Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 10:55 PM
Study NCT ID:
NCT06901167
Status:
RECRUITING
Last Update Posted:
2025-05-30
First Post:
2025-03-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of a Residential In-Reach Program in Regional and Rural Australia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000208', 'term': 'Acute Disease'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This will be a stepped-wedge trial, in which all enrolled facilities and participants will receive the same intervention, but the intervention roll-out will be conducted in a sequential manner based on a randomised order. During the 14 months of the trial, all facilities and participants will receive the same intervention, but for different lengths of time depending on the randomisation.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-25', 'studyFirstSubmitDate': '2025-03-04', 'studyFirstSubmitQcDate': '2025-03-23', 'lastUpdatePostDateStruct': {'date': '2025-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of times the residential in-reach program is utilised', 'timeFrame': 'From enrolment to the end of the trial for 14 months', 'description': 'Cost-effectiveness outcome: number of times the RACHs enrolled in this trial utilises the residential in-reach program, both in-person and via telehealth.\n\nCollection schedule:\n\n* Once at the end of the evaluation\n* At the level of each residential aged care home each month Collection approach: Extraction from hospital records'}, {'measure': 'Number of times the Victorian Virtual Emergency Department is utilised', 'timeFrame': 'From enrolment to the end of the trial for 14 months', 'description': 'Cost-effectiveness outcome: number of times the RACHs enrolled in this trial uses the Victorian Virtual Emergency Department.\n\nCollection schedule:\n\n* Once at the end of the evaluation\n* At the level of each residential aged care home each month Collection approach: Extraction from residential aged care home records'}, {'measure': 'Number of times that the general practitioner is utilised', 'timeFrame': 'From enrolment to the end of the trial for 14 months', 'description': 'Cost-effectiveness outcome: number of times that the RACHs enrolled in this trial consults the general practitioner, both in-person and via telehealth, including in and out of hours consultations.\n\nCollection schedule:\n\n* Once at the end of the evaluation\n* At the level of each residential aged care home each month Collection approach: Extraction from residential aged care home records'}, {'measure': 'Number of calls to Ambulance Victoria', 'timeFrame': 'From enrolment to the end of the trial for 14 months', 'description': 'Cost-effectiveness outcome: number of times the RACHs enrolled in this trial calls an ambulance for their residents.\n\nCollection schedule:\n\n* Once at the end of the evaluation\n* At the level of each residential aged care home each month Collection approach: Extraction from residential aged care home records and Ambulance Victoria records'}, {'measure': 'Number of transfers to hospital via Ambulance Victoria', 'timeFrame': 'From enrolment to the end of the trial for 14 months', 'description': 'Cost-effectiveness outcome: number of times that Ambulance Victoria transfers a resident from one of the RACHs enrolled in this trial to hospital.\n\nCollection schedule:\n\n* Once at the end of the evaluation\n* At the level of each residential aged care home each month Collection approach: Extraction from residential aged care home records and Ambulance Victoria records'}], 'primaryOutcomes': [{'measure': 'Rate of presentations from residential aged care homes to emergency departments and emergency care centres', 'timeFrame': 'From enrolment to the end of the trial for 14 months', 'description': 'Primary clinical effectiveness outcome\n\nCollection schedule:\n\n* Once at the end of the evaluation\n* At the level of each residential aged care home presentation to hospital each month Collection approach: Extraction from hospital records and extraction from residential aged care home systems'}], 'secondaryOutcomes': [{'measure': 'Days spent in hospital by aged care home resident', 'timeFrame': 'From enrolment to the end of the trial for 14 months', 'description': 'Secondary clinical effectiveness outcome\n\nCollection