Ignite Creation Date:
2024-05-06 @ 2:17 PM
Last Modification Date:
2024-10-26 @ 1:28 PM
Study NCT ID:
NCT04271046
Status:
COMPLETED
Last Update Posted:
2024-02-01
First Post:
2019-04-16
Brief Title:
STAR Caregivers - Virtual Training and Follow-up
Sponsor:
Kaiser Permanente
Organization:
Kaiser Permanente
Study Overview
Official Title:
STAR Caregivers - Virtual Training and Follow-up
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STAR-C-VTF
Brief Summary:
This study evaluates the effectiveness of a caregiver outreach training and support program for caregivers of people with dementia who are using antipsychotic medication to manage agitationaggression The Investigators will conduct a randomized trial of the caregiver program compared to a control group to measure differences in caregiver burden and discontinuation of antipsychotic medication use The results will help in expanding access to and delivery of empirically supported behavioral health services for caregivers and people with dementia
Detailed Description:
Alzheimers Disease and related dementias ADRD are debilitating conditions affecting more than 5 million Americans in 2014 With aging of the population it is projected that 84 million people will be diagnosed with ADRD over the next 15 years and health care costs attributable to ADRD are projected to be more than 12 trillion by 2050 Behavioral and Psychological Symptoms of Dementia BPSD anxiety agitation depression are common and often involve aggressive behavior towards family caregivers CG in response to unmet needs discomfort or frustration BPSD are disturbing and frequently lead to caregivers seeking medication to control patient symptoms Antipsychotic use in persons with dementia PWD more than doubles mortality risk however many caregivers are willing to accept those risks The Choosing Wisely Guidelines from the American Psychiatric Association and American Geriatrics Society both recommend against prescribing antipsychotics as a first-line treatment for BPSD STAR-Caregivers is an efficacious first-line behavioral treatment endorsed by the Administration on Aging that involves caregiver training to manage BPSD However the program has not been implemented widely - partly due to the cost of the programs difficulty conducting outreach and modality of training in person with written materials Adequate caregiver training and commensurate reduction in caregiver burden are the mediators mechanisms the Investigators will engage in this Stage III trial to reduce BPSD and discontinue antipsychotic medication use by PWD
The STAR-Caregivers program is an education training and support intervention demonstrated efficacious in reducing BPSD The original program involved 8 face-to-face in-home training sessions and 4 follow-up phone calls The condensed version involves 4 in-home sessions with 2 phone follow-ups18 Neither of these is feasible from a payer perspective The investigators propose to test a self-directed remote version called STAR-virtual training and follow-up STAR-VTF that leverages secure email within the member portal at Kaiser Permanente Washington to improve access to training fidelity to the STAR principles and to lower the cost of the program
The investigators propose a Stage III trial to ascertain the feasibility and acceptability of STAR-VTF in which a caregiver training materials are delivered electronically and learning is self-directed b caregivers have one orientation phone visit with a social worker and c where caregivers receive ongoing support from a social worker via telephone and secure messaging in the web-based member portal Investigators will compare outcomes in the STAR-VTF group to an attention control group mailed material links to websites and generic secure messages
The specific aims are
Aim 1 Assess the feasibility and acceptability of conducting caregiver outreach training and support via social workers including 1 willingness of caregivers to interact primarily through secure messaging contact rates and 2 willingness of caregivers to complete self-directed training training completion rates
Aim 2 Assess the feasibility and acceptability of the program from the payer perspective including 1 average time spent per home-visit including preparation and travel time 2 average time per month spent responding to caregiver emails and coordinating care with primary care physicians and 3 differences in face-to-face primary care urgent care and emergency department visit rates by PWD
Aim 3 Test the hypotheses that H1 caregiver participants in STAR-VTF will have lower levels of caregiver burden at 8 weeks and 6 months compared to an attention control group and H2 PWD participants in STAR-VTF will have lower rates of antipsychotic medication use at 6 months compared to control Secondary outcomes are caregiver depression and caregiver self-efficacy The investigators propose to recruit 100 CG-PWD dyads 50 per arm
