Compared Efficacy of Nurse-led and GP-led Geriatric Assessment in PrImary Care (CEPIA)

July 24, 2017 updated by: Assistance Publique - Hôpitaux de Paris

Compared Efficacy of Nurse-led and GP-led Geriatric Assessment in PrImary Care: A Pragmatic Three-arm Cluster Randomized Controlled Trial

Older patients account for around 10% of the population, of which 57% have a long-term illness, and 33% were admitted in the past year.

Geriatric assessment (GA) is a multidimensional assessment of general health status that can help identifying deficiencies and followed by a personalized care plan.

Assessment and management of elderly patients is a daily concern for the general practitioner (GP) but conflicting results have been reported so far relating to the clinical impact of GA when applied in the primary care setting.

This study protocol aims to assess the effect on morbi-mortality of a complex intervention in patients aged ≥70 years with chronic conditions in primary care. It aims to demonstrate that a GA adapted to primary care, followed by a personalized care plan and combined with successful interprofessional collaboration can improve clinically relevant outcomes in elderly patients with chronic conditions such as one-year overall mortality, unplanned hospital admission, emergency visits, or institutionalization.

The CEPIA study will also help addressing the issue of whether an improved benefit could be achieved from a systematic nurse-led or a case-by-case GP-led GA.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

750

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Creteil, France, 94010
        • Recruiting
        • Faculté de Médecine, Université Paris Est Créteil (UPEC)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients aged≥70 years with a long-term illness scheme or hospital admission the past 3 months
  • Visiting their preferred general practioner (GP) or another GP in the same practice
  • patient oral non opposition

Exclusion Criteria:

  • Patient who does not speak French
  • Severe disease with a life expectancy <12 months
  • Institutionalized patients
  • Patient insured under the French national health insurance system

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Systematic nurse-led GA
Interactive educational seminar for GPs and nurses, and focused on geriatric assessment in primary care combined with Systematic nurse-led GA and dedicated hotline for GPs seeking geriatric advice
Other: health care organization

Nurse-led or GP-led Geriatric assessment combined with an educational seminar focused on GA and personalized care-plan as well as a dedicated hotline for general practitioners seeking a geriatric advice

Interactive educational seminar Primary care

Other Names:
  • Nurse-led or GP-led Geriatric assessment combined with an educational seminar
Experimental: GP-led GA on a case-by-case basis, as decided by the GP
Interactive educational seminar for GPs, and focused on Geriatric assessment in primary care combined with a GP-led GA on a case-by-case basis, as decided by the GP, and a dedicated hotline for GPs seeking geriatric advice
Other: health care organization

Nurse-led or GP-led Geriatric assessment combined with an educational seminar focused on GA and personalized care-plan as well as a dedicated hotline for general practitioners seeking a geriatric advice

Interactive educational seminar Primary care

Other Names:
  • Nurse-led or GP-led Geriatric assessment combined with an educational seminar
No Intervention: No intervention
No educational seminar Usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Primary composite endpoint combined with: - Percentage of all-cause mortality - Percentage of Unplanned hospital admission - Percentage of Emergency visits. - Percentage of Institutionalization
Time Frame: At 12 months
At 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of all-cause mortality
Time Frame: At 12 months
At 12 months
Percentage of Unplanned hospital admission
Time Frame: At 12 months
At 12 months
Percentage of Emergency visits
Time Frame: At 12 months
At 12 months
Percentage of Institutionalization
Time Frame: At 12 months
At 12 months
Quality of life (Duke profile score)
Time Frame: At Day 0 and 12 months
At Day 0 and 12 months
Autonomy by KATZ ALD score
Time Frame: At Day 0 and 12 months
At Day 0 and 12 months
Number of medication prescription (polypharmacy)
Time Frame: Up to 12 months
Up to 12 months
Percentage of Geriatric assessment performed
Time Frame: Up to 12 months
Up to 12 months
Percentage of personalized care plan performed
Time Frame: Up to 12 months
Up to 12 months
Percentage of geriatric phone advices requested by GPs
Time Frame: Up to 12 months
Up to 12 months
Percentage of health care actions planned
Time Frame: Up to 12 months
Up to 12 months
Percentage of satisfied general practitioner with the intervention
Time Frame: 27months after the beginning of the study
self-assessment
27months after the beginning of the study
Satisfaction of general practitioners and nurses after completion of intervention
Time Frame: 12 months after the beginning of the study
interview of general practionners and nurses by independant investigator
12 months after the beginning of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Emilie Ferrat, MCU-MG, Université Paris Est (UPEC), IMRB, A-TVB DHU, CEpiA EA 7376 (Clinical Epidemiology and Ageing Unit)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 24, 2016

Primary Completion (Anticipated)

August 24, 2018

Study Completion (Anticipated)

August 24, 2018

Study Registration Dates

First Submitted

January 22, 2016

First Submitted That Met QC Criteria

January 22, 2016

First Posted (Estimate)

January 27, 2016

Study Record Updates

Last Update Posted (Actual)

July 26, 2017

Last Update Submitted That Met QC Criteria

July 24, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • K140707

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Multimorbidity

Clinical Trials on health care organization

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Pakistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe