NCT Number: NCT07182357
This study will test a care management intervention to guide end-of-life care and hospice transitions for persons with dementia and their care partners receiving home healthcare and ascertain feasibility, acceptability, fidelity, and usability of a dementia care management hospice transitions checklist. This study will also examine hospice enrollment, time to enrollment, and care partner satisfaction with the intervention. The intervention will be delivered within usual care management within a large home healthcare agency.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
New York, 10010, United States
Location status: Recruiting
Komal P Murali, PhD, RN, ACNP-BC
CONTACT
Komal P Murali, PhD, RN, ACNP-BC
PRINCIPAL_INVESTIGATOR
Margaret McDonald, MSW
CONTACT
This study has the following design: Unblinded, Non-Randomized, Single-Arm Intervention Study (Feasibility Trial). In this study, the team will pilot test the care management checklist intervention with care partners of persons with dementia. This intervention will be tested for feasibility (primary outcome), acceptability, fidelity, and usability (secondary) for in a single arm feasibility trial. The intervention will be administered (NIH Stage 1B) within usual care management for hospice transitions with care partners of PLWD. This study will also examine hospice enrollment and time to enrollment, and care partner satisfaction with the intervention.
The study population includes care partners and persons living with dementia; HHC professionals who engage in hospice transitions care management with care partners of PLWD (e.g., care managers who are nurses or social workers) and field nurses; Medical providers who engage in hospice transitions communication (e.g., home care physicians and nurse practitioners); HHC administrators who oversee and manage the delivery of care management prior to hospice transitions.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion:
Care Partners and PLWD Dyad:
HHC Professionals:
Care Managers and Field Nurses:
Medical Providers:
HHC Administrators:
Exclusion
Care Partner and PLWD Dyad
HHC Professionals: Care Managers, Medical Providers, Administrators
Intervention: After appropriate care partners of hospice-eligible PLWD are identified who will be receiving the checklist intervention, care managers will perform telephonic outreach to engage them in a conversation about care needs (as they would in typical clinical practice). The telephonic outreach will be followed up with a recommendation for follow up by a medical provider who may conduct a hospice care assessment and engage the care partner in decision-making surrounding the hospice referral and enrollment process.
This intervention was co-designed with care partners, home healthcare professionals, administrators, and medical providers. It is meant to be comprehensive and speak to the needs of all relevant parties engaged in the care of persons with dementia. It is developed so that it can be scaled and implemented widely.
Time frame: After enrollment and study participation, we will collect feasibility data within 1 month after intervention receipt.
The primary outcome is feasibility. Feasibility will be measured for each group including recruitment and retention rates, rate of completion of the intervention as the proportion of individuals who use and receive the intervention, and whether the different components of the intervention are achievable.
Time frame: After intervention delivery, we will collect secondary outcome data within 1 month.
The secondary outcome is acceptability. Acceptability will be reflected in process measures required in a transitional care management intervention. For example, intervention components will be measured including if the care manager/interventionist successfully receives the training and resources to successfully deliver the intervention and the number of HHC professionals for whom the intervention was acceptable. Outcome measure: Percentage of participants who find the intervention acceptable.
Time frame: To be measured within 1 month of intervention delivery.
Fidelity will be assessed through healthcare professional adherence to study protocols and consistency in delivery of the intervention over time. Fidelity will be measured by assessing frequency of adherence to study protocols and pre-specified data collection processes and procedures (through participant response questionnaire). The percentage of individuals who maintained fidelity will also be measured.
Time frame: To be measured within 1 month of intervention delivery.
Usability will also be assessed and measured based on the percentage of people for whom the intervention was successfully usable (care partners and HHC professionals) and whether the checklist training and integration into care management is practicable. Usability will be measured as yes/no binary responses in a follow up questionnaire.
Time frame: Hospice enrollment and time to enrollment (of the person with dementia) will be measured at 1 and 6 months after intervention receipt.
We will assess hospice enrollment and time to enrollment of the person with dementia (using the electronic health record) after the intervention.
Time frame: To be measured within 1 month of intervention receipt.
Care partner satisfaction will be evaluated using the 20-item Family Satisfaction with Advanced Cancer Care (FAMCARE), which has been validated for use in dementia care.
Scoring the Original 20-Item FAMCARE Scale Identify the Scale's Items: The scale consists of 20 individual items designed to assess various aspects of care.
Apply Likert Scale Scoring: Each item is rated on a 5-point Likert scale, with responses typically including:
Very Satisfied Satisfied Undecided Dissatisfied Very Dissatisfied
Calculate the Overall Score: The overall score is the sum of the responses to all 20 items.
Interpret the Score: A higher total score signifies greater satisfaction with the healthcare provided to the patient and themselves. If a family member rates their satisfaction on a 5-point scale from 1 (Very Dissatisfied) to 5 (Very Satisfied) for all 20 items, then a higher sum of these ratings (e.g., close to 100) would indicate high satisfaction, while a lower sum is lower satisfaction.
Contact information is provided by the study sponsor or research team.
New York University
Other
ENGAGE-D: Designing Care Management for Hospice Transitions for Persons Living With Advanced Dementia
Acronym: ENGAGE-D
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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