Health Care UtilizationNCT04778761
ACP Video Intervention for Patients With Life-Limiting Illness
A study testing Home ACP Video in people with Health Care Utilization and End Stage Disease, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The goal of this research is to increase patients' knowledge about advance care planning (ACP) discussions and hospice care for patients with serious illness receiving home-based care. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Health Care Utilization, End Stage Disease
- What is being tested?
- Home ACP Video
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2021to 1 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 21 or over
- Have a one-year prognosis or less as determined by Clover Health's validated algorithm
- Speak either English or one of the other 25 languages in which the video intervention is available
Who cannot join
- Visually impaired beyond 20/200 corrected
- Acute psychiatric illness or other comorbid condition that impairs cognitive ability to participate in advance care planning discussion as determined by the primary House Call Provider.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Trial of a Home-Advance Care Planning Video Intervention for Patients With Life-Limiting Illness
The goal of this research is to increase patients' knowledge about advance care planning (ACP) discussions and hospice care for patients with serious illness receiving home-based care.
Read the detailed description
ACP is a process that allows patients to communicate their wishes and preferences or medical care, when they are seriously ill, to their medical providers. The study investigators would like to assess whether a home-ACP video can improve patient-clinician communication about patients wishes for their medical care and lead to more patient-centered care.
This study is a randomized clinical trial of a Home-ACP intervention among 500 adult patients with serious illness receiving medical care at home with the Clover Health House Calls Program. Study participants will be assigned to one of two groups. In one group, participants will continue to receive usual care with their home-based care team. In the second group, participants will continue to receive their usual care with their home-based care team and also view an ACP video that helps them understand ACP and provides education about ACP and hospice care.
- Conditions
- Health Care Utilization, End Stage Disease
- Being tested
- Home ACP Video
- Medical subject headings
- Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home ACP VideoBehavioural
A video focused on Advance Care Planning and Hospice for patients with serious illness
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Usual care entails receiving usual medical care by the home-based care team. |
| Video intervention | Experimental | In addition to usual care, the intervention will entail having a visit by a trained study clinician to provide access to the ACP video. The study clinician will discuss the content of the video and answer any questions. Receives: Behavioral: Home ACP Video |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospice utilization
Compare the use of hospice (yes vs. no) between the study groups
Measured: up to one year follow-up or death
Secondary outcomes (8)
Hospice length of stay
Compare hospice length-of-stay between the study groups
Measured: up to one year follow-up or death
Rates of documented resuscitation preferences in the Electronic Health Record
Compare documented resuscitation preferences in the Electronic Health Record between the two groups
Measured: up to one year follow-up or death
Rates of Advance Care Planning documentation in the Electronic Health Record
Compare advance care planning documentation in the Electronic Health Record between the two groups
Measured: up to one year follow-up or death
Patient knowledge about Advance Care Planning
Compare patient's knowledge about advance care planning using a 5-item knowledge questionnaire (range 0-5), higher score indicate more knowledge
Measured: Up to two days following the intervention visit
Patient reported confidence in care
Compare patient's reported confidence in their medical care using a single Likert response question between the two study groups. Score range from 0-4. Higher scores indicate higher confidence in care
Measured: up to two days following the intervention visit
Patient reported satisfaction with clinician communication
Compare patient satisfaction with their communication with their clinician using the CAHPS subscale. Score range 0-20. Higher score indicate better satisfaction with communication
Measured: up to two days following the intervention visit
Patient reported decisional satisfaction
Compare patient reported decisional satisfaction between the study groups using the Satisfaction with Decision Scale. Scale range from 6-30. Higher scores indicate higher satisfaction with decision
Measured: up to two days following the intervention visit
Patient reported decisional certainty
Compare patient reported decisional certainty between the two groups using the Decision Conflict Scale. Score ranges from 0 to 100. Higher scores indicate higher decisional conflict
Measured: up to two days following the intervention visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start1 Apr 2021
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Care UtilizationStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, El-Jawahri, Areej,M.D., Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04778761
- Sponsor's protocol ID
- 2020P001277
- Status last verified
- Oct 2026
- First submitted
- 4 Feb 2021
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of a Home-Advance Care Planning Video Intervention for Patients With Life-Limiting Illness
- ClinicalTrials.gov ID
- NCT04778761
- Acronym / sponsor ID
- 2020P001277
- Conditions
- Health Care Utilization, End Stage Disease
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 3 Mar 2021 (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.
The goal of this research is to increase patients' knowledge about advance care planning (ACP) discussions and hospice care for patients with serious illness receiving home-based care.
Detailed description
ACP is a process that allows patients to communicate their wishes and preferences or medical care, when they are seriously ill, to their medical providers. The study investigators would like to assess whether a home-ACP video can improve patient-clinician communication about patients wishes for their medical care and lead to more patient-centered care.
This study is a randomized clinical trial of a Home-ACP intervention among 500 adult patients with serious illness receiving medical care at home with the Clover Health House Calls Program. Study participants will be assigned to one of two groups. In one group, participants will continue to receive usual care with their home-based care team. In the second group, participants will continue to receive their usual care with their home-based care team and also view an ACP video that helps them understand ACP and provides education about ACP and hospice care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Usual care entails receiving usual medical care by the home-based care team. |
| Video intervention | Experimental | Behavioral: Home ACP VideoIn addition to usual care, the intervention will entail having a visit by a trained study clinician to provide access to the ACP video. The study clinician will discuss the content of the video and answer any questions. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 21 or over
- Have a one-year prognosis or less as determined by Clover Health's validated algorithm
- Speak either English or one of the other 25 languages in which the video intervention is available
Key exclusion criteria (2 listed)
- Visually impaired beyond 20/200 corrected
- Acute psychiatric illness or other comorbid condition that impairs cognitive ability to participate in advance care planning discussion as determined by the primary House Call Provider.
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 |
|---|---|---|
| Home ACP VideoA video focused on Advance Care Planning and Hospice for patients with serious illness | Behavioural | Video intervention |
Primary outcome
Hospice utilization
Time frame: up to one year follow-up or death
Compare the use of hospice (yes vs. no) between the study groups
8 secondary outcomes
Hospice length of stay
Time frame: up to one year follow-up or death
Rates of documented resuscitation preferences in the Electronic Health Record
Time frame: up to one year follow-up or death
Rates of Advance Care Planning documentation in the Electronic Health Record
Time frame: up to one year follow-up or death
Patient knowledge about Advance Care Planning
Time frame: Up to two days following the intervention visit
Patient reported confidence in care
Time frame: up to two days following the intervention visit
Patient reported satisfaction with clinician communication
Time frame: up to two days following the intervention visit
Patient reported decisional satisfaction
Time frame: up to two days following the intervention visit
Patient reported decisional certainty
Time frame: up to two days following the intervention visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home ACP Video in people with Health Care Utilization and End Stage Disease, run by Massachusetts General Hospital 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 2 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: under way, not looking for participants, as of the sponsor's last update on 27 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Hospice utilization (time frame: up to one year follow-up or death). 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 27 Oct 2026.