University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Location status: Recruiting
Location contact
Kathryn Wessell, MPH
CONTACT
Laura C. Hanson, MD, MPH
CONTACT
NCT Number: NCT06565169
This study will test the Dementia Advance Care Planning (AD ACP) Toolkit intervention to usual care in facilitating goals of care (GOC) discussions between People Living with Dementia (PLwD) and primary care team members over an 18-month period. The primary outcome is to assess the frequency and quality of GOC discussions with PLwD. Secondary outcomes include the identification of preferred surrogates, assessment of decisional capacity, and the completion of portable ACP orders. This randomized clinical trial aims to determine if the AD ACP Toolkit can enhance ACP practices and improve care planning outcomes for PLwD compared to the standard care approach.
Interested in participating?
Request Info18 year–99 year
All sexes
Interventional
Not applicable
Chapel Hill, North Carolina, 27599, United States
Location status: Recruiting
Kathryn Wessell, MPH
CONTACT
Laura C. Hanson, MD, MPH
CONTACT
This project will test an advance care planning (ACP) toolkit for primary care teams caring for patients living with Alzheimer's Disease and related dementias (AD/ADRD) in a cluster randomized control trial. In 20 primary clinics, the advance care planning practices, including goals of care discussions will be examined as the primary outcome, with secondary outcomes including health care utilization, and implementation outcomes. The AD ACP intervention will be tested to determine whether it can enable primary care teams to better conduct goals of care (GOC) discussions more efficiently and thus increase the number of GOC discussions held as compared to controls. The AD ACP Toolkit will be delivered to 10 intervention primary care clinics and usual care to 10 control clinics using a computerized case-finding algorithm within a large integrated health care system. The primary aim is to conduct a trial comparing the AD ACP Toolkit to usual care on GOC discussions and other ACP measures. The second aim is to examine the 18-month healthcare utilization outcomes for all PLwD with >50% 5-year mortality risk between intervention and control. Secondary analyses will be conducted to examine outcomes by key patient and team characteristics. Lastly (aim 3), implementation will be assessed via surveys in the intervention clinics followed by interviews to explain variations in those outcomes. This work will improve how to incorporate ACP approaches for aging-related conditions by primary care teams and may be adaptable to other outpatient specialties such as oncology or cardiology.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Primary care team member (PCTM) eligibility:
PLwD eligibility:
Exclusion criteria
Primary care team member exclusion criteria:
PLwD exclusion criteria:
Included in arm/group descriptions
Other names: AD-ACP
Included in arm/group descriptions
Time frame: 18 months
Presence of a documented Goals of Care (GOC) discussion between the primary care team member and the Person Living with Dementia (PLwD) or their surrogate decision-maker. Medical record documentation of discussion must include a) communication about dementia stage or prognosis AND b) decision-making for at least one major treatment: CPR/mechanical ventilation, hospitalization, treatments for infections, artificial/feeding/hydration, OR hospice.
Time frame: 18 months
Choice of a surrogate decision-maker for the PLwD documented in the medical record.
Time frame: 18 months
Assessment and report of decision-making capacity for the PLwD documented in the medical record.
Time frame: 18 months
Completion of portable ACP orders using a state-approved DNR or POLST form documented in the medical record.
Time frame: 18 months
Discussion of prognosis or future medical complications of Alzheimer's Disease/Alzheimer's Disease and Related Dementias (AD/ADRD) between the primary care team member and the PLwD or their surrogate decision-maker documented in the medical record.
Time frame: 30 months
Number of emergency room visits and hospital admissions.
Time frame: 30 months
The percentage of active users at each clinic who have completed at least one training of either type
Time frame: 30 months
Duration of hospitalizations from day of admission to day of discharge.
Time frame: 30 months
Percent of PLwD with a referral order to Palliative Care in the medical record.
Time frame: 30 months
Percent of PLwD with a referral order to Hospice in the medical record.
Time frame: 30 months
Number of documented code status and health care proxy in the medical records
Time frame: 6 months after provider training
Scores of Organizational Readiness to Implementing Change (ORIC) - range 12-60 with higher scores indicating greater organizational readiness
Time frame: 30 months
Scores of Intervention Appropriateness Measure (IAM) - range 4-20 with higher scores indicating greater appropriateness
Time frame: 30 months
Scores of Feasibility of Intervention Measure (FIM) - range 4-20 with higher scores indicating greater feasibility
Time frame: 30 months
Scores of primary care team members on post-intervention quizzes, participation in clinic-level and primary care team member-level ACP audit-and-feedback, refresher sessions and in-services, periodic coaching from the research team.
Contact information is provided by the study sponsor or research team.
Christine E. Kistler, MD, MASc
CONTACT
Janelle J. Christensen, PhD, MPH
CONTACT
University of Pittsburgh
Other
Improving Primary Care Clinician's Advance Care Planning Alzheimer's Disease and Related Dementias
Acronym: AD-ACP
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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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