Alzheimer DiseasePROVENNCT02612688
Pragmatic Trial of Video Education in Nursing Homes
A study testing ACP Video Program in people with Alzheimer Disease and Dementia, run by Brown University at 2 sites in United States.
Trial summary
This is a pragmatic cluster-randomized control trial (RCT) of an Advance Care Planning (ACP) Video Program for nursing home (NH) patients ≥ 65 years old who are cared for in 360 NH facilities (intervention arm n=119; control arm n=241) within two NH health care systems: Genesis HealthCare and PruittHealth. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Alzheimer Disease, Dementia, Heart Failure
- What is being tested?
- ACP Video Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 197,692 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Mar 2016to 31 May 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
- Facilities are within Genesis HealthCare or PruittHealth health care systems
- Facilities have facility identifiers that indicate that they are Medicare/Medicaid-certified nursing facilities in the U.S.
- Facilities serve both short and long-stay patients
- Facilities have >50 beds
- Facilities have an electronic medical records system
- Facilities had at least 20 admissions and 20 annual Minimum Data Set (MDS) assessments (regardless of whether they were discharged alive) in 2013
Who cannot join
- Facilities excluded per corporate leaders in health care system because of recent turnover in NH administrator or Director of Nursing
- Facilities excluded per corporate leaders in health care system because of recent bad state or federal quality assurance survey (e.g. restriction on admissions, levied large civil monetary penalty, etc.)
- Facilities excluded per corporate leaders in health care system because of current new initiatives/competing demands
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Genesis HealthCare
Kennett Square, Pennsylvania, 19348
PruittHealth
Norcross, Georgia, 30093
About this study
Official title: PROVEN: Pragmatic Trial of Video Education in Nursing Homes
This is a pragmatic cluster-randomized control trial (RCT) of an Advance Care Planning (ACP) Video Program for nursing home (NH) patients ≥ 65 years old who are cared for in 360 NH facilities (intervention arm n=119; control arm n=241) within two NH health care systems: Genesis HealthCare and PruittHealth. The intervention NH facilities will implement the ACP Video Program, while the control NH facilities will follow their usual ACP procedures. The trial will evaluate the effectiveness of the ACP Video Program by comparing hospitalizations, advance directives, and hospice use in the intervention vs. control NHs.
Read the detailed description
Nursing homes are complex health care systems that serve increasingly sick patients who have advanced comorbid conditions. NHs are often charged with guiding patients through decisions about the direction of their treatment. Patients at NHs commonly get aggressive care that may be inconsistent with their preferences and of little clinical benefit. Identifying effective approaches that NHs can use to better promote goal-directed care and optimize resources is a research, public health, and clinical priority.
Advance care planning is the most consistent modifiable factor associated with better palliative care outcomes. Traditional ACP relies on verbal descriptions of hypothetical health states and treatments. This approach is limited because complex scenarios are difficult to envision, counseling is inconsistent, and verbal explanations are hindered by literacy and language barriers.
To address these shortcomings, the PROVEN project has developed video-assisted ACP decision-support tools that have shown efficacy in small randomized controlled trials. While several large health care systems have begun to adopt the videos, efforts have not rigorously evaluated outcomes-a critical step prior to widespread implementation.
The goal of PROVEN is to conduct a pragmatic cluster-randomized trial to evaluate the effectiveness of the ACP Video Program in the NH setting by partnering with 2 large health care systems that operate 456 nursing homes nationwide. This work has the potential to improve the care provided to millions of older Americans in nursing homes and enable future pragmatic trials in this setting.
- Being tested
- ACP Video Program
- Keywords
- Advance Care Planning, Advance Directives, Alzheimer Disease, Dementia, Do-Not-Resuscitate Orders, Enteral Nutrition, Heart Failure, Hospices, Hospitalization, Instructional Films and Videos, Intubation, Nursing Homes, Parenteral Nutrition, Pragmatic Clinical Trials, Pulmonary Disease, Chronic Obstructive, Randomized Controlled Trials, Resuscitation Orders, Skilled Nursing Facilities
- Medical subject headings
- Alzheimer Disease, Dementia, Heart Failure, Pulmonary Disease, Chronic Obstructive, Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACP Video ProgramBehavioural
The ACP Video Program consists of five videos that address ACP decisions: (1) General Goals of Care, (2) Goals of Care for Advanced Dementia, (3) Hospice, (4) Hospitalization, and (5) ACP for Healthy Patients. NH staff will offer videos to patients at these clinical triggers: (1) Within 7 days of admission or readmission; (2) Every 6 months for long-stay patients; (3) When there is a significant change in clinical status; (4) When a treatment decision arises for which there is a specific video; and (5) Special circumstances when goals of care are being considered (e.g., family visiting).
