NCT05302310

Brief Summary

Background: The care of older people, often suffering from multiple chronic health problems is complex. As a result, many home-dwelling older people receive long-term care by a large number of care providers often in various care settings, which are neither centralized nor coordinated, putting older people are at risk for fragmented care. To address the complex needs and overcome fragmentation of care, implementation of integrated care models has been recommended. Integrated care has been described as a person-centred model of care that is structured to support coordinated, pro-active care led by a multidisciplinary core team and a lead coordinator communicating and cooperating across and within health and social sectors. However, a systematic review and meta analysis published by our research team could not show convincing evidence regarding the beneficial impact of integrated care models on health and service outcomes. But our study highlighted that the majority of the studies included effectiveness outcomes only and lacked process and implementation outcomes hindering to determine whether the negative conclusions were due to intervention or implementation failure. Therefore, this indicates the need for effectiveness studies which include process evaluations, contextual analysis, and measuring proximal implementation outcomes to determine if, how and why community-based integrated care for frail older adults is successful in practice. To facilitate the uptake of integrated care in daily practice and overcome implementation issues, principles and methods from the field of implementation science should be incorporated into future research. In January 2018, the Canton Basel-Landschaft (BL) published a new legal framework to redesign care for home-dwelling older people in the canton. This legal framework mandates the reorganization of the Canton BL into larger care regions and the creation of an Information and Advice Center (IAC) in each of these care regions. The legislation mandates the IAC to be staffed with at least a nurse. Subsequently, the INSPIRE research team has been working together with the Canton and the care region of Leimental to help operationalize and evaluate a care model for the IAC. The overall INSPIRE project is a three-phase implementation science project which aims to develop, implement and evaluate an integrated care model for the IAC for home-dwelling older adults in Canton BL. Phase 1: consisted in the development of the community-based integrated care model. Phase 2: We will assess the feasibility of the community-based integrated model of care at the IAC in Leimental. Phase 3: we will evaluate the effectiveness of this intervention. The current study focuses in the phase 2. Aims:

  1. 1.assess feasibility of recruitment to the IAC including external (e.g., strategies used to promote the IAC services) and internal processes (e.g., the number of visitors to the IAC; how clients heard of the IAC; among others);
  2. 2.assess the adoption, acceptability, feasibility, and fidelity of the integrated care model at the IAC BPA in Leimental;
  3. 3.explore perceptions of older adults and their caregivers, IAC staff, and external health and social care providers towards the implemented care model, and if adaptations are needed to the care model or the implementation strategies/process.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

March 21, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 31, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2022

Completed
Last Updated

November 29, 2022

Status Verified

November 1, 2022

Enrollment Period

6 months

First QC Date

March 21, 2022

Last Update Submit

November 27, 2022

Conditions

Keywords

FeasibilityDelivery of Health Care, Integratedimplementation scienceadvance practice nurse

Outcome Measures

Primary Outcomes (5)

  • To assess the adoption of the integrated care model at the IAC, and explore perceptions of IAC staff towards the implemented care model, and if adaptations are needed to the care model or the implementation strategies.

    \- Adoption is defined as the intention, initial decision, or action to try to employ a new intervention. Adoption will be qualitatively determined during the study through the regular meetings with the IAC Nurse(s) and Social Worker (\[sample 3\]. These regular meetings will be led by the INSPIRE research team (e.g., Implementation Lead).

    2 months

  • To assess the acceptability of the integrated care model at the IAC, and explore perceptions of older adults and their caregivers, IAC staff towards the implemented care model.

    \- Acceptability is defined as the perception among stakeholders that the intervention is agreeable (31). Acceptability will be captured qualitatively through regular meetings with the IAC Nurse(s) and Social worker (sample 3) as well as through interviews with a nested sample of older adults (e.g., aged 75+, Groningen Frailty Indicator \[GFI\] score ≥4, received a CGA; see sample 1C) and their informal caregiver (sample 2; e.g., spouse, family member or neighbour), when possible.

