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Pragmatic Trial of Video Education in Nursing Homes (PROVEN)

This study is currently recruiting participants.
See Contacts and Locations
Verified July 2016 by Vincent Mor, Brown University
Sponsor:
Collaborators:
National Institute on Aging (NIA)
Hebrew SeniorLife
Massachusetts General Hospital
Genesis HealthCare
PruittHealth
Information provided by (Responsible Party):
Vincent Mor, Brown University
ClinicalTrials.gov Identifier:
NCT02612688
First received: November 19, 2015
Last updated: July 14, 2016
Last verified: July 2016
  Purpose
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 Intervention
Alzheimer Disease Dementia Heart Failure Pulmonary Disease, Chronic Obstructive Behavioral: ACP Video Program

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: PROVEN: Pragmatic Trial of Video Education in Nursing Homes

Resource links provided by NLM:


Further study details as provided by Vincent Mor, Brown University:

Primary Outcome Measures:
  • Number of hospitalizations/person-days alive among patients >=65 years old who are in a NH >=90 days and who have EITHER advanced dementia or advanced congestive heart failure/chronic obstructive lung disease [ Time Frame: 12-month follow-up period ]
    Number of hospitalizations/person-days alive among patients >=65 years old who are in a NH >=90 days and who have EITHER advanced dementia or advanced congestive heart failure/chronic obstructive lung disease


Secondary Outcome Measures:
  • Presence of advance directives: Do Not Hospitalize, Do Not Resuscitate, or no tube-feeding among patients >=65 years old who are in a NH >=90 days and who have EITHER advanced dementia or advanced congestive heart failure/chronic obstructive lung disease [ Time Frame: 12-month follow-up period ]
    Presence of advance directives: Do Not Hospitalize, Do Not Resuscitate, or no tube-feeding among patients >=65 years old who are in a NH >=90 days and who have EITHER advanced dementia or advanced congestive heart failure/chronic obstructive lung disease

  • Burdensome treatments (feeding tubes, parenteral therapy) received among patients >=65 years old who are in a NH >=90 days and who have EITHER advanced dementia or advanced congestive heart failure/chronic obstructive lung disease [ Time Frame: 12-month follow-up period ]
    Burdensome treatments (feeding tubes, parenteral therapy) received among patients >=65 years old who are in a NH >=90 days and who have EITHER advanced dementia or advanced congestive heart failure/chronic obstructive lung disease

  • Presence of advance directives: Do Not Hospitalize, Do Not Resuscitate, or no tube-feeding among patients >=65 years old who are in a NH <90 days and who have EITHER advanced dementia or advanced congestive heart failure/chronic obstructive lung disease [ Time Frame: 12-month follow-up period ]
    Presence of advance directives: Do Not Hospitalize, Do Not Resuscitate, or no tube-feeding among patients >=65 years old who are in a NH <90 days and who have EITHER advanced dementia or advanced congestive heart failure/chronic obstructive lung disease

  • Number of hospitalizations/person-days alive among patients >=65 years old who are in a NH <90 days and who have EITHER advanced dementia or advanced congestive heart failure/chronic obstructive lung disease [ Time Frame: Within 100 days of post-acute care admission ]
    Number of hospitalizations/person-days alive among patients >=65 years old who are in a NH <90 days and who have EITHER advanced dementia or advanced congestive heart failure/chronic obstructive lung disease

  • Hospice enrollment among patients >=65 years old who are in a NH <90 days and who have EITHER advanced dementia or advanced congestive heart failure/chronic obstructive lung disease [ Time Frame: Within 100 days of post-acute care admission ]
    Hospice enrollment among patients >=65 years old who are in a NH <90 days and who have EITHER advanced dementia or advanced congestive heart failure/chronic obstructive lung disease

  • Presence of advance directives: Do Not Hospitalize, Do Not Resuscitate, or no tube-feeding among NH patients >=65 years old who have NEITHER advanced dementia NOR advanced congestive heart failure/chronic obstructive lung disease [ Time Frame: 12-month follow-up period ]
    Presence of advance directives: Do Not Hospitalize, Do Not Resuscitate, or no tube-feeding among NH patients >=65 years old who have NEITHER advanced dementia NOR advanced congestive heart failure/chronic obstructive lung disease

  • Number of hospitalizations/person-days alive among NH patients >=65 years old who have NEITHER advanced dementia NOR advanced congestive heart failure/chronic obstructive lung disease [ Time Frame: 12-month follow-up period ]
    Number of hospitalizations/person-days alive among NH patients >=65 years old who have NEITHER advanced dementia NOR advanced congestive heart failure/chronic obstructive lung disease

  • Hospice enrollment among NH patients >=65 years old who have NEITHER advanced dementia NOR advanced congestive heart failure/chronic obstructive lung disease [ Time Frame: 12-month follow-up period ]
    Hospice enrollment among NH patients >=65 years old who have NEITHER advanced dementia NOR advanced congestive heart failure/chronic obstructive lung disease


Estimated Enrollment: 152160
Study Start Date: January 2016
Estimated Study Completion Date: August 2019
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   65 Years and older   (Adult, Senior)
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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: Sherry Johnson, RN, BSN    776-806-6817    sbjohnson@pruitthealth.com   
United States, Pennsylvania
Genesis HealthCare Recruiting
Kennett Square, Pennsylvania, United States, 19348
Contact: Kevin Hook, MA, MSN, CRNP    610-925-4060    Kevin.Hook@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
  More Information

Additional Information:
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 )
Study First Received: November 19, 2015
Last Updated: July 14, 2016

Keywords provided by Vincent Mor, Brown University:
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

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

ClinicalTrials.gov processed this record on July 17, 2017