NCT02084108

Brief Summary

Introduction: Care of frail and dependent elders with multiple chronic conditions is a major challenge for health care systems. The objective of this study is to evaluate the effect of coordinating the existing structures in the private and public sector for the care of frail and dependent persons over age 60, and susceptible of presenting complex bio-psycho-social issues. This approach is aimed at improving the coordination, continuity, quality and efficacy of care in this population, which presents a high risk of hospitalization, emergency room visits, institutionalization and mortality. Methods: Three-year cluster randomised controlled trial. A control group receiving usual care (follow up by primary care physician and home nursing service) will be compared to an intervention group that will be provided, in addition, in-home multidimensional geriatric assessment with access to a 24h/7 day a week call service, and coordinated long-term follow-up. Survival analyses will be conducted to compare the outcomes between groups. Primary outcome: \- Hospitalizations: rates of first hospitalization, number, cause and length of stay. Secondary outcomes:

  • Emergency room visits: rates of first visit, number and cause
  • Institutionalization: number of patients
  • Mortality: rate and number of deaths and place of death (home versus hospital)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
301

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2009

Longer than P75 for not_applicable

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

Study Start

First participant enrolled

July 1, 2009

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 7, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 11, 2014

Completed
Last Updated

March 11, 2014

Status Verified

March 1, 2014

Enrollment Period

3.4 years

First QC Date

March 7, 2014

Last Update Submit

March 10, 2014

Conditions

Keywords

Frail and dependent older adultsIntegrated careHome careMultidimensional geriatric assessmentRAI-HC (resident assessment instrument- Home care)Palliative care.

Outcome Measures

Primary Outcomes (1)

  • Hospitalizations: rates of first hospitalization, number and reason

    Three years

Secondary Outcomes (3)

  • Emergency room visits: rates of first visit, number and cause.

    Three years

  • Institutionalization: number of patients

    Three years

  • Mortality: rate and number of deaths and place of death (home versus hospital)

    Three years

Study Arms (2)

Control arm= usual care

NO INTERVENTION

Two clusters of patients over 60 years of age followed by a primary care physician and routinely evaluated by the home nursing service with the resident assessment instrument-home care (RAI-HC) and identified as frail by pre-defined clinical criteria.

Intervention arm

OTHER

The intervention arm will consist of two clusters of patients over 60 years of age followed by a primary care physician and routinely evaluated by the home nursing service with the RAI-HC and identified as frail by predefined clinical criteria that will receive in addition an in-home multidimensional geriatric assessment, access 24 hours a day, 7 days a week to a call service provided by the Community Geriatrics Unit and coordinated long-term follow-up.

Other: intervention

Interventions

intervention group that will be provided, in addition, in-home multidimensional geriatric assessment with access to a 24h/7 day a week call service, and coordinated long-term follow-up.

Intervention arm

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients followed by the home nursing service and primary care physician
  • Over 60 years of age
  • Able to give consent (patient or caregiver)
  • Able to speak French
  • Meeting frailty criteria as determined by one of the following alarms detected by the RAI-HC:
  • Alarm 8: cognition
  • Alarm 12: social role and function
  • Alarm 15: falls
  • Alarm 22: frailty of the informal care giver system.

You may not qualify if:

  • Age under 60 years
  • Unable (patient or caregiver) to give informed consent
  • Unable to communicate adequately in French
  • Patients' not receiving nursing visits (only receiving practical aid or services from occupational therapists).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospital of Geneva

Geneva, Canton of Geneva, 1211, Switzerland

Location

Related Publications (1)

  • Di Pollina L, Guessous I, Petoud V, Combescure C, Buchs B, Schaller P, Kossovsky M, Gaspoz JM. Integrated care at home reduces unnecessary hospitalizations of community-dwelling frail older adults: a prospective controlled trial. BMC Geriatr. 2017 Feb 14;17(1):53. doi: 10.1186/s12877-017-0449-9.

MeSH Terms

Conditions

Chronic Disease

Interventions

Methods

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor in medecin

Study Record Dates

First Submitted

March 7, 2014

First Posted

March 11, 2014

Study Start

July 1, 2009

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

March 11, 2014

Record last verified: 2014-03

Locations