Preventing and Approaching Crises for Frail Community-dwelling Patients Through Innovative Care (PRACTIC) - an Effectiveness Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Change in PGI (PRACTIC Goal-setting Interview) from baseline to 3 months
研究概览
简要总结
Preventing and approaching crises for frail community-dwelling patients through innovative care (PRACTIC). Participatory action research in a cluster randomised controlled trial. The primary purpose of this study is to test the effectiveness of an adapted version of a bio-psychosocial person centred model (TIME) to prevent and resolve crises for frail community-dwelling people receiving home care services. The investigators have formulated the following research questions (RQ):
RQ1: Can the TIME model adapted for home care service, prevent, and resolve crises in frail people receiving home care services? RQ2: Which participant characteristics or organizational factors are associated with the effect of the TIME model? RQ3: What are the experiences of the users of home care services on how crises were approached during the trial?
详细描述
This study is part of the larger PRACTIC (Preventing and approaching crises for frail community-dwelling patients through innovative care) study. This is a six-month cluster randomized controlled trial (RCT). The trial will be conducted in 30 municipalities including 150 frail community-dwelling participants receiving homecare services judged by the services to have imminent crises. The proposed sample of 150 participants is based on a power calculation with clusters of approximately 5 participants from each of the 30 municipalities. Each municipality will be defined as a cluster and will be randomized to receive either the locally adapted TIME intervention (the intervention group) or care as usual (the control group). TIME is a manual-based, multicomponent programme that will include a rigorous assessment of the crises, one or more interdisciplinary case conferences and the testing and evaluation of customised treatment measures. For the interviews in RQ3, the investigators will use a purposeful sample of approximately 15 dyads with 15 patients and next of kin from the intervention municipalities in the RCT
Specially trained nurses (data assessors) from the project's research centre who are not affiliated with the municipalities will, together with staff members in the home care services, assess patients' baseline characteristics before randomisation. The data assessors will assess the effect of the intervention via telephone by interviewing the participants, the next of kin and the staff members who know the patient best, at three months and six months after baseline assessments. The interviews will based on a semi-structured interview guide where the participants will be asked to reflect on two main themes.
To evaluate the effects of a bio-psychosocial intervention like TIME to prevent and resolve crises in a heterogenous population, there is a need for a goal-oriented outcome compromising this variability. The goal of the intervention and the outcome will necessarily vary from patient to patient. The investigators will therefore use a individual goal-oriented interview, the PRACTIC goal-setting interview (PGI), based on The Bangor Goalsetting Interview, BGSI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Specially trained nurses (data assessors) from the project's research centre who are not affiliated with the municipalities will, together with staff members in the home care services, assess patients' baseline characteristics before randomisation. These data assessors will after randomisation be blinded to the randomisation result. They will assess the effect of the intervention via telephone by interviewing the participants, the next of kin and the staff members who know the patient best, at three months and six months after baseline assessments.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •for patients:
- •in need of home care services
- •a score ≥5 on the Clinical Frailty Scale (indicating mild to severe frailty)
- •perceived by the home care service as being in an unstable situation with a high risk for acute institutionalisation or showing resistance to care.
排除标准
- •for patients:
- •- expected short life expectancy (i.e., <4 weeks).
- •Inclusion criteria for next of kin (for RQ3):
- •being next of kin of a user of home care services who meets the above mentioned inclusion criteria
- •regular contact with the patient (i.e., at least once a week).
研究组 & 干预措施
Interventions municipalities
Locally adapted TIME (Targeted Interdisciplinary Model for Evaluation and Treatment of Neuropsychiatric Symptoms) intervention. Municipalities will be randomly assigned to either the intervention group or the control group. A biostatician will perform the randomisation procedure independently of the project management team and the municipalities. The project management team will provide the home care services in the municipalities with the randomisation and allocation results immediately following this procedure. The intervention will start with the educational sessions (described below) within one to two weeks after randomisation.
干预措施: TIME model in the prevention and treatment of crises in frail community-dwelling people (Other)
Control municipalities
Care as usual
结局指标
主要结局
Change in PGI (PRACTIC Goal-setting Interview) from baseline to 3 months
时间窗: Change from baseline at 3 months using the PGI (scale of 1-10)
The primary outcome of the trial is the difference in the change between intervention and control group in individual goal achievement to resolve or reduce the challenges of the crises.
次要结局
- Change in medication from medical records(at 6 months)
- Change in distress perceived by the next of kin(at 6 months)
- Change in rejection of care(at 6 months)
- Change in PGI (PRACTIC Goal-setting Interview)(at 6 moths)
- Institutionalization(at 6 months)
- Change in symptoms (NPS)(at 6 months)
- Change in quality of life measured(at 6 moths)
- Change at Activities of Daily Living(at 6 months)
- EQ-5D questionnaire(6 months)
- Clinical Frailty scale(6 months)
- Change in symptoms (NPS)(at 3 months)
- Change in quality of life measured(at 3 months)
- Change in distress perceived by the next of kin(at 3 months)
- Change in rejection of care(at 3 months)
- Change at Activities of Daily Living(at 3 months)
- Change in medication from medical records(at 3 months)
- Institutionalization(at 3 months)