SHARED DECISION MAKING IN LONG-TERM CARE FACILITIES

Dementia Clinical Trial

Official title:

SHARED DECISION MAKING ON A 'LIFE-AND-CARE PLAN' IN LONG-TERM CARE FACILITIES

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02118701
• Other study ID #: 258883
• Status: Completed
• Phase: N/A
• First received: April 14, 2014
• Last updated: May 18, 2017
• Start date: January 2014

Study information

• Verified date: May 2015
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Dementia

Intervention

Other:
• Shared Decision-Making educational training

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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'.		6 months after the SDM interview