SHARED DECISION MAKING IN LONG-TERM CARE FACILITIES

• ClinicalTrials.gov Identifier: NCT02118701
• Recruitment Status: Completed
• First Posted: April 21, 2014
• Last Update Posted: May 19, 2017
• Sponsor: Radboud University Medical Center
• Information provided by (Responsible Party): Radboud University Medical Center

Tracking Information

• First Submitted Date: April 14, 2014
• First Posted Date: April 21, 2014
• Last Update Posted Date: May 19, 2017
• Study Start Date: January 2014
• Actual Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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

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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care
• Condition: Dementia
• Intervention: Other: Shared Decision-Making educational training

Study Arms

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. doi: 10.1002/nop2.42. eCollection 2016 Jul.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 16, 2014): 40
• Original Estimated Enrollment: Same as current
• Study Completion Date: Not Provided
• Actual Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT02118701
• Other Study ID Numbers: 258883
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Radboud University Medical Center
• Original Responsible Party: Same as current
• Current Study Sponsor: Radboud University Medical Center
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Radboud University Medical Center
• Verification Date: May 2015