Clinical trial NCT01506219: Geriatrician-performed Comprehensive Geriatric Care in an Outpatient Community Rehabilitation Unit
Official title: Geriatrician-performed Comprehensive Geriatric Care in Older Adults Referred to an Outpatient Community Rehabilitation Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fragility
Keywords: Randomized controlled trial
Comprehensive geriatric care
Activity of daily living
Quality of life
Healthcare utilization
Community rehabilitation unit
Medication adjustment
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: University of Aarhus
First posted: 2012-01-09
Enrollment: 368
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A pragmatic open assessor-blinded clinical randomized controlled trial with two parallel groups.
Primary purpose: TREATMENT

Brief summary: Introduction:

Older adults with multiple illnesses represent the fastest growing sector of society and make increasing demands on all sectors of the health care system, particularly in outpatient community rehabilitation units due to shorter time of stay in acute care units and hospitals. The aim of this study is to investigate the effect of geriatrician-performed comprehensive geriatric care (CGC) in older people referred to an outpatient community rehabilitation unit.

Methods:

The study is a prospective randomized controlled trial. Settings: two community care rehabilitation units in Aarhus Municipality, Denmark. Inclusion: persons aged 65 and older from home or hospital. Exclusion: persons who received palliative care or had been assessed by a geriatrician during the past month. Intervention: medical history, physical examination, blood tests, medication adjustment and related treatments performed by a geriatrician. Control: usual care in a community rehabilitation unit. Number of hospital admissions and emergency department (ED) visits (primary outcome), number of GP contacts, activities of daily living, physical and cognitive functioning, quality of life, data on institutionalization, medication status, and mortality are assessed at day 30 and 90 after arrival at the rehabilitation unit.

Project status:

The outpatient CGC model is developed, implemented and compared with usual care in a pragmatic RCT.

Detailed description: Procedure Participants were recruited consecutively from the rehabilitation unit Vikaergaarden in the period from January 17, 2012 to May 29, 2015, and from the rehabilitation unit Thorsgaarden from October 20, 2014 to May 29, 2015. The random allocation of the participants to an intervention group (IG) or a control group (CG) was done by an independent external organization ("TrialPartner", Public Health and Quality Improvement, Central Denmark Region). The permuted block sizes stratified the randomization according to sex, age, and place of referral. The randomization took place within three days after the participants' arrival to the rehabilitation unit. Owing to the nature of this study, it was impossible to blind participants and their relatives to the allocation group. The project manager was blinded to the study outcomes, which were collected from the registers or by the blinded research occupational therapist. Rehabilitation units' staff, particularly physiotherapists, were not blinded.

Care in the CG The patients were referred for rehabilitation either from hospital or home by the hospital personnel or by the home care staff.The typical standard rehabilitation and care program lasts five weeks. The interdisciplinary approach is based on the patient's whole situation, capability and wishes/needs. On the first day of rehabilitation, the patient's functional status is observed by the rehabilitation unit's physiotherapists and occupational therapists, and a nutritional screening is performed by the rehabilitation unit's nutritionist.The team members discuss the patient's discharge destination and necessary arrangements with the patient and his/her relatives at the mid-term meeting and before discharge from the rehabilitation unit. Municipality nurse participates in these meeting personally or by telephone. Destination after discharge is based upon the patient's motivation, functional and medical status.

The patient's GPs visit the patients during the stay if required or occasionally by own initiative depending on practice routine and geographical distance. GPs mostly visit frail and high-risk elderly patients especially if recently hospitalized. Acute medical aid is called for in case of illness after 4.p.m. and on weekends and public holidays.

Care in the IG Participants in the IG had the same access to usual care and additionally underwent a CGC performed by a physician specialized in geriatric medicine. The intervention included medical history, physical examination, blood tests, medication adjustment and treatments, including intravenous antibiotics or blood transfusions conducted by the geriatrician at the rehabilitation units. The geriatrician was employed 18.5 hours per week and was present at the rehabilitation units for four days a week, and could be contacted on telephone for any reason by participants, their relatives, or the units' staff on weekdays from 8 a.m. to 3 p.m.

BaselineAssessments Before randomization baseline characteristics were registered from medical records by the project manager, comprising age, gender, place of referral, marital status, residence, previous diagnoses, list of medications and comorbidity burden by Charlson Comorbidity Index (CCI). Baseline functional status and quality of life measures were assessed on day 3 from admission to the rehabilitation units by a research occupational therapist.

Statistics The numbers of hospital admissions, ED visits, ambulatory contacts, and GP contacts will be compared by Incidence Rate Ratios (IRR) with 95% confidence intervals (CI). IRR will be calculated using negative binominal regression with adjustment for mortality by including the risk time as an exposure variable.