schedule:\n\n* Once at the end of the evaluation\n* At the level of each residential aged care home presentation to hospital each month Collection approach: Extraction from hospital records and extraction from residential aged care home systems'}, {'measure': 'Location of mortality in hospital', 'timeFrame': 'From enrolment to the end of the trial for 14 months', 'description': 'Secondary clinical effectiveness outcome\n\nCollection schedule:\n\n* Once at the end of the evaluation\n* At the level of each residential aged care home presentation to hospital each month Collection approach: Extraction from hospital records and extraction from residential aged care home systems'}, {'measure': 'Number of barriers to residential-in-reach program implementation', 'timeFrame': 'From enrolment to 1 month after the end of the trial, for 15 months', 'description': 'Secondary implementation outcome - collected once via semi-structured interviews with key stakeholders (health service staff, residential aged care home staff).'}, {'measure': 'Number of enablers to residential-in-reach program implementation', 'timeFrame': 'From enrolment to 1 month after the end of the trial, for 15 months', 'description': 'Secondary implementation outcome - collected once via semi-structured interviews with key stakeholders (health service staff, residential aged care home staff).'}, {'measure': 'Stakeholder reported feasibility of the residential-in-reach program implementation', 'timeFrame': 'From enrolment to 1 month after the end of the trial, for 15 months', 'description': 'Secondary implementation outcome - collected once via semi-structured interviews with key stakeholders (health service staff, residential aged care home staff).'}, {'measure': 'Stakeholder reported acceptability of the residential in-reach program', 'timeFrame': 'From enrolment to the end of the trial for 14 months', 'description': 'Secondary implementation outcome - collected via semi-structured interviews with key stakeholders (health service staff, residential aged care home staff, general practitioners, aged care home residents) after occasions of service on a monthly basis.'}, {'measure': 'Stakeholder reported appropriateness of the residential in-reach program', 'timeFrame': 'From enrolment to the end of the trial for 14 months', 'description': 'Secondary implementation outcome - collected via semi-structured interviews with key stakeholders (health service staff, residential aged care home staff, general practitioners, aged care home residents) after occasions of service on a monthly basis.'}, {'measure': 'Number of aged care staff who attend education sessions for the use of the residential in-reach program', 'timeFrame': 'From enrolment to the end of the trial for 14 months', 'description': 'Secondary implementation outcome - recorded attendance of education sessions for residential aged care home staff for the use of the residential in-reach program.'}, {'measure': 'Number of adaptations made to the residential in-reach program', 'timeFrame': 'From enrolment to the end of the trial fo', 'description': 'Secondary implementation outcome - documented adaptations made to the program during the trial period.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['stepped-wedge trial', 'residential aged care home', 'residential in reach', 'hospital avoidance'], 'conditions': ['Aged', 'Acute Disease']}, 'referencesModule': {'references': [{'pmid': '32690008', 'type': 'BACKGROUND', 'citation': 'Sunner C, Giles MT, Parker V, Dilworth S, Bantawa K, Kable A, Oldmeadow C, Foureur M. PACE-IT study protocol: a stepped wedge cluster randomised controlled trial evaluating the implementation of telehealth visual assessment in emergency care for people living in residential aged-care facilities. BMC Health Serv Res. 2020 Jul 20;20(1):672. doi: 10.1186/s12913-020-05539-1.'}, {'pmid': '36081333', 'type': 'BACKGROUND', 'citation': 'Sunner C, Giles MT, Kable A, Foureur M. Experiences of nurses working in RACFs and EDs utilising visual telehealth consultation to assess the need for RACF resident transfer to ED: A qualitative descriptive study. J Clin Nurs. 2023 Aug;32(15-16):4694-4709. doi: 10.1111/jocn.16529. Epub 2022 Sep 8.'