TY - JOUR
T1 - Sharing health care wishes in primary care (SHARE) among older adults with possible cognitive impairment in primary care
T2 - Study protocol for a randomized controlled trial
AU - Wolff, Jennifer L.
AU - Cagle, John
AU - Echavarria, Diane
AU - Dy, Sydney M.
AU - Giovannetti, Erin R.
AU - Boyd, Cynthia M.
AU - Hanna, Valecia
AU - Hussain, Naaz
AU - Reiff, Jenni S.
AU - Scerpella, Danny
AU - Zhang, Talan
AU - Roth, David L.
N1 - Publisher Copyright:
© 2023
PY - 2023/6
Y1 - 2023/6
N2 - Objective: Little is known about effective strategies to improve advance care planning (ACP) for persons with cognitive impairment in primary care, the most common setting of care. We describe a randomized controlled trial to test the efficacy of a multicomponent communication intervention, “Sharing Healthcare Wishes in Primary Care” (SHARE). Participants: Planned enrollment of 248 dyads of adults 80 years and older with possible cognitive impairment and their care partner, from primary care clinics at 2 Mid-Atlantic health systems. Methods: The treatment protocol encompasses an introductory letter from the clinic; access to a designated facilitator trained in ACP; person-family agenda-setting to align perspectives about the family's role; and print education. The control protocol encompasses minimally enhanced usual care, which includes print education and a blank advance directive. Randomization occurs at the individual dyad-level. Patient and care partner surveys are fielded at baseline, 6-, 12-, and 24- months. Fidelity of interventionist delivery of the protocol is measured through audio-recordings of ACP conversations and post-meeting reports, and by ongoing monitoring and support of interventionists. Outcomes: The primary outcome is quality of end-of-life care communication at 6 months; secondary outcomes include ACP process measures. An exploratory aim examines end-of-life care quality and bereaved care partner experiences for patients who die by 24 months. Conclusions: Caregiver burden, clinician barriers, and impaired decisional capacity amplify the difficulty and importance of ACP discussions in the context of cognitive impairment: this intervention will comprehensively examine communication processes for this special subpopulation in a key setting of primary care. Registration: ClinicalTrials.gov: NCT04593472.
AB - Objective: Little is known about effective strategies to improve advance care planning (ACP) for persons with cognitive impairment in primary care, the most common setting of care. We describe a randomized controlled trial to test the efficacy of a multicomponent communication intervention, “Sharing Healthcare Wishes in Primary Care” (SHARE). Participants: Planned enrollment of 248 dyads of adults 80 years and older with possible cognitive impairment and their care partner, from primary care clinics at 2 Mid-Atlantic health systems. Methods: The treatment protocol encompasses an introductory letter from the clinic; access to a designated facilitator trained in ACP; person-family agenda-setting to align perspectives about the family's role; and print education. The control protocol encompasses minimally enhanced usual care, which includes print education and a blank advance directive. Randomization occurs at the individual dyad-level. Patient and care partner surveys are fielded at baseline, 6-, 12-, and 24- months. Fidelity of interventionist delivery of the protocol is measured through audio-recordings of ACP conversations and post-meeting reports, and by ongoing monitoring and support of interventionists. Outcomes: The primary outcome is quality of end-of-life care communication at 6 months; secondary outcomes include ACP process measures. An exploratory aim examines end-of-life care quality and bereaved care partner experiences for patients who die by 24 months. Conclusions: Caregiver burden, clinician barriers, and impaired decisional capacity amplify the difficulty and importance of ACP discussions in the context of cognitive impairment: this intervention will comprehensively examine communication processes for this special subpopulation in a key setting of primary care. Registration: ClinicalTrials.gov: NCT04593472.
KW - Advance care planning
KW - Cognitive impairment
KW - Primary care
KW - Randomized controlled trial
UR - http://www.scopus.com/inward/record.url?scp=85153852349&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85153852349&partnerID=8YFLogxK
U2 - 10.1016/j.cct.2023.107208
DO - 10.1016/j.cct.2023.107208
M3 - Article
C2 - 37116645
AN - SCOPUS:85153852349
SN - 1551-7144
VL - 129
JO - Contemporary Clinical Trials
JF - Contemporary Clinical Trials
M1 - 107208
ER -