Advance Care PlanningIMPACTNCT03609658
Integrated Multidisciplinary Patient and Family Advance Care Planning Trial
A study testing Nurse Navigator Pathway in people with Advance Care Planning, run by Wake Forest University Health Sciences at 9 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Advance Care Planning
- What is being tested?
- Nurse Navigator Pathway
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 146 participants
- Where
- 9 sitesUnited States
- Study dates
- 2 Nov 2018to 10 Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Family & Community Medicine of Asheboro
Asheboro, North Carolina, 27203
Claremont Family Medicine
Claremont, North Carolina, 28610
Conover Family Practice
Conover, North Carolina, 28613
Chronic Complex Care
High Point, North Carolina, 27262
Cornerstone Internal Medicine at Westchester
High Point, North Carolina, 27262
High Point Family Practice
High Point, North Carolina, 27262
Thomasville Family Practice
Thomasville, North Carolina, 27360
Downtown Health Plaza
Winston-Salem, North Carolina, 27101
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: 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.
Read the 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.
- Conditions
- Advance Care Planning
- Being tested
- Nurse Navigator Pathway, Usual Care
- Keywords
- Vulnerable Older Adults, Nurse Navigator, Usual Care, Family, Multimorbid patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse Navigator PathwayBehavioural
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 CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Nurse Navigator Pathway Group | Experimental | 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) Receives: Behavioral: Nurse Navigator Pathway |
| Usual Care Group | Sham comparator | Participants in the Usual Care group will follow usual daily living activities for the duration of the study (12 months). Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: End of Study (Month 13)
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.
Measured: End of Study (Month 13)
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.
Measured: End of Study (Month 13)
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.
Measured: End of Study (Month 13)
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.
Measured: End of Study (Month 13)
Secondary outcomes (3)
Advance Care Planning Billing Code Usage
ACP billing codes: 99497 and 99498 usages will be recorded
Measured: End of Study (Month 13)
Number of Designated Surrogate Decision Makers
Reported as the number of designated surrogate decision makers documented in Electronic Health Record (EHR).
Measured: End of Study (Month 13)
Advance Directive Completion
Reported as the number of scanned advance directive documents in the EHR.
Measured: End of Study (Month 13)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start2 Nov 2018
- Primary completion10 Dec 2019
- Study completion10 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (71)Papers the sponsor has linked to this study.
- Other trials for Advance Care PlanningStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There are two groups. 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. Note that patients that do not consent to the intervention are still counted as part of control group under an intent-to-treat paradigm, which necessitates passive ascertainment mechanisms for outcomes (i.e. administrative claims or the EHR).
- Masking
- None (open label)
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Duke University
- Responsible party
- Sponsor
- Investigators
- Jennifer Gabbard, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03609658
- Sponsor's protocol ID
- IRB00049370
- Acronym
- IMPACT
- Status last verified
- Jun 2021
- First submitted
- 25 Jul 2018
- Last updated
- 6 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
U.S. Census Bureau. International database. Table 094. Midyear population, by age and sex. Available at http://www.census.gov/population/www/projections/natdet-D1A.htmlExternal Web Site Icon.
Gomez-Batiste X, Martinez-Munoz M, Blay C, Amblas J, Vila L, Costa X, Espaulella J, Espinosa J, Constante C, Mitchell GK. Prevalence and characteristics of patients with advanced chronic conditions in need of palliative care in the general population: a cross-sectional study. Palliat Med. 2014 Apr;28(4):302-11. doi: 10.1177/0269216313518266. Epub 2014 Jan 8.
PubMed 24403380"Methods for Analysis of the Financing and Use of Long-Term Services and Supports," supplemental material for Rising Demand for Long-Term Services and Supports for Elderly People (June 2013), www.cbo.gov/publication/44370.
Schoenborn NL, Cayea D, McNabney M, Ray A, Boyd C. Prognosis communication with older patients with multimorbidity: Assessment after an educational intervention. Gerontol Geriatr Educ. 2017 Oct-Dec;38(4):471-481. doi: 10.1080/02701960.2015.1115983. Epub 2016 Feb 17.
PubMed 26885757Morrison RS. Research priorities in geriatric palliative care: an introduction to a new series. J Palliat Med. 2013 Jul;16(7):726-9. doi: 10.1089/jpm.2013.9499. Epub 2013 May 30. No abstract available.
