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SHARED DECISION MAKING IN LONG-TERM CARE FACILITIES

Primary Purpose

Dementia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Shared Decision-Making educational training
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dementia focused on measuring Shared decision making, Dementia, Long-term care, Nursing home, Care plan

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • diagnosis of dementia based on the Diagnostic and Statistical Manual of Mental Disorders (DSM) IV
  • from moderate to severe cognitive decline (Global Deterioration Scale from 4 to 6)
  • supported by a family caregiver who can be involved

Exclusion Criteria:

  • unable to pronounce simple sentences

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    SDM care planning

    Arm Description

    Outcomes

    Primary Outcome Measures

    The proportion of residents whose preferences and needs, together with the related actions to meet them, are known, documented and satisfied in their 'life-and-care plans'.

    Secondary Outcome Measures

    Full Information

    First Posted
    April 14, 2014
    Last Updated
    May 18, 2017
    Sponsor
    Radboud University Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02118701
    Brief Title
    SHARED DECISION MAKING IN LONG-TERM CARE FACILITIES
    Official Title
    SHARED DECISION MAKING ON A 'LIFE-AND-CARE PLAN' IN LONG-TERM CARE FACILITIES
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2014 (undefined)
    Primary Completion Date
    May 2015 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Radboud University Medical Center

    4. Oversight

    5. Study Description

    Brief Summary
    Shared Decision Making (SDM) is defined as a process where healthcare professionals and patients make decisions together, using the best available evidence. SDM, as a communication and decision method, can be used also with persons suffering from dementia. Yet, SDM with persons with dementia or even with their family caregivers is not widespread. The present research project aims to develop and evaluate an SDM framework in care planning to be implemented in long-term care facilities, in order to obtain a constantly developing care plan that focuses not only on the medical, physical, psychosocial and spiritual needs of the resident, but that considers and documents his preferences and the actions taken by caregivers to meet them. The current project is a controlled exploratory study. Case studies that involve a triad in each case, composed by the resident with moderate or severe dementia, his family caregiver and the professional usually taking care for the resident, will be used (n=16 professionals; n=40 residents; n=40 family caregivers). Professional caregivers of two nursing homes, one located in Italy and one in the Netherlands, will receive a specific training in SDM principles and will guide the SDM interview within the triad. Primary outcome will be the proportion of residents whose preferences and needs, together with the related actions to meet them, are known, documented and satisfied in their 'life-and-care plans'. Secondary outcomes are the residents' and family caregivers' quality of life; the family caregivers' sense of competence and the healthcare professionals' job satisfaction. Semi-structured interviews and focus group interviews will be performed to assess satisfaction with the intervention and barriers and facilitators to its implementation. Assessments are performed at baseline and six months after the intervention. We hypothesize that the use of the SDM process in care planning will increase the number of met needs and will improve the residents' and family caregivers quality of life, the family caregivers' sense of competence and the healthcare professionals' job satisfaction. The key element of this study is that it will contribute to our knowledge about the efficacy and feasibility of an SDM framework in care planning in long-term care facilities with persons with moderate to severe dementia.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dementia
    Keywords
    Shared decision making, Dementia, Long-term care, Nursing home, Care plan

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    SDM care planning
    Arm Type
    Experimental
    Intervention Type
    Other
    Intervention Name(s)
    Shared Decision-Making educational training
    Primary Outcome Measure Information:
    Title
    The proportion of residents whose preferences and needs, together with the related actions to meet them, are known, documented and satisfied in their 'life-and-care plans'.
    Time Frame
    6 months after the SDM interview

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: diagnosis of dementia based on the Diagnostic and Statistical Manual of Mental Disorders (DSM) IV from moderate to severe cognitive decline (Global Deterioration Scale from 4 to 6) supported by a family caregiver who can be involved Exclusion Criteria: unable to pronounce simple sentences

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    27708828
    Citation
    Mariani E, Engels Y, Koopmans R, Chattat R, Vernooij-Dassen M. Shared decision-making on a 'life-and-care plan' in long-term care facilities: research protocol. Nurs Open. 2016 Mar 6;3(3):179-187. doi: 10.1002/nop2.42. eCollection 2016 Jul.
    Results Reference
    derived

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    SHARED DECISION MAKING IN LONG-TERM CARE FACILITIES

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