| Study group | Role | What they receive |
|---|---|---|
| ACP Video Program | Experimental | Facility asked to implement ACP Video Program Receives: Behavioral: ACP Video Program |
| Usual ACP procedures | No intervention | Facility follows usual ACP procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Transfer Rate in Target Cohort
Number of hospital transfers (number of transfers/person-days alive) over a 12-month observation period among Medicare fee-for-service long-stay residents (in a NH >=90 days) who are >=65 years old and who have EITHER advanced dementia or advanced congestive heart failure/chronic obstructive lung disease
Measured: 12-month observation period
Secondary outcomes (19)
Hospital Transfer Rate Among Long-stay Residents Without Advanced Illness
Number of hospital transfers (number of transfers/person-days alive) over a 12-month observation period among Medicare fee-for-service long-stay residents (in a NH >=90 days) who are >=65 years old and who have NEITHER advanced dementia NOR advanced congestive heart failure/chronic obstructive lung disease
Measured: 12-month observation period
Hospital Transfer Rate Among Short-stay Residents With Advanced Illness
Number of hospital transfers (number of transfers/person-days alive) over a 100-day observation period among Medicare fee-for-service short-stay residents (in a NH <90 days) who are >=65 years old and who have EITHER advanced dementia OR advanced congestive heart failure/chronic obstructive lung disease
Measured: 100-day observation period
Hospital Transfer Rate Among Short-stay Residents Without Advanced Illness
Number of hospital transfers (number of transfers/person-days alive) over a 100-day observation period among Medicare fee-for-service short-stay residents (in a NH <90 days) who are >=65 years old and who have NEITHER advanced dementia NOR advanced congestive heart failure/chronic obstructive lung disease
Measured: 100-day observation period
Proportion of Target Cohort With Last Observed Advance Directive Status
Proportion of long-stay residents (in a NH >=90 days) who are >=65 years old and who have EITHER advanced dementia OR advanced congestive heart failure/chronic obstructive lung disease whose last observed advance directive status during their 12-month observation period was: Full Code, Do Not Resuscitate (NOT Do Not Hospitalize), or Do Not Hospitalize. A resident whose last observed status was both Do Not Resuscitate and Do Not Hospitalize is categorized as Do Not Hospitalize only. Analyses will be limited to Genesis HealthCare facilities in which >75% of residents have any advance directive because the remaining Genesis HealthCare and PruittHealth facilities do not have reliable sources for these data.
Measured: 12-month observation period
Proportion of Long-stay Residents Without Advanced Illness With Last Observed Advance Directive Status
Proportion of long-stay residents (in a NH >=90 days) who are >=65 years old and who do have NEITHER advanced dementia NOR advanced congestive heart failure/chronic obstructive lung disease whose last observed advance directive status during their 12-month observation period was: Full Code, Do Not Resuscitate (NOT Do Not Hospitalize), or Do Not Hospitalize. A resident whose last observed status was both Do Not Resuscitate and Do Not Hospitalize is categorized as Do Not Hospitalize only. Analyses will be limited to Genesis HealthCare facilities in which >75% of residents have any advance directive because the remaining Genesis HealthCare and PruittHealth facilities do not have reliable sources for these data.
Measured: 12-month observation period
Proportion of Short-stay Residents With Advanced Illness With Last Observed Advance Directive Status
Proportion of short-stay residents (in a NH <90 days) who are >=65 years old and who have EITHER advanced dementia OR advanced congestive heart failure/chronic obstructive lung disease whose last observed advance directive status during their 100-day observation period was: Full Code, Do Not Resuscitate (NOT Do Not Hospitalize), or Do Not Hospitalize. A resident whose last observed status was both Do Not Resuscitate and Do Not Hospitalize is categorized as Do Not Hospitalize only. Analyses will be limited to Genesis HealthCare facilities in which >75% of residents have any advance directive because the remaining Genesis HealthCare and PruittHealth facilities do not have reliable sources for these data.