PubMed 23721426Signorielli N: Physical disabilities, impairment and safety,mental illness, and death. In: Mass Media Images and Impact on Health: A Sourcebook. Westport, CT: Greenwood Press, 1993, pp. 37-42.
Fortin M, Bravo G, Hudon C, Vanasse A, Lapointe L. Prevalence of multimorbidity among adults seen in family practice. Ann Fam Med. 2005 May-Jun;3(3):223-8. doi: 10.1370/afm.272.
PubMed 15928225Fortin M, Soubhi H, Hudon C, Bayliss EA, van den Akker M. Multimorbidity's many challenges. BMJ. 2007 May 19;334(7602):1016-7. doi: 10.1136/bmj.39201.463819.2C.
PubMed 17510108Marengoni A, Angleman S, Melis R, Mangialasche F, Karp A, Garmen A, Meinow B, Fratiglioni L. Aging with multimorbidity: a systematic review of the literature. Ageing Res Rev. 2011 Sep;10(4):430-9. doi: 10.1016/j.arr.2011.03.003. Epub 2011 Mar 23.
PubMed 21402176Smith SM, O'Dowd T. Chronic diseases: what happens when they come in multiples? Br J Gen Pract. 2007 Apr;57(537):268-70. No abstract available.
PubMed 17394728Taylor AW, Price K, Gill TK, Adams R, Pilkington R, Carrangis N, Shi Z, Wilson D. Multimorbidity - not just an older person's issue. Results from an Australian biomedical study. BMC Public Health. 2010 Nov 22;10:718. doi: 10.1186/1471-2458-10-718.
PubMed 21092218Vogeli C, Shields AE, Lee TA, Gibson TB, Marder WD, Weiss KB, Blumenthal D. Multiple chronic conditions: prevalence, health consequences, and implications for quality, care management, and costs. J Gen Intern Med. 2007 Dec;22 Suppl 3(Suppl 3):391-5. doi: 10.1007/s11606-007-0322-1.
PubMed 18026807Menotti A, Mulder I, Nissinen A, Giampaoli S, Feskens EJ, Kromhout D. Prevalence of morbidity and multimorbidity in elderly male populations and their impact on 10-year all-cause mortality: The FINE study (Finland, Italy, Netherlands, Elderly). J Clin Epidemiol. 2001 Jul;54(7):680-6. doi: 10.1016/s0895-4356(00)00368-1.
PubMed 11438408Fortin M, Lapointe L, Hudon C, Vanasse A, Ntetu AL, Maltais D. Multimorbidity and quality of life in primary care: a systematic review. Health Qual Life Outcomes. 2004 Sep 20;2:51. doi: 10.1186/1477-7525-2-51.
PubMed 15380021Townsend A, Hunt K, Wyke S. Managing multiple morbidity in mid-life: a qualitative study of attitudes to drug use. BMJ. 2003 Oct 11;327(7419):837. doi: 10.1136/bmj.327.7419.837.
PubMed 14551097
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Approach to Patient and Family Engagement for Advance Care Planning for Vulnerable Older Adult Within an Accountable Care Organization (ACO)
- ClinicalTrials.gov ID
- NCT03609658
- Acronym / sponsor ID
- IMPACT / IRB00049370
- Conditions
- Advance Care Planning
- Keywords
- Vulnerable Older Adults, Nurse Navigator, Usual Care, Family, Multimorbid patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Duke University
- Study start
- 2 Nov 2018 (actual)
- Primary completion
- 10 Dec 2019 (actual)
- Study completion
- 10 Dec 2019 (actual)
- First posted
- 1 Aug 2018 (actual)
- Results
- Posted 6 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- There are two groups. 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. Note that patients that do not consent to the intervention are still counted as part of control group under an intent-to-treat paradigm, which necessitates passive ascertainment mechanisms for outcomes (i.e. administrative claims or the EHR).
| Arm | Type | Receives |
|---|---|---|
| Nurse Navigator Pathway Group | Experimental | Behavioral: Nurse Navigator PathwayParticipants 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) |
| Usual Care Group | Sham comparator | Behavioral: Usual CareParticipants in the Usual Care group will follow usual daily living activities for the duration of the study (12 months). |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nurse Navigator PathwayIn 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. | Behavioural | Nurse Navigator Pathway Group |
| Usual CareIn 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. | Behavioural | Usual Care Group |
Primary outcome
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.
