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

NCT02302820 | Completed

• 1 other identifier: 14-006947
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Advance Care Planning; Nurse Care Coordination; Comparative Effectiveness; Advance Directive; Decision Aides

Outcome Measures

Primary Outcomes (1)

• Composite Measure of Acceptability and Feasibility

  Data regarding acceptability and feasibility of the study methods will be recorded following CONSORT Guidelines to monitor accrual and retention and include the percent of patients eligible for the study over the study period; percent of patients who are approached and accept study participation, percent of patients who complete the intervention and percent of forms completed. Patient satisfaction with the ACP decision aids will be measured using the Patient Satisfaction with ACP Survey.

  4 months

Secondary Outcomes (1)

• Composite Measure of Effects and Comparisons of the Four ACP Decision Aids

  4 months

Study Arms (4)

Make Your Wishes Known

ACTIVE COMPARATOR

A Decision Aid that uses interactions, videos, vignettes. A formatted Advance Directive; saved data that may be revisited to produce a revised Advance Directive

Other: Advance Care Planning Intervention

Mayo Clinic-Advance Health Care Planning

ACTIVE COMPARATOR

Not an online decision aid Written instructions, worksheets, and Advance Directive to complete

Other: Advance Care Planning Intervention

Mydirectives.com

ACTIVE COMPARATOR

Online decision aid that uses interactions, videos, and vignettes. An electronically stored Advance Directive that may be printed.

Other: Advance Care Planning Intervention

Prepare

ACTIVE COMPARATOR

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.

Other: Advance Care Planning Intervention

Interventions

Advance Care Planning Intervention 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.

Make Your Wishes Known; Mayo Clinic-Advance Health Care Planning; Mydirectives.com; Prepare

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• No vulnerable populations will be included in this study.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Multiple Chronic Conditions

Condition Hierarchy (Ancestors)

Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Diane Holland, RN, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Nurse Researcher

Study Record Dates

• First Submitted: October 3, 2014
• First Posted: November 27, 2014
• Study Start: December 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: January 5, 2016

Record last verified: 2016-01

Locations

US (1)