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
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
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
NCT ID
NCT02118701
First Posted
April 14, 2014
Last Updated
May 18, 2017
Sponsor
Radboud University Medical Center
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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