Advanced Care PlanningACP-COVIDNCT04660422
Advance Care Planning: Communicating With Outpatients for Vital Informed Decision
An observational study of Advanced Care Planning and Shared Decision Making, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial summary
This Pre-Post, open-cohort design, pragmatic trial with 150 clinicians and will evaluate the effectiveness of the use of telehealth Advanced Care Planning (ACP) Program by comparing ACP documentation among 13,000 patients over 65 Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Advanced Care Planning, Shared Decision Making, Video Decision Aids
- What is being tested?
- VitalTalk communication skills training, ACP Decisions Video Program and Intervention training:
- Type of treatment
- Injection or infusion
- How many people
- 42,019 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2020to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Older adult
Study population: To be eligible for this study, individuals must be aged 65 or over, affiliated with the Northwell Health clinic. For each of the three periods of the study, those patients over the age of 65 who are engaged (e.g., seen in person, telehealth, etc.) with the clinic during that time period will be included in that time period.
Who may be able to join
- Clinic Eligibility: Clinics affiliated with Northwell Health may be included in the study.
- Clinician, Staff Eligibility: Any staff member identified by the site-PIs are affiliated with Northwell Health.
- Patient Eligibility: To be eligible for this study, individuals must be aged 65 or over, affiliated with the Northwell Health clinic. For each of the three periods of the study, those patients over the age of 65 who are engaged (e.g., seen in person, telehealth, etc.) with the clinic during that time period will be included in that time period
Who cannot join
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
- Prisoners
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Advance Care Planning: Communicating With Outpatients for Vital Informed Decisions
This Pre-Post, open-cohort design, pragmatic trial with 150 clinicians and will evaluate the effectiveness of the use of telehealth Advanced Care Planning (ACP) Program by comparing ACP documentation among 13,000 patients over 65
Read the detailed description
This study is investigating if the use of telehealth ACP Program will improve and sustain rates of ACP from the time that the intervention is implemented compared to two time periods prior to the intervention. The Comprehensive ACP Program combines two widely disseminated interventions to assess impact when used concurrently.
- One is VitalTalk clinician communication skills training (www.vitaltalk.org) during which the primary care clinicians will practice ACP with simulated patient actors under the guidance of a trained VitalTalk facilitator.
- The second is the ACP Decisions video decision aids (www.acpdecisions.org) which are directed to patients and provide education about ACP. This inclusive ACP approach treats patients and clinicians as equal stakeholders providing both with the communication skills and tools needed to make decisions about COVID-19 medical care before the toughest choices arise.
- The training is four cumulative hours, most of which is spent in communication skills work, and the remainder learning how to introduce the videos into one's practice. No patients participate in the training. The ambulatory practices included in this intervention gain access to the ACP Decisions videos, which can be introduced to patients. Videos may be seen in clinic or sent to patients' homes via an electronic or paper code.
- We will recruit up to 30 clinicians from participating clinics who completed the intervention training and ask them to complete a qualitative interview to learn about their experience with the ACP intervention.
- Conditions
- Advanced Care Planning, Shared Decision Making, Video Decision Aids, Communication Skills, Advance Directives, Natural Language Processing
- Being tested
- VitalTalk communication skills training, ACP Decisions Video Program, Intervention training:, Medical Record Review
- Keywords
- Covid 19, Advanced Care Planning, Shared decision making, Video decision aids, Communication skills, Serious illness decision making, Health care proxy, Advance directives, Natural language processing
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VitalTalk communication skills trainingOther
Clinicians will receive VitalTalk intensive communication skills training via highly structured Zoom conference. They will learn skills relevant to discussions about ACP and COVID-19 including delivering serious news, eliciting goals of care, and managing difficult conversations via telehealth platforms.
ACP Decisions Video ProgramOther
All clinicians will also be trained remotely on the ACP Decisions Video Program using the ACP app. Training will instruct clinicians on how to: 1. Introduce the COVID-19 videos to patients and caregivers; 2. Select the appropriate video(s) from the entire suite according to patients' needs; and, 3. Prescribe videos for patients and caregivers using the electronic platform. The suite of ACP videos is designed to address common ACP decisions confronting patients at risk or with COVID-19 and the caregivers.
