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

IntroductionAntimicrobial resistance is a growing global health threat, driven by increasing inappropriate use of antimicrobials. High prevalence of unnecessary use of antimicrobials in residential aged care facilities (RACFs) has driven demand for the development and implementation of antimicrobial stewardship (AMS) programmes. The Stepped-wedge Trial to increase antibiotic Appropriateness in Residential aged care facilities and model Transmission of antimicrobial resistance (START) will implement and evaluate the impact of a nurse-led AMS programme on antimicrobial use in 12 RACFs.Methods and analysisThe START trial will implement and evaluate a nurse-led AMS programme via a stepped-wedge cluster randomised controlled trial design in 12 RACFs over 16 months. The AMS programme will incorporate education, aged care-specific treatment guidelines, documentation forms, and audit and feedback strategies that will target aged care staff, general practitioners, pharmacists, and residents and their families. The intervention will primarily focus on urinary tract infections, lower respiratory tract infections, and skin and soft tissue infections. RACFs will transition from control to intervention phases in random order, two at a time, every 2 months, with a 2-month transition, wash-in period. The primary outcome is the cumulative proportion of residents within each facility prescribed an antibiotic during each month and total days of antibiotic use per 1000 occupied bed days. Secondary outcomes include the number of courses of systemic antimicrobial therapy, antimicrobial appropriateness, antimicrobial resistant organisms, Clostridioides difficile infection, change in antimicrobial susceptibility profiles, hospitalisations and all-cause mortality. Analyses will be conducted according to the intention-to-treat principle.Ethics and disseminationEthics approval has been granted by the Alfred Hospital Human Research Ethics Committee (HREC/18/Alfred/591). Research findings will be disseminated through peer-reviewed publications, conferences and summarised reports provided to participating RACFs.Trial registration numberNCT03941509.

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Implementation of ‘Goals of Patient Care’ medical treatment orders in residential aged care facilities: protocol for a randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2016-013909 ◽

2017 ◽

Vol 7 (3) ◽

pp. e013909 ◽

Cited By ~ 2

Author(s):

Ruth S Martin ◽

Barbara J Hayes ◽

Anastasia Hutchinson ◽

Paul Yates ◽

Wen Kwang Lim

Keyword(s):

Randomised Controlled Trial ◽

Medical Treatment ◽

Patient Care ◽

Controlled Trial ◽

Aged Care ◽

Residential Aged Care ◽

Care Facilities ◽

Aged Care Facilities ◽

Residential Aged Care Facilities ◽

Randomised Controlled

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Behavioural activation in nursing homes to treat depression (BAN-Dep): study protocol for a pragmatic randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2019-032421 ◽

2019 ◽

Vol 9 (10) ◽

pp. e032421 ◽

Cited By ~ 2

Author(s):

Diana Velasquez Reyes ◽

Hema Patel ◽

Nicola Lautenschlager ◽

Andrew H Ford ◽

Eleanor Curran ◽

...

Keyword(s):

Older Adults ◽

Depressive Symptoms ◽

Controlled Trial ◽

Aged Care ◽

Residential Aged Care ◽

Behavioural Activation ◽

Care Facilities ◽

Aged Care Facilities ◽

Residential Aged Care Facilities ◽

Randomised Controlled

IntroductionDepression is a common disorder among older people living in residential aged care facilities. Several trials have demonstrated the effectiveness of behavioural therapies in treating depressive symptoms in older adults living in the community and in residential aged care. Behavioural Activation is demonstrably effective even when delivered by non-specialists (staff without formal psychological training), although strategies for adapting its use in residential aged care facilities are yet to be explored. This study will determine whether training residential care staff in the use of a structured Behavioural Activation programme is more effective at decreasing depressive symptoms among older residents than internet-based training about depression recognition and management alone.Method and analysisThe behavioural activation in nursing homes to treat depression (BAN-Dep) trial is a pragmatic two-arm parallel clustered randomised controlled trial. It will recruit 666 residents aged 60 or older from 100 residential aged care facilities, which will be randomly assigned to the Behavioural Activation or control intervention. Staff in both treatment groups will be encouraged to complete theBeyondblueProfessional Education to Aged Care e-learning programme to improve their recognition of and ability to respond to depression in older adults. Selected staff from intervention facilities will undergo additional training to deliver an 8-module Behavioural Activation programme to residents with subthreshold symptoms of depression-they will receive ongoing Mental support from trained Behavioural Activation therapists. Outcome measures will be collected by blind research officer at baseline and after 3, 6 and 12 months. The Patient Health Questionnaire-9 is the primary outcome measure of the study.Ethics and disseminationThe trial will comply with the principles of the Declaration of Helsinki for Human Rights and is overseen by the University of Western Australia (reference RA/4/20/4234) and Melbourne Health (reference number HREC/18/MH/47) Ethics Committees. The results of this research project will be disseminated through publications and/or presentations in a variety of media to health professionals, academics, clinicians and the public. Only de-identified group data will be presented.Trial registrationACTRN12618000634279.

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Integrating pharmacists into aged care facilities to improve the quality use of medicine (PiRACF Study): Protocol for a cluster randomised controlled trial

10.21203/rs.3.rs-38456/v1 ◽

2020 ◽

Author(s):

sam kosari ◽

Jane Koerner ◽

Mark Naunton ◽

Gregory M Peterson ◽

Ibrahim Haider ◽

...