Measured: 100-day observation period
Proportion of Short-stay Residents Without Advanced Illness With Last Observed Advance Directive Status
Proportion of short-stay residents (in a NH <90 days) who are >=65 years old and who have NEITHER advanced dementia NOR advanced congestive heart failure/chronic obstructive lung disease whose last observed advance directive status during their 100-day observation period was: Full Code, Do Not Resuscitate (NOT Do Not Hospitalize), or Do Not Hospitalize. A resident whose last observed status was both Do Not Resuscitate and Do Not Hospitalize is categorized as Do Not Hospitalize only. Analyses will be limited to Genesis HealthCare facilities in which >75% of residents have any advance directive because the remaining Genesis HealthCare and PruittHealth facilities do not have reliable sources for these data.
Measured: 100-day observation period
Proportion of Target Cohort Receiving Any Burdensome Treatment
Proportion of long-stay residents (in a NH >=90 days) who are >=65 years old and who have EITHER advanced dementia OR advanced congestive heart failure/chronic obstructive lung disease who receive any burdensome treatment (new feeding tube insertions, parenteral therapy, intubation, ICU care) during a 12-month observation period
Measured: 12-month observation period
Proportion of Long-stay Residents Without Advanced Illness Receiving Any Burdensome Treatment
Proportion of long-stay residents (in a NH >=90 days) who are >=65 years old and who have NEITHER advanced dementia NOR advanced congestive heart failure/chronic obstructive lung disease who receive any burdensome treatment (new feeding tube insertions, parenteral therapy, intubation, ICU care) during a 12-month observation period
Measured: 12-month observation period
Proportion of Short-stay Residents With Advanced Illness Receiving Any Burdensome Treatment
Proportion of short-stay residents (in a NH <90 days) who are >=65 years old and who have EITHER advanced dementia OR advanced congestive heart failure/chronic obstructive lung disease who receive any burdensome treatment (new feeding tube insertions, parenteral therapy, intubation, ICU care) during a 100-day observation period among
Measured: 100-day observation period
Proportion of Short-stay Residents Without Advanced Illness Receiving Any Burdensome Treatment
Proportion of short-stay residents (in a NH <90 days) who are >=65 years old and who have NEITHER advanced dementia NOR advanced congestive heart failure/chronic obstructive lung disease who receive any burdensome treatment (new feeding tube insertions, parenteral therapy, intubation, ICU care) during a 100-day observation period
Measured: 100-day observation period
Proportion of Target Cohort With Any Hospice Enrollment
Proportion of long-stay residents (in a NH >=90 days) who are >=65 years old and who have EITHER advanced dementia OR advanced congestive heart failure/chronic obstructive lung disease with any hospice enrollment during a 12-month observation period
Measured: 12-month observation period
Proportion of Long-stay Residents Without Advanced Illness With Any Hospice Enrollment
Proportion of long-stay residents (in a NH >=90 days) who are >=65 years old and who have NEITHER advanced dementia NOR advanced congestive heart failure/chronic obstructive lung disease with any hospice enrollment during a 12-month observation period
Measured: 12-month observation period
Proportion of Short-stay Residents With Advanced Illness With Any Hospice Enrollment
Proportion of short-stay residents (in a NH <90 days) who are >=65 years old and who have EITHER advanced dementia OR advanced congestive heart failure/chronic obstructive lung disease with any hospice enrollment during a 100-day observation period
Measured: 100-day observation period
Proportion of Short-stay Residents Without Advanced Illness With Any Hospice Enrollment
Proportion of short-stay residents (in a NH <90 days) who are >=65 years old and who have NEITHER advanced dementia NOR advanced congestive heart failure/chronic obstructive lung disease with any hospice enrollment during a 100-day observation period
Measured: 100-day observation period
Proportion of Target Cohort That Has Medicare ACP Billing Codes
Proportion of long-stay residents (in a NH >=90 days) who are >=65 years old and who have EITHER advanced dementia OR advanced congestive heart failure/chronic obstructive lung disease who have any Medicare ACP billing code during their 12-month observation period
Measured: 12-month observation period
Proportion of Long-stay Residents Without Advanced Illness That Has Medicare ACP Billing Codes
Proportion of long-stay residents (in a NH >=90 days) who are >=65 years old and who have NEITHER advanced dementia NOR advanced congestive heart failure/chronic obstructive lung disease who have any Medicare ACP billing code during their 12-month observation period
Measured: 12-month observation period
