Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2025-12-25 @ 4:19 AM
NCT ID:
NCT02302820
Brief Summary:
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.
Detailed Description:
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.
Study:
NCT02302820
Study Brief:
Protocol Section:
NCT02302820