Keyword(s):

Controlled Trial ◽

Medication Management ◽

Care Facility ◽

Cluster Randomised Controlled Trial ◽

Aged Care ◽

Residential Aged Care ◽

Aged Care Facility ◽

Care Facilities ◽

Aged Care Facilities ◽

Residential Aged Care Facilities

Abstract BackgroundMedication management in residential aged care facilities is an ongoing concern. Numerous studies have reported high rates of inappropriate prescribing and medication use in aged care facilities, which contribute to residents’ adverse health outcomes. There is a need for new models of care that enhance inter-disciplinary collaboration between residential aged care facility staff and healthcare professionals, to improve medication management. Pilot research has demonstrated the feasibility and benefits of integrating a pharmacist into the aged care facility team to improve the quality use of medicines. This protocol describes the design and methods for a cluster randomised controlled trial to evaluate the outcomes and conduct economic evaluation of a service model where on-site pharmacists are integrated into residential aged care facility healthcare teams to improve medication management.MethodsIntervention aged care facilities will employ on-site pharmacists to work as part of their healthcare teams. Pharmacists will assume responsibility for medication management, and collaborate with facility nurses, prescribers, community pharmacists, residents and families to improve the quality use of medicines. The intervention will last for 12 months. Aged care facilities in the control group will continue usual care. The target sample size is 1,188 residents from a minimum of 13 aged care facilities. The primary outcome is the appropriateness of prescribing, measured by the proportion of residents who are prescribed at least one potentially inappropriate medicine according to the 2019 Beers Criteria. Secondary outcomes include hospital and Emergency Department presentations, fall rates, prevalence and dose of antipsychotics and benzodiazepines, Anticholinergic Cognitive Burden Score, staff influenza vaccination rate, time spent on medication rounds, appropriateness of dose form modification and completeness of resident’s allergy and adverse drug reaction documentation. A cost-consequence and cost-effectiveness analysis will be embedded in the trial.DiscussionThe results of this study will provide information on clinical and economic outcomes of a model that integrates on-site pharmacists into Australian residential aged care facilities. The results will provide policymakers with recommendations relevant to further implementation of this model.Trial registrationACTRN: ACTRN12620000430932, retrospectively registered with ANZCTR on 1 April 2020. Available from https://www.anzctr.org.au/TrialSearch.aspx#&&conditionCode=&dateOfRegistrationFrom=&interventionDescription=&interventionCodeOperator=OR&primarySponsorType=&gender=&distance=&postcode=&pageSize=20&ageGroup=&recruitmentCountryOperator=OR&recruitmentRegion=&ethicsReview=&countryOfRecruitment=&registry=&searchTxt=ACTRN12620000430932&studyType=&allocationToIntervention=&dateOfRegistrationTo=&recruitmentStatus=&interventionCode=&healthCondition=&healthyVolunteers=&page=1&conditionCategory=&fundingSource=&trialStartDateTo=&trialStartDateFrom=&phase=

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Integrating pharmacists into aged care facilities to improve the quality use of medicine (PiRACF Study): protocol for a cluster randomised controlled trial

Trials ◽

10.1186/s13063-021-05335-0 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Sam Kosari ◽

Jane Koerner ◽

Mark Naunton ◽

Gregory M. Peterson ◽

Ibrahim Haider ◽

...

Keyword(s):

Controlled Trial ◽

Medication Management ◽

Care Facility ◽

Cluster Randomised Controlled Trial ◽

Aged Care ◽

Residential Aged Care ◽

Aged Care Facility ◽

Care Facilities ◽

Aged Care Facilities ◽

Residential Aged Care Facilities

Abstract Background Medication management in residential aged care facilities is an ongoing concern. Numerous studies have reported high rates of inappropriate prescribing and medication use in aged care facilities, which contribute to residents’ adverse health outcomes. There is a need for new models of care that enhance inter-disciplinary collaboration between residential aged care facility staff and healthcare professionals, to improve medication management. Pilot research has demonstrated the feasibility and benefits of integrating a pharmacist into the aged care facility team to improve the quality use of medicines. This protocol describes the design and methods for a cluster randomised controlled trial to evaluate the outcomes and conduct economic evaluation of a service model where on-site pharmacists are integrated into residential aged care facility healthcare teams to improve medication management. Methods Intervention aged care facilities will employ on-site pharmacists to work as part of their healthcare teams 2 to 2.5 days per week for 12 months. On-site pharmacists, in collaboration with facility nurses, prescribers, community pharmacists, residents and families will conduct medication management activities to improve the quality use of medicines. Aged care facilities in the control group will continue usual care. The target sample size is 1188 residents from a minimum of 13 aged care facilities. The primary outcome is the appropriateness of prescribing, measured by the proportion of residents who are prescribed at least one potentially inappropriate medicine according to the 2019 Beers Criteria. Secondary outcomes include hospital and emergency department presentations, fall rates, prevalence and dose of antipsychotics and benzodiazepines, Anticholinergic Cognitive Burden Score, staff influenza vaccination rate, time spent on medication rounds, appropriateness of dose form modification and completeness of resident’s allergy and adverse drug reaction documentation. A cost-consequence and cost-effectiveness analysis will be embedded in the trial. Discussion The results of this study will provide information on clinical and economic outcomes of a model that integrates on-site pharmacists into Australian residential aged care facilities. The results will provide policymakers with recommendations relevant to further implementation of this model. Trial registration ACTRN12620000430932. Registered on 1 April 2020 with ANZCTR

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