Intervention training:Other
Training will instruct the clinicians on how to: i. more effectively communicate with patients regarding COVID- 19, ii. have ACP conversations with patients, iii. introduce the videos to patients and families, iv. use the videos as an adjunct to ACP counseling by clinicians, v. select the appropriate video(s) from the entire suite as according to patients' needs, and, vi. use the app or electronic platform for prescribing videos to be seen at home (telehealth visits), or to be viewed in clinic with an iPad.
Medical Record ReviewOther
13,000 (total) patients aged 65 or older for our primary (completed advance care plans) outcome. ACP can include designating a health care proxy, discussion of advance directives, goals-of-care discussions, CPR discussions, palliative care discussions and referrals, as well as hospice. Each of these ACP outcomes will also be compared in secondary analyses using NLP. These data will be obtained from the EHR. All patient participants will only be included for medical record review.
| Study group | Role | What they receive |
|---|---|---|
| Pre-COVID-19 ACP baseline | Two six-month control periods prior to the wide-scale implementation of the intervention, allow us to measure a baseline rate of ACP activity and identify the "pre-COVID-19 ACP baseline rate" and a "COVID-19 ACP baseline rate.
September 15, 2019 - March 14, 2020, Receives: Other: Medical Record Review | |
| COVID-19 rate | Two six-month control periods prior to the wide-scale implementation of the intervention, allow us to measure a baseline rate of ACP activity and identify the "pre-COVID-19 ACP baseline rate" and a "COVID-19 ACP baseline rate.
March 15, 2020 - September 14, 2020 Receives: Other: Medical Record Review | |
| ACP rate | ACP rate during the implementation period, which begins December 15, 2020 and continues for six months, to the rates in the previous two control periods December 15, 2020-June 15, 2021 Receives: Other: VitalTalk communication skills training; Other: ACP Decisions Video Program; Other: Intervention training:; Other: Medical Record Review |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate for Advanced Care Planning (ACP) documentation
This study tests the effects of an ACP Program that trains clinicians and provides patients with a video decision aid on rates of ACP among 13,000 patients at risk, or with, COVID-19. All patients over 65 engaged with the enrolled clinics over the course of each time period in each of the three study periods will be included in the analysis. Rates of ACP are determined by natural language processing data extraction of electronic health records. Generalized linear mixed models will be used to compare outcomes between intervention and control periods.
Measured: 2 Years
Secondary outcomes (4)
Rate of orders for resuscitation preferences
Same methodology as Primary Outcome
Measured: 2 years
Rate of palliative care consultation
Same methodology as Primary Outcome
Measured: 2 years
Rate of referral to hospice
Same methodology as Primary Outcome
Measured: 2 years
Advanced Care Planning (ACP) documentation rates among under-represented minority groups.
The analysis will use a difference in differences approach comparing the changes from the control period to the intervention period between White and non-White racial minority and between non-Medicaid and Medicaid patients.
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2020
- Study start15 Dec 2020
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Advanced Care PlanningStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 42,019 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, James A. Tulsky, Dana-Farber Cancer Institute
- Investigators
- James A. Tulsky, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04660422
- Sponsor's protocol ID
- 20-600
- Other IDs
- UH3AG060626-03S1
- Acronym
- ACP-COVID
- Status last verified
- Jun 2022
- First submitted
- 3 Dec 2020
- Last updated
- 5 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Publications
Murray GF, Lakin JR, Paasche-Orlow MK, Tulsky JA, Volandes A, Davis AD, Zupanc SN, Carney MT, Burns E, Martins-Welch D, LaVine N, Itty JE, Fix GM. Structural Barriers to Well-grounded Advance Care Planning for the Seriously Ill: a Qualitative Study of Clinicians' and Administrators' Experiences During a Pragmatic Trial. J Gen Intern Med. 2023 Dec;38(16):3558-3565. doi: 10.1007/s11606-023-08320-2. Epub 2023 Jul 24.
PubMed 37488368Volandes AE, Zupanc SN, Paasche-Orlow MK, Lakin JR, Chang Y, Burns EA, LaVine NA, Carney MT, Martins-Welch D, Emmert K, Itty JE, Moseley ET, Davis AD, El-Jawahri A, Gundersen DA, Fix GM, Yacoub AM, Schwartz P, Gabry-Kalikow S, Garde C, Fischer J, Henault L, Burgess L, Goldman J, Kwok A, Singh N, Alvarez Suarez AL, Gromova V, Jacome S, Tulsky JA, Lindvall C. Association of an Advance Care Planning Video and Communication Intervention With Documentation of Advance Care Planning Among Older Adults: A Nonrandomized Controlled Trial. JAMA Netw Open. 2022 Feb 1;5(2):e220354. doi: 10.1001/jamanetworkopen.2022.0354.