}, {'pmid': '27547277', 'type': 'BACKGROUND', 'citation': 'Lukin B, Fan LJ, Zhao JZ, Sun JD, Dingle K, Purtill R, Tapp S, Hou XY. Emergency department use among patients from residential aged care facilities under a Hospital in the Nursing Home scheme in public hospitals in Queensland Australia. World J Emerg Med. 2016;7(3):183-90. doi: 10.5847/wjem.j.1920-8642.2016.03.004.'}, {'pmid': '35012480', 'type': 'BACKGROUND', 'citation': 'Hullick C, Conway J, Hall A, Murdoch W, Cole J, Hewitt J, Oldmeadow C, Attia J. Video-telehealth to support clinical assessment and management of acutely unwell older people in Residential Aged Care: a pre-post intervention study. BMC Geriatr. 2022 Jan 10;22(1):40. doi: 10.1186/s12877-021-02703-y.'}, {'pmid': '32237279', 'type': 'BACKGROUND', 'citation': 'Haines TP, Palmer AJ, Tierney P, Si L, Robinson AL. A new model of care and in-house general practitioners for residential aged care facilities: a stepped wedge, cluster randomised trial. Med J Aust. 2020 May;212(9):409-415. doi: 10.5694/mja2.50565. Epub 2020 Apr 1.'}, {'pmid': '37916580', 'type': 'BACKGROUND', 'citation': 'Chambers D, Cantrell A, Preston L, Marincowitz C, Wright L, Conroy S, Lee Gordon A. Reducing unplanned hospital admissions from care homes: a systematic review. Health Soc Care Deliv Res. 2023 Oct;11(18):1-130. doi: 10.3310/KLPW6338.'}]}, 'descriptionModule': {'briefSummary': 'Residential In-Reach (RIR) programs are designed to provide responsive care for residents in residential aged care homes (RACH) with the aim of avoiding unnecessary hospital transfers. The evidence for their clinical and cost-effectiveness and implementation has been established in urban settings, but there is a small amount of low-quality evidence for rural and regional settings. The Grampians Region Health Service Partnership Resi-In-Reach Redesign Committee will be implementing a new RIR program to be offered to all RACHs in the Grampians region, this project aims to evaluate the clinical and cost-effectiveness of this program, and its implementation in the rural and regional setting. A stepped-wedge trial will be conducted so that as the RIR program is gradually rolled-out across the region, outcomes can be compared in the same facilities across time and between different facilities. The primary outcome measure will be presentation to emergency departments and urgent care centres, and data will also be collected on other clinical outcomes and barriers and enablers of implementing the program. It is anticipated that there will be a reduction in hospital presentations, and a range of barriers and enablers unique to the rural and regional setting will emerge.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Health services that have emergency departments and/or emergency care centres that admit residents from residential aged care homes (RACH)\n* RACHs that do not currently have access to RIR programs\n* health service staff who have been involved with the set-up and delivery of the RIR program,\n* RACH staff who have experience of or accessing the RIR service for residents at least once,\n* residents living at a RACH who has experienced receiving medical care from the RIR program and can provide informed consent, or a family member of the resident,\n* general practitioners whose case load includes residents from RACHs.\n\nExclusion Criteria:\n\n• RACHs that already have access to a RIR program will be excluded'}, 'identificationModule': {'nctId': 'NCT06901167', 'briefTitle': 'Evaluation of a Residential In-Reach Program in Regional and Rural Australia', 'organization': {'class': 'OTHER', 'fullName': 'Monash University'}, 'officialTitle': 'Evaluation of a Region-wide Residential In-Reach (RIR) Program in Regional and Rural Health Services: A Stepped-wedge Trial', 'orgStudyIdInfo': {'id': 'HREC/112397/GHSJOG-2025-462490'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Residential-in-reach', 'description': 'All enrolled residential aged care homes will be able to access the residential-in-reach (RIR) program intervention. The RIR program provides a consultation service from a central hospital to an aged care facility in the Grampians region in the state of Victoria, Australia. Aged care staff will make a telehealth referral to central hub, where a nurse practitioner will triage the patient and make recommendations (for example, monitor resident condition, more examples: comprehensive assessment for unwell residents, liaison