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

Not Applicable

Active, not recruiting

• Conditions: Frailty
• Interventions: Other: TIME model in the prevention and treatment of crises in frail community-dwelling people

• Registration Number: NCT05651659
• Lead Sponsor: Sykehuset Innlandet HF

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.

Study Timeline

• Study First Submitted: 2022-12-07
• Study First Submitted QC: 2022-12-07
• Study First Posted: 2022-12-15
• Study Start: 2023-01-09
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-12
• Last Update Posted: 2025-03-13
• Primary Completion: 2026-04-01
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interventions municipalities	TIME model in the prevention and treatment of crises in frail community-dwelling people	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.

Primary Outcome Measures

Name	Time	Method
Change in PGI (PRACTIC Goal-setting Interview) from baseline to 3 months	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.

Secondary Outcome Measures

Name	Time	Method
Change in medication from medical records	at 6 months	Medication from medical records
Change in distress perceived by the next of kin	at 6 months	Distress perceived by the next of kin measured by the Relative Stress Scale (RSS). Total score between 0-60, higher score in an area, more likely higher relative stress.
Change in rejection of care	at 6 months	Rejection of care - Minimal Data Set (MDS)
Change in PGI (PRACTIC Goal-setting Interview)	at 6 moths	the differences in the change between intervention and control group in the BGSI scale at 6 months, in neuropsychiatric symptoms
Institutionalization	at 6 months	Change in level of care
Change in symptoms (NPS)	at 6 months	Neuropsychiatric symptoms (NPS) measured by the Neuropsychiatric Inventory (NPI-NH). Score for each symptom: 0-12 points. Total score 144
Change in quality of life measured	at 6 moths	Quality of life measured by the Quality of Life in Late Stage Dementia scale (QUALID).The score will remain between 11 and 55, with 11 representing the highest quality of life.
Change at Activities of Daily Living	at 6 months	Activities of Daily Living - assessed with the Physical Self-Maintenance Scale (PSMS).; Total score between 0-30, higher score in an area, more likely that the patient may be in need of help in that area.
EQ-5D questionnaire	6 months	The EQ-5D questionnaire to evaluate pain and discomfort. The dimension pain/discomfort has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The respondent is asked to indicate his/her health state by ticking (or placing a cross) in the box against the most appropriate statement.
Clinical Frailty scale	6 months	Frailty tool that evaluates specific domains including comorbidity, function, and cognition to generate a frailty score ranging from 1 (very fit) to 9 (terminally ill).

Trial Locations

Locations (1)

Sykehuset Innlandet; 🇳🇴 Ottestad, Norway