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.
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.
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.
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.
3 secondary outcomes
Advance Care Planning Billing Code Usage
Time frame: End of Study (Month 13)
Number of Designated Surrogate Decision Makers
Time frame: End of Study (Month 13)
Advance Directive Completion
Time frame: End of Study (Month 13)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundU.S. Census Bureau. International database. Table 094. Midyear population, by age and sex. Available at http://www.census.gov/population/www/projections/natdet-D1A.htmlExternal Web Site Icon.
- Background: PubMed 24403380Gomez-Batiste X, Martinez-Munoz M, Blay C, Amblas J, Vila L, Costa X, Espaulella J, Espinosa J, Constante C, Mitchell GK. Prevalence and characteristics of patients with advanced chronic conditions in need of palliative care in the general population: a cross-sectional study. Palliat Med. 2014 Apr;28(4):302-11. doi: 10.1177/0269216313518266. Epub 2014 Jan 8.
- Background"Methods for Analysis of the Financing and Use of Long-Term Services and Supports," supplemental material for Rising Demand for Long-Term Services and Supports for Elderly People (June 2013), www.cbo.gov/publication/44370.
- Background: PubMed 26885757Schoenborn NL, Cayea D, McNabney M, Ray A, Boyd C. Prognosis communication with older patients with multimorbidity: Assessment after an educational intervention. Gerontol Geriatr Educ. 2017 Oct-Dec;38(4):471-481. doi: 10.1080/02701960.2015.1115983. Epub 2016 Feb 17.
- Background: PubMed 23721426Morrison RS. Research priorities in geriatric palliative care: an introduction to a new series. J Palliat Med. 2013 Jul;16(7):726-9. doi: 10.1089/jpm.2013.9499. Epub 2013 May 30. No abstract available.
- BackgroundSignorielli N: Physical disabilities, impairment and safety,mental illness, and death. In: Mass Media Images and Impact on Health: A Sourcebook. Westport, CT: Greenwood Press, 1993, pp. 37-42.
- Background: PubMed 15928225Fortin M, Bravo G, Hudon C, Vanasse A, Lapointe L. Prevalence of multimorbidity among adults seen in family practice. Ann Fam Med. 2005 May-Jun;3(3):223-8. doi: 10.1370/afm.272.
- Background: PubMed 17510108Fortin M, Soubhi H, Hudon C, Bayliss EA, van den Akker M. Multimorbidity's many challenges. BMJ. 2007 May 19;334(7602):1016-7. doi: 10.1136/bmj.39201.463819.2C.
- Background: PubMed 21402176Marengoni A, Angleman S, Melis R, Mangialasche F, Karp A, Garmen A, Meinow B, Fratiglioni L. Aging with multimorbidity: a systematic review of the literature. Ageing Res Rev. 2011 Sep;10(4):430-9. doi: 10.1016/j.arr.2011.03.003. Epub 2011 Mar 23.
- Background: PubMed 17394728Smith SM, O'Dowd T. Chronic diseases: what happens when they come in multiples? Br J Gen Pract. 2007 Apr;57(537):268-70. No abstract available.
- Background: PubMed 21092218Taylor AW, Price K, Gill TK, Adams R, Pilkington R, Carrangis N, Shi Z, Wilson D. Multimorbidity - not just an older person's issue. Results from an Australian biomedical study. BMC Public Health. 2010 Nov 22;10:718. doi: 10.1186/1471-2458-10-718.
- Background: PubMed 18026807Vogeli C, Shields AE, Lee TA, Gibson TB, Marder WD, Weiss KB, Blumenthal D. Multiple chronic conditions: prevalence, health consequences, and implications for quality, care management, and costs. J Gen Intern Med. 2007 Dec;22 Suppl 3(Suppl 3):391-5. doi: 10.1007/s11606-007-0322-1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Gabbard, MD principal investigator
Wake Forest University Health Sciences
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse Navigator Pathway in people with Advance Care Planning, run by Wake Forest University Health Sciences at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patient's Documented Advance Care Planning Discussion- Nurse Navigator (time frame: End of Study (Month 13)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03609658, which also lists 71 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2021.