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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

Tracking Information
First Submitted Date  ICMJE November 19, 2015
First Posted Date  ICMJE November 24, 2015
Results First Submitted Date  ICMJE May 29, 2020
Results First Posted Date  ICMJE June 18, 2020
Last Update Posted Date June 18, 2020
Actual Study Start Date  ICMJE March 1, 2016
Actual Primary Completion Date May 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 9, 2018)
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
Original Primary Outcome Measures  ICMJE
 (submitted: November 20, 2015)
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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 9, 2018)
  • 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
  • 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
  • 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
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: November 20, 2015)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pragmatic Trial of Video Education in Nursing Homes
Official Title  ICMJE PROVEN: Pragmatic Trial of Video Education in Nursing Homes
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Alzheimer Disease
  • Dementia
  • Heart Failure
  • Pulmonary Disease, Chronic Obstructive
Intervention  ICMJE 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).
Study Arms  ICMJE
  • Experimental: ACP Video Program
    Facility asked to implement ACP Video Program
    Intervention: Behavioral: ACP Video Program
  • No Intervention: Usual ACP procedures
    Facility follows usual ACP procedures
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 8, 2019)
197692
Original Estimated Enrollment  ICMJE
 (submitted: November 20, 2015)
97213
Actual Study Completion Date  ICMJE May 31, 2019
Actual Primary Completion Date May 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02612688
Other Study ID Numbers  ICMJE 4UH3AG049619-02( U.S. NIH Grant/Contract )
4UH3AG049619-02 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Vincent Mor, Brown University
Study Sponsor  ICMJE Brown University
Collaborators  ICMJE
  • National Institute on Aging (NIA)
  • Hebrew SeniorLife
  • Massachusetts General Hospital
  • Genesis HealthCare
  • PruittHealth
Investigators  ICMJE
Principal Investigator: Vincent Mor, PhD Brown University
Principal Investigator: Susan Mitchell, MD, MPH Hebrew SeniorLife
Principal Investigator: Angelo Volandes, MD, MPH Massachusetts General Hospital
PRS Account Brown University
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP