Emergency MedicineNCT03402763
Intervention to Promote Advance Care Planning for Older Adults in the Emergency Department
A study testing Educational Video and Primary Care Provider Email in people with Emergency Medicine and Advance Care Planning, run by University of North Carolina, Chapel Hill.
Trial summary
There is an urgent need to increase advance care planning among older adults in order to ensure that patients receive care of the end of life that is consistent with their values and preferences. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Emergency Medicine, Advance Care Planning
- What is being tested?
- Educational Video and Primary Care Provider Email
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2016to 1 Feb 2017
- Phase
- Interventional
- 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
Who may be able to join
- Ability to provide informed consent
- Ability to communicate in English
- Age 65-79 years with a serious medical illness: (1) Established diagnosis of metastatic cancer, advanced heart failure, chronic obstructive lung disease, end stage liver disease, end stage renal disease, (2) Unable to walk or requires human assistance with walking, (3) Two hospitalizations within the last 6 months
- Age 80 years or older
Who cannot join
- Critically ill (emergency severity index = 1)
- Cognitively impaired based on Six Item Screener < 4 or lack the capacity to consent
- Currently enrolled in hospice or comfort care program
- No working phone number
- Non English speaker
About this study
There is an urgent need to increase advance care planning among older adults in order to ensure that patients receive care of the end of life that is consistent with their values and preferences. Emergency departments (EDs) provide an opportunity to reach a large proportion of older adults who have not yet completed advance care planning at a time when they are likely to recognize the need for such planning. The purpose of this pilot is to examine the potential of a video-supported intervention initiated during the emergency department visit to promote advance care planning.
Read the detailed description
The overarching goal of this project is to understand the impact of an ED-initiated intervention on the promotion of advance care planning (ACP) among older adults. Participants are given either a short informational handout on the process and choices involved in ACP or watch a 6-minute video about ACP. The video describes cardiopulmonary resuscitation (CPR), breathing tube placement, and mechanical breathing support in addition to the general process of ACP. Following the video, patients in the intervention will also have an email sent to their primary care provider. The email will inform the primary care provider that the patient has watched a video about ACP, include a brief synopsis of the video, and provide instructions as to how to document the patient's preferences in the hospital's electronic health record in a way that will be accessible to other providers. Outcomes will include documentation of end-of-life care preferences in the electronic health records and patient-reported conversation with their provider as well as conversations with loved ones.
- Conditions
- Emergency Medicine, Advance Care Planning
- Being tested
- Educational Video, Primary Care Provider Email
- Keywords
- Advance care planning, Older adults, Emergency department
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational VideoBehavioural
The intervention is an educational video presented to patients in the ED with the intent to promote ACP among older adults.
Primary Care Provider EmailBehavioural
For intervention patients, an email will be sent to primary care providers explaining that the patient has seen a video about advance care planning, providing a synopsis of the video, and giving instructions about how to document end-of-life care preferences in the electronic health record.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | No intervention | Participants receive a short informational handout on the process and choices involved in advance care planning. |
| Intervention | Experimental | Participants are shown a 6-minute video that describe CPR, breathing tube placement, and mechanical breathing support in addition to the general process of advance care planning. Receives: Behavioral: Educational Video; Behavioral: Primary Care Provider Email |
What is being measured
The primary outcome is the main question the study is designed to answer.
Documentation of end-of-life preferences in the electronic health record
Since the ED visit, does the patient have any new preferences about CPR, intubation, or palliative care documented in their electronic health record?
Measured: 3 months
Secondary outcomes (2)
Conversation with Regular Provider
Patient-reported conversation with their regular provider (primary care physician, admitting physician, other outpatient provider) about what they would want done if they became very sick, had serious breathing trouble, heart stopped, or they could not make medical decisions from him or herself.
Measured: 3 months
Conversation with Loved One
Patient-reported conversation with a trusted loved one (spouse, children, or sibling) about what they would want done if they became very sick, had serious breathing trouble, heart stopped, or they could not make medical decisions from him or herself.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2018
- Study start1 Feb 2016
- Primary completion1 Feb 2017
- Study completion1 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergency MedicineStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- Participants will (1) be given either a short informational handout on the process and choices involved in advanced care planning or (2) be shown a less 6 minute video describing CPR, breathing tube placement and mechanical breathing support in addition to the general process of advanced care planning.
