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临床试验/NCT01506219
NCT01506219已完成不适用

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

Aarhus University Hospital4 个研究点 分布在 1 个国家目标入组 368 人开始时间: 2012年1月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
368
试验地点
4
主要终点
Number of hospital admissions and ED visits (the secondary healthcare utilization)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

研究组 & 干预措施

Geriatrician-performed CGC

Experimental

Geriatrician-performed CGC in addition to the usual care at Community Rehabilitation Unit.

干预措施: Geriatrician-performed CGC (Procedure)

Usual care

No Intervention

Usual services at Community Rehabilitation Unit.

结局指标

主要结局

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

时间窗: At 90 days after admission to the rehabilitation units

Numbers of all hospital admissions and ED visits

次要结局

  • Number of ambulatory contacts (the secondary healthcare utilization)(At 90 days after admission to the rehabilitation unit (during + after the rehabilitation stay))
  • Number of days in hospital (the secondary healthcare utilization)(At 90 days after admission to the rehabilitation unit)
  • Number of GP contacts (the primary healthcare utilization)(At 90 days after admission to the rehabilitation unit (during + after the rehabilitation stay))
  • Mortality(At 30 and 90 days after admission to the rehabilitation unit.)
  • Changes in ADL measured by the Modified Barthel-100 Index (MBI)(From the baseline assessment at day 3 to 10, 30 and 90 days after admission to the rehabilitation unit)
  • Residential status(Between baseline and 90 after admission to the rehabilitation unit)
  • Walking aids use(Between baseline and 90 days after admission to the rehabilitation unit)
  • Personal social services extent(Between baseline and 90 days after admission to the rehabilitation unit)
  • Home care(Between baseline and 90 days after admission to the rehabilitation unit)
  • District nurses availability(Between baseline and 90 days after admission to the rehabilitation unit)
  • Changes in Overall Quality of Life (OQoL) measured by the Depression List (DL).(From the baseline assessment at dag 3 to 10, 30 and 90 days after admission to the rehabilitation unit)
  • Changes in cognitive functioning measured by the Mini-mental state examenation (MMSE)(From the baseline assessment at dag 3 to 10, 30 and 90 days after admission to the rehabilitation unit)
  • Changes in physical functioning measured by the 30-second Chair Stand Test (30s-CST)(From the baseline assessment at dag 3 to 10, 30 and 90 days after admission to the rehabilitation unit)
  • Medication status and medication burden(Between baseline and 90 days after admission to the rehabilitation unit)

研究者

发起方
Aarhus University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (4)

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