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R01AG066804

Project Grant

Overview

Grant Description
Effectiveness of Engaging in Advance Care Planning Talks (ENACT) Group Visits Intervention in Primary Care for Older Adults with and without Alzheimer's Dementia - Project Summary

Individuals living with Alzheimer's disease and related dementias (ADRD) may experience unwanted, intensive, or burdensome end-of-life care because their preferences for care are unknown to their medical decision-makers. For example, nearly 41% of individuals with ADRD undergo at least one intensive intervention (e.g., mechanical ventilation, artificial nutrition) in the last 3 months of life, which may prolong life but does not address quality of life. Thus, timely discussions about advance care planning (ACP) are imperative before individuals with dementia lose decision-making capacity.

Persons with cognitive impairment, spanning from mild cognitive impairment to dementia, are often cared for in primary care. However, primary care settings do not have effective models that can systematically integrate clinician-patient discussions and decision-making about ACP for older adults with and without cognitive impairment who still have decision-making capacity.

To address these gaps, we designed, refined with stakeholder input, and demonstrated the feasibility, acceptability, and efficacy of a theory-based and practical ACP group visit intervention, ENACT Group Visits (Engaging in Advance Care Planning Talks) among older primary care patients. ENACT Group Visits are two facilitated discussions, one month apart, led by a physician or advanced practice provider and a social worker. The intervention uses evidence-based ACP materials and leverages the group dynamic to promote patient goal-setting and self-efficacy.

In a single-clinic pilot study, patients randomized to the ENACT Group Visits intervention had a 26% higher rate of ACP documents at 6 months, compared to a control arm of mailed ACP materials (p=0.007). This study aims to test the effectiveness of ENACT Group Visits to increase ACP documentation (one aspect of ACP) and to evaluate its effectiveness among patients across a spectrum of cognitive impairment, including early dementia.

The proposed 2-arm, patient-level randomized trial will be conducted in five primary care clinics and is powered to compare ENACT Group Visits intervention vs control mailed ACP materials. We will use 1:1 allotment and patient-level block randomization by presence or absence of cognitive impairment. The study will use components of PREPAREā„¢, an evidence-based ACP program designed to decrease cognitive burden, and an easy-to-read advance directive.

Aim 1 will determine the effectiveness of ENACT Group Visits vs control at 6 months to increase ACP documentation (primary outcome), ACP readiness, decision self-efficacy, and quality of communication (secondary outcomes). Aim 2 will determine whether the effectiveness of ENACT Group Visits intervention varies by cognitive impairment, including ADRD. Aim 3 will describe acceptability and feasibility, as well as intervention fidelity and implementation outcomes, of ENACT Group Visits intervention using qualitative and mixed methods.

This primary care-based effectiveness trial of ENACT Group Visits intervention among older adults, including those with dementia, will generate needed evidence for implementing effective ACP interventions into real-world primary care settings.
Funding Goals
TO ENCOURAGE BIOMEDICAL, SOCIAL, AND BEHAVIORAL RESEARCH AND RESEARCH TRAINING DIRECTED TOWARD GREATER UNDERSTANDING OF THE AGING PROCESS AND THE DISEASES, SPECIAL PROBLEMS, AND NEEDS OF PEOPLE AS THEY AGE. THE NATIONAL INSTITUTE ON AGING HAS ESTABLISHED PROGRAMS TO PURSUE THESE GOALS. THE DIVISION OF AGING BIOLOGY EMPHASIZES UNDERSTANDING THE BASIC BIOLOGICAL PROCESSES OF AGING. THE DIVISION OF GERIATRICS AND CLINICAL GERONTOLOGY SUPPORTS RESEARCH TO IMPROVE THE ABILITIES OF HEALTH CARE PRACTITIONERS TO RESPOND TO THE DISEASES AND OTHER CLINICAL PROBLEMS OF OLDER PEOPLE. THE DIVISION OF BEHAVIORAL AND SOCIAL RESEARCH SUPPORTS RESEARCH THAT WILL LEAD TO GREATER UNDERSTANDING OF THE SOCIAL, CULTURAL, ECONOMIC AND PSYCHOLOGICAL FACTORS THAT AFFECT BOTH THE PROCESS OF GROWING OLD AND THE PLACE OF OLDER PEOPLE IN SOCIETY. THE DIVISION OF NEUROSCIENCE FOSTERS RESEARCH CONCERNED WITH THE AGE-RELATED CHANGES IN THE NERVOUS SYSTEM AS WELL AS THE RELATED SENSORY, PERCEPTUAL, AND COGNITIVE PROCESSES ASSOCIATED WITH AGING AND HAS A SPECIAL EMPHASIS ON ALZHEIMER'S DISEASE. SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM: TO EXPAND AND IMPROVE THE SBIR PROGRAM, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, TO INCREASE SMALL BUSINESS PARTICIPATION IN FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION. SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM: TO STIMULATE AND FOSTER SCIENTIFIC AND TECHNOLOGICAL INNOVATION THROUGH COOPERATIVE RESEARCH DEVELOPMENT CARRIED OUT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO FOSTER TECHNOLOGY TRANSFER BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION.
Grant Program (CFDA)
Place of Performance
Aurora, Colorado 800452527 United States
Geographic Scope
Single Zip Code
Analysis Notes
Amendment Since initial award the total obligations have increased 369% from $780,725 to $3,661,571.
The Regents Of The Univ. Of Colorado was awarded ENACT Group Visits: Enhancing Advance Care Planning for Older Adults Project Grant R01AG066804 worth $3,661,571 from National Institute on Aging in March 2021 with work to be completed primarily in Aurora Colorado United States. The grant has a duration of 5 years and was awarded through assistance program 93.866 Aging Research. The Project Grant was awarded through grant opportunity Basic and Translational Research on Decision Making in Aging and Alzheimer's Disease (R01 - Clinical Trial Optional).

Status
(Ongoing)

Last Modified 7/21/25

Period of Performance
3/15/21
Start Date
2/28/26
End Date
90.0% Complete

Funding Split
$3.7M
Federal Obligation
$0.0
Non-Federal Obligation
$3.7M
Total Obligated
100.0% Federal Funding
0.0% Non-Federal Funding

Activity Timeline

Interactive chart of timeline of amendments to R01AG066804

Transaction History

Modifications to R01AG066804

Additional Detail

Award ID FAIN
R01AG066804
SAI Number
R01AG066804-13476549
Award ID URI
SAI UNAVAILABLE
Awardee Classifications
Public/State Controlled Institution Of Higher Education
Awarding Office
75NN00 NIH National Insitute on Aging
Funding Office
75NN00 NIH National Insitute on Aging
Awardee UEI
MW8JHK6ZYEX8
Awardee CAGE
0P6C1
Performance District
CO-06
Senators
Michael Bennet
John Hickenlooper

Budget Funding

Federal Account Budget Subfunction Object Class Total Percentage
National Institute on Aging, National Institutes of Health, Health and Human Services (075-0843) Health research and training Grants, subsidies, and contributions (41.0) $1,478,457 100%
Modified: 7/21/25