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

Information source: Mayo Clinic
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Advance Care Planning; Nurse Care Coordination; Multiple Chronic Health Conditions

Intervention: Advance Care Planning Intervention (Other)

Phase: N/A

Status: Recruiting

Sponsored by: Mayo Clinic

Official(s) and/or principal investigator(s):
Diane Holland, RN, PhD, Principal Investigator, Affiliation: Mayo Clinic

Overall contact:
Diane E Holland, PhD, Phone: 507-255-1036, Email: holland.diane@mayo.edu


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Primary outcome: Composite Measure of Acceptability and Feasibility

Secondary outcome: Composite Measure of Effects and Comparisons of the Four ACP Decision Aids

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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Patients on the list of each NCC who do not have an Advance Directive on file in the Mayo electronic health record will be invited to participate. Inclusion Criteria: This study will include community-dwelling adult patients with multiple chronic health conditions who do not have an Advance Directive document on file and their SDM/HCA if identified during the course of the intervention. We will accrue 40 patients and up to 40 SDM/HCAs to participate in this pilot study as subjects (80 total participants). Exclusion Criteria: Because the ACP process, as part of self-management, is a deliberative process, patients with dementia or a serious, persisting psychiatric diagnosis identified in the medical record will be excluded. Patients whose cannot speak or read English will be excluded since it is beyond the scope of this pilot study to employ interpreters. No vulnerable populations will be included in this study.

Locations and Contacts

Diane E Holland, PhD, Phone: 507-255-1036, Email: holland.diane@mayo.edu

Mayo Clinic in Rochester, Rochester, Minnesota 55905, United States; Recruiting
Additional Information

Starting date: December 2014
Last updated: May 20, 2015

Page last updated: August 23, 2015

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