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

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ClinicalTrials.gov Identifier: NCT01506219
Recruitment Status : Completed
First Posted : January 9, 2012
Last Update Posted : January 23, 2018
Sponsor:
Collaborator:
University of Aarhus
Information provided by (Responsible Party):
University of Aarhus ( Aarhus University Hospital )

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.


Condition or disease Intervention/treatment
Fragility Procedure: Geriatrician-performed CGC

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 368 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A pragmatic open assessor-blinded clinical randomized controlled trial with two parallel groups.
Masking: Single (Outcomes Assessor)
Masking Description:

The geriatrician was blinded to the primary endpoint data that were drawn from the National Patient Registry via Researcher Service. The dataset was generated by the Registry's staff blinded to the patient allocation.

It was impossible to blind the participants and their relatives or the geriatrician and the rehabilitation units' staff to the allocation group.

The research nurse was not blinded to patient allocation for practical reasons. The research occupational therapist was blinded to treatment allocation.

Primary Purpose: Treatment
Official Title: Geriatrician-performed Comprehensive Geriatric Care in Older Adults Referred to an Outpatient Community Rehabilitation Unit
Actual Study Start Date : January 17, 2012
Primary Completion Date : May 29, 2015
Study Completion Date : June 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Geriatrician-performed CGC
Geriatrician-performed CGC in addition to the usual care at Community Rehabilitation Unit.
Procedure: Geriatrician-performed CGC
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.
No Intervention: Usual care
Usual services at Community Rehabilitation Unit.



Primary Outcome Measures :
  1. Number of hospital admissions and ED visits (the secondary healthcare utilization) [ Time Frame: At 90 days after admission to the rehabilitation units ]
    Numbers of all hospital admissions and ED visits


Secondary Outcome Measures :
  1. Number of ambulatory contacts (the secondary healthcare utilization) [ Time Frame: At 90 days after admission to the rehabilitation unit (during + after the rehabilitation stay) ]
    All ambulatory contacts, except to the Department of Radiology

  2. Number of days in hospital (the secondary healthcare utilization) [ Time Frame: At 90 days after admission to the rehabilitation unit ]
    All days spent in hospital

  3. Number of GP contacts (the primary healthcare utilization) [ Time Frame: At 90 days after admission to the rehabilitation unit (during + after the rehabilitation stay) ]
    Numbers of all out of hour GP visits or phone calls, daytime GP consultations and visits, phone and email consultations, and other GP services

  4. Mortality [ Time Frame: At 30 and 90 days after admission to the rehabilitation unit. ]
    Mortality rates calculated as the percentage of deaths in the total population per Group (Cox regression analysis used to calculate hazard ratios)

  5. Changes in ADL measured by the Modified Barthel-100 Index (MBI) [ Time Frame: From the baseline assessment at day 3 to 10, 30 and 90 days after admission to the rehabilitation unit ]
    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

  6. Changes in Overall Quality of Life (OQoL) measured by the Depression List (DL). [ Time Frame: From the baseline assessment at dag 3 to 10, 30 and 90 days after admission to the rehabilitation unit ]
    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

  7. Changes in cognitive functioning measured by the Mini-mental state examenation (MMSE) [ Time Frame: From the baseline assessment at dag 3 to 10, 30 and 90 days after admission to the rehabilitation unit ]
    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

  8. Changes in physical functioning measured by the 30-second Chair Stand Test (30s-CST) [ Time Frame: From the baseline assessment at dag 3 to 10, 30 and 90 days after admission to the rehabilitation unit ]
    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

  9. Residential status [ Time Frame: Between baseline and 90 after admission to the rehabilitation unit ]
    Calculated in survivors as percentages of persons living in their own home, sheltered housing or nursing home

  10. Walking aids use [ Time Frame: Between baseline and 90 days after admission to the rehabilitation unit ]
    Percentages of participants using stick, walker or wheelchair

  11. Personal social services extent [ Time Frame: Between baseline and 90 days after admission to the rehabilitation unit ]
    Percentages of participants with the personal social services (included practical help and shopping, transport, and emergency call)

  12. Home care [ Time Frame: Between baseline and 90 days after admission to the rehabilitation unit ]
    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)

  13. District nurses availability [ Time Frame: Between baseline and 90 days after admission to the rehabilitation unit ]
    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

  14. Medication status and medication burden [ Time Frame: Between baseline and 90 days after admission to the rehabilitation unit ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01506219


Locations
Denmark
Department of Geriatrics, Aarhus University Hospital
Aarhus, Denmark, 8000
Rehabilitation Unit Vikaergaarden and Thorsgaarden
Aarhus, Denmark, 8240
Sponsors and Collaborators
Aarhus University Hospital
University of Aarhus
Investigators
Principal Investigator: Dmitri Zintchouk, MD Department of Geriatrics, Aarhus University Hospital, Denmark
Study Director: Else Marie Damsgaard, MD, DMSc Department of Geriatrics, Aarhus University Hospital, Denmark

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT01506219     History of Changes
Other Study ID Numbers: NZ-151111-VHDZ
First Posted: January 9, 2012    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of Aarhus ( Aarhus University Hospital ):
Randomized controlled trial
Comprehensive geriatric care
Activity of daily living
Quality of life
Healthcare utilization
Community rehabilitation unit
Medication adjustment