Integrated Multidisciplinary Patient and Family Advance Care Planning Trial (IMPACT)

July 14, 2021 updated by: Wake Forest University Health Sciences

Integrated Approach to Patient and Family Engagement for Advance Care Planning for Vulnerable Older Adult Within an Accountable Care Organization (ACO)

The purpose of this study is to compare ways to engage sick patients and their family members in Advance Care Planning (ACP) discussions. Two pathways will be tested, discussions using a Nurse Navigator led pathway versus usual care.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is a randomized, pragmatic, comparative effectiveness trial for determining better ways to engage multimorbid patients and their family members in Advance Care Planning through a Nurse Navigator led pathway versus usual care. Investigators propose to utilize Zelen's design (a more recent label/generalization for this type of design is the cohort multiple randomized controlled trial (cmRCT), a pragmatic clinical trial design whereby all participants are randomized prior to informed consent, and then only patients randomized to the interventional arm are approached for consent and subsequently enrolled in the intervention group.

Study Type

Interventional

Enrollment (Actual)

146

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Asheboro, North Carolina, United States, 27203
        • Family & Community Medicine of Asheboro
      • Claremont, North Carolina, United States, 28610
        • Claremont Family Medicine
      • Conover, North Carolina, United States, 28613
        • Conover Family Practice
      • High Point, North Carolina, United States, 27262
        • Chronic Complex Care
      • High Point, North Carolina, United States, 27262
        • Cornerstone Internal Medicine at Westchester
      • High Point, North Carolina, United States, 27262
        • High Point Family Practice
      • Thomasville, North Carolina, United States, 27360
        • Thomasville Family Practice
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Health Sciences
      • Winston-Salem, North Carolina, United States, 27101
        • Downtown Health Plaza

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged 65 or older patient within the Wake Forest/Cornerstone ACO
  • Have seen their primary care provider within the Wake Forest/Cornerstone network in the past 12 months
  • English speaking
  • No documented Advance Directive in the EHR
  • Impairments in either physical function, cognition, and/or frailty

Exclusion Criteria:

  • No available proxy (e.g. in setting of cognitive impairment)
  • Severe/advanced dementia
  • Moderate to severe hearing loss
  • Non-English speaking
  • No phone number available for patient

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Nurse Navigator Pathway Group
Participants in this Nurse Navigator led ACP pathway group will participate in ACP discussions, surveys, and participant visit(s) for duration of the study (12 months)
Behavioral: Nurse Navigator Pathway
In the Nurse Navigator Pathway, nurse navigators are being used as leverage to: approach qualified patients to initiate advance care planning discussions, schedule advance care planning visit with patients' primary care provider to further discuss advance care planning and to mail advance care planning resources to patients after their initial advance care planning discussion.
SHAM_COMPARATOR: Usual Care Group
Participants in the Usual Care group will follow usual daily living activities for the duration of the study (12 months).
Behavioral: Usual Care
In the Usual Care arm, there is no approach by nurse navigators to initiate advance care planning discussions and it does not have a structure advance care planning visit. Therefore, no further action is required for the patients who were randomly assigned to the usual care arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patient's Documented Advance Care Planning Discussion- Nurse Navigator
Time Frame: End of Study (Month 13)
Reported as the number of documentations completed in the newly created ACP note template for nurse navigator note templates.
End of Study (Month 13)
Number of Patient's Documented Advance Care Planning Discussions - Provider
Time Frame: End of Study (Month 13)
Reported as the number of documentations completed in the newly created ACP note template for provider note templates.
End of Study (Month 13)
Quality of Advance Care Planning Discussion - Nurse Navigator
Time Frame: End of Study (Month 13)
Measured by the newly created ACP note template for both nurse navigator (score ranging from 0-8). Score of 5 or higher determines better outcome.
End of Study (Month 13)
Quality of Advance Care Planning Discussion - Provider
Time Frame: End of Study (Month 13)
Measured by the newly created ACP note template for provider note templates (score ranging from 0-15). Score of 8 or higher in the provider template determines better outcome.
End of Study (Month 13)
Quality of Advance Care Planning Discussion From the Patient's Perspective
Time Frame: End of Study (Month 13)
Measured by the Quality about End of Life (EOL) Communication (QOC), The instrument is reported as 2 subscales: "general communication skills" and "communication about end-of-life care." Score range for the subscales is 1-11 Higher scores determine better outcomes.
End of Study (Month 13)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Advance Care Planning Billing Code Usage
Time Frame: End of Study (Month 13)
ACP billing codes: 99497 and 99498 usages will be recorded
End of Study (Month 13)
Number of Designated Surrogate Decision Makers
Time Frame: End of Study (Month 13)
Reported as the number of designated surrogate decision makers documented in Electronic Health Record (EHR).
End of Study (Month 13)
Advance Directive Completion
Time Frame: End of Study (Month 13)
Reported as the number of scanned advance directive documents in the EHR.
End of Study (Month 13)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Medical Scope of Treatment (MOST) Discussions
Time Frame: End of Study (Month 13)
Reported as the number of completed MOST discussion within the new ACP template and/or scanned form in the EHR
End of Study (Month 13)
After-death Bereaved Family Member Interview
Time Frame: Month 29
The After-death bereaved family member interview measures the quality of end of life care. Interview is analyzed utilizing Q-pro software for qualitative data.
Month 29
Frequency of Patient Healthcare Utilization
Time Frame: End of Study (Month 13)
Frequency is measured by the number of healthcare events recorded in the EHR.
End of Study (Month 13)
Cost of Patient Healthcare Utilization
Time Frame: End of Study (Month 13)
Cost of patient healthcare utilization per group
End of Study (Month 13)
Provider Satisfaction With the Intervention Scale
Time Frame: Month 11
This is a likert scale total score (0-78). Higher scores denotes better outcomes
Month 11
Number of Protocol Deviations
Time Frame: End of Study (Month 13)
The number of protocol deviations will be reported to measure the fidelity of study implementation.
End of Study (Month 13)
Usability of the ACP Documentation Tool (ACPWiseTool)
Time Frame: End of Study (Month 13)
Measured by the System Usability Scale (SUS) survey. Likert Scale of strongly disagree, disagree, neutral, agree, and strongly agree. Score ranges from 1 to 5. Higher score equates higher usability.
End of Study (Month 13)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Collaborators

Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 2, 2018

Primary Completion (ACTUAL)

December 10, 2019

Study Completion (ACTUAL)

December 10, 2019

Study Registration Dates

First Submitted

July 25, 2018

First Submitted That Met QC Criteria

July 25, 2018

First Posted (ACTUAL)

August 1, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 6, 2021

Last Update Submitted That Met QC Criteria

July 14, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB00049370

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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