Advance Care Planning GuideTailored for Primary Care Patients

Validation of a Novel EHR Patient Portal Advance Care Planning Delivery System

this project seeks to: validate results of ACP framework pilot study in a larger randomized controlled trial (rates and quality of ACP documentation) prior to using participatory design to develop an Electronic Health Record (EHR)-tethered patient portal delivered ACP communication guide, tailored for use in busy primary care settings, incorporating patients, caregivers, and primary care providers

Study Overview

• Status: Completed
• Conditions: Chronic Disease; Communication Research; Advance Care Planning
• Intervention / Treatment: Other: Patient Centered Medical Home Based Electronic Framework for Advance Care Planning

• Study Type: Observational
• Enrollment (Actual): 419

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43212
      • Ohio State University Wexner Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The investigators seek to test participant intervention in a pragmatic primary care environment to the patient populations described above.

Description

Inclusion Criteria:

• must have an activated patient portal account over 50 years of age scheduled for a well visit appointment or chronic visit follow up English speaking

Exclusion Criteria:

• under 50
• inactive patient portal account

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Intervention; The investigators seek to conduct a pragmatic trial including 2 sister clinical sites to test an innovation using a patient portal framework for Advance Care Planning. The intervention site implemented the intervention (secure patient portal delivered pre-visit planning framework for Advance Care Planning communication). The presence of ACP and the quality of documentation will be assessed through post-intervention chart review. Practice level enrollment was sought for the trial, and the framework will be delivered to all patients during a period of roll out. About 250 patients will receive the intervention.	Other: Patient Centered Medical Home Based Electronic Framework for Advance Care Planning; The intervention tested a pre-visit ACP workflow centered around a framework sent via secure Electronic Health Record (EHR)-linked patient portal in a real world clinical setting. The primary objectives were to determine its impact on frequency and quality of ACP documentation.; Other Names: Secure patient portal delivered pre-visit planning for advance care planning
control; The control site delivered usual care during the same period of roll out.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of Advance Care Planning (ACP) documentation as noted in description	Presence of Electronic Health Record problem list based ACP documentation or presence of Electronic Health Record scanned completed Advance Directive document	4 weeks post-intervention

Collaborators and Investigators

• Sponsor: Ohio State University

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2017
• Primary Completion (Actual): August 18, 2017
• Study Completion (Actual): December 15, 2018

Study Registration Dates

• First Submitted: February 26, 2018
• First Submitted That Met QC Criteria: April 5, 2019
• First Posted (Actual): April 8, 2019

Study Record Updates

• Last Update Posted (Actual): April 8, 2019
• Last Update Submitted That Met QC Criteria: April 5, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Chronic Disease
• Other Study ID Numbers: 2015H0350

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No