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

Primary Purpose

Frailty

Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
TIME model in the prevention and treatment of crises in frail community-dwelling people
Sponsored by
Sykehuset Innlandet HF
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Frailty focused on measuring frailty, crises, home care services, community-dwelling people, behavioural and psychological symptoms of dementia (BPSD), psychosocial interventions, case conferences

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria 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. Exclusion Criteria 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).

Sites / Locations

  • Sykehuset InnlandetRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Interventions municipalities

Control municipalities

Arm Description

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.

Care as usual

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
Change in symptoms (NPS)
Neuropsychiatric symptoms (NPS) measured by the Neuropsychiatric Inventory (NPI-NH). Score for each symptom: 0-12 points. Total score 144.
Change in symptoms (NPS)
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
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 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.
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.
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.
Change in rejection of care
Rejection of care - Minimal Data Set (MDS)
Change in rejection of care
Rejection of care - Minimal Data Set (MDS)
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.
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.
Change in medication from medical records
Medication from medical records
Change in medication from medical records
Medication from medical records
Institutionalization
Change in level of care
Institutionalization
Change in level of care
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).
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.

Full Information

First Posted
December 7, 2022
Last Updated
August 14, 2023
Sponsor
Sykehuset Innlandet HF
Collaborators
Norwegian University of Science and Technology, The Norwegian National Advisory Unit on Ageing and Health, Helse Stavanger HF, Hochschule für Gesundheit, University of Applied Sciences, Bochum, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT05651659
Brief Title
Preventing and Approaching Crises for Frail Community-dwelling Patients Through Through Innovative Care (PRACTIC)
Acronym
PRACTIC
Official Title
Preventing and Approaching Crises for Frail Community-dwelling Patients Through Innovative Care (PRACTIC) - an Effectiveness Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 9, 2023 (Actual)
Primary Completion Date
August 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sykehuset Innlandet HF
Collaborators
Norwegian University of Science and Technology, The Norwegian National Advisory Unit on Ageing and Health, Helse Stavanger HF, Hochschule für Gesundheit, University of Applied Sciences, Bochum, Germany

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty
Keywords
frailty, crises, home care services, community-dwelling people, behavioural and psychological symptoms of dementia (BPSD), psychosocial interventions, case conferences

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Cluster randomized controlled trial (RCT) with two parallel groups: intervention municipalities and control municipalities
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Interventions municipalities
Arm Type
Experimental
Arm Description
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.
Arm Title
Control municipalities
Arm Type
No Intervention
Arm Description
Care as usual
Intervention Type
Other
Intervention Name(s)
TIME model in the prevention and treatment of crises in frail community-dwelling people
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in PGI (PRACTIC Goal-setting Interview) from baseline to 3 months
Description
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.
Time Frame
Change from baseline at 3 months using the PGI (scale of 1-10)
Secondary Outcome Measure Information:
Title
Change in PGI (PRACTIC Goal-setting Interview)
Description
the differences in the change between intervention and control group in the BGSI scale at 6 months, in neuropsychiatric symptoms
Time Frame
at 6 moths
Title
Change in symptoms (NPS)
Description
Neuropsychiatric symptoms (NPS) measured by the Neuropsychiatric Inventory (NPI-NH). Score for each symptom: 0-12 points. Total score 144.
Time Frame
at 3 months
Title
Change in symptoms (NPS)
Description
Neuropsychiatric symptoms (NPS) measured by the Neuropsychiatric Inventory (NPI-NH). Score for each symptom: 0-12 points. Total score 144
Time Frame
at 6 months
Title
Change in quality of life measured
Description
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.
Time Frame
at 3 months
Title
Change in quality of life measured
Description
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.
Time Frame
at 6 moths
Title
Change in distress perceived by the next of kin
Description
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.
Time Frame
at 3 months
Title
Change in distress perceived by the next of kin
Description
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.
Time Frame
at 6 months
Title
Change in rejection of care
Description
Rejection of care - Minimal Data Set (MDS)
Time Frame
at 3 months
Title
Change in rejection of care
Description
Rejection of care - Minimal Data Set (MDS)
Time Frame
at 6 months
Title
Change at Activities of Daily Living
Description
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.
Time Frame
at 3 months
Title
Change at Activities of Daily Living
Description
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.
Time Frame
at 6 months
Title
Change in medication from medical records
Description
Medication from medical records
Time Frame
at 3 months
Title
Change in medication from medical records
Description
Medication from medical records
Time Frame
at 6 months
Title
Institutionalization
Description
Change in level of care
Time Frame
at 3 months
Title
Institutionalization
Description
Change in level of care
Time Frame
at 6 months
Title
Clinical Frailty scale
Description
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).
Time Frame
6 months
Title
EQ-5D questionnaire
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria 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. Exclusion Criteria 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anette Væringstad, MSch
Phone
+47 995 40 470
Email
Anette.vaeringstad@sykehuset-innlandet.no
First Name & Middle Initial & Last Name or Official Title & Degree
Bjørn Lichtwarck, MD. PhD
Phone
+47 975 23 048
Email
Bjorn.Lichtwarck@sykehuset-innlandet.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sverre Bergh, MD. PhD
Organizational Affiliation
Sykehuset Innlandet HF
Official's Role
Study Director
Facility Information:
Facility Name
Sykehuset Innlandet
City
Ottestad
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anette Væringstad
Phone
99540470
Email
anette.vaeringstad@sykehuset-innlandet.no

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Collaborating partners in the study will not have access to any of the data.

Learn more about this trial

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

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