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FragilityGCGCCRUNCT01506219

Geriatrician-performed Comprehensive Geriatric Care in an Outpatient Community Rehabilitation Unit

A study testing Geriatrician-performed CGC in people with Fragility, run by Aarhus University Hospital at 2 sites in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Fragility
What is being tested?
Geriatrician-performed CGC
Could I receive a placebo?
No, everyone receives an active treatment
How many people
368 participants
Where
2 sitesDenmark
Study dates
17 Jan 2012to 30 Jun 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Denmark2 sites
  • Department of Geriatrics, Aarhus University Hospital

    Aarhus, 8000

  • Rehabilitation Unit Vikaergaarden and Thorsgaarden

    Aarhus, 8240

Other trials in Denmark

About this study

Official title: Geriatrician-performed Comprehensive Geriatric Care in Older Adults Referred to an Outpatient Community Rehabilitation Unit

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.

Read more

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.

Read the 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).

Conditions
Fragility
Being tested
Geriatrician-performed CGC
Keywords
Randomized controlled trial, Comprehensive geriatric care, Activity of daily living, Quality of life, Healthcare utilization, Community rehabilitation unit, Medication adjustment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Geriatrician-performed CGCProcedure or surgery

    Individual disease management and coping was provided using the holistic approach during the face-to-face counselling, where the actual problems, expectations and aims were defined in dialogue with the patient and/or relatives. Afterwards, targeted problem solving with focus on the potentially reversible causes of functional deterioration was established. Finally, medication adjustment was carried out with particular attention to drugs which may lead to iatrogenic functional deterioration, delirium, falls, and malnutrition. Furthermore, the intervention included intravenous antibiotics or blood transfusions (if indicated) conducted by the geriatrician at the rehabilitation units.

Study groups in NCT01506219
Study groupRoleWhat they receive
Geriatrician-performed CGCExperimentalGeriatrician-performed CGC in addition to the usual care at Community Rehabilitation Unit.
Receives: Procedure: Geriatrician-performed CGC
Usual careNo interventionUsual services at Community Rehabilitation Unit.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of hospital admissions and ED visits (the secondary healthcare utilization)

    Numbers of all hospital admissions and ED visits

    Measured: At 90 days after admission to the rehabilitation units

Secondary outcomes (14)
  1. Number of ambulatory contacts (the secondary healthcare utilization)

    All ambulatory contacts, except to the Department of Radiology

    Measured: At 90 days after admission to the rehabilitation unit (during + after the rehabilitation stay)

  2. Number of days in hospital (the secondary healthcare utilization)

    All days spent in hospital

    Measured: At 90 days after admission to the rehabilitation unit

  3. Number of GP contacts (the primary healthcare utilization)

    Numbers of all out of hour GP visits or phone calls, daytime GP consultations and visits, phone and email consultations, and other GP services

    Measured: At 90 days after admission to the rehabilitation unit (during + after the rehabilitation stay)

  4. Mortality

    Mortality rates calculated as the percentage of deaths in the total population per Group (Cox regression analysis used to calculate hazard ratios)

    Measured: At 30 and 90 days after admission to the rehabilitation unit.

  5. Changes in ADL measured by the Modified Barthel-100 Index (MBI)

    MBI is a 10-item instrument that provides a score of basic daily activities. The scores range from 0-100, with a higher score indicating greater independence. The MBI changes calculated as the mean differences in the MBI sum-scores, and as percentage of participants who worsened/did not change vs who improved their MBI from day 3 to day 90

    Measured: From the baseline assessment at day 3 to 10, 30 and 90 days after admission to the rehabilitation unit

  6. Changes in Overall Quality of Life (OQoL) measured by the Depression List (DL).

    DL is an interview-based questionnaire validated among nursing home residents and can be completed by persons themselves with a MMSE score ≥ 5. DL consists of 15 questions covering emotional well-being, social relationships, life-satisfaction, comfort, functional competence, and autonomy. The scale ranges from 0 (best quality of life) to score 30 (poorest quality of life). DL changes calculated as the mean differences in the DL sum-scores, and as percentage of participants who worsened/did not change vs who improved their DL from day 3 to day 90

