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Pragmatic Trial of Video Education in Nursing Homes (PROVEN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02612688
Recruitment Status : Completed
First Posted : November 24, 2015
Results First Posted : June 18, 2020
Last Update Posted : June 18, 2020
Sponsor:
Collaborators:
National Institute on Aging (NIA)
Hebrew SeniorLife
Massachusetts General Hospital
Genesis HealthCare
PruittHealth
Information provided by (Responsible Party):
Vincent Mor, Brown University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Investigator, Outcomes Assessor);   Primary Purpose: Health Services Research
Conditions Alzheimer Disease
Dementia
Heart Failure
Pulmonary Disease, Chronic Obstructive
Intervention Behavioral: ACP Video Program
Enrollment 197692
Recruitment Details  
Pre-assignment Details  
Arm/Group Title ACP Video Program Usual ACP Procedures
Hide Arm/Group Description

Facility asked to implement 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).

Facility follows usual ACP procedures
Period Title: Overall Study
Started 33035 70013
Completed 33035 70013
Not Completed 0 0
Arm/Group Title Advance Care Planning (ACP) Video Program Usual Advance Care Planning (ACP) Procedures Total
Hide Arm/Group Description

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).

Facility follows usual Advance Care Planning (ACP) procedures Total of all reporting groups
Overall Number of Baseline Participants 33035 70013 103048
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 33035 participants 70013 participants 103048 participants
80.8  (8.9) 80.9  (8.8) 80.9  (8.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33035 participants 70013 participants 103048 participants
Female
19818
  60.0%
42170
  60.2%
61988
  60.2%
Male
13217
  40.0%
27843
  39.8%
41060
  39.8%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race/Ethnicity Number Analyzed 33035 participants 70013 participants 103048 participants
White
26888
  81.4%
58872
  84.1%
85760
  83.2%
Black
4904
  14.8%
8575
  12.2%
13479
  13.1%
Asian
240
   0.7%
617
   0.9%
857
   0.8%
Hispanic
287
   0.9%
626
   0.9%
913
   0.9%
North American Native
331
   1.0%
407
   0.6%
738
   0.7%
Other
215
   0.7%
491
   0.7%
706
   0.7%
Unknown
170
   0.5%
425
   0.6%
595
   0.6%
1.Primary Outcome
Title Hospital Transfer Rate in Target Cohort
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ACP Video Program Usual ACP Procedures
Hide Arm/Group Description:

Facility asked to implement 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).

Facility follows usual ACP procedures
Overall Number of Participants Analyzed 4171 8308
Mean (Standard Deviation)
Unit of Measure: person-years
2.4  (11.8) 2.8  (13.7)
2.Secondary Outcome
Title Hospital Transfer Rate Among Long-stay Residents Without Advanced Illness
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ACP Video Program Usual ACP Procedures
Hide Arm/Group Description:

Facility asked to implement 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).

Facility follows usual ACP procedures
Overall Number of Participants Analyzed 5766 11782
Mean (Standard Deviation)
Unit of Measure: person-years
1.65  (3.9) 1.68  (4.8)
3.Secondary Outcome
Title Hospital Transfer Rate Among Short-stay Residents With Advanced Illness
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ACP Video Program Usual ACP Procedures
Hide Arm/Group Description:

Facility asked to implement 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).

Facility follows usual ACP procedures
Overall Number of Participants Analyzed 2538 5290
Mean (Standard Deviation)
Unit of Measure: person-years
6.9  (17.8) 6.8  (16.8)
4.Secondary Outcome
Title Hospital Transfer Rate Among Short-stay Residents Without Advanced Illness
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ACP Video Program Usual ACP Procedures
Hide Arm/Group Description:

Facility asked to implement 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).

