Preventing and Approaching Crises for Frail Community-dwelling Patients Through Through Innovative Care (PRACTIC)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-09

Study Completion Date

2026-04-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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?

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Advanced Care Planning for the Severely Ill Home-dwelling Elderly

NCT05681585

Advance Care Planning

RECRUITING NA

Multifactorial Intervention on Frailty in Vulnerable Older Adults

NCT02554994

Frailty

COMPLETED NA

Animal-assisted Interventions in Health Promotion for Elderly With Dementia

NCT02008630

Dementia

COMPLETED NA

Feasibility of a Multidisciplinary Student-Led Program to Improve Frailty in Nursing Home Residents

NCT07182747

Frailty

NOT_YET_RECRUITING NA

FOCUS- Frailty Management Optimization Through EIP AHA Commitments and Utilization of Stakeholders Input

NCT03194412

Frailty

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Frailty

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Cluster randomized controlled trial (RCT) with two parallel groups: intervention municipalities and control municipalities

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

TIME model in the prevention and treatment of crises in frail community-dwelling people

Intervention Type OTHER

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.This multicomponent interdisciplinary model consisting of three overlapping phases. First the assessment phase where the care staff and the physician collaborate in a comprehensive bio-psychosocial assessment. The second phase is the reflection phase with interdisciplinary case conferences based on principles from cognitive behavioural therapy and abc-method, where a customized treatment plan is developed. The abc-method from cognitive behavioural therapy is used as an analytic tool for the analyses of the complex challenges in the case conferences. In the third phase the treatment plan is implemented and evaluated systematically.

Control municipalities

Care as usual

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

TIME model in the prevention and treatment of crises in frail community-dwelling people

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.This multicomponent interdisciplinary model consisting of three overlapping phases. First the assessment phase where the care staff and the physician collaborate in a comprehensive bio-psychosocial assessment. The second phase is the reflection phase with interdisciplinary case conferences based on principles from cognitive behavioural therapy and abc-method, where a customized treatment plan is developed. The abc-method from cognitive behavioural therapy is used as an analytic tool for the analyses of the complex challenges in the case conferences. In the third phase the treatment plan is implemented and evaluated systematically.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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.

2. regular contact with the patient (i.e., at least once a week).