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Table 1 Outcome and study eligibility measures

From: Feasibility study of an optimised person-centred intervention to improve mental health and reduce antipsychotics amongst people with dementia in care homes: study protocol for a randomised controlled trial

 

Domain

Purpose

How long to complete

Who completes

Pre-BL

BL

Ongoing

Post-int

Measures of home

Number and approximate proportion of residents with dementia

Demographic

Eligibility

1 hour - records search and informant interview

Researcher

Y

  

Y

Rating on CQC criteria

Demographic

Eligibility

15 mins - records search

Researcher

Y

  

Y

Measures of individual

Demographics

Demographic

Demographics

10 mins - records search and informant interview

Researcher

 

Y

 

Y

Functional assessment staging (FAST) [26]

Diagnostic criteria

Eligibility

15 mins trial assessments and informant interview

Researcher

Y

  

Y

CDR [25]

Diagnostic criteria

Eligibility

15 mins - trial assessments and informant interview

Researcher

Y

   

Antipsychotic use (number and proportion of people and dose)

Medication use

Quantitative

5 mins per resident - records search and drug chart

Researcher

 

Y

 

Y

Primary outcome

Use of other psychotropic drugs (No. and proportion of people and dose)

Medication use

Quantitative

5 mins per resident - records search and drug chart

Researcher

 

Y

 

Y

Secondary outcome

Cohen-Mansfield agitation inventory (CMAI) [27]

Agitation

Quantitative

10 mins

Researcher with staff

 

Y

 

Y

 

Primary outcome

      

Neuropsychiatric inventory - nursing home version (NPI-NH) [28]

Other behavioural and neuro-psychiatric symptoms including apathy and psychosis

Quantitative

20 mins

Researcher with staff

 

Y

 

Y

Secondary outcome

      

Cornell depression scale [29]

Mood

Quantitative

10-15 mins

Researcher with staff and residents

 

Y

 

Y

Secondary outcome

Rating anxiety in dementia (RAID) [30]

Mood

Quantitative

10-15 mins each

Researcher with staff and residents

 

Y

 

Y

Secondary outcome

Camberwell assessment of need in the elderly (CANE) [31]

Unmet needs

Quantitative

30 mins each

Researcher with staff and residents

 

Y

 

Y

 

Secondary outcome

     

Assessment of QoL for people with dementia (DEMQOL) [32]

Quality of life (QoL)

Quantitative

20 mins each

Researcher with staff and separately with residents

 

Y

 

Y

 

Secondary Outcome

     

QoL in Alzheimer’s disease (QoL-AD) [33]

Quality of life

Quantitative

5-10 mins

Researcher with staff and separately with residents

 

Y

 

Y

Secondary Outcome

Quality of interaction schedule (QUIS, observational tool) [34]

Quality of interactions between staff and residents

Quantitative

2 hours observation per home

Researcher

 

Y

 

Y

Secondary Outcome

Falls record

Falls

Quantitative

5 mins

Care staff

  

Y

 
  

Secondary outcome

      

Case examples

Skills and attitude development

Qualitative

 

Researcher

Y

   

Implementation process

 

Qualitative

 

Researcher

Y

   

Staff time

 

Economic

 

Researcher

  

Y

 

Economic measures

Client service receipt inventory [35]

Information on service contacts

Economic

45 mins

Researcher

  

Y

 

Administrative records

Cost of intervention

Economic

 

Researcher

   

Y

  1. CQC, Care Quality Commission; QUIS, quality of interaction schedule; BL, Baseline; Pre-int, Pre-intervention; Y, Yes.