RecruitingNot applicable

Evaluating Novel Healthcare Approaches to Nurturing and Caring for Hospitalized Elders

Evaluating Novel Healthcare Approaches to Nurturing and Caring for Hospitalized Elders (ENHANCE)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
70 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares the Hospital Elder Life Program (HELP) with FAM-HELP, which also involves family members and care partners. It tests how well these programs prevent delirium (sudden confusion) and make it less severe in hospital patients age 70 and older. It also looks at results reported by patients and families and how FAM-HELP works in different hospitals.

The goal of this clinical trial is to compare the Hospital Elder Life Program (HELP) with a family-augmented version of HELP (FAM-HELP), that includes family members and care partners, for the prevention of delirium in older patients during hospital admission. The main objectives of the trial are the following: 1. To compare the effectiveness of FAM-HELP and HELP in reducing both the incidence of delirium and its severity. 2. To compare the effectiveness of FAM-HELP and HELP in improving patient- and family-reported outcomes. 3. To explore the implementation context, process, and outcomes of the FAM-HELP program in diverse hospital settings.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Agree to join after learning about the study.
  • Be age 70 or older.
  • Be expected to stay in the hospital for at least 72 hours (3 days).
  • Have a family member or care partner who can be there in person.
  • Have at least one risk for sudden confusion, such as trouble thinking, doing daily tasks, seeing, or hearing, or not having enough fluid in the body.
  • Be able to complete a test of thinking and memory at the start.

Who can't join

  • Have sudden confusion when admitted to the hospital.
  • Cannot speak to communicate, such as because of a coma or use of a breathing machine.
  • Cannot fully take part in the program, such as because of an illness near the end of life or severe dementia (loss of memory and thinking skills).
  • Have behavior that could put staff at risk, such as violence.
  • Have heart surgery or surgery inside the skull.
  • Have an active brain or nerve disease as the main reason for the hospital stay.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Provision of informed consent * At least 70 years of age * Anticipated length of hospital stay at least 72 hours * Family member or care partner available to be on-site in the hospital * At least one delirium risk factor (e.g., cognitive or functional impairment, dehydration, vision or hearing impairment) * Evaluable cognitive function at baseline (i.e., ability to complete baseline cognitive function assessment) Exclusion Criteria: * Delirium on admission * Unable to communicate verbally (e.g., coma, mechanical ventilation) * Unable to participate fully in interventions (e.g., terminal condition, advanced dementia) * Staff safety concerns (e.g., violent behavior) * Cardiac or intracranial surgery (due to competing causes of delirium) * Active neurologic disease (as primary reason for admission)

Study sites (7)

CA

ME

MI

PA

UT

WI