Comprehensive Geriatric Assessment for Frail Older People

• ClinicalTrials.gov Identifier: NCT02773914
• Recruitment Status: Completed
• First Posted: May 16, 2016
• Last Update Posted: February 25, 2021
• Sponsor: Göteborg University
• Collaborator: Umeå University
• Information provided by (Responsible Party): Göteborg University

Study Description

Brief Summary:

The present study "Comprehensive Geriatric Assessment for frail older people in Swedish acute care settings - a randomized controlled study" comprises two study arms: one intervention and one control group. It is a multicentre trial with 5 centres with diverse local conditions in different parts of Sweden, with an implementation study alongside.

The intervention "Comprehensive Geriatric Assessment (CGA) for frail older people" addresses people 75 years and older who are seeking acute hospital care at the hospital emergency department, and who are identified as frail. The CGA intervention, including a multidisciplinary team that assesses the patients socio-demographic background, social network, health and medical history, medications, functional status, cognitive status, nutritional status, somatic status and psychosocial status including depression, as well as treatment and planning for discharge and follow-up, contributes to a person-centred, and a comprehensive assessment tailored for each person. The results of this study are expected to optimize the implementation of future complex interventions and lead to the improvement of the care, support and rehabilitation for frail older people with complex needs.

This study will contribute to an evidence base for full scale implementation of CGA in Swedish hospital care. The process evaluation, aiming to provide insight into function and consequences of the intervention, why it works or fails, is an important part of the design that will contribute with insights into real life conditions that may be challenging in implementing CGA. The investigators will evaluate fidelity and quality of the implementation, clarify causal mechanisms and identify contextual factors associated with variation in outcomes. The development of screening for frailty and CGA are potential and important tools to identify needs of this older population, and to direct the right health care actions towards those in most need.

The study will address the following research questions:

1. Can Comprehensive Geriatric Assessment for frail older patients in Swedish acute hospital settings:

   • increase/maintain independence, functional status, health related quality of life and life satisfaction?
   • increase satisfaction with health care?
   • reduce health care consumption?
2. How feasible and acceptable are the study processes and procedures of CGA from the perspective of care givers and older persons in Swedish settings?

Condition or disease	Intervention/treatment	Phase
Dependency	Other: Comprehensive Geriatric Assessment	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 155 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Comprehensive Geriatric Assessment for Frail Older People in Swedish Acute Care Settings: A Randomized Controlled Study
• Actual Study Start Date: March 2016
• Actual Primary Completion Date: January 27, 2020
• Actual Study Completion Date: January 27, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: CGA intervention; The CGA intervention will include multidisciplinary teams consisting of physician, nurse (RN), physiotherapist (PT), occupational therapist (OT) and social worker (SW). The team will work according to CGA, and have the primary and continuing responsibility for planning of hospital care and discharge. CGA will include assessment of socio-demographic background, social network, health and medical history, medications, functional status, cognitive status, nutritional status, somatic status and psychosocial status including depression, as well as treatment and planning for discharge and follow-up.	Other: Comprehensive Geriatric Assessment; Comprehensive Geriatric Assessment intervention
No Intervention: Control group; The control group receives usual hospital care, that is care given at an ordinary medical hospital ward, without the specialized multi-disciplinary team approach and CGA.

Outcome Measures

Primary Outcome Measures :

1. Dependence in Activities of Daily Living (ADL-staircase) [ Time Frame: Baseline, 1-month follow-up, 6-month follow-up and 12-month follow-up ]
   Changes in number of person dependent in one or more daily activity from baseline to follow-up.

Secondary Outcome Measures :

1. Capability (ICECAP-O) [ Time Frame: Baseline, 1-month follow-up, 6-month follow-up and 12-month follow-up ]
   Changes in scores of ICECAP-O from baseline to follow-up.
2. Self-rated Health (SF-36) [ Time Frame: Baseline, 1-month follow-up, 6-month follow-up and 12-month follow-up ]
   Changes in number of person with good self-rated health from baseline to follow-up.
3. Satisfaction with quality of care (Questionnaire) [ Time Frame: 1-month follow-up ]
   Number of persons satisfied with quality of care

Eligibility Criteria

• Ages Eligible for Study: 75 Years and older (Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• All patients 75 years and older seeking acute hospital care at the hospital emergency department will be screened for frailty.

Exclusion Criteria:

• Those with symptoms of predefined diagnoses such as stroke, acute myocardial infarction and hip fractures, admitted through "fast tracks" directly to a designated ward without passing the emergency department.

Contacts and Locations

Locations

Sweden

Gothenburg University

Gothenburg, Sweden

Sponsors and Collaborators

Göteborg University

Umeå University

Investigators

• Principal Investigator: Isabelle Ottenvall Hammar, Sahlgrenska Akademin Göteborgs Universitet; Institute of Neuroscience and Physiology

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Westgård T, Ottenvall Hammar I, Holmgren E, Ehrenberg A, Wisten A, Ekdahl AW, Dahlin-Ivanoff S, Wilhelmson K. Comprehensive geriatric assessment pilot of a randomized control study in a Swedish acute hospital: a feasibility study. Pilot Feasibility Stud. 2018 Jan 29;4:41. doi: 10.1186/s40814-018-0228-1. eCollection 2018.

• Responsible Party: Göteborg University
• ClinicalTrials.gov Identifier: NCT02773914
• Other Study ID Numbers: CGA for frail older people
• First Posted: May 16, 2016
• Last Update Posted: February 25, 2021
• Last Verified: February 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Göteborg University:

Activity of Daily Living (ADL); Comprehensive Geriatric Assessment; Elderly; Frailty; Randomized controlled study