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Completed

NCT Number: NCT03609658

Integrated Multidisciplinary Patient and Family Advance Care Planning Trial

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.

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Key information

Conditions

Advance Care Planning

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Family & Community Medicine of Asheboro, Asheboro, North Carolina, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nurse Navigator Pathway

Behavioral

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.

Usual Care

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Secondary outcomes

  1. Advance Care Planning Billing Code Usage

    Time frame: End of Study (Month 13)

    ACP billing codes: 99497 and 99498 usages will be recorded

  2. 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).

  3. Advance Directive Completion

    Time frame: End of Study (Month 13)

    Reported as the number of scanned advance directive documents in the EHR.

Other outcomes

  1. 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

  2. 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.

  3. 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.

  4. Cost of Patient Healthcare Utilization

    Time frame: End of Study (Month 13)

    Cost of patient healthcare utilization per group

  5. Provider Satisfaction With the Intervention Scale

    Time frame: Month 11

    This is a likert scale total score (0-78). Higher scores denotes better outcomes

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • Duke University

Registry information

Official study title

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

Acronym: IMPACT

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 1, 2018
Registry last updated
Aug 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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