    Measured: From the baseline assessment at dag 3 to 10, 30 and 90 days after admission to the rehabilitation unit

  7. Changes in cognitive functioning measured by the Mini-mental state examenation (MMSE)

    MMSE is a 10-minute bedside measure of impaired thinking. The items of the MMSE include tests of orientation, registration, recall, calculation and attention, naming, repetition, comprehension, reading, writing and drawing.The MMSE changes calculated as the mean differences in the MMSE sum-scores, and as percentage of participants who worsened/did not change vs who improved their MMSE from day 3 to day 90

    Measured: From the baseline assessment at dag 3 to 10, 30 and 90 days after admission to the rehabilitation unit

  8. Changes in physical functioning measured by the 30-second Chair Stand Test (30s-CST)

    The 30-second chair stand test measures body strength, by determining the number of times the participant can stand up fully and sit down in 30 seconds, with the arms crossed over the chest. We have used the modified version of this test, where use of armrest is allowed. The 30-second Chair Stand Test changes calculated as the mean differences in the 30s-CST sum-scores, and as percentage of participants who worsened/did not change vs who improved their 30s-CST from day 3 to day 90

    Measured: From the baseline assessment at dag 3 to 10, 30 and 90 days after admission to the rehabilitation unit

  9. Residential status

    Calculated in survivors as percentages of persons living in their own home, sheltered housing or nursing home

    Measured: Between baseline and 90 after admission to the rehabilitation unit

  10. Walking aids use

    Percentages of participants using stick, walker or wheelchair

    Measured: Between baseline and 90 days after admission to the rehabilitation unit

  11. Personal social services extent

    Percentages of participants with the personal social services (included practical help and shopping, transport, and emergency call)

    Measured: Between baseline and 90 days after admission to the rehabilitation unit

  12. Home care

    Data on homecare in own home/sheltered housing obtained in survivors living in own home/sheltered housing, and calculated as percentages of persons with homecare (weekly or one or more times daily)

    Measured: Between baseline and 90 days after admission to the rehabilitation unit

  13. District nurses availability

    Data on district nurse availability in own home/sheltered housing obtained in survivors living in own home/sheltered housing, and calculated as percentages of persons with district nurses availability

    Measured: Between baseline and 90 days after admission to the rehabilitation unit

  14. Medication status and medication burden

    Calculated as percentages of the persons using regularly drugs according to their ATC codes. Polypharmacy was categorized into 3 groups based on the number of regular drugs prescribed. Hyper-polypharmacy was defined as concurrent prescription of 10 or more drugs per day; polypharmacy was defined as prescription of 5 to 9 drugs, and non-polypharmacy represented patients prescribed 4 or fewer drugs concomitantly. Medication burden were assessed in a pragmatic way by selection of specific medications with anticholinergic effects and sedative effects. The chose of the selected drugs matched the drugs where the indication should reassess in the older adults according to the National Board of Health.

    Measured: Between baseline and 90 days after admission to the rehabilitation unit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2012 (estimated)
  2. Study start17 Jan 2012
  3. Primary completion29 May 2015
  4. Study completion30 Jun 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
A pragmatic open assessor-blinded clinical randomized controlled trial with two parallel groups.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
368 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01506219
Sponsor's protocol ID
NZ-151111-VHDZ
Acronym
GCGCCRU
Status last verified
Oct 2017
First submitted
28 Dec 2011
Last updated
23 Jan 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 29395938

Questions about this trial

What is this clinical trial studying?

A study testing Geriatrician-performed CGC in people with Fragility, run by Aarhus University Hospital at 2 sites in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of hospital admissions and ED visits (the secondary healthcare utilization) (time frame: At 90 days after admission to the rehabilitation units). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01506219, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2018.

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