Aging, Alzheimer Disease, Alzheimer's Disease (Incl Subtypes), Dementia
Conditions
Keywords
Advance Care Planning, Primary Care, Goals of Care, Communication
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALPrimary Care Team Advance Care Planning With People with Alzheimer's Disease or a Related Dementia Training
Included in arm/group descriptions
BEHAVIORALCare as Usual
Included in arm/group descriptions
Sponsors
University of Pittsburgh
University of North Carolina, Chapel Hill
National Institute on Aging (NIA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
The PI and all personnel involved in the outcomes assessment will remain masked to study arm assignment until the end of the study, while the UNC site co-investigators will deliver training and feedback reports to intervention sites and will not be masked.
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
Primary care team member (PCTM) eligibility: * Must be an MD/APP, employed at a primary care clinic within UNC HEALTH clinics with ≥60 PLwD encounters per year, who sees older adult patients, along with their associated nurses and social workers. * Eligibility for training with AD ACP Toolkit will include the above and the provision of care at an intervention clinic. * For Aim 3, only the trained intervention site primary care team members will be eligible for the implementation surveys or the interviews. PLwD eligibility: * Must be a PLwD age 65 years or older seen by either the intervention or control sites' primary care teams' MD/APP in the 18-month intervention window for Aim 1. * PLwD will be eligible only after we confirm the presence of the AD/ADRD diagnosis. * All PLwD with a ≥50% 5-year all-cause mortality risk seen by the PCTM MD/APP over the 18-month intervention period will be eligible for the healthcare utilization analyses in Aim 2.
Exclusion criteria
Primary care team member
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Goals of Care Discussions | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surrogate Decision-Maker | 18 months | Choice of a surrogate decision-maker for the PLwD documented in the medical record. |
| Decision-Making Capacity | 18 months | Assessment and report of decision-making capacity for the PLwD documented in the medical record. |
| Portable Advance Care Planning (ACP) Orders | 18 months | Completion of portable ACP orders using a state-approved DNR or POLST form documented in the medical record. |
| Prognosis Discussion | 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. |
| Hospital Transfers | 30 months | Number of emergency room visits and hospital admissions. |
| Adoption | 30 months | The percentage of active users at each clinic who have completed at least one training of either type |
| Length-of-Stay | 30 months | Duration of hospitalizations from day of admission to day of discharge. |
| Palliative Care Referral | 30 months | Percent of PLwD with a referral order to Palliative Care in the medical record. |
| Hospice Referral | 30 months | Percent of PLwD with a referral order to Hospice in the medical record. |
| Goal-concordant care | 30 months | Number of documented code status and health care proxy in the medical records |
| Acceptability | 6 months after provider training | Scores of Organizational Readiness to Implementing Change (ORIC) - range 12-60 with higher scores indicating greater organizational readiness |
| Appropriateness | 30 months | Scores of Intervention Appropriateness Measure (IAM) - range 4-20 with higher scores indicating greater appropriateness |
| Feasibility | 30 months | Scores of Feasibility of Intervention Measure (FIM) - range 4-20 with higher scores indicating greater feasibility |
| Fidelity | 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. |
Countries
United States
Contacts
CONTACTChristine E. Kistler, MD, MASc
CONTACTJanelle J. Christensen, PhD, MPH
PRINCIPAL_INVESTIGATORChristine E. Kistler, MD, MASc
University of Pittsburgh, Department of Medicine, Division of Geriatric Medicine
PRINCIPAL_INVESTIGATORLaura C. Hanson, MD, MPH
University of North Carolina, Chapel Hill
Outcome results
None listed