Proportion of Short-stay Residents With Advanced Illness That Has Medicare ACP Billing Codes
Proportion of short-stay residents (in a NH <90 days) who are >=65 years old and who have EITHER advanced dementia OR advanced congestive heart failure/chronic obstructive lung disease who have any Medicare ACP billing code during their 100-day observation period
Measured: 100-day observation period
Proportion of Short-stay Residents Without Advanced Illness That Has Medicare ACP Billing Codes
Proportion of short-stay residents (in a NH <90 days) who are >=65 years old and who have NEITHER advanced dementia NOR advanced congestive heart failure/chronic obstructive lung disease who have any Medicare ACP billing code during their 100-day observation period
Measured: 100-day observation period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2015 (estimated)
- Study start1 Mar 2016
- Primary completion31 May 2019
- Study completion31 May 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 (6)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 197,692 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), Hebrew SeniorLife, Massachusetts General Hospital, Genesis HealthCare, PruittHealth
- Responsible party
- Principal investigator, Vincent Mor, Brown University
- Investigators
- Vincent Mor, PhD, Principal investigator, Brown UniversitySusan Mitchell, MD, MPH, Principal investigator, Hebrew SeniorLifeAngelo Volandes, MD, MPH, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02612688
- Sponsor's protocol ID
- 4UH3AG049619-02
- Other IDs
- 4UH3AG049619-02
- Acronym
- PROVEN
- Status last verified
- Sep 2020
- First submitted
- 19 Nov 2015
- Last updated
- 12 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
McCreedy EM, Yang X, Mitchell SL, Gutman R, Teno J, Loomer L, Moyo P, Volandes A, Gozalo PL, Belanger E, Ogarek J, Mor V. Effect of advance care planning video on do-not-hospitalize orders for nursing home residents with advanced illness. BMC Geriatr. 2022 Apr 8;22(1):298. doi: 10.1186/s12877-022-02970-3.
PubMed 35392827Mitchell SL, Volandes AE, Gutman R, Gozalo PL, Ogarek JA, Loomer L, McCreedy EM, Zhai R, Mor V. Advance Care Planning Video Intervention Among Long-Stay Nursing Home Residents: A Pragmatic Cluster Randomized Clinical Trial. JAMA Intern Med. 2020 Aug 1;180(8):1070-1078. doi: 10.1001/jamainternmed.2020.2366.
PubMed 32628258Palmer JA, Parker VA, Barre LR, Mor V, Volandes AE, Belanger E, Loomer L, McCreedy E, Mitchell SL. Understanding implementation fidelity in a pragmatic randomized clinical trial in the nursing home setting:a mixed-methods examination. Trials. 2019 Nov 28;20(1):656. doi: 10.1186/s13063-019-3725-5.
PubMed 31779684Palmer JA, Parker VA, Mor V, Volandes AE, Barre LR, Belanger E, Carter P, Loomer L, McCreedy E, Mitchell SL. Barriers and facilitators to implementing a pragmatic trial to improve advance care planning in the nursing home setting. BMC Health Serv Res. 2019 Jul 29;19(1):527. doi: 10.1186/s12913-019-4309-5.
PubMed 31357993Loomer L, McCreedy E, Belanger E, Palmer JA, Mitchell SL, Volandes AE, Mor V. Nursing Home Characteristics Associated With Implementation of an Advance Care Planning Video Intervention. J Am Med Dir Assoc. 2019 Jul;20(7):804-809.e1. doi: 10.1016/j.jamda.2019.01.133. Epub 2019 Mar 7.
PubMed 30852167Palmer JA, Mor V, Volandes AE, McCreedy E, Loomer L, Carter P, Dvorchak F, Mitchell SL. A dynamic application of PRECIS-2 to evaluate implementation in a pragmatic, cluster randomized clinical trial in two nursing home systems. Trials. 2018 Aug 22;19(1):453. doi: 10.1186/s13063-018-2817-y.
PubMed 30134976
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROVEN: Pragmatic Trial of Video Education in Nursing Homes
- ClinicalTrials.gov ID
- NCT02612688
- Acronym / sponsor ID
- PROVEN / 4UH3AG049619-02
- Keywords
- Advance Care Planning, Advance Directives, Alzheimer Disease, Dementia, Do-Not-Resuscitate Orders, Enteral Nutrition, Heart Failure, Hospices
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 197,692 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), Hebrew SeniorLife, Massachusetts General Hospital, Genesis HealthCare, PruittHealth
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 24 Nov 2015 (estimated)
- Results
- Posted 18 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pragmatic cluster-randomized control trial (RCT) of an Advance Care Planning (ACP) Video Program for nursing home (NH) patients ≥ 65 years old who are cared for in 360 NH facilities (intervention arm n=119; control arm n=241) within two NH health care systems: Genesis HealthCare and PruittHealth. The intervention NH facilities will implement the ACP Video Program, while the control NH facilities will follow their usual ACP procedures. The trial will evaluate the effectiveness of the ACP Video Program by comparing hospitalizations, advance directives, and hospice use in the intervention vs. control NHs.
