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Pragmatic Trial of Video Education in Nursing Homes (PROVEN)

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ClinicalTrials.gov Identifier: NCT02612688
Recruitment Status : Recruiting
First Posted : November 24, 2015
Last Update Posted : May 15, 2018
Sponsor:
Collaborators:
National Institute on Aging (NIA)
Hebrew SeniorLife
Massachusetts General Hospital
Genesis HealthCare
PruittHealth
Information provided by (Responsible Party):
Vincent Mor, Brown University

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.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Dementia Heart Failure Pulmonary Disease, Chronic Obstructive Behavioral: ACP Video Program Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 211469 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: PROVEN: Pragmatic Trial of Video Education in Nursing Homes
Actual Study Start Date : March 2016
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Nursing Homes

Arm Intervention/treatment
Experimental: ACP Video Program
Facility asked to implement ACP Video Program
Behavioral: 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).

No Intervention: Usual ACP procedures
Facility follows usual ACP procedures



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Hospital transfer rate among long-stay residents without advanced illness [ 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 NEITHER advanced dementia NOR advanced congestive heart failure/chronic obstructive lung disease

  2. Hospital transfer rate among short-stay residents with advanced illness [ Time Frame: 100-day observation period ]
    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

  3. Hospital transfer rate among short-stay residents without advanced illness [ Time Frame: 100-day observation period ]
    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

  4. Proportion of target cohort that has an advance directive status [ Time Frame: 12-month observation period ]
    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.

  5. Proportion of long-stay residents without advanced illness that has an advance directive [ Time Frame: 12-month observation period ]
    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.

  6. Proportion of short-stay residents with advanced illness that has an advance directive [ Time Frame: 100-day observation period ]
    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.

  7. Proportion of short-stay residents without advanced illness that has an advance directive [ Time Frame: 100-day observation period ]
    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.

  8. Average time to switch advance directives in target cohort [ Time Frame: 12-month observation period ]
    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.

  9. Average time to switch advance directives among long-stay residents without advanced illness [ Time Frame: 12-month observation period ]
    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.

  10. Average time to switch advance directives among short-stay residents with advanced illness [ Time Frame: 100-day observation period ]
    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.

  11. Average time to switch advance directives among short-stay residents without advanced illness [ Time Frame: 100-day observation period ]
    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.

  12. Proportion of target cohort receiving any burdensome treatment [ Time Frame: 12-month observation period ]
    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

  13. Proportion of long-stay residents without advanced illness receiving any burdensome treatment [ Time Frame: 12-month observation period ]
    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

  14. Proportion of short-stay residents with advanced illness receiving any burdensome treatment [ Time Frame: 100-day observation period ]
    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

  15. Proportion of short-stay residents without advanced illness receiving any burdensome treatment [ Time Frame: 100-day observation period ]
    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

  16. Proportion of target cohort with any hospice enrollment [ Time Frame: 12-month observation period ]
    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

  17. Proportion of long-stay residents without advanced illness with any hospice enrollment [ Time Frame: 12-month observation period ]
    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

  18. Proportion of short-stay residents with advanced illness with any hospice enrollment [ Time Frame: 100-day observation period ]
    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

  19. Proportion of short-stay residents without advanced illness with any hospice enrollment [ Time Frame: 100-day observation period ]
    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

  20. Proportion of target cohort that has Medicare ACP billing codes [ Time Frame: 12-month observation period ]
    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

  21. Proportion of long-stay residents without advanced illness that has Medicare ACP billing codes [ Time Frame: 12-month observation period ]
    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

  22. 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 (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

  23. Proportion of short-stay residents without advanced illness that has Medicare ACP billing codes [ Time Frame: 100-day observation period ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02612688


Contacts
Contact: Faye V Dvorchak 401-863-2486 faye_dvorchak@brown.edu
Contact: Cindy J Williams 401-863-9627 cindy_williams@brown.edu

Locations
United States, Georgia
PruittHealth Recruiting
Norcross, Georgia, United States, 30093
Contact: Crystal Bowens    770-279-6240    crharris@pruitthealth.com   
United States, Pennsylvania
Genesis HealthCare Recruiting
Kennett Square, Pennsylvania, United States, 19348
Contact: Julie Britton, MSN, DNP    610-925-2176    julie.britton@genesishcc.com   
Sponsors and Collaborators
Brown University
National Institute on Aging (NIA)
Hebrew SeniorLife
Massachusetts General Hospital
Genesis HealthCare
PruittHealth
Investigators
Principal Investigator: Vincent Mor, PhD Brown University
Principal Investigator: Susan Mitchell, MD, MPH Hebrew SeniorLife
Principal Investigator: Angelo Volandes, MD, MPH Massachusetts General Hospital

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Vincent Mor, Professor of Medical Science, Florence Pirce Grant University Professor, Health Services, Policy & Practice, Brown University
ClinicalTrials.gov Identifier: NCT02612688     History of Changes
Other Study ID Numbers: 4UH3AG049619-02 ( U.S. NIH Grant/Contract )
4UH3AG049619-02 ( U.S. NIH Grant/Contract )
First Posted: November 24, 2015    Key Record Dates
Last Update Posted: May 15, 2018
Last Verified: May 2018

Keywords provided by Vincent Mor, Brown University:
Hospices
Advance Care Planning
Advance Directives
Alzheimer Disease
Dementia
Do-Not-Resuscitate Orders
Enteral Nutrition
Heart Failure
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

Additional relevant MeSH terms:
Heart Failure
Lung Diseases
Alzheimer Disease
Dementia
Chronic Disease
Pulmonary Disease, Chronic Obstructive
Heart Diseases
Cardiovascular Diseases
Respiratory Tract Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Disease Attributes
Pathologic Processes
Lung Diseases, Obstructive