Pragmatic Trial of Video Education in Nursing Homes (PROVEN)
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Purpose
| 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 |
- 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
- 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 |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT02612688
| Contact: Faye V Dvorchak | 401-863-2486 | faye_dvorchak@brown.edu | |
| Contact: Cindy J Williams | 401-863-9627 | cindy_williams@brown.edu |
| 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 | |
| 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


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