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

Frailty Clinical Trial

— PRACTIC  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05651659
• Other study ID #: 150667
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 9, 2023
• Est. completion date: April 12, 2024

Study information

• Verified date: December 2023
• Source: Sykehuset Innlandet HF
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: April 12, 2024
• Est. primary completion date: April 12, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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).

Related Conditions & MeSH terms

• Frailty

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Norway	Sykehuset Innlandet	Ottestad

Sponsors (5)

Lead Sponsor	Collaborator
Sykehuset Innlandet HF	Helse Stavanger HF, Hochschule für Gesundheit, University of Applied Sciences, Bochum, Germany, Norwegian University of Science and Technology, The Norwegian National Advisory Unit on Ageing and Health

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in PGI (PRACTIC Goal-setting Interview) from baseline to 3 months	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.	Change from baseline at 3 months using the PGI (scale of 1-10)
Secondary	Change in PGI (PRACTIC Goal-setting Interview)	the differences in the change between intervention and control group in the BGSI scale at 6 months, in neuropsychiatric symptoms	at 6 moths
Secondary	Change in symptoms (NPS)	Neuropsychiatric symptoms (NPS) measured by the Neuropsychiatric Inventory (NPI-NH). Score for each symptom: 0-12 points. Total score 144.	at 3 months
Secondary	Change in symptoms (NPS)	Neuropsychiatric symptoms (NPS) measured by the Neuropsychiatric Inventory (NPI-NH). Score for each symptom: 0-12 points. Total score 144	at 6 months
Secondary	Change in quality of life measured	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.	at 3 months
Secondary	Change in quality of life measured	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.	at 6 moths
Secondary	Change in distress perceived by the next of kin	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.	at 3 months
Secondary	Change in distress perceived by the next of kin	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.	at 6 months
Secondary	Change in rejection of care	Rejection of care - Minimal Data Set (MDS)	at 3 months
Secondary	Change in rejection of care	Rejection of care - Minimal Data Set (MDS)	at 6 months
Secondary	Change at Activities of Daily Living	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.	at 3 months
Secondary	Change at Activities of Daily Living	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.	at 6 months
Secondary	Change in medication from medical records	Medication from medical records	at 3 months
Secondary	Change in medication from medical records	Medication from medical records	at 6 months
Secondary	Institutionalization	Change in level of care	at 3 months
Secondary	Institutionalization	Change in level of care	at 6 months
Secondary	Clinical Frailty scale	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).	6 months
Secondary	EQ-5D questionnaire	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.	6 months