Nurse-led Patient-centered Advance Care Planning: A Pilot Study

NCT ID: NCT02302820

Last Updated: 2016-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2015-11-30

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.

Conditions

Advance Care Planning; Nurse Care Coordination; Multiple Chronic Health Conditions

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Make Your Wishes Known

A Decision Aid that uses interactions, videos, vignettes.

A formatted Advance Directive; saved data that may be revisited to produce a revised Advance Directive

Group Type: ACTIVE_COMPARATOR

Advance Care Planning Intervention

Intervention Type: OTHER

ACP Intervention The ACP intervention involves structured discussions between patients and NCCs using 1 of 4 decision aids in order to clarify patient's values, goals and preferences for "living well" and sharing goals with family, SDM/HCA, and the health care team. Because the time needed for reflective thinking, decision making and discussions with family are important components of the ACP process, the intervention is designed to occur in at least 3 NCC/patient visits over approximately 4 weeks. The NCC will assist patients in the ACP process following scripts specific to each of the decision aids.

Mayo Clinic-Advance Health Care Planning

Not an online decision aid

Written instructions, worksheets, and Advance Directive to complete

Group Type: ACTIVE_COMPARATOR

Advance Care Planning Intervention

Intervention Type: OTHER

ACP Intervention The ACP intervention involves structured discussions between patients and NCCs using 1 of 4 decision aids in order to clarify patient's values, goals and preferences for "living well" and sharing goals with family, SDM/HCA, and the health care team. Because the time needed for reflective thinking, decision making and discussions with family are important components of the ACP process, the intervention is designed to occur in at least 3 NCC/patient visits over approximately 4 weeks. The NCC will assist patients in the ACP process following scripts specific to each of the decision aids.

Mydirectives.com

Online decision aid that uses interactions, videos, and vignettes.

An electronically stored Advance Directive that may be printed.

Group Type: ACTIVE_COMPARATOR

Advance Care Planning Intervention

Intervention Type: OTHER

ACP Intervention The ACP intervention involves structured discussions between patients and NCCs using 1 of 4 decision aids in order to clarify patient's values, goals and preferences for "living well" and sharing goals with family, SDM/HCA, and the health care team. Because the time needed for reflective thinking, decision making and discussions with family are important components of the ACP process, the intervention is designed to occur in at least 3 NCC/patient visits over approximately 4 weeks. The NCC will assist patients in the ACP process following scripts specific to each of the decision aids.

Prepare

An online decision aid that uses interactions, videos and vignettes.

A printed summary useful for transposing values and treatment wishes into an Advance Directive; a list of action steps.

Group Type: ACTIVE_COMPARATOR

Advance Care Planning Intervention

Intervention Type: OTHER

ACP Intervention The ACP intervention involves structured discussions between patients and NCCs using 1 of 4 decision aids in order to clarify patient's values, goals and preferences for "living well" and sharing goals with family, SDM/HCA, and the health care team. Because the time needed for reflective thinking, decision making and discussions with family are important components of the ACP process, the intervention is designed to occur in at least 3 NCC/patient visits over approximately 4 weeks. The NCC will assist patients in the ACP process following scripts specific to each of the decision aids.

Interventions

Advance Care Planning Intervention

ACP Intervention The ACP intervention involves structured discussions between patients and NCCs using 1 of 4 decision aids in order to clarify patient's values, goals and preferences for "living well" and sharing goals with family, SDM/HCA, and the health care team. Because the time needed for reflective thinking, decision making and discussions with family are important components of the ACP process, the intervention is designed to occur in at least 3 NCC/patient visits over approximately 4 weeks. The NCC will assist patients in the ACP process following scripts specific to each of the decision aids.

Intervention Type: OTHER

Eligibility Criteria

Exclusion Criteria

No vulnerable populations will be included in this study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Diane Holland

Clinical Nurse Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Diane Holland, RN, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

14-006947

Identifier Type: -

Identifier Source: org_study_id