with the General Practitioners for diagnosis and treatment plan, provide education and support to staff) or further referrals (for example, refer to geriatrician or call an ambulance).', 'interventionNames': ['Other: Residential In-Reach Program']}], 'interventions': [{'name': 'Residential In-Reach Program', 'type': 'OTHER', 'description': 'All enrolled residential aged care homes will be able to access the residential-in-reach (RIR) program intervention. The RIR program provides a consultation service from a central hospital to an aged care facility in the Grampians region in the state of Victoria, Australia. Aged care staff will make a telehealth referral to central hub, where a nurse practitioner will triage the patient and make recommendations (for example, monitor resident condition, more examples: comprehensive assessment for unwell residents, liaison with the General Practitioners for diagnosis and treatment plan, provide education and support to staff) or further referrals (for example, refer to geriatrician or call an ambulance).', 'armGroupLabels': ['Residential-in-reach']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3377', 'city': 'Ararat', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Michele Colin', 'role': 'CONTACT', 'email': 'michele.conlin@eghs.net.au', 'phone': '61 03 5352 9300'}, {'name': 'Michele Conlin', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jake Romein', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'East Grampians Health Service', 'geoPoint': {'lat': -37.28542, 'lon': 142.92728}}, {'zip': '3350', 'city': 'Ballarat', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Narelle Ryan', 'role': 'CONTACT', 'email': 'narelle.Ryan@gh.org.au', 'phone': '61 0417 590 832'}, {'name': 'Narelle Ryan', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Grampians Health', 'geoPoint': {'lat': -37.56622, 'lon': 143.84957}}, {'zip': '3373', 'city': 'Beaufort', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Andrea Flenley', 'role': 'CONTACT', 'email': 'andreaf@bshs.org.au', 'phone': '61 03 5349 1600'}], 'facility': 'Beaufort and Skipton Health Service', 'geoPoint': {'lat': -37.42996, 'lon': 143.38347}}, {'zip': '3460', 'city': 'Daylesford', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Susan Jennings', 'role': 'CONTACT', 'email': 'susan.jennings@chrh.org.au', 'phone': '61 03 5321 6500'}], 'facility': 'Central Highlands Rural Health', 'geoPoint': {'lat': -37.34113, 'lon': 144.14256}}, {'zip': '3465', 'city': 'Maryborough', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Debbie Rogers', 'role': 'CONTACT', 'email': 'drogers@mdhs.vic.gov.au', 'phone': '61 03 5461 0333'}], 'facility': 'Maryborough District Health Service', 'geoPoint': {'lat': -37.04562, 'lon': 143.73923}}, {'zip': '3418', 'city': 'Nhill', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Cheree Schneider', 'role': 'CONTACT', 'email': 'Cheree.Schneider@wwhs.net.au', 'phone': '61 03 5391 4222'}], 'facility': 'West Wimmera Health Service', 'geoPoint': {'lat': -36.33333, 'lon': 141.65006}}, {'zip': '3478', 'city': 'Saint Arnaud', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Genette Heslop', 'role': 'CONTACT', 'email': 'genette.heslop@ewhs.org.au', 'phone': '61 03 5477 2100'}], 'facility': 'East Wimmera Health Service', 'geoPoint': {'lat': -36.6168, 'lon': 143.25873}}, {'zip': '3393', 'city': 'Warracknabeal', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Joseph Bermudo', 'role': 'CONTACT', 'email': 'josph.bermudo@rnh.net.au', 'phone': '61 03 5396 1200'}], 'facility': 'Rural Northwest Health', 'geoPoint': {'lat': -36.25326, 'lon': 142.39281}}], 'centralContacts': [{'name': 'Dai Pu', 'role': 'CONTACT', 'email': 'debbie.pu@monash.edu', 'phone': '61 03 9904 4004'}, {'name': 'Catherine Huggins', 'role': 'CONTACT', 'email': 'kate.huggins@deakin.edu.au'}], 'overallOfficials': [{'name': 'Terry Haines', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Monash University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be analysed and reported on. Planned data management involves analysis and reporting of aggregated data from all participants from all sites.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Monash University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Deakin University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}