Mortality rates after 30 and 90 days will be calculated as percentages of deaths in total population per group. In non-survivors and in case of missing baseline observations, the missing measures will be set to the worst possible values. The worst value imputation method will be used in all other cases of missing values.

The mean group values will be analyzed using repeated measurements mixed model. Dichotomous variables will be created to investigate distribution between participants who worsened/did not change versus participants who improved their functional status or quality of life, and analyzed using logistic regression. Results will be expressed as odds ratios (ORs) with 95% CIs.

Subgroup analyses will be conducted to explore if effects of intervention when compared to usual care depended on the baseline comorbidity burden low/moderate (CCI 0-2) versus high (CCI ≥3 points). The subgroup analyses will be carried out for the functional status and quality of life.

There were no drop-outs during the study and data on healthcare utilization are complete. Intention-to-treat analyses will be performed in the all 368 participants. The two-sided significance level of 5% will be used for evaluation of statistical significance in the primary and secondary endpoints.

(The materials and methods are described in detail elsewhere: Zintchouk D, Lauritzen T, Damsgaard EM. "Comprehensive Geriatric Care Versus Standard Care For Elderly Referred To A Rehabilitation Unit - A Randomized Controlled Trial". J Aging Res Clin Practice 2017;inpress. Published online December 15, 2016, http://dx.doi.org/10.14283/jarcp.2016.126).

Eligibility criteria: Inclusion Criteria:

1. Age 65+ years old in Aarhus Municipality, Denmark
2. Referral to a community rehabilitation unit by general practitioner, home care services or a hospital department staff
3. Written informed consent

Exclusion Criteria:

1. Persons, who received Comprehensive Geriatric Assessment within last 1 month
2. Persons in the palliative care at the time of referral

Primary outcomes:
measure: Number of hospital admissions and ED visits (the secondary healthcare utilization)
timeFrame: At 90 days after admission to the rehabilitation units
Secondary outcomes:
measure: Number of ambulatory contacts (the secondary healthcare utilization)
timeFrame: At 90 days after admission to the rehabilitation unit (during + after the rehabilitation stay)
measure: Number of days in hospital (the secondary healthcare utilization)
timeFrame: At 90 days after admission to the rehabilitation unit
measure: Number of GP contacts (the primary healthcare utilization)
timeFrame: At 90 days after admission to the rehabilitation unit (during + after the rehabilitation stay)
measure: Mortality
timeFrame: At 30 and 90 days after admission to the rehabilitation unit.
measure: Changes in ADL measured by the Modified Barthel-100 Index (MBI)
timeFrame: From the baseline assessment at day 3 to 10, 30 and 90 days after admission to the rehabilitation unit
measure: Changes in Overall Quality of Life (OQoL) measured by the Depression List (DL).
timeFrame: From the baseline assessment at dag 3 to 10, 30 and 90 days after admission to the rehabilitation unit
measure: Changes in cognitive functioning measured by the Mini-mental state examenation (MMSE)
timeFrame: From the baseline assessment at dag 3 to 10, 30 and 90 days after admission to the rehabilitation unit
measure: Changes in physical functioning measured by the 30-second Chair Stand Test (30s-CST)
timeFrame: From the baseline assessment at dag 3 to 10, 30 and 90 days after admission to the rehabilitation unit
measure: Residential status
timeFrame: Between baseline and 90 after admission to the rehabilitation unit
measure: Walking aids use
timeFrame: Between baseline and 90 days after admission to the rehabilitation unit
measure: Personal social services extent
timeFrame: Between baseline and 90 days after admission to the rehabilitation unit
measure: Home care
timeFrame: Between baseline and 90 days after admission to the rehabilitation unit
measure: District nurses availability
timeFrame: Between baseline and 90 days after admission to the rehabilitation unit
measure: Medication status and medication burden
timeFrame: Between baseline and 90 days after admission to the rehabilitation unit
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Geriatrics, Aarhus University Hospital
city: Aarhus
country: Denmark
facility: Rehabilitation Unit Vikaergaarden and Thorsgaarden
Study officials:
affiliation: Department of Geriatrics, Aarhus University Hospital, Denmark
name: Dmitri Zintchouk, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Geriatrics, Aarhus University Hospital, Denmark
name: Else Marie Damsgaard, MD, DMSc
role: STUDY_DIRECTOR
References:
citation: Zintchouk D, Gregersen M, Lauritzen T, Damsgaard EM. Geriatrician-performed comprehensive geriatric care in older adults referred to an outpatient community rehabilitation unit: A randomized controlled trial. Eur J Intern Med. 2018 May;51:18-24. doi: 10.1016/j.ejim.2018.01.022. Epub 2018 Feb 1.