Clinical trial NCT02773914: Comprehensive Geriatric Assessment for Frail Older People
Official title: Comprehensive Geriatric Assessment for Frail Older People in Swedish Acute Care Settings: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dependency
Keywords: Activity of Daily Living (ADL)
Comprehensive Geriatric Assessment
Elderly
Frailty
Randomized controlled study
Lead sponsor: Göteborg University
Sponsor class: OTHER
Collaborators: name: Umeå University
First posted: 2016-05-16
Enrollment: 155
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study "Comprehensive Geriatric Assessment for frail older people in Swedish acute care settings - a randomized controlled study" comprised two study arms: one intervention and one control group. The aim of the study was to evaluate the effects of the Comprehensive Geriatric Assessment (CGA) for frail older people in Swedish acute hospital settings - the CGA-Swed study. The intervention group received the CGA and a control group received medical assessment without the CGA. Follow-ups were conducted after 1, 6 and 12 months, with dependence in activities of daily living (ADL) as the primary outcome measure. The study group consisted of frail older people, 75 years and older, in need of acute medical hospital care. The study design, randomization and process evaluation carried out were intended to ensure the quality of the study. Baseline data showed that the randomisation was successful and that the sample included frail older people with high dependence in ADL, and with a high comorbidity. Thus, the CGA contributed to early recognition of frail older people's needs and ensured a care plan and follow-up. When investigating the long-term effects on frail older people's ADL 12 months after receiving the CGA, results showed that twelve participants in the intervention group (15.4%), and four participants in the control group (5.2%) had improved in their ADL 1 year after discharge. Qualitative interviews with CGA-participants also showed that the participants felt respected as a person when receiving care on a CGA acute geriatric ward.

Detailed description: The aim of the study "Comprehensive Geriatric Assessment for frail older people in Swedish acute care settings - a randomized controlled study" was to evaluate the effects of the Comprehensive Geriatric Assessment (CGA) for frail older people in Swedish acute hospital settings.

The study addressed 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?

The intervention addressed people 75 years and older who were seeking acute hospital care at the hospital emergency department, and who were identified as being frail. The CGA intervention included a multidisciplinary team that assessed the patient's 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. The intervention was person-centred, and comprised a comprehensive assessment tailored for each person.

In total, one-hundred and fifty-five people participated in the study; 78 in the intervention group and 77 in the control group. Participants in the intervention group had a higher odds ratio of reporting having received written information and felt that care met their needs during their hospital stay. At the 12-month follow up, 78 people participated (40 in the control and 38 in the intervention). Results showed that twelve participants in the intervention group (15.4%), and four participants in the control group (5.2%) had improved in their ADL 1 year after discharge. Further, people who received the CGA intervention had higher odds of receiving antidepressant treatment, suggesting that CGA improves recognition of mental health needs during an unplanned hospital admission. Qualitative interviews with participants receiving the CGA showed that the care they received on the CGA ward met their needs. The participants felt respected as a person when receiving care on a CGA acute geriatric ward. This was achieved by having a reciprocal relationship with the ward staff, enabling their participation in decisions when engaged in communication and understanding.

Eligibility 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.

Primary outcomes:
measure: Dependence in Activities of Daily Living
timeFrame: 1 year
Secondary outcomes:
measure: Self-rated Health
timeFrame: 1 year
measure: Satisfaction With Quality of Care
timeFrame: 1 month follow-up
measure: Life Satisfaction
timeFrame: 1 year
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Isabelle Andersson Hammar
Study officials:
affiliation: Göteborg University
name: Isabelle Andersson Hammar, Assoc.prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Göteborg University
name: Katarina Wilhelmson, Professor
role: STUDY_DIRECTOR
References:
citation: Andersson Hammar I, Westgard T, Dahlin-Ivanoff S, Wilhelmson K. Frail older people with decreased cognition can perceive reduced self-determination in self-care and social relationships. BMC Geriatr. 2024 Jan 3;24(1):7. doi: 10.1186/s12877-023-04492-y.
citation: Westgard T, Hammar IA, Wilhelmson K, Waern M. Comprehensive geriatric assessment is associated with increased antidepressant treatment in frail older people with unplanned hospital admissions-results from the randomised controlled study CGA-Swed. BMC Geriatr. 2022 Aug 5;22(1):645. doi: 10.1186/s12877-022-03324-9.
citation: Wilhelmson K, Andersson Hammar I, Westgard T, Holmquist Henrikson L, Dahlin-Ivanoff S. Positive effects on activities of daily living one year after receiving comprehensive geriatric assessment - results from the randomised controlled study CGA-Swed. BMC Geriatr. 2022 Mar 3;22(1):180. doi: 10.1186/s12877-022-02862-6.
citation: Wilhelmson K, Hammar IA, Ehrenberg A, Niklasson J, Eckerblad J, Ekerstad N, Westgard T, Holmgren E, Aberg ND, Ivanoff SD. Comprehensive Geriatric Assessment for Frail Older People in Swedish Acute Care Settings (CGA-Swed): A Randomised Controlled Study. Geriatrics (Basel). 2020 Jan 24;5(1):5. doi: 10.3390/geriatrics5010005.
citation: Westgard T, Andersson Hammar I, Dahlin-Ivanoff S, Wilhelmson K. Can Comprehensive Geriatric Assessment Meet Frail Older People's Needs? Results from the Randomized Controlled Study CGA-Swed. Geriatrics (Basel). 2020 Dec 4;5(4):101. doi: 10.3390/geriatrics5040101.
citation: Westgard T, Wilhelmson K, Dahlin-Ivanoff S, Ottenvall Hammar I. Feeling Respected as a Person: a Qualitative Analysis of Frail Older People's Experiences on an Acute Geriatric Ward Practicing a Comprehensive Geriatric Assessment. Geriatrics (Basel). 2019 Jan 25;4(1):16. doi: 10.3390/geriatrics4010016.
citation: Westgard 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.