Helping Older Persons Emerge Stronger

NCT02863081 | Completed

• 1 other identifier: 2016H0001
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

Select Specialty, a national network of more than 100 LTACHs across the United States, has expressed the desire to adopt the ABCDEF bundle as a "standard of care" for its patients. As part of this initiative, Select first plans to conduct an ABCDEF bundle quality improvement project in one of its local hospitals. The overall purpose of this before-after study is to study prospectively the process and effects of implementing the ABCDEF bundle into the everyday care of patients requiring prolonged mechanical ventilation in the LTACH setting.

Conditions

Delirium; Ventilators; Pain; Agitation; Anxiety

Outcome Measures

Primary Outcomes (3)

• Facilitators/Barriers to successful ABCDEF bundle implementation in the LTACH setting

  Achieved through surveys and focus groups of LTACH providers

  9 months

• Pain

  As measured by numeric rating scale of behavioral pain sclae

  9 months

• All cause mortality

  9 months

Secondary Outcomes (16)

• Level of Arousal

  9 months

• Delirium

  9 months

• Anxiety Anxiety

  9 months

• Other Symptoms

  9 month

• Opioid Withdrawal

  9 months

Study Arms (2)

Healthcare providers

All healthcare providers working in the participating LTACH will be asked to complete 2 surveys and invited to participate in focus group meetings

Other: Survey; Other: interview

Patients

81 LTACH patients will be enrolled over the course of a 9 month period. Each patient and their LAR will be interviewed at the time of LTACH admission to garner information about their pre hospitalization physical, functional, and cognitive health status. Each day enrolled patients will undergo daily symptom assessments and medical record reviews. At the time of LTACH discharge all enrolled patients will be interviewed again to garner information about their discharge physical, functional, and cognitive health status.

Other: interview

Interventions

Survey OTHER

Administered to healthcare providers

Also known as: Focus group interviews

Healthcare providers

interview OTHER

Administered to patients and LAR (i.e., interviews)

Also known as: symptom assessment, Medical record review

Healthcare providers; Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

1. Healthcare providers working in a LTACH 2. Chronically critically ill patients requiring mechanical ventilation at the time of LTACH admission

You may not qualify if:

• None
• Aims 2 and 3:
• \>18 years old
• Admitted to the LTACH with a tracheostomy
• Require mechanical ventilation \> 8 hours a day upon LTACH admission
• English speaking
• Severe neurologic deficits defined as coma (i.e., Richmond Agitation Sedation Score \< -4 or -5 due to stroke, intracranial hemorrhage, cranial trauma, malignancy, anoxic brain injury, or cerebral edema)
• Chronic ventilator dependence that is deemed "not weanable" by admitting LTACH physician.

Sponsors & Collaborators

• Ohio State University: lead
• Select Medical: collaborator

Study Sites (1)

The Ohio State University College of Nursing

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Delirium; Pain; Psychomotor Agitation; Anxiety Disorders

Interventions

Surveys and Questionnaires; Interviews as Topic

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Dyskinesias; Psychomotor Disorders; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor College of Nursing

Study Record Dates

• First Submitted: August 4, 2016
• First Posted: August 11, 2016
• Study Start: July 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: September 19, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)