Advance Care Planning Clinical Trial
— IMPACTOfficial title:
Integrated Approach to Patient and Family Engagement for Advance Care Planning for Vulnerable Older Adult Within an Accountable Care Organization (ACO)
Verified date | June 2021 |
Source | Wake Forest University Health Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Wake Forest University Health Sciences | Duke University |
United States,
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* Note: There are 69 references in all — Click here to view all references
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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