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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03609658
Other study ID # IRB00049370
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 2, 2018
Est. completion date December 10, 2019

Study information

Verified date June 2021
Source Wake Forest University Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 146
Est. completion date December 10, 2019
Est. primary completion date December 10, 2019
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
United States Family & Community Medicine of Asheboro Asheboro North Carolina
United States Claremont Family Medicine Claremont North Carolina
United States Conover Family Practice Conover North Carolina
United States Chronic Complex Care High Point North Carolina
United States Cornerstone Internal Medicine at Westchester High Point North Carolina
United States High Point Family Practice High Point North Carolina
United States Thomasville Family Practice Thomasville North Carolina
United States Downtown Health Plaza Winston-Salem North Carolina
United States Wake Forest University Health Sciences Winston-Salem North Carolina

Sponsors (2)

Lead Sponsor Collaborator
Wake Forest University Health Sciences Duke University

Country where clinical trial is conducted

United States, 

References & Publications (69)

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* Note: There are 69 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Other Number of Medical Scope of Treatment (MOST) Discussions 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)
Other After-death Bereaved Family Member Interview 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
Other Frequency of Patient Healthcare Utilization Frequency is measured by the number of healthcare events recorded in the EHR. End of Study (Month 13)
Other Cost of Patient Healthcare Utilization Cost of patient healthcare utilization per group End of Study (Month 13)
Other Provider Satisfaction With the Intervention Scale This is a likert scale total score (0-78). Higher scores denotes better outcomes Month 11
Other Number of Protocol Deviations The number of protocol deviations will be reported to measure the fidelity of study implementation. End of Study (Month 13)
Other Usability of the ACP Documentation Tool (ACPWiseTool) 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)
Primary Number of Patient's Documented Advance Care Planning Discussion- Nurse Navigator Reported as the number of documentations completed in the newly created ACP note template for nurse navigator note templates. End of Study (Month 13)
Primary Number of Patient's Documented Advance Care Planning Discussions - Provider Reported as the number of documentations completed in the newly created ACP note template for provider note templates. End of Study (Month 13)
Primary Quality of Advance Care Planning Discussion - Nurse Navigator 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)
Primary Quality of Advance Care Planning Discussion - Provider 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)
Primary Quality of Advance Care Planning Discussion From the Patient's Perspective 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 Advance Care Planning Billing Code Usage ACP billing codes: 99497 and 99498 usages will be recorded End of Study (Month 13)
Secondary Number of Designated Surrogate Decision Makers Reported as the number of designated surrogate decision makers documented in Electronic Health Record (EHR). End of Study (Month 13)
Secondary Advance Directive Completion Reported as the number of scanned advance directive documents in the EHR. End of Study (Month 13)
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