Facility follows usual ACP procedures
Overall Number of Participants Analyzed 23304 50195
Mean (Standard Deviation)
Unit of Measure: person-years
4.5  (10.3) 4.4  (10.4)
5.Secondary Outcome
Title Proportion of Target Cohort That Has an Advance Directive Status
Hide Description 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 Do Not Resuscitate, Do Not Hospitalize, Do Not Intubate, or feeding restrictions. 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
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Proportion of Long-stay Residents Without Advanced Illness That Has an Advance Directive
Hide Description 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 Do Not Resuscitate, Do Not Hospitalize, Do Not Intubate, or feeding restrictions. 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
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Proportion of Short-stay Residents With Advanced Illness That Has an Advance Directive
Hide Description 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 Do Not Resuscitate, Do Not Hospitalize, Do Not Intubate, or feeding restrictions. 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
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Proportion of Short-stay Residents Without Advanced Illness That Has an Advance Directive
Hide Description 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 Do Not Resuscitate, Do Not Hospitalize, Do Not Intubate, or feeding restrictions. 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
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Average Time to Switch Advance Directives in Target Cohort
Hide Description Among 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 AND who are full code when they become part of the study (on admission to a NH), the average time to switching from full code to Do Not Resuscitate, Do Not Hospitalize, Do Not Intubate, or feeding restrictions during their 12-month observation period. Analyses will be limited to Genesis HealthCare facilities in which >75% of patients 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
Outcome Measure Data Not Reported
10.Secondary Outcome
Title Average Time to Switch Advance Directives Among Long-stay Residents Without Advanced Illness
Hide Description Among 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 AND who are full code when they become part of the study (on admission to a NH), the average time to switching from full code to Do Not Resuscitate, Do Not Hospitalize, Do Not Intubate, or feeding restrictions during their 12-month observation period. Analyses will be limited to Genesis HealthCare facilities in which >75% of patients 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
Outcome Measure Data Not Reported
11.Secondary Outcome
Title Average Time to Switch Advance Directives Among Short-stay Residents With Advanced Illness
Hide Description Among 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 AND who are full code when they become part of the study (on admission to a NH), the average time to switching from full code to Do Not Resuscitate, Do Not Hospitalize, Do Not Intubate, or feeding restrictions during their 100-day observation period. Analyses will be limited to Genesis HealthCare facilities in which >75% of patients 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
Outcome Measure Data Not Reported
12.Secondary Outcome
Title Average Time to Switch Advance Directives Among Short-stay Residents Without Advanced Illness
Hide Description Among 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 AND who are full code when they become part of the study (on admission to a NH), the average time to switching from full code to Do Not Resuscitate, Do Not Hospitalize, Do Not Intubate, or feeding restrictions during their 100-day observation period. Analyses will be limited to Genesis HealthCare facilities in which >75% of patients 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
Outcome Measure Data Not Reported
13.Secondary Outcome
Title Proportion of Target Cohort Receiving Any Burdensome Treatment
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ACP Video Program Usual ACP Procedures
Hide Arm/Group Description:

Facility asked to implement 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).

Facility follows usual ACP procedures
Overall Number of Participants Analyzed 4171 8308
Measure Type: Count of Participants
Unit of Measure: Participants
453
  10.9%
971
  11.7%
14.Secondary Outcome
Title Proportion of Long-stay Residents Without Advanced Illness Receiving Any Burdensome Treatment
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ACP Video Program Usual ACP Procedures
Hide Arm/Group Description:

Facility asked to implement 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).

Facility follows usual ACP procedures
Overall Number of Participants Analyzed 5766 11782
Measure Type: Count of Participants
Unit of Measure: Participants
465
   8.1%
1028
   8.7%
15.Secondary Outcome
Title Proportion of Short-stay Residents With Advanced Illness Receiving Any Burdensome Treatment
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ACP Video Program Usual ACP Procedures
Hide Arm/Group Description:

Facility asked to implement 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).

Facility follows usual ACP procedures
Overall Number of Participants Analyzed 2538 5290
Measure Type: Count of Participants
Unit of Measure: Participants
294
  11.6%
621
  11.7%
16.Secondary Outcome
Title Proportion of Short-stay Residents Without Advanced Illness Receiving Any Burdensome Treatment
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ACP Video Program Usual ACP Procedures
Hide Arm/Group Description:

Facility asked to implement 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).

Facility follows usual ACP procedures
Overall Number of Participants Analyzed 23304 50195
Measure Type: Count of Participants
Unit of Measure: Participants
1726
   7.4%
3405
   6.8%
17.Secondary Outcome
Title Proportion of Target Cohort With Any Hospice Enrollment
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ACP Video Program Usual ACP Procedures
Hide Arm/Group Description:

Facility asked to implement 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).

Facility follows usual ACP procedures
Overall Number of Participants Analyzed 4171 8308
Measure Type: Count of Participants
Unit of Measure: Participants
904
  21.7%
1878
  22.6%
18.Secondary Outcome
Title Proportion of Long-stay Residents Without Advanced Illness With Any Hospice Enrollment
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ACP Video Program Usual ACP Procedures
Hide Arm/Group Description:

Facility asked to implement 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).

