Efficacy and cost-effectiveness of a community based model of care for older patients with complex needs: a study protocol for a multicentre randomized controlled trial using a stepped wedge cluster design

The Older Persons ENablement And Rehabilitation for Complex Health conditions (OPEN ARCH) model of care intervention extends the Geriatric Evaluation and Management (GEM) model of care and enables a direct path from General Practitioners (GP) to a community based geriatrician for comprehensive interdisciplinary assessment and care management. OPEN ARCH then facilitates timely access to the most appropriate care in the community that if provided early, could enable the older person’s health to be supported such that they can remain living in the community and not require hospital attendance or admission. The OPEN ARCH intervention have two components: 1) fast track specialist geriatric assessment via a community based referral to a geriatrician in local GP practices; and, 2) an enablement service offering the coordination and implementation of health and social care services customised to patient need in the community. The OPEN ARCH intervention will be delivered within primary health care. Patients who are deemed eligible by GP screening evaluation and meet inclusion criteria will be requested to provide informed consent. Those who agree to participate will be fast-tracked, within 1-2 weeks, for a consultation with a specialist geriatrician. It is worth noting that participants will have access to this assessment via their GP, this will avoid the expected wait-times associated with standard access via hospital ‘out-patients’. A CGA will be conducted with their GP within the first phase of the intervention period. Alternatively, if a participant is unable to attend the assessment at the practice, a geriatrician will offer a home visit. During the first interview and assessment, the geriatrician will provide an in-depth, standardised CGA, a multi-dimensional, interdisciplinary process used to quantify an older individual's medical, psychosocial and functional capabilities, including diagnosis, identification of problems, goal setting, and forming an individualised comprehensive management plan for holistic treatment, rehabilitation, support and follow up. The type and number of referrals to primary allied health care professionals and community support services will be determined by individual clinical needs and delivered in the community (GP, allied health practice or community health centre) or at home. Examples of allied health services that will be offered include: occupational therapy, physiotherapy, dietetics and social work. Community social support services such as personal care assistance, meals and domestic assistance will be arranged through My Aged Care and community health providers. Based on recommendations from the CGA, the enablement officer will meet with participants to develop individual care plans. The enablement officer, who is an advanced health professional specialising in aged care, will further coordinate participant’s community care by linking them with existing services. Although a registered clinician, their role is not to provide discipline specific services, but rather draw on existing public, private and non-government allied health, nursing and social support services available in the community to facilitate care coordination goals. All participants will continue to consult with their GP for usual medical care. Location The study will be conducted at three sites in Far North Queensland (Australia): Cairns, Kuranda and Weipa. Twelve GPs will be recruited and randomised as ‘clusters’ at baseline using simple randomization. Each GP cluster will then recruit 10-12 participants. Recruitment of GPs The OPEN ARCH intervention builds on a successful collaboration between Cairns and Hinterland and Hospital and Health Service clinicians with local GP practices. Ten GPs within the Cairns area (urban) and the Cairns Hinterland region (rural) and Weipa (remote) will be approached to participate in the study. The project manager will conduct informed consent for the GP to participate in the study. Randomisation of GPs All GPs (n=12) will be randomised as ‘clusters’ at baseline using simple randomisation. Such cluster randomisation allows control for the ‘between GPs variance’. Two clusters will be commencing the intervention at each step, as per recommendations of Barker et al, 2017, to ensure that the intervention effect estimator maintains the nominal 5% significance level and is reasonably unbiased. All clusters will ultimately receive the intervention for the same length of time. Participants recruitment The treating GP, enrolled in the study, will select patients based on set eligibility criteria. The GP will discuss the study with individual patients and invite them to provide verbal consent to be contacted by the project manager to further discuss the project. The project team will arrange a time to meet with interested participants to discuss the OPEN ARCH intervention and study requirements, inviting them to provide informed consent for inclusion in the study. Participants who do not wish to provide consent for inclusion in the OPEN ARCH intervention may still access specialist geriatric assessment via the existing Cairns Hospital Outpatient referral pathway, but they will not be offered access the OPEN ARCH community care coordination offered by the enablement officers, or a geriatric assessment at their GP clinic. Participation in this study is voluntary. Patient participants will be informed that they can withdraw at any time without giving a reason and that refusal to participate will not have any impact on current or future access to geriatric or GP services. If requested by the participant any information they may have provided will be withdrawn from the study. We do not anticipate that GPs will withdraw their consent to participate in the study. However, should a GP move their practice or retire, then their patient participants will also be withdrawn from the study and they will not be invited to participate in any further data collection. Routine geriatric assessments will still be available to all patients via the usual outpatient referral system and any links with services initiated by the enablement officer may continue independently of the OPEN ARCH intervention. Staffing For the purposes of this study the following staffing will be recruited: 1) a program manager, who will facilitate GP engagement, patient recruitment and consent, data collection, data management and reporting. 2) A community embedded specialist in geriatric medicine to provide comprehensive geriatric assessments and management plans at the GPs rooms. 3) Two community based care coordinators (enablement officers), who will facilitate access to health care services, social supports and self-management options. These positions are solely community embedded, designed to coordinate hospital based specialist geriatric and other primary care services, such as social care services, allied health and rehabilitation services. Frequency of analyses All data will be collected at Baseline ‘0’ with retrospective collection for three months to ‘-1’, following every three months data collection, at the time points ‘1’, ‘2’, and ‘3’, except for participant’ experiences which will be collected at the end on the study period.