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Pragmatic Trial of Video Education in Nursing Homes

PROVEN: Pragmatic Trial of Video Education in Nursing Homes

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02612688
Acronym
PROVEN
Enrollment
197692
Registered
2015-11-24
Start date
2016-03-01
Completion date
2019-05-31
Last updated
2020-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease, Dementia, Heart Failure, Pulmonary Disease, Chronic Obstructive

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

Brief 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. 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.

Interventions

BEHAVIORALACP Video Program

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).

Sponsors

National Institute on Aging (NIA)
CollaboratorNIH
Hebrew SeniorLife
CollaboratorOTHER
Massachusetts General Hospital
CollaboratorOTHER
Genesis HealthCare
CollaboratorOTHER
PruittHealth
CollaboratorOTHER
Brown University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Hospital Transfer Rate in Target Cohort12-month observation periodNumber 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

Secondary

MeasureTime frameDescription
Hospital Transfer Rate Among Short-stay Residents With Advanced Illness100-day observation periodNumber 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
Hospital Transfer Rate Among Short-stay Residents Without Advanced Illness100-day observation periodNumber 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
Proportion of Target Cohort With Last Observed Advance Directive Status12-month observation periodProportion 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.
Proportion of Long-stay Residents Without Advanced Illness With Last Observed Advance Directive Status12-month observation periodProportion 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.
Proportion of Short-stay Residents With Advanced Illness With Last Observed Advance Directive Status100-day observation periodProportion 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.
Proportion of Short-stay Residents Without Advanced Illness With Last Observed Advance Directive Status100-day observation periodProportion 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.
Proportion of Target Cohort Receiving Any Burdensome Treatment12-month observation periodProportion 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
Proportion of Long-stay Residents Without Advanced Illness Receiving Any Burdensome Treatment12-month observation periodProportion 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
Proportion of Short-stay Residents With Advanced Illness Receiving Any Burdensome Treatment100-day observation periodProportion 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
Hospital Transfer Rate Among Long-stay Residents Without Advanced Illness12-month observation periodNumber 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
Proportion of Target Cohort With Any Hospice Enrollment12-month observation periodProportion 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
Proportion of Long-stay Residents Without Advanced Illness With Any Hospice Enrollment12-month observation periodProportion 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
Proportion of Short-stay Residents With Advanced Illness With Any Hospice Enrollment100-day observation periodProportion 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
Proportion of Short-stay Residents Without Advanced Illness With Any Hospice Enrollment100-day observation periodProportion 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
Proportion of Target Cohort That Has Medicare ACP Billing Codes12-month observation periodProportion 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
Proportion of Long-stay Residents Without Advanced Illness That Has Medicare ACP Billing Codes12-month observation periodProportion 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
Proportion of Short-stay Residents With Advanced Illness That Has Medicare ACP Billing Codes100-day observation periodProportion 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
Proportion of Short-stay Residents Without Advanced Illness That Has Medicare ACP Billing Codes100-day observation periodProportion 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
Proportion of Short-stay Residents Without Advanced Illness Receiving Any Burdensome Treatment100-day observation periodProportion 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

Countries

United States

Participant flow

Participants by arm

ArmCount
Advance Care Planning (ACP) Video Program
Facility asked to implement Advance Care Planning (ACP) Video Program ACP Video Program: 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).
33,035
Usual Advance Care Planning (ACP) Procedures
Facility follows usual Advance Care Planning (ACP) procedures
70,013
Total103,048

Baseline characteristics

CharacteristicAdvance Care Planning (ACP) Video ProgramUsual Advance Care Planning (ACP) ProceduresTotal
Age, Continuous80.8 years
STANDARD_DEVIATION 8.9
80.9 years
STANDARD_DEVIATION 8.8
80.9 years
STANDARD_DEVIATION 8.9
Race/Ethnicity, Customized
Race/Ethnicity
Asian
240 Participants617 Participants857 Participants
Race/Ethnicity, Customized
Race/Ethnicity
Black
4904 Participants8575 Participants13479 Participants
Race/Ethnicity, Customized
Race/Ethnicity
Hispanic
287 Participants626 Participants913 Participants
Race/Ethnicity, Customized
Race/Ethnicity
North American Native
331 Participants407 Participants738 Participants
Race/Ethnicity, Customized
Race/Ethnicity
Other
215 Participants491 Participants706 Participants
Race/Ethnicity, Customized
Race/Ethnicity
Unknown
170 Participants425 Participants595 Participants
Race/Ethnicity, Customized
Race/Ethnicity
White
26888 Participants58872 Participants85760 Participants
Sex: Female, Male
Female
19818 Participants42170 Participants61988 Participants
Sex: Female, Male
Male
13217 Participants27843 Participants41060 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
8,403 / 33,03517,251 / 70,013
other
Total, other adverse events
0 / 33,0350 / 70,013
serious
Total, serious adverse events
0 / 33,0350 / 70,013

Outcome results

Primary

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

Time frame: 12-month observation period

ArmMeasureValue (MEAN)Dispersion
ACP Video ProgramHospital Transfer Rate in Target Cohort2.4 person-yearsStandard Deviation 11.8
Usual ACP ProceduresHospital Transfer Rate in Target Cohort2.8 person-yearsStandard Deviation 13.7
Secondary

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

Time frame: 12-month observation period

ArmMeasureValue (MEAN)Dispersion
ACP Video ProgramHospital Transfer Rate Among Long-stay Residents Without Advanced Illness1.65 person-yearsStandard Deviation 3.9
Usual ACP ProceduresHospital Transfer Rate Among Long-stay Residents Without Advanced Illness1.68 person-yearsStandard Deviation 4.8
Secondary

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

Time frame: 100-day observation period

ArmMeasureValue (MEAN)Dispersion
ACP Video ProgramHospital Transfer Rate Among Short-stay Residents With Advanced Illness6.9 person-yearsStandard Deviation 17.8
Usual ACP ProceduresHospital Transfer Rate Among Short-stay Residents With Advanced Illness6.8 person-yearsStandard Deviation 16.8
Secondary

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

Time frame: 100-day observation period

ArmMeasureValue (MEAN)Dispersion
ACP Video ProgramHospital Transfer Rate Among Short-stay Residents Without Advanced Illness4.5 person-yearsStandard Deviation 10.3
Usual ACP ProceduresHospital Transfer Rate Among Short-stay Residents Without Advanced Illness4.4 person-yearsStandard Deviation 10.4
Secondary

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

Time frame: 12-month observation period

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ACP Video ProgramProportion of Long-stay Residents Without Advanced Illness Receiving Any Burdensome Treatment465 Participants
Usual ACP ProceduresProportion of Long-stay Residents Without Advanced Illness Receiving Any Burdensome Treatment1028 Participants
Secondary

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

Time frame: 12-month observation period

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ACP Video ProgramProportion of Long-stay Residents Without Advanced Illness That Has Medicare ACP Billing Codes571 Participants
Usual ACP ProceduresProportion of Long-stay Residents Without Advanced Illness That Has Medicare ACP Billing Codes1157 Participants
Secondary

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

Time frame: 12-month observation period

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ACP Video ProgramProportion of Long-stay Residents Without Advanced Illness With Any Hospice Enrollment373 Participants
Usual ACP ProceduresProportion of Long-stay Residents Without Advanced Illness With Any Hospice Enrollment832 Participants
Secondary

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.

Time frame: 12-month observation period

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
ACP Video ProgramProportion of Long-stay Residents Without Advanced Illness With Last Observed Advance Directive StatusFull Code1150 Participants
ACP Video ProgramProportion of Long-stay Residents Without Advanced Illness With Last Observed Advance Directive StatusDo Not Resuscitate1714 Participants
ACP Video ProgramProportion of Long-stay Residents Without Advanced Illness With Last Observed Advance Directive StatusDo Not Hospitalize369 Participants
Usual ACP ProceduresProportion of Long-stay Residents Without Advanced Illness With Last Observed Advance Directive StatusFull Code2210 Participants
Usual ACP ProceduresProportion of Long-stay Residents Without Advanced Illness With Last Observed Advance Directive StatusDo Not Resuscitate3018 Participants
Usual ACP ProceduresProportion of Long-stay Residents Without Advanced Illness With Last Observed Advance Directive StatusDo Not Hospitalize431 Participants
Secondary

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

Time frame: 100-day observation period

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ACP Video ProgramProportion of Short-stay Residents With Advanced Illness Receiving Any Burdensome Treatment294 Participants
Usual ACP ProceduresProportion of Short-stay Residents With Advanced Illness Receiving Any Burdensome Treatment621 Participants
Secondary

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

Time frame: 100-day observation period

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ACP Video ProgramProportion of Short-stay Residents With Advanced Illness That Has Medicare ACP Billing Codes224 Participants
Usual ACP ProceduresProportion of Short-stay Residents With Advanced Illness That Has Medicare ACP Billing Codes479 Participants
Secondary

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

Time frame: 100-day observation period

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ACP Video ProgramProportion of Short-stay Residents With Advanced Illness With Any Hospice Enrollment588 Participants
Usual ACP ProceduresProportion of Short-stay Residents With Advanced Illness With Any Hospice Enrollment1220 Participants
Secondary

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.

Time frame: 100-day observation period

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
ACP Video ProgramProportion of Short-stay Residents With Advanced Illness With Last Observed Advance Directive StatusFull Code482 Participants
ACP Video ProgramProportion of Short-stay Residents With Advanced Illness With Last Observed Advance Directive StatusDo Not Resuscitate581 Participants
ACP Video ProgramProportion of Short-stay Residents With Advanced Illness With Last Observed Advance Directive StatusDo Not Hospitalize103 Participants
Usual ACP ProceduresProportion of Short-stay Residents With Advanced Illness With Last Observed Advance Directive StatusFull Code761 Participants
Usual ACP ProceduresProportion of Short-stay Residents With Advanced Illness With Last Observed Advance Directive StatusDo Not Resuscitate858 Participants
Usual ACP ProceduresProportion of Short-stay Residents With Advanced Illness With Last Observed Advance Directive StatusDo Not Hospitalize82 Participants
Secondary

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

Time frame: 100-day observation period

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ACP Video ProgramProportion of Short-stay Residents Without Advanced Illness Receiving Any Burdensome Treatment1726 Participants
Usual ACP ProceduresProportion of Short-stay Residents Without Advanced Illness Receiving Any Burdensome Treatment3405 Participants
Secondary

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

Time frame: 100-day observation period

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ACP Video ProgramProportion of Short-stay Residents Without Advanced Illness That Has Medicare ACP Billing Codes1669 Participants
Usual ACP ProceduresProportion of Short-stay Residents Without Advanced Illness That Has Medicare ACP Billing Codes4068 Participants
Secondary

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

Time frame: 100-day observation period

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ACP Video ProgramProportion of Short-stay Residents Without Advanced Illness With Any Hospice Enrollment2273 Participants
Usual ACP ProceduresProportion of Short-stay Residents Without Advanced Illness With Any Hospice Enrollment4875 Participants
Secondary

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.

Time frame: 100-day observation period

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
ACP Video ProgramProportion of Short-stay Residents Without Advanced Illness With Last Observed Advance Directive StatusFull Code8289 Participants
ACP Video ProgramProportion of Short-stay Residents Without Advanced Illness With Last Observed Advance Directive StatusDo Not Resuscitate4541 Participants
ACP Video ProgramProportion of Short-stay Residents Without Advanced Illness With Last Observed Advance Directive StatusDo Not Hospitalize462 Participants
Usual ACP ProceduresProportion of Short-stay Residents Without Advanced Illness With Last Observed Advance Directive StatusFull Code12899 Participants
Usual ACP ProceduresProportion of Short-stay Residents Without Advanced Illness With Last Observed Advance Directive StatusDo Not Resuscitate6392 Participants
Usual ACP ProceduresProportion of Short-stay Residents Without Advanced Illness With Last Observed Advance Directive StatusDo Not Hospitalize493 Participants
Secondary

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

Time frame: 12-month observation period

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ACP Video ProgramProportion of Target Cohort Receiving Any Burdensome Treatment453 Participants
Usual ACP ProceduresProportion of Target Cohort Receiving Any Burdensome Treatment971 Participants
Secondary

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

Time frame: 12-month observation period

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ACP Video ProgramProportion of Target Cohort That Has Medicare ACP Billing Codes356 Participants
Usual ACP ProceduresProportion of Target Cohort That Has Medicare ACP Billing Codes685 Participants
Secondary

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

Time frame: 12-month observation period

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ACP Video ProgramProportion of Target Cohort With Any Hospice Enrollment904 Participants
Usual ACP ProceduresProportion of Target Cohort With Any Hospice Enrollment1878 Participants
Secondary

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.

Time frame: 12-month observation period

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
ACP Video ProgramProportion of Target Cohort With Last Observed Advance Directive StatusFull Code295 Participants
ACP Video ProgramProportion of Target Cohort With Last Observed Advance Directive StatusDo Not Resuscitate1288 Participants
ACP Video ProgramProportion of Target Cohort With Last Observed Advance Directive StatusDo Not Hospitalize387 Participants
Usual ACP ProceduresProportion of Target Cohort With Last Observed Advance Directive StatusFull Code570 Participants
Usual ACP ProceduresProportion of Target Cohort With Last Observed Advance Directive StatusDo Not Resuscitate2010 Participants
Usual ACP ProceduresProportion of Target Cohort With Last Observed Advance Directive StatusDo Not Hospitalize300 Participants

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026