This will be the first study to test a low intensity self-directed caregiver training program with remote support from social workers It will also be the first study to measure changes in antipsychotic medication use by PWD after caregiver training Kaiser Permanente is an ideal setting because investigators have access to the complete electronic health record EHR prescription medication use health care use and demographic data The investigators will be able to identify and enroll participants in real-time using an automated data troll as investigators have done previously This study will be an important step in expanding access to training and support in a format that could be implemented within integrated delivery systems with capitated payments ie Accountable Care Organizations Growing use of EHR portals in these organizations will further increase demand for web-based care managementsupport Demand will also increase as todays near-retirees familiar with web-based applications develop ADRD Kaiser Permanente has pioneered such efforts and is the lead site in the Mental Health Research Network MHRN Findings from this study will inform a future multi-site pragmatic trial across the 13 health systems and 12 million enrollees in the MHRN
The STAR-Caregivers program is an education training and support intervention demonstrated efficacious in reducing BPSD The original program involved 8 face-to-face in-home training sessions and 4 follow-up phone calls The condensed version involves 4 in-home sessions with 2 phone follow-ups18 Neither of these is feasible from a payer perspective The investigators propose to test a self-directed remote version called STAR-virtual training and follow-up STAR-VTF that leverages secure email within the member portal at Kaiser Permanente Washington to improve access to training fidelity to the STAR principles and to lower the cost of the program
The investigators propose a Stage III trial to ascertain the feasibility and acceptability of STAR-VTF in which a caregiver training materials are delivered electronically and learning is self-directed b caregivers have one orientation phone visit with a social worker and c where caregivers receive ongoing support from a social worker via telephone and secure messaging in the web-based member portal Investigators will compare outcomes in the STAR-VTF group to an attention control group mailed material links to websites and generic secure messages
The specific aims are
Aim 1 Assess the feasibility and acceptability of conducting caregiver outreach training and support via social workers including 1 willingness of caregivers to interact primarily through secure messaging contact rates and 2 willingness of caregivers to complete self-directed training training completion rates
Aim 2 Assess the feasibility and acceptability of the program from the payer perspective including 1 average time spent per home-visit including preparation and travel time 2 average time per month spent responding to caregiver emails and coordinating care with primary care physicians and 3 differences in face-to-face primary care urgent care and emergency department visit rates by PWD
Aim 3 Test the hypotheses that H1 caregiver participants in STAR-VTF will have lower levels of caregiver burden at 8 weeks and 6 months compared to an attention control group and H2 PWD participants in STAR-VTF will have lower rates of antipsychotic medication use at 6 months compared to control Secondary outcomes are caregiver depression and caregiver self-efficacy The investigators propose to recruit 100 CG-PWD dyads 50 per arm
This will be the first study to test a low intensity self-directed caregiver training program with remote support from social workers It will also be the first study to measure changes in antipsychotic medication use by PWD after caregiver training Kaiser Permanente is an ideal setting because investigators have access to the complete electronic health record EHR prescription medication use health care use and demographic data The investigators will be able to identify and enroll participants in real-time using an automated data troll as investigators have done previously This study will be an important step in expanding access to training and support in a format that could be implemented within integrated delivery systems with capitated payments ie Accountable Care Organizations Growing use of EHR portals in these organizations will further increase demand for web-based care managementsupport Demand will also increase as todays near-retirees familiar with web-based applications develop ADRD Kaiser Permanente has pioneered such efforts and is the lead site in the Mental Health Research Network MHRN Findings from this study will inform a future multi-site pragmatic trial across the 13 health systems and 12 million enrollees in the MHRN
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01AG061926-01 | NIH | None | httpsreporternihgovquickSearch1R01AG061926-01 |