-ent residential aged care placement, where needed, redu-cing the likelihood of unexpected hospital admissionsfrom community-residing patients. Furthermore, withfewer hospitalisations, older people are likely to achievebetter well-being outcomes if they remain living inde-pendently and well supported in the community [2].The feasibility and sustainability of the OPEN ARCH

intervention are ensured by the placement of the inter-vention within primary care settings and MBS fundingavailable to GPs (Item Numbers 735, 739, 743); utilisa-tion of case conferencing and shared medical records.Further, providing knowledge translation, education andsupport with system navigation skills to both GPs andpractice nurses will ensure a long-term solution to issuesrelated to system functioning and integration. This trialwill determine the impact of the OPEN ARCH interven-tion on the health and quality of life outcomes, healthand social services utilisation of older people who havemultiple chronic conditions and emerging complex careneeds. The trial will involve an economic evaluation todetermine whether the model can be consideredcost-effective when compared to the standard care.

LimitationsThe study populations are, by definition, at risk of naturalfunctional and cognitive decline that may be marked overthe study period. Although the study design applies mul-tiple methods to best capture intervention effects, thebenefits in slowing down deterioration may not be suc-cessful in some participants due to their frailty. Within thequantitative methods are cross-sectional and case–control(pre–post intervention) analysis, which will assess betweenand within clusters differences. The pre–post analyses willutilise paired analyses where each participant acts as theirown control. These methods plus the inclusion of qualita-tive surveys should tease out even minor benefits ofOPEN ARCH, when presented with accelerated decline.The sample size calculation has allowed attrition, so thesefactors should allow statistical significant effect size withinOPEN ARCH achievable.

Trial statusIn November 2018, the study was 6 months postbaseline.

Additional file

Additional file 1: SPIRIT 2013 Checklist: Recommended items to addressin a clinical trial protocol and related documents (DOC 121 kb)

AbbreviationsCGA: Comprehensive geriatric assessment; CHHHS: Cairns and HinterlandHospital and Health Service; ED: Emergency Department; GEM: Geriatricevaluation and management; GP: General practitioner; ICER: Incrementalcost-effectiveness ratio; NHMRC: National Health Medical Research Council;OPEN ARCH: Older Persons ENablement And Rehabilitation for ComplexHealth conditions; QALY: Quality adjusted life year; QoL: Quality of life;SPIRIT: Standard Protocol Items: Recommendations for Interventional Trials;TCHHS: Torres and Cape Hospital and Health Service

FundingThis study is funded by the Queensland Health Integrated Care InnovationFund, supported by Cairns and Hinterland Hospital and Health Service,Northern Queensland Primary Health Network, and Torres and Cape Hospitaland Health Service.

Availability of data and materialsThe datasets generated and/or analysed during the current study are notpublicly available and could be made available from the correspondingauthor upon reasonable request. This process is required as the data aregoverned by state and federal health organisations.

Authors’ contributionsES conceived of the project and was in charge of overall direction andplanning. IK and SJ took the lead in writing the manuscript. IK designed theeconomic evaluation. JM was the project manager. RQ, DH and CMDprovided critical feedback and helped shape the study and manuscript. Allauthors read and approved the final manuscript.

Authors’ informationIK is a Senior Postdoctoral Fellow in Health Economics at the Centre forIndigenous Health Equity Research, School of Health, Medical and AppliedSciences at CQUniversity and an Adjunct Senior Research Fellow at theCairns Institute, James Cook University.SJ is an Epidemiologist, currently employed in project management withTorres and Cape Hospital and Health Service, and is also an Adjunct

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Research Fellow at the Cairns Institute, James Cook University andCQUniversity.JM is OPEN ARCH project manager at Cairns and Hinterland Hospital andHealth Service.RQ is an Older Persons Liaison Service clinician at Cairns and HinterlandHospital and Health Service, and a research officer within the Health AgeingResearch Team (HART) at James Cook University.DH is a Health Practitioner Principal Research Fellow at Cairns and HinterlandHospital and Health Service.CMD is a Professor in Health Economics at the Centre for Indigenous HealthEquity Research and School of Health, Medical and Applied Sciences atCQUniversity.ES is a Clinical Director, Older Persons, Sub-acute and Rehabilitation (OPSAR)Cairns and Hinterland Hospital and Health Service, and an Adjunct AssociateProfessor at James Cook University.

Ethics approval and consent to participateThis study has received approval from the Far North Queensland HumanResearch Ethics Committees (HREC/17/QCH/104-1174). The study will becarried out in compliance with national and state legal and regulatoryrequirements; and according to the Australian Medical Association Code ofEthics and the International Principles of Good Clinical Practice (ICH-GCP).Any modifications to the protocol, which may impact on the conduct of thestudy, including changes of study objectives, study design, population,sample sizes, study procedures or significant administrative aspects, will bemade in agreement with the ethics committees prior to implementation[11]. Administrative changes of the protocol, as minor corrections and/orclarifications that have no effect on the study, will be agreed upon by theresearch steering committee and documented in a memorandum [11]. Theresearch steering committee will meet every second month to review theprogress and any potential safety considerations that arise during the courseof the OPEN ARCH trial with research governance provided by both theCHHHS and the TCHHS Governance Committees.

Consent for publicationNot applicable. Published data will be aggregated and de-identified.

Competing interestsThe authors declare that they have no competing interests.

Publisher’s NoteSpringer Nature remains neutral with regard to jurisdictional claims inpublished maps and institutional affiliations.

Author details1Centre for Indigenous Health Equity Research and School of Health, Medicaland Applied Sciences, CQUniversity, Cairns, QLD, Australia. 2The CairnsInstitute, James Cook University, Cairns, QLD, Australia. 3Medical Services,Torres and Cape Hospital and Health Service, Cairns, QLD, Australia. 4Cairnsand Hinterland Hospital and Health Service, Cairns, QLD, Australia. 5Collegeof Medicine and Dentistry, James Cook University, Cairns, QLD, Australia.6Division of Tropical Health and Medicine, James Cook University, Cairns,QLD, Australia.

Received: 4 December 2017 Accepted: 3 November 2018

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