Pragmatic Trial of Video Education in Nursing Homes (NCT02612688) | Clinical Trial Compass
CompletedNot Applicable
Pragmatic Trial of Video Education in Nursing Homes
United States197,692 participantsStarted 2016-03-01
Plain-language 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.
Who can participate
Age range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.