PubMed 35201306
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advance Care Planning: Communicating With Outpatients for Vital Informed Decisions
- ClinicalTrials.gov ID
- NCT04660422
- Acronym / sponsor ID
- ACP-COVID / 20-600
- Conditions
- Advanced Care Planning, Shared Decision Making, Video Decision Aids, Communication Skills, Advance Directives, Natural Language Processing
- Keywords
- Covid 19, Advanced Care Planning, Shared decision making, Video decision aids, Communication skills, Serious illness decision making, Health care proxy, Advance directives
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42,019 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 9 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Pre-Post, open-cohort design, pragmatic trial with 150 clinicians and will evaluate the effectiveness of the use of telehealth Advanced Care Planning (ACP) Program by comparing ACP documentation among 13,000 patients over 65
Detailed description
This study is investigating if the use of telehealth ACP Program will improve and sustain rates of ACP from the time that the intervention is implemented compared to two time periods prior to the intervention. The Comprehensive ACP Program combines two widely disseminated interventions to assess impact when used concurrently.
- One is VitalTalk clinician communication skills training (www.vitaltalk.org) during which the primary care clinicians will practice ACP with simulated patient actors under the guidance of a trained VitalTalk facilitator.
- The second is the ACP Decisions video decision aids (www.acpdecisions.org) which are directed to patients and provide education about ACP. This inclusive ACP approach treats patients and clinicians as equal stakeholders providing both with the communication skills and tools needed to make decisions about COVID-19 medical care before the toughest choices arise.
- The training is four cumulative hours, most of which is spent in communication skills work, and the remainder learning how to introduce the videos into one's practice. No patients participate in the training. The ambulatory practices included in this intervention gain access to the ACP Decisions videos, which can be introduced to patients. Videos may be seen in clinic or sent to patients' homes via an electronic or paper code.
- We will recruit up to 30 clinicians from participating clinics who completed the intervention training and ask them to complete a qualitative interview to learn about their experience with the ACP intervention.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pre-COVID-19 ACP baseline | – | Other: Medical Record ReviewTwo six-month control periods prior to the wide-scale implementation of the intervention, allow us to measure a baseline rate of ACP activity and identify the "pre-COVID-19 ACP baseline rate" and a "COVID-19 ACP baseline rate. September 15, 2019 - March 14, 2020, |
| COVID-19 rate | – | Other: Medical Record ReviewTwo six-month control periods prior to the wide-scale implementation of the intervention, allow us to measure a baseline rate of ACP activity and identify the "pre-COVID-19 ACP baseline rate" and a "COVID-19 ACP baseline rate. March 15, 2020 - September 14, 2020 |
| ACP rate | – | Other: VitalTalk communication skills training, Other: ACP Decisions Video Program, Other: Intervention training:, Other: Medical Record ReviewACP rate during the implementation period, which begins December 15, 2020 and continues for six months, to the rates in the previous two control periods December 15, 2020-June 15, 2021 |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- To be eligible for this study, individuals must be aged 65 or over, affiliated with the Northwell Health clinic. For each of the three periods of the study, those patients over the age of 65 who are engaged (e.g., seen in person, telehealth, etc.) with the clinic during that time period will be included in that time period.
Key inclusion criteria (3 listed)
- Clinic Eligibility: Clinics affiliated with Northwell Health may be included in the study.
- Clinician, Staff Eligibility: Any staff member identified by the site-PIs are affiliated with Northwell Health.
