Advance Care Planning Clinical Trial
Official title:
Nurse-led Patient-centered Advance Care Planning: A Pilot Study
This study begins to look at ways nurses in primary care might help patients engage in Advance Care Planning and communicate their values and preferences to family and doctors.
The purpose of this pilot study is to determine the feasibility and acceptability of study
procedures in comparing the effectiveness of four advance care planning (ACP) decision aids
when used by Nurse Care Coordinators (NCCs) with their patients in primary care. Study
activities include face-to-face participation in primarily 3 one-hour meetings with their
NCC and completion of study questionnaires at baseline and at completion of the
intervention. If during the ACP process the patient identifies a surrogate decision
maker/health care agent (SDM/HCA), the SDM/HCA will be invited to also participate in the
study by answering a questionnaire when the patient has completed the ACP intervention.
Findings from prior studies provide evidence of the success of the ACP decision aids for use
in the ACP process. The proposed study is a logical next step to meet the need to enhance
patient-centeredness in primary care practices. The study team is strategically positioned
to successfully conduct the proposed study with adequate support and skills available. The
proposed study is innovative in that it compares the effectiveness of evidence-based ACP
decision aids when used by primary care nurses in collaboration with the patients they
serve.
A four-arm, prospective, comparative, feasibility design is proposed. Participants will be
recruited from the caseloads of NCCs from Mayo Clinic's primary care practice. After
enrollment patients will be randomly assigned to either one of 3 ACP web-based decision aids
or an ACP educational brochure decision aid arm to receive education and guidance related to
the ACP process.
The central hypothesis is that ACP by NCCs in collaboration with patients in primary care
settings is feasible and effective when supported by a decision aid. All 4 ACP decision aids
have been proven successful when used by patients independently, but no evidence exists
regarding their success when used in a patient/clinician collaboration in primary care.
Group differences will direct us to explore whether one or more ACP decision aid performs
better than others, thereby indicating that successful ACP by NCCs in primary care settings
may be supported by particular decision aids. Direct benefits to subjects involved are not
assured, but information regarding the ACP process and the possibility of identifying a
surrogate decision maker and completion of an advance directive provides a potential
benefit.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
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