ACTRN12620000577910已完成未知
A cluster randomised controlled trial of a pharmacist-led intervention for people living with severe and persistent mental illness to support medication adherence, physical health and psychological wellbeing
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 351
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 16 Years 至 o limit（—）
- 性别
- All
入选标准
- •Pharmacy eligibility
- •Community pharmacies will be included if they:
- •are located within the selected RCT regions;
- •be approved to dispense pharmaceutical benefits as part of the Pharmaceutical Benefits Scheme (PBS) defined in Section 90 of the National Health Act 1953 (Cth) (Section 90 Pharmacy);
- •are accredited against Quality Care Community Pharmacy Standard (AS85000);
- •have a demographic of clientele that includes consumers living with SPMI;
- •routinely provide MedsCheck as an established professional service (i.e. MedsCheck is not a new service in the pharmacy);
- •can guarantee that the PharMIbridge intervention is carried out by a Registered Pharmacist that has successfully completed the training and any consultations are undertaken with the consumer and/or the consumer’s carer with consideration of the consumer’s comfort and right to privacy
- •have a private consultation room or area for confidential conversations and assessments;
- •consent (by the pharmacy owner/manager) to participate; and,
- •have an established working relationship with local GP practices or centres, mental health care teams, and/or are already engaged with mental health promotion.
- •Similar to professional practice guidelines for MedsCheck, it is a requirement that trained pharmacists involved in the RCT are not responsible for dispensing or other professional duties whilst interacting with consumer participants (e.g. when providing a MedsCheck service or undertaking the Initial Health Review as part of the PharMIbridge intervention). As some pharmacies in the selected RCT regions may only have one pharmacist on-duty at a particular time, these consultations must be conducted outside the standard pharmacy operating hours or whilst another pharmacist is on duty.
- •Community pharmacies that are involved in the 6CPA Community Pharmacy in Health Care Homes Trial, or any other trials, would be assessed for suitability in terms of workload.
- •Consumer Eligibility
- •Consumers will be eligible to participate in the RCT if they meet all of the following criteria:
- •have the capacity to provide consent (as determined by a trained pharmacist and/or member of the consumer participant’s treating team);
- •aged 16 years and over and residing in the community;
- •be using at least one antipsychotic or mood stabiliser for at least six-months, continuously, for the treatment of SPMI such as schizophrenia or bipolar disorder (consumers who change medication during this time would still be eligible to participate, and can be using other medication for their mental and physical health);
- •have a complex medication need (e.g. adherence concerns) or unmanaged physical health problems;
- •provide consent for pharmacists to contact at least one of their treating healthcare professionals (GP, case manager, psychiatrist) regarding RCT participation; and,
- •provide consent for researchers to access their medication dispensing data from the pharmacy, MBS, PBS, hospitalisation and emergency department visit data for 12-months pre- and 6-months post- RCT period.
排除标准
- •Pharmacies will be excluded from the RCT if they:
- •are not located within the selected RCT regions;
- •would find it particularly difficult to recruit the required number of consumer participants living with a SPMI (i.e. do not see many of these consumers);
- •do not currently provide or a regular provider of a MedsCheck service;
- •do not have a private consultation area where conversations and assessments can be kept confidential;
- •do not actively engage with other healthcare professionals (e.g. local GP) or mental health care teams; and,
- •do not have approval to participate from the pharmacy owner or manager.
- •Consumers will be excluded from participating in the RCT if they:
- •are aged under 16 years;
- •have unstable mental health symptoms as recognised by the pharmacist or deemed unsuitable for participation by their treating healthcare professional or carer;
- •use antipsychotic or mood stabiliser medications inconsistently or ‘when required’, or have not used these medications on a regular basis for the last six months;
- •are prescribed an antipsychotic or mood stabiliser medication for the treatment of another illness other than those defined in inclusion criteria (for example, off-label use for alternative condition such as quetiapine for sleep or anxiety); or
- •do not give consent to contact their treating healthcare professionals, or to access PBS, MBS, hospitalisation and/or emergency department data.
研究者
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