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van CCT (UK)

van CCT (UK)

Advance Care Planning in elderly care

- candidate number16144
- NTR NumberNTR4454
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR22-jan-2014
- Secondary IDsNL.46444.078.13 Medisch Ethische Toetsings Commissie (METC)
- Public TitleAdvance Care Planning in elderly care
- Scientific TitleCosts and effects of Advance Care Planning in elderly care
- hypothesisCurrently, health care and medical decision-making for older people are often insufficiently patient-centred. Communication about people’s needs and preferences is typically postponed until acute events necessitate short-term medical decision-making. At that stage, patients are often unprepared or unable to make decisions while relatives and professional caregivers are unaware of their wishes and preferences, which may result in overtreatment and a suboptimal quality of the last phase of life. The main objective of this project is to assess the effects, the costs and the cost-effectiveness of ACP in elderly care. In this study we focus on patients living in care homes or living at home and receiving home care. As far as we are aware, the proposed study is a unique study, it does not overlap with any ongoing or finalized projects. We hypothesize that ACP will lead to better patient activation and quality of life in the intervention group compared to the control group, while reducing health care costs. All in all we expect ACP to provide a superior way to organize care for older persons in comparison to usual care.
- Healt Condition(s) or Problem(s) studiedOlder adults, Elderly care, Advance Care Planning
- Inclusion criteriaIn order to be eligible to participate in this study, a subject must meet all of the following criteria: - > 75 years of age; - Mentally competent, as measured by a Mini–Mental State Examination (MMSE score > 16 and subsequently by judgement of caregiver; - Fluent in Dutch; - Living in a care home or at home receiving home care; - Being frail, as measured by the Tilburg Frailty Index (TFI score of 5 or more) Study participants who leave the care home during follow-up remain included in the study. If study participants pass away during follow-up, the interview will be held with a relative as a proxy for the participant’s perspective
- Exclusion criteriaAn individual who does not meet the described inclusion criteria will be excluded from participation in this study.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 10-feb-2014
- planned closingdate1-sep-2015
- Target number of participants196
- InterventionsControl groups will be offered usual care. Individuals in the intervention group will be offered formal ACP using the Respecting Choices Model in addition to their usual care. This programme, developed in the US and Australia, involves a coordinated approach to ACP whereby trained nurse facilitators, in collaboration with treating physicians, assist residents and their families to reflect on the resident’s goals, values and beliefs and to discuss their health care wishes. This discussion also directs individuals to identify specific activities and experiences that contribute to, or detract from, their quality of life. Individuals are encouraged to appoint a surrogate decision-maker, and to document their wishes about the care they do or do not want to receive in an advance directive. These wishes can e.g. concern the (non)use of burdensome life-prolonging interventions such as hospitalisation, cardio-pulmonary resuscitation, etc. The intervention will concern a 1-hour meeting, but additional meetings are possible. The content of the meeting will be structured by the use of a checklist.
- Primary outcomePrimary effect outcome measure: - Patient activation (PAM-13)
- Secondary outcome- Quality of life (SF-12) - Satisfaction with health care (PSQ-18-SF6) - Health care costs (for the calculation of the health care costs we will distinguish intramural and extramural medical costs) - Use of burdensome medical interventions: hospitalisations, use of ventilation, resuscitation, chemotherapy, feeding tube, operations, antibiotics - Appointment of surrogate decision-maker and documentation of care wishes in advance directives
- Timepoints- Patient Activation Measure (PAM-13): during inclusion and one year later - Generic Health-Releated Quality of Life (SF-12): during inclusion and one year later - The Patient Satisfaction Questionnaire Short Form (PSQ-18-SF6): during inclusion and one year later - Medical files of all residents and of people receiving home care will be studied with the use of a checklist, one year post-intervention. The following points will be studied: - People’s characteristics: age, gender, SES, diagnosis, co morbidity - Registration of completion of advance directive and assignment of proxy decision-maker including date of completion - Medical care in the last 12 months: hospitalizations, other transfers (number, length of stay), use of ventilation, resuscitation, chemotherapy, feeding tube, operations, antibiotics - Furthermore a cost effectiveness analysis (CEA) and a budget impact analysis (BIA) will be done one-year post- intervention
- Trial web site
- statusopen: patient inclusion
- CONTACT for SCIENTIFIC QUERIESProf. Dr. A. Heide, van der
- Sponsor/Initiator Erasmus Medical Center, Rotterdam
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development, Innovation Fund Laurens Rotterdam
- PublicationsWe will write articles for (inter)national scientific and lay journals on care for older people, health care, palliative care, health policy, and health economics.
- Brief summaryEnd-of-life care involves high costs, but frequently fails in providing optimal patient centred care and quality of life. In the US, Advance Care Planning (ACP), a formalised process of communication about care preferences, has resulted in better patient outcomes and significant cost savings. In the Netherlands, interest in ACP is increasing, but data on cost-effectiveness are lacking. We aim to assess effects of ACP in older people residing in Dutch care homes or revceiving home care and hypothesize that ACP will lead to better patient activation and quality of life in the intervention group compared to the control group, while reducing health care costs.
- Main changes (audit trail)
- RECORD22-jan-2014 - 9-apr-2014

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