    2 months

  • To assess the feasibility of the integrated care model at the IAC, and explore perceptions of older adults and their caregivers, and IAC staff towards the implemented care model

    \- Feasibility is defined as the perception among participating care providers that the intervention is feasible (31). Feasibility will be assessed for recruitment (e.g., referral to the IAC) and aspects of the care model (i.e., screening, CGA, creation of a care plan and collaboration to coordinate care, and follow-up). Feasibility will be captured qualitatively in this study through a) the regular meetings with the IAC staff (sample 3) and b) the interviews with a nested sample of participating older adults (sample 1C) and informal caregivers (sample 2), when possible. A final consensus meeting will be held at the end of the study with the INSPIRE research team, the Head of the IAC and the IAC Nurse(s) and Social Worker to confirm whether the care model is indeed "feasible" and we are ready to move into the effectiveness study.

    2 months

  • To assess the fidelity of the integrated care model at the IAC, and explore perceptions of the IAC staff towards the implemented care model, and if adaptations are needed to the care model or the implementation strategies.

    \- Fidelity is defined as the degree to which the intervention is implemented as it was designed in the original protocol. Fidelity will be quantitatively measured in this study phase by reviewing participating older adults' IAC health records (see sample 1B; e.g., aged 64+, living at home, have a IAC health record) to primarily determine if the care model components (i.e., screening, comprehensive geriatric assessment \[CGA\], care coordination and individualized care plan, and follow-up were delivered as intended. Fidelity will also be explored qualitatively in the regular meetings with the IAC staff (sample 3).

    2 months

  • To explore implementation processes related to collaboration between IAC staff and external health and social care professionals when coordinating care for an older adult

    \- The Normalization MeAsure Development questionnaire (NoMAD) will be sent to external health and social care providers who have collaborated with the IAC staff for coordination of care of a participating older adult. It is a three-part (A, B, C), 23-item survey. Part A (2-items) asks about their role and job category; in part B, two general questions about the intervention are rated with a response scale of 0-10 (0=not at all, 5=somewhat, 10=completely); and part C (19-items) is in the format of a 5-point Likert scale to indicate level of agreement (1=strongly agree, 3=neutral, 5=strongly disagree). There are four constructs assessed in Part C which are related to the Normalization Process Theory, being: a) coherence (4-items), b) cognitive participation (4-items), c) collective action (7-items; 1 of which we removed due to context), and d) reflexive monitoring (5-items). The NoMAD has a reliability of α = 0.89 for the 20 items and has been cited in many research studies

    2 months

Secondary Outcomes (1)

  • To assess feasibility of recruitment to the Fachstelle and evaluate recruitment strategies

    2 months

Other Outcomes (1)

  • Individual characteristics to describe the sample of consenting older adults (sample 1B) using the IAC services

    at baseline: 1 week after enrollment

Study Arms (6)

Older adults (1A)

All older adults visiting/contacting the Information and Advice Center

Older adults (1B)

These older adults will receive the integrated care (intervention) provided by the nurse and the social worker of the Information and Advice Center

Other: integrated care

Older adults (1C)

This group corresponds to a nested sample of older adults who will receive the integrated care (intervention) provided by the nurse and the social worker of the Information and Advice Center and will participate in interviews with the research team.

Other: integrated care

Informal caregivers (2)

The informal caregivers of older adults receiving the integrated care (intervention) provided by the nurse and the social worker of the Information and Advice Center will participate in interviews with the research team.

IAC nurse and social worker (3)

The nurse and the social worker who provide the integrated care (intervention) in the Information and Advice Center will participate in bi-weekly meetings with the research team

External collaborators (4)

The external collaborators who are involved in the care of the participating older adults and have collaborated with the nurse and the social worker of the Information and Advice Center will complete a survey sent by mail or e-mail.