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Timothy F Platts-Mills, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03402763
- Sponsor's protocol ID
- 15-3371
- Status last verified
- Jan 2018
- First submitted
- 10 Jan 2018
- Last updated
- 18 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to upload the data from the study on Open Science Framework.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention to Promote Advance Care Planning for Older Adults in the Emergency Department
- ClinicalTrials.gov ID
- NCT03402763
- Acronym / sponsor ID
- 15-3371
- Conditions
- Emergency Medicine, Advance Care Planning
- Keywords
- Advance care planning, Older adults, Emergency department
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 1 Feb 2017 (actual)
- Study completion
- 1 Feb 2017 (actual)
- First posted
- 18 Jan 2018 (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.
There is an urgent need to increase advance care planning among older adults in order to ensure that patients receive care of the end of life that is consistent with their values and preferences. Emergency departments (EDs) provide an opportunity to reach a large proportion of older adults who have not yet completed advance care planning at a time when they are likely to recognize the need for such planning. The purpose of this pilot is to examine the potential of a video-supported intervention initiated during the emergency department visit to promote advance care planning.
Detailed description
The overarching goal of this project is to understand the impact of an ED-initiated intervention on the promotion of advance care planning (ACP) among older adults. Participants are given either a short informational handout on the process and choices involved in ACP or watch a 6-minute video about ACP. The video describes cardiopulmonary resuscitation (CPR), breathing tube placement, and mechanical breathing support in addition to the general process of ACP. Following the video, patients in the intervention will also have an email sent to their primary care provider. The email will inform the primary care provider that the patient has watched a video about ACP, include a brief synopsis of the video, and provide instructions as to how to document the patient's preferences in the hospital's electronic health record in a way that will be accessible to other providers. Outcomes will include documentation of end-of-life care preferences in the electronic health records and patient-reported conversation with their provider as well as conversations with loved ones.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will (1) be given either a short informational handout on the process and choices involved in advanced care planning or (2) be shown a less 6 minute video describing CPR, breathing tube placement and mechanical breathing support in addition to the general process of advanced care planning.
| Arm | Type | Receives |
|---|---|---|
| Control Arm | No intervention | –Participants receive a short informational handout on the process and choices involved in advance care planning. |
| Intervention | Experimental | Behavioral: Educational Video, Behavioral: Primary Care Provider EmailParticipants are shown a 6-minute video that describe CPR, breathing tube placement, and mechanical breathing support in addition to the general process of advance care planning. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Ability to provide informed consent
- Ability to communicate in English
- Age 65-79 years with a serious medical illness: (1) Established diagnosis of metastatic cancer, advanced heart failure, chronic obstructive lung disease, end stage liver disease, end stage renal disease, (2) Unable to walk or requires human assistance with walking, (3) Two hospitalizations within the last 6 months
- Age 80 years or older
Key exclusion criteria (5 listed)
- Critically ill (emergency severity index = 1)
- Cognitively impaired based on Six Item Screener < 4 or lack the capacity to consent
- Currently enrolled in hospice or comfort care program
- No working phone number
- Non English speaker
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 |
|---|---|---|
| Educational VideoThe intervention is an educational video presented to patients in the ED with the intent to promote ACP among older adults. | Behavioural | Intervention |
| Primary Care Provider EmailFor intervention patients, an email will be sent to primary care providers explaining that the patient has seen a video about advance care planning, providing a synopsis of the video, and giving instructions about how to document end-of-life care preferences in the electronic health record. | Behavioural | Intervention |
Primary outcome
Documentation of end-of-life preferences in the electronic health record
Time frame: 3 months
Since the ED visit, does the patient have any new preferences about CPR, intubation, or palliative care documented in their electronic health record?
2 secondary outcomes
Conversation with Regular Provider
Time frame: 3 months
Conversation with Loved One
Time frame: 3 months
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 18 Jan 2018.
- Individual participant dataSharing planned: Yes. We plan to upload the data from the study on Open Science Framework.
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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.
Timothy F Platts-Mills, MD principal investigator
University of North Carolina, Chapel Hill
Questions about this trial
What is this clinical trial studying?
A study testing Educational Video and Primary Care Provider Email in people with Emergency Medicine and Advance Care Planning, run by University of North Carolina, Chapel Hill.
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 4 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 18 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Documentation of end-of-life preferences in the electronic health record (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jan 2018.