Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06636214
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-23
Brief Title:
Adapting Changing Talk Online CHATO to CHATO-Inclusive
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Adapting the CHATO Communication Intervention for Diverse Nursing Home Communities
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study will adapt and test the current CHATO training to be more culturally acceptable for nursing homes with diverse staff and residents
Detailed Description:
A person is diagnosed with Alzheimers disease or related dementia ADADRD every 65 seconds and most persons living with dementia PLWD experience nursing home NH care at some stageDementia is most prevalent among Black and Hispanic Americans who are increasingly cared for in NHs NH staff shortages and lack of dementia care skills limit care quality especially in NHs serving high proportions of minority residents Care is complicated by the behavioral and psychological symptoms of dementia BPSD of PLWD who cannot express their unmet physical and psychosocial needs BPSD increase staff stress and time to complete care and contribute to staff turnover injury and inappropriate psychotropic medication use
The PI and other researchers have empirically verified that BPSD occur when staff use elderspeak speech like baby talk that features inappropriately intimate terms of endearment diminutives such as honey belittling pronoun substitutions that imply dependence we need a bath and harsh task-oriented commands sit down Elderspeak conveys a message of disrespect and incompetence to PLWD who react with withdrawal or BPSD The investigators R03 study first established that elderspeak use more than doubled the occurrences of resident responses of BPSD measured by timed sequential behavioral analyses of BPSD in relation to type of staff communication in video data The investigators R01 trial NR011455 confirmed that the three-session Changing TalkCHAT staff education intervention reduced staff elderspeak use that significantly reduced resident BPSDThe evidence-based CHAT intervention was transitioned to online modules CHATO maintaining content active engagement and application activities with equal knowledge gain mechanism of action and improved participation and completion rates The investigators are currently testing CHATO in a pragmatic national trial in 128 NHs R01AG069171 However NHs serving high minority-resident populations with fewer resources and staff and more frequent and serious care deficiencies including high antipsychotic medication use rates have been less likely to respond to recruitment and study participation Research has established that tailoring interventions and intensification of recruitment and implementation approaches are frequently necessary to reach and achieve intervention success to overcome health care disparities in diverse care settings
This study will engage staff from NHs serving diverse residents with an expert stakeholder advisory panel to adapt the content and format of CHATO to the new CHATO-Inclusive CHATO-I to increase cultural competency and inclusiveness for diverse NH communities The investigators will then conduct a cluster randomized trial in NHs N40 with high proportions 25 of minority residents NHs will be randomized to intervention or waitlist control groups and one of two waves for staff completion of the tailored CHATO-I intervention with high intensity implementation support The investigators will test feasibility and acceptability and use hierarchical mixed model analyses to evaluate preliminary effects of the intervention on BPSD and psychoactive medication use in a pragmatic evaluation of NH Electronic Medical Record EMR data
Aim 1 years 1 and 2 Tailor recruitment implementation support and intervention content and format for NHs serving diverse residents Administrators directors of nursing and care staff from six NHs N24 serving diverse residents will complete current CHATO and participate in focus groups Thematic analyses of transcribed recordings will identify tailoring modifications for diverse NH communities The ADAPT framework will guide adaptation of CHATO to CHATO-I with support from diversity consultants and stakeholders
Aim 2 years 3 to 5 Test feasibility acceptability and preliminary effects of CHATO-I in 40 NHs serving diverse residents in a cluster-randomized waitlist-controlled trial Enrollment and completion rates will be used to evaluate feasibility and acceptability Aim 2a Mixed modeling will evaluate change in resident BPSD and psychoactive medication use from eight quarters of Minimum Data Set MDS and Nursing Home Quality Measure NHQM data Aim 2b We hypothesize that resident BPSD and psychoactive medication use will be reduced post-CHATO-I
Aim 3 years 3 to 5 Validate the mechanism of action of CHATO-I Additional modeling analyses will evaluate the effects of CHATO-I on learning outcomes gains in knowledge confidence recognition and intention to use learned skills on resident BPSD and psychoactive medication use We hypothesize that greater staff knowledge gain and intention to use new skills will be associated with greater outcome reductions