Interventions

i) Screening of older people for risk of frailty using a frailty screening tool, to identify the appropriate care they will require: * Older adults with low risk of frailty will receive health promotion and preventive care from the Information and Advice Center nurse and/or social worker. * Older adults at risk will receive the following: ii) a Comprehensive Geriatric Assessment (CGA) delivered by the Information and Advice Center nurse and social worker over the course of multiple appointments, to identify the health and social care needs and goals of the older person; iii) Development of an individualized care plan by a multidisciplinary team, which will include evidence-based interventions and be coordinated by the Information and Advice Center nurse and/or the social worker; and iv) follow-up depending on the situation of each older person, and adaptation of the individualized care plan, as needed.

Older adults (1B)Older adults (1C)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The groups will be selected from: * Residents of the care region of Leimental in Canton Basel-Landschaft in Switzerland: Older adults (1A), Older adults (1B), Older adults (1C), Informal caregivers (2) an * Information and Advice Center of the care region of Leimental: nurse and social worker (3) * Community (care region of Leimental): External collaborators (4)

You may qualify if:

  • Aged 64 years or older (as this is the statutory retirement age for women in Switzerland and the minimum age of the group we expect to use the Fachstelle services) Living at home German or English-speaking Providing Individual/Proxy Informed Consent (See "3A Informed Consent - Older adult"/"3B Informed Consent -Relative").
  • Had a Fachstelle health record created

You may not qualify if:

  • Residing in a nursing home or planned permanent admission to a nursing home Receiving end-of-life care
  • Older adults (1C)
  • Aged 75 years or older Living at home Living in the participating care region Leimental English or German-speaking Groningen Frailty Indicator \[GFI\] ≥4 If the older adult had a CGA by the IAC staff Providing Individual/Proxy Informed Consent (See 3A "Informed Consent - Older adult"/ 3B "Informed Consent -Relative")
  • Residing in a nursing home or planned permanent admission to a nursing home Receiving end-of-life care Participation in another study with health-related interventions within the 30 days preceding or during the present study GFI \< 4 If the older adult did not have a CGA by the IAC staff
  • Informal caregivers (2)
  • Individuals who attended a IAC appointment (in the center or at home) with a participating older adult.
  • The older adult must agree for the INSPIRE research team to contact the informal caregiver.
  • Individuals who did not attend a IAC appointment with a participating older adult or who were not present in a home visit by IAC staff (as the interview questions focus on their perception of the IAC's feasibility and acceptability) Any individuals whom the older adult did not agree for the INSPIRE research team to be contacted
  • IAC nurse and social worker (3)
  • Individuals employed by the IAC BPA Leimental as a Nurse or Social Worker
  • Other individuals employed by the IAC BPA Leimental (e.g., Administration)
  • External collaborators (4)
  • Individual health or social care providers who are indicated in the IAC health record as having worked together with the IAC nurse(s) or social worker in the care coordination of a participating older adult
  • Individual health or social care providers who have not contributed to the coordination of care with the IAC staff for a participating older adult

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fachstelle BPA Leimental (Information and Advice Center of Leimental)

Oberwil, Basel-Landschaft, 4104, Switzerland

Location

Related Publications (27)

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Related Links

MeSH Terms

Conditions

Frailty

Interventions

Delivery of Health Care, Integrated

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Delivery of Health CarePatient Care ManagementHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Sabina M De Geest, Prof. Dr.

    Institute of Nursing Science, University of Basel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

March 21, 2022

First Posted

March 31, 2022

Study Start

March 21, 2022

Primary Completion

September 30, 2022

Study Completion

October 10, 2022

Last Updated

November 29, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will share

All data collected in this project will be archived following strictly the current Swiss legal requirements for data protection and will be performed according to the Ordinance HRO Art. 5. Identifying health related data are stored for 10 years after publication of the research project. The delinked study data may be stored longer to answer new research questions, such as in the case of comparative research with national and international groups. The audio recordings will be will be saved for a period of 10 years and destroyed thereafter. At the end of the project, anonymous INSPIRE feasibility study data will be deposited in an appropriate data depository (e.g., Zenodo), as per funding requirements.

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
The data will be available at the end of the INSPIRE Project (2024)

Locations