- Patient Eligibility: To be eligible for this study, individuals must be aged 65 or over, affiliated with the Northwell Health clinic. For each of the three periods of the study, those patients over the age of 65 who are engaged (e.g., seen in person, telehealth, etc.) with the clinic during that time period will be included in that time period
Key exclusion criteria (3 listed)
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
- Prisoners
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 |
|---|---|---|
| VitalTalk communication skills trainingClinicians will receive VitalTalk intensive communication skills training via highly structured Zoom conference. They will learn skills relevant to discussions about ACP and COVID-19 including delivering serious news, eliciting goals of care, and managing difficult conversations via telehealth platforms. | Other | ACP rate |
| ACP Decisions Video ProgramAll clinicians will also be trained remotely on the ACP Decisions Video Program using the ACP app. Training will instruct clinicians on how to: 1. Introduce the COVID-19 videos to patients and caregivers; 2. Select the appropriate video(s) from the entire suite according to patients' needs; and, 3. Prescribe videos for patients and caregivers using the electronic platform. The suite of ACP videos is designed to address common ACP decisions confronting patients at risk or with COVID-19 and the caregivers. | Other | ACP rate |
| Intervention training:Training will instruct the clinicians on how to: i. more effectively communicate with patients regarding COVID- 19, ii. have ACP conversations with patients, iii. introduce the videos to patients and families, iv. use the videos as an adjunct to ACP counseling by clinicians, v. select the appropriate video(s) from the entire suite as according to patients' needs, and, vi. use the app or electronic platform for prescribing videos to be seen at home (telehealth visits), or to be viewed in clinic with an iPad. | Other | ACP rate |
| Medical Record Review13,000 (total) patients aged 65 or older for our primary (completed advance care plans) outcome. ACP can include designating a health care proxy, discussion of advance directives, goals-of-care discussions, CPR discussions, palliative care discussions and referrals, as well as hospice. Each of these ACP outcomes will also be compared in secondary analyses using NLP. These data will be obtained from the EHR. All patient participants will only be included for medical record review. | Other | ACP rate, COVID-19 rate, Pre-COVID-19 ACP baseline |
Primary outcome
Rate for Advanced Care Planning (ACP) documentation
Time frame: 2 Years
This study tests the effects of an ACP Program that trains clinicians and provides patients with a video decision aid on rates of ACP among 13,000 patients at risk, or with, COVID-19. All patients over 65 engaged with the enrolled clinics over the course of each time period in each of the three study periods will be included in the analysis. Rates of ACP are determined by natural language processing data extraction of electronic health records. Generalized linear mixed models will be used to compare outcomes between intervention and control periods.
4 secondary outcomes
Rate of orders for resuscitation preferences
Time frame: 2 years
Rate of palliative care consultation
Time frame: 2 years
Rate of referral to hospice
Time frame: 2 years
Advanced Care Planning (ACP) documentation rates among under-represented minority groups.
Time frame: 2 Years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2022.
- Derived from this study: PubMed 37488368Murray GF, Lakin JR, Paasche-Orlow MK, Tulsky JA, Volandes A, Davis AD, Zupanc SN, Carney MT, Burns E, Martins-Welch D, LaVine N, Itty JE, Fix GM. Structural Barriers to Well-grounded Advance Care Planning for the Seriously Ill: a Qualitative Study of Clinicians' and Administrators' Experiences During a Pragmatic Trial. J Gen Intern Med. 2023 Dec;38(16):3558-3565. doi: 10.1007/s11606-023-08320-2. Epub 2023 Jul 24.
- Derived from this study: PubMed 35201306Volandes AE, Zupanc SN, Paasche-Orlow MK, Lakin JR, Chang Y, Burns EA, LaVine NA, Carney MT, Martins-Welch D, Emmert K, Itty JE, Moseley ET, Davis AD, El-Jawahri A, Gundersen DA, Fix GM, Yacoub AM, Schwartz P, Gabry-Kalikow S, Garde C, Fischer J, Henault L, Burgess L, Goldman J, Kwok A, Singh N, Alvarez Suarez AL, Gromova V, Jacome S, Tulsky JA, Lindvall C. Association of an Advance Care Planning Video and Communication Intervention With Documentation of Advance Care Planning Among Older Adults: A Nonrandomized Controlled Trial. JAMA Netw Open. 2022 Feb 1;5(2):e220354. doi: 10.1001/jamanetworkopen.2022.0354.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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.
James A. Tulsky, MD principal investigator
Dana-Farber Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Care Planning and Shared Decision Making, run by Dana-Farber Cancer Institute at 1 site 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 3 inclusion and 3 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 5 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rate for Advanced Care Planning (ACP) documentation (time frame: 2 Years). 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 NCT04660422, which also lists 2 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 5 Jul 2022.