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SHARED DECISION MAKING IN LONG-TERM CARE FACILITIES

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02118701
Recruitment Status : Completed
First Posted : April 21, 2014
Last Update Posted : May 19, 2017
Sponsor:
Information provided by (Responsible Party):
Radboud University

Tracking Information
First Submitted Date  ICMJE April 14, 2014
First Posted Date  ICMJE April 21, 2014
Last Update Posted Date May 19, 2017
Study Start Date  ICMJE January 2014
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 16, 2014)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02118701 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SHARED DECISION MAKING IN LONG-TERM CARE FACILITIES
Official Title  ICMJE SHARED DECISION MAKING ON A 'LIFE-AND-CARE PLAN' IN LONG-TERM CARE FACILITIES
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Dementia
Intervention  ICMJE Other: Shared Decision-Making educational training
Study Arms  ICMJE Experimental: SDM care planning
Intervention: Other: Shared Decision-Making educational training
Publications * 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. eCollection 2016 Jul.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 16, 2014)
40
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02118701
Other Study ID Numbers  ICMJE 258883
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Radboud University
Study Sponsor  ICMJE Radboud University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Radboud University
Verification Date May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP