Clinical trial NCT05651659: Preventing and Approaching Crises for Frail Community-dwelling Patients Through Through Innovative Care (PRACTIC)
Official title: Preventing and Approaching Crises for Frail Community-dwelling Patients Through Innovative Care (PRACTIC) - an Effectiveness Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Frailty
Keywords: frailty
crises
home care services
community-dwelling people
behavioural and psychological symptoms of dementia (BPSD)
psychosocial interventions
case conferences
Lead sponsor: Sykehuset Innlandet HF
Sponsor class: OTHER
Collaborators: name: Norwegian University of Science and Technology
name: The Norwegian National Advisory Unit on Ageing and Health
name: Helse Stavanger HF
name: Hochschule für Gesundheit, University of Applied Sciences, Bochum, Germany
First posted: 2022-12-15
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster randomized controlled trial (RCT) with two parallel groups: intervention municipalities and control municipalities
Primary purpose: PREVENTION

Brief summary: 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?

Detailed description: 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.

Eligibility criteria: Inclusion Criteria for patients:

1. in need of home care services
2. a score ≥5 on the Clinical Frailty Scale (indicating mild to severe frailty)
3. perceived by the home care service as being in an unstable situation with a high risk for acute institutionalisation or showing resistance to care.

Exclusion Criteria for patients:

- expected short life expectancy (i.e., \<4 weeks).

Inclusion criteria for next of kin (for RQ3):

1. being next of kin of a user of home care services who meets the above mentioned inclusion criteria
2. regular contact with the patient (i.e., at least once a week).

Primary outcomes:
measure: Change in PGI (PRACTIC Goal-setting Interview) from baseline to 3 months
timeFrame: Change from baseline at 3 months using the PGI (scale of 1-10)
Secondary outcomes:
measure: Change in PGI (PRACTIC Goal-setting Interview)
timeFrame: at 6 moths
measure: Change in symptoms (NPS)
timeFrame: at 3 months
measure: Change in symptoms (NPS)
timeFrame: at 6 months
measure: Change in quality of life measured
timeFrame: at 3 months
measure: Change in quality of life measured
timeFrame: at 6 moths
measure: Change in distress perceived by the next of kin
timeFrame: at 3 months
measure: Change in distress perceived by the next of kin
timeFrame: at 6 months
measure: Change in rejection of care
timeFrame: at 3 months
measure: Change in rejection of care
timeFrame: at 6 months
measure: Change at Activities of Daily Living
timeFrame: at 3 months
measure: Change at Activities of Daily Living
timeFrame: at 6 months
measure: Change in medication from medical records
timeFrame: at 3 months
measure: Change in medication from medical records
timeFrame: at 6 months
measure: Institutionalization
timeFrame: at 3 months
measure: Institutionalization
timeFrame: at 6 months
measure: Clinical Frailty scale
timeFrame: 6 months
measure: EQ-5D questionnaire
timeFrame: 6 months
Other outcomes:
Locations:
city: Ottestad
country: Norway
facility: Sykehuset Innlandet
Study officials:
affiliation: Sykehuset Innlandet HF
name: Sverre Bergh, MD. PhD
role: STUDY_DIRECTOR
References: