NCT06368674

Brief Summary

Coordination and integration between care settings is essential for the quality of care of frail older patients. An active follow-up by a case manager (CM) after discharge form an acute geriatric hospital ward has the potential to bridge the gap between hospital, primary and municipality care for frail older people. This study evaluates the effects of an active follow-up by a CM in primary care after discharge from a geriatric ward, with the following research questions: Can an active follow-up by CM for frail older people discharged from an acute geriatric ward, compared to those not receiving active follow up, Maintain/increase independence in activities of daily living, self-rated health and life satisfaction? Increase satisfaction with health care? Reduce health care consumption/be cost-effective? How feasible is the intervention and the study design from the perspective of the caregivers and the older person? This is a clinical controlled study with a process evaluation. Inclusion criteria are 75 years or older, frail and admitted to a geriatric ward. This study is relevant since today's highly specialized acute care is poorly adapted to the comprehensive needs of frail older people, and exposes them to avoidable risks such as loss of functional capacities causing unnecessary care needs and decreased wellbeing. Active follow-up by a CM after discharge may be an important way to integrate the care for frail older people, after receiving in-hospital geriatric care. This can improve the quality of care for this vulnerable group, and direct the right health care actions towards those in most need. The intervention is a active follow-up after discharge by a CM (nurse) in primary care. CM will secure that discharge and care plans are executed and to address new needs. If there are unmet needs, the CM will ensure that adequate actions are performed to meet the needs. The intervention group consists of participants discharged to a primary health care centre with a CM, who actively follows-up after discharge. The control group consists of participants discharged to a primary health care centre without CM, and thereby no active follow-up after discharge. All participants will be followed-up by the research team during one year, concerning dependence in activities of daily living, self-rated health, health care consumption and satisfaction with care.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
9mo left

Started Jun 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress72%
Jun 2024Feb 2027

First Submitted

Initial submission to the registry

April 11, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 16, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

June 6, 2024

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

April 11, 2025

Status Verified

April 1, 2025

Enrollment Period

2.6 years

First QC Date

April 11, 2024

Last Update Submit

April 9, 2025

Conditions

Keywords

Person-centred care

Outcome Measures

Primary Outcomes (1)

  • Dependency in Activities of Daily Living (ADL)

    The primary outcome, dependence in activities of daily living, is measured using the ADL-staircase assessment. It measures dependence in 9 activities: cleaning, shopping, transportation, cooking, bathing, dressing, going to the toilet, transferring, and feeding. Dependence is defined as a state in which another person is involved in the activity by giving personal or directive assistance. The sum of dependence in the nine activities of daily living will be calculated, range 0-9, with a clinical significant change of ≥1 unit between baseline and follow up.

    Baseline to 12 months

Secondary Outcomes (4)

  • Self-rated health

    Baseline to 12 months

  • Life satisfaction

    Baseline to 12 months

  • Satisfaction with quality of care

    Baseline to 12 months

  • Health economics

    12 months

Study Arms (2)

Intervention group Case Manager (CM)

EXPERIMENTAL

The intervention group will receive extra follow-up by a CM after discharge.

Other: Intervention group Case Manager (CM)

Control group

OTHER

The control group will receive usual follow-up after discharge, i.e. no active follow-up

Other: Control Group

Interventions

The CM will be informed about the discharge plan from the nurse at the geriatric ward, as will the municipality for those with need of home help care. An outline of the intervention has been created with managers from primary care and rehabilitation within primary care and municipality care. Core components in the intervention will be active follow-up of the discharge, rehabilitation and care plans. If there are plans that have not been executed or unmet needs, the CM will take adequate contacts to ensure that actions are made to meet the needs. These contacts can be, e.g. the GP for medical needs, the rehabilitation unit in primary or municipality care for unmet rehabilitation needs, and the home help service for unmet care needs. The CM will have a network of contact persons in hospital, primary and community care, as well as in rehabilitation in primary and community care, in order to facilitate for prompt actions to meet the needs.

Intervention group Case Manager (CM)

The participants in the control group with a planned follow-up by a primary health care centre within the catchment area of the Sahlgrenska University Hospital that does not have CMs designated for active follow up of discharged frail older people. Thus, the participants in the control group will not actively be followed-up after discharge.

Control group

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may not qualify if:

  • Less that 75 years old, Not residing in a permanent residence.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Gothenburg

Gothenburg, Sweden

RECRUITING

MeSH Terms

Conditions

Frailty

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Central Study Contacts

Theresa Westgård, PhD, Associate Professor

CONTACT

Isabelle Andersson Hammar, PhD, Associate Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Clinical control study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2024

First Posted

April 16, 2024

Study Start

June 6, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

February 1, 2027

Last Updated

April 11, 2025

Record last verified: 2025-04

Locations