Detailed description
Nursing homes are complex health care systems that serve increasingly sick patients who have advanced comorbid conditions. NHs are often charged with guiding patients through decisions about the direction of their treatment. Patients at NHs commonly get aggressive care that may be inconsistent with their preferences and of little clinical benefit. Identifying effective approaches that NHs can use to better promote goal-directed care and optimize resources is a research, public health, and clinical priority.
Advance care planning is the most consistent modifiable factor associated with better palliative care outcomes. Traditional ACP relies on verbal descriptions of hypothetical health states and treatments. This approach is limited because complex scenarios are difficult to envision, counseling is inconsistent, and verbal explanations are hindered by literacy and language barriers.
To address these shortcomings, the PROVEN project has developed video-assisted ACP decision-support tools that have shown efficacy in small randomized controlled trials. While several large health care systems have begun to adopt the videos, efforts have not rigorously evaluated outcomes-a critical step prior to widespread implementation.
The goal of PROVEN is to conduct a pragmatic cluster-randomized trial to evaluate the effectiveness of the ACP Video Program in the NH setting by partnering with 2 large health care systems that operate 456 nursing homes nationwide. This work has the potential to improve the care provided to millions of older Americans in nursing homes and enable future pragmatic trials in this setting.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACP Video Program | Experimental | Behavioral: ACP Video ProgramFacility asked to implement ACP Video Program |
| Usual ACP procedures | No intervention | –Facility follows usual ACP procedures |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Facilities are within Genesis HealthCare or PruittHealth health care systems
- Facilities have facility identifiers that indicate that they are Medicare/Medicaid-certified nursing facilities in the U.S.
- Facilities serve both short and long-stay patients
- Facilities have >50 beds
- Facilities have an electronic medical records system
Key exclusion criteria (3 listed)
- Facilities excluded per corporate leaders in health care system because of recent turnover in NH administrator or Director of Nursing
- Facilities excluded per corporate leaders in health care system because of recent bad state or federal quality assurance survey (e.g. restriction on admissions, levied large civil monetary penalty, etc.)
- Facilities excluded per corporate leaders in health care system because of current new initiatives/competing demands
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 |
|---|---|---|
| ACP Video ProgramThe ACP Video Program consists of five videos that address ACP decisions: (1) General Goals of Care, (2) Goals of Care for Advanced Dementia, (3) Hospice, (4) Hospitalization, and (5) ACP for Healthy Patients. NH staff will offer videos to patients at these clinical triggers: (1) Within 7 days of admission or readmission; (2) Every 6 months for long-stay patients; (3) When there is a significant change in clinical status; (4) When a treatment decision arises for which there is a specific video; and (5) Special circumstances when goals of care are being considered (e.g., family visiting). | Behavioural | ACP Video Program |
Primary outcome
Hospital Transfer Rate in Target Cohort
Time frame: 12-month observation period
Number of hospital transfers (number of transfers/person-days alive) over a 12-month observation period among Medicare fee-for-service long-stay residents (in a NH >=90 days) who are >=65 years old and who have EITHER advanced dementia or advanced congestive heart failure/chronic obstructive lung disease
19 secondary outcomes
Hospital Transfer Rate Among Long-stay Residents Without Advanced Illness
Time frame: 12-month observation period
Hospital Transfer Rate Among Short-stay Residents With Advanced Illness
Time frame: 100-day observation period
Hospital Transfer Rate Among Short-stay Residents Without Advanced Illness
Time frame: 100-day observation period
Proportion of Target Cohort With Last Observed Advance Directive Status
Time frame: 12-month observation period
Proportion of Long-stay Residents Without Advanced Illness With Last Observed Advance Directive Status
Time frame: 12-month observation period
Proportion of Short-stay Residents With Advanced Illness With Last Observed Advance Directive Status
Time frame: 100-day observation period
Proportion of Short-stay Residents Without Advanced Illness With Last Observed Advance Directive Status