Facility follows usual ACP procedures
Overall Number of Participants Analyzed 5766 11782
Measure Type: Count of Participants
Unit of Measure: Participants
373
   6.5%
832
   7.1%
19.Secondary Outcome
Title Proportion of Short-stay Residents With Advanced Illness With Any Hospice Enrollment
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ACP Video Program Usual ACP Procedures
Hide Arm/Group Description:

Facility asked to implement 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).

Facility follows usual ACP procedures
Overall Number of Participants Analyzed 2538 5290
Measure Type: Count of Participants
Unit of Measure: Participants
588
  23.2%
1220
  23.1%
20.Secondary Outcome
Title Proportion of Short-stay Residents Without Advanced Illness With Any Hospice Enrollment
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ACP Video Program Usual ACP Procedures
Hide Arm/Group Description:

Facility asked to implement 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).

Facility follows usual ACP procedures
Overall Number of Participants Analyzed 23304 50195
Measure Type: Count of Participants
Unit of Measure: Participants
2273
   9.8%
4875
   9.7%
21.Secondary Outcome
Title Proportion of Target Cohort That Has Medicare ACP Billing Codes
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ACP Video Program Usual ACP Procedures
Hide Arm/Group Description:

Facility asked to implement 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).

Facility follows usual ACP procedures
Overall Number of Participants Analyzed 4171 8308
Measure Type: Count of Participants
Unit of Measure: Participants
356
   8.5%
685
   8.2%
22.Secondary Outcome
Title Proportion of Long-stay Residents Without Advanced Illness That Has Medicare ACP Billing Codes
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ACP Video Program Usual ACP Procedures
Hide Arm/Group Description:

Facility asked to implement 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).

Facility follows usual ACP procedures
Overall Number of Participants Analyzed 5766 11782
Measure Type: Count of Participants
Unit of Measure: Participants
571
   9.9%
1157
   9.8%
23.Secondary Outcome
Title Proportion of Short-stay Residents With Advanced Illness That Has Medicare ACP Billing Codes
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ACP Video Program Usual ACP Procedures
Hide Arm/Group Description:

Facility asked to implement 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).

Facility follows usual ACP procedures
Overall Number of Participants Analyzed 2538 5290
Measure Type: Count of Participants
Unit of Measure: Participants
224
   8.8%
479
   9.1%
24.Secondary Outcome
Title Proportion of Short-stay Residents Without Advanced Illness That Has Medicare ACP Billing Codes
Hide Description 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
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title ACP Video Program Usual ACP Procedures
Hide Arm/Group Description:

Facility asked to implement 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).

Facility follows usual ACP procedures
Overall Number of Participants Analyzed 23304 50195
Measure Type: Count of Participants
Unit of Measure: Participants
1669
   7.2%
4068
   8.1%
Time Frame 12 months
Adverse Event Reporting Description We had three mechanisms to capture potential serious adverse events: (1) 'Serious Negative Reaction' Form and protocol to be initiated by nursing home staff within 4 hours of an observed event; (2) Entry of observed event details by nursing home staff in a Video Status Report User-Defined Assessment (VSR UDA) embedded in the electronic medical record system; and (3) Qualitative interviews conducted by research staff with nursing home staff that included questions about observed events.
 
Arm/Group Title ACP Video Program Usual ACP Procedures
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Facility asked to implement 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).

Facility follows usual ACP procedures
All-Cause Mortality
ACP Video Program Usual ACP Procedures
Affected / at Risk (%) Affected / at Risk (%)
Total   8403/33035 (25.44%)   17251/70013 (24.64%) 
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ACP Video Program Usual ACP Procedures
Affected / at Risk (%) Affected / at Risk (%)
Total   0/33035 (0.00%)   0/70013 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
ACP Video Program Usual ACP Procedures
Affected / at Risk (%) Affected / at Risk (%)
Total   0/33035 (0.00%)   0/70013 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
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Name/Title: Jessica A. Ogarek, Senior Biostatistician
Organization: Brown University
Phone: 401-863-9356
EMail: jessica_ogarek@brown.edu
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Vincent Mor, Brown University
ClinicalTrials.gov Identifier: NCT02612688    
Other Study ID Numbers: 4UH3AG049619-02 ( U.S. NIH Grant/Contract )
4UH3AG049619-02 ( U.S. NIH Grant/Contract )
First Submitted: November 19, 2015
First Posted: November 24, 2015
Results First Submitted: May 29, 2020
Results First Posted: June 18, 2020
Last Update Posted: June 18, 2020