This Stage 1B research will use the NIA Health Disparities Framework to adapt and expand testing of the evidence-based CHATO intervention for NHs serving diverse resident populations increasing communication knowledge to reduce health disparities BPSD and psychotropic medication use This research addresses the National Plan to Address Alzheimers disease goals NIAs milestones for nonpharmacological interventions and the National Academy National Imperative to improve NH quality through culturally tailored intervention
The PI and other researchers have empirically verified that BPSD occur when staff use elderspeak speech like baby talk that features inappropriately intimate terms of endearment diminutives such as honey belittling pronoun substitutions that imply dependence we need a bath and harsh task-oriented commands sit down Elderspeak conveys a message of disrespect and incompetence to PLWD who react with withdrawal or BPSD The investigators R03 study first established that elderspeak use more than doubled the occurrences of resident responses of BPSD measured by timed sequential behavioral analyses of BPSD in relation to type of staff communication in video data The investigators R01 trial NR011455 confirmed that the three-session Changing TalkCHAT staff education intervention reduced staff elderspeak use that significantly reduced resident BPSDThe evidence-based CHAT intervention was transitioned to online modules CHATO maintaining content active engagement and application activities with equal knowledge gain mechanism of action and improved participation and completion rates The investigators are currently testing CHATO in a pragmatic national trial in 128 NHs R01AG069171 However NHs serving high minority-resident populations with fewer resources and staff and more frequent and serious care deficiencies including high antipsychotic medication use rates have been less likely to respond to recruitment and study participation Research has established that tailoring interventions and intensification of recruitment and implementation approaches are frequently necessary to reach and achieve intervention success to overcome health care disparities in diverse care settings
This study will engage staff from NHs serving diverse residents with an expert stakeholder advisory panel to adapt the content and format of CHATO to the new CHATO-Inclusive CHATO-I to increase cultural competency and inclusiveness for diverse NH communities The investigators will then conduct a cluster randomized trial in NHs N40 with high proportions 25 of minority residents NHs will be randomized to intervention or waitlist control groups and one of two waves for staff completion of the tailored CHATO-I intervention with high intensity implementation support The investigators will test feasibility and acceptability and use hierarchical mixed model analyses to evaluate preliminary effects of the intervention on BPSD and psychoactive medication use in a pragmatic evaluation of NH Electronic Medical Record EMR data
Aim 1 years 1 and 2 Tailor recruitment implementation support and intervention content and format for NHs serving diverse residents Administrators directors of nursing and care staff from six NHs N24 serving diverse residents will complete current CHATO and participate in focus groups Thematic analyses of transcribed recordings will identify tailoring modifications for diverse NH communities The ADAPT framework will guide adaptation of CHATO to CHATO-I with support from diversity consultants and stakeholders
Aim 2 years 3 to 5 Test feasibility acceptability and preliminary effects of CHATO-I in 40 NHs serving diverse residents in a cluster-randomized waitlist-controlled trial Enrollment and completion rates will be used to evaluate feasibility and acceptability Aim 2a Mixed modeling will evaluate change in resident BPSD and psychoactive medication use from eight quarters of Minimum Data Set MDS and Nursing Home Quality Measure NHQM data Aim 2b We hypothesize that resident BPSD and psychoactive medication use will be reduced post-CHATO-I
Aim 3 years 3 to 5 Validate the mechanism of action of CHATO-I Additional modeling analyses will evaluate the effects of CHATO-I on learning outcomes gains in knowledge confidence recognition and intention to use learned skills on resident BPSD and psychoactive medication use We hypothesize that greater staff knowledge gain and intention to use new skills will be associated with greater outcome reductions
This Stage 1B research will use the NIA Health Disparities Framework to adapt and expand testing of the evidence-based CHATO intervention for NHs serving diverse resident populations increasing communication knowledge to reduce health disparities BPSD and psychotropic medication use This research addresses the National Plan to Address Alzheimers disease goals NIAs milestones for nonpharmacological interventions and the National Academy National Imperative to improve NH quality through culturally tailored intervention
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None