Time frame: 100-day observation period
Proportion of Target Cohort Receiving Any Burdensome Treatment
Time frame: 12-month observation period
Proportion of Long-stay Residents Without Advanced Illness Receiving Any Burdensome Treatment
Time frame: 12-month observation period
Proportion of Short-stay Residents With Advanced Illness Receiving Any Burdensome Treatment
Time frame: 100-day observation period
Proportion of Short-stay Residents Without Advanced Illness Receiving Any Burdensome Treatment
Time frame: 100-day observation period
Proportion of Target Cohort With Any Hospice Enrollment
Time frame: 12-month observation period
Proportion of Long-stay Residents Without Advanced Illness With Any Hospice Enrollment
Time frame: 12-month observation period
Proportion of Short-stay Residents With Advanced Illness With Any Hospice Enrollment
Time frame: 100-day observation period
Proportion of Short-stay Residents Without Advanced Illness With Any Hospice Enrollment
Time frame: 100-day observation period
Proportion of Target Cohort That Has Medicare ACP Billing Codes
Time frame: 12-month observation period
Proportion of Long-stay Residents Without Advanced Illness That Has Medicare ACP Billing Codes
Time frame: 12-month observation period
Proportion of Short-stay Residents With Advanced Illness That Has Medicare ACP Billing Codes
Time frame: 100-day observation period
Proportion of Short-stay Residents Without Advanced Illness That Has Medicare ACP Billing Codes
Time frame: 100-day observation period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35392827McCreedy EM, Yang X, Mitchell SL, Gutman R, Teno J, Loomer L, Moyo P, Volandes A, Gozalo PL, Belanger E, Ogarek J, Mor V. Effect of advance care planning video on do-not-hospitalize orders for nursing home residents with advanced illness. BMC Geriatr. 2022 Apr 8;22(1):298. doi: 10.1186/s12877-022-02970-3.
- Derived from this study: PubMed 32628258Mitchell SL, Volandes AE, Gutman R, Gozalo PL, Ogarek JA, Loomer L, McCreedy EM, Zhai R, Mor V. Advance Care Planning Video Intervention Among Long-Stay Nursing Home Residents: A Pragmatic Cluster Randomized Clinical Trial. JAMA Intern Med. 2020 Aug 1;180(8):1070-1078. doi: 10.1001/jamainternmed.2020.2366.
- Derived from this study: PubMed 31779684Palmer JA, Parker VA, Barre LR, Mor V, Volandes AE, Belanger E, Loomer L, McCreedy E, Mitchell SL. Understanding implementation fidelity in a pragmatic randomized clinical trial in the nursing home setting:a mixed-methods examination. Trials. 2019 Nov 28;20(1):656. doi: 10.1186/s13063-019-3725-5.
- Derived from this study: PubMed 31357993Palmer JA, Parker VA, Mor V, Volandes AE, Barre LR, Belanger E, Carter P, Loomer L, McCreedy E, Mitchell SL. Barriers and facilitators to implementing a pragmatic trial to improve advance care planning in the nursing home setting. BMC Health Serv Res. 2019 Jul 29;19(1):527. doi: 10.1186/s12913-019-4309-5.
- Derived from this study: PubMed 30852167Loomer L, McCreedy E, Belanger E, Palmer JA, Mitchell SL, Volandes AE, Mor V. Nursing Home Characteristics Associated With Implementation of an Advance Care Planning Video Intervention. J Am Med Dir Assoc. 2019 Jul;20(7):804-809.e1. doi: 10.1016/j.jamda.2019.01.133. Epub 2019 Mar 7.
- Derived from this study: PubMed 30134976Palmer JA, Mor V, Volandes AE, McCreedy E, Loomer L, Carter P, Dvorchak F, Mitchell SL. A dynamic application of PRECIS-2 to evaluate implementation in a pragmatic, cluster randomized clinical trial in two nursing home systems. Trials. 2018 Aug 22;19(1):453. doi: 10.1186/s13063-018-2817-y.
- NIH Collaboratory website for UH3 Project: Pragmatic Trial of Video Education in Nursing Homes (PROVEN)Link provided by the sponsor.
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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.
Vincent Mor, PhD principal investigator
Brown University
Susan Mitchell, MD, MPH principal investigator
Hebrew SeniorLife
Angelo Volandes, MD, MPH principal investigator
Massachusetts General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACP Video Program in people with Alzheimer Disease and Dementia, run by Brown University at 2 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 6 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 12 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. 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 18 Jun 2020). 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?
Hospital Transfer Rate in Target Cohort (time frame: 12-month observation period). 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 NCT02612688, which also lists 6 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 12 Oct 2020.