Helping Older Persons Emerge Stronger

Pain Clinical Trial

— HOPES  

Official title:

Helping Older Persons Emerge Stronger (HOPES) After Intensive Care Unit Admission

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02863081
• Other study ID #: 2016H0001
• Status: Completed
• Phase: N/A
• First received: August 4, 2016
• Last updated: September 18, 2017
• Start date: July 2016
• Est. completion date: July 1, 2017

Study information

• Verified date: September 2017
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

The 300,000 chronically critically ill patients each year who require prolonged mechanical ventilation (PMV)1,2 represent an ever-growing, extremely vulnerable, proportion of intensive care unit (ICU) survivors.3 The increasing number of these patients is an important factor in the expanded use of long-term acute care hospitals (LTACHs), centers that specialize in mechanical ventilation weaning and rehabilitation. The 412 LTACHs currently operated in the United States admit more than 130,000 patients annually and account for more than $5 billion in Medicare expenditures each year.4,5 Unfortunately, LTACH stays for patients requiring PMV are typically complicated and associated with a number of poor outcomes including very high one-year mortality rates (44-77%),6,7 severe and enduring brain dysfunction (i.e., coma and/or delirium), life-altering functional decline, substantial pain and suffering, caregiver burden and diminished quality of life.6-11 While returning home is often an important goal for patients and their families,3 this is a rare outcome in this population.11 Rather, patients requiring PMV often experience multiple transitions in care in the year following their original hospital admission (median of 4), which results in further costs and persistent, profound disability.9 Despite these disheartening findings, to date there is very limited scientific evidence available to help clinicians care for the chronically critically ill, particularly those requiring PMV in LTACHs.

Chronically critically ill patients are generally older, sicker and have more comorbidities than their acutely ill counterparts.12 Importantly, they also suffer from much greater symptom burden, with up to 90% of patients experiencing at least one distressing symptom during the course of their illness (e.g., pain, dyspnea, weakness).13 While these symptoms are often thought of as unfortunate and inevitable consequences of critical illness,14 evidence suggests that the inappropriate management of these symptoms may actually be causal to the poor outcomes experienced by this group.15 For example, the results of numerous, well-designed, clinical trials conducted in the traditional ICU setting by our team and others suggest regular pain, agitation, and delirium assessment, prevention and treatment, coupled with strategies that decrease patients' exposure to sedative medications, support early mobilization, promote evidence-based mechanical ventilation discontinuation approaches, and actively engage and empower family members in patient care can positively affect important patient-centered outcomes (e.g., improved survival and physical/cognitive ability).16-26 One unifying method of implementing these evidence based interventions into everyday practice is consistent and reliable use of the ABCDEF bundle (i.e., Assess, prevent, and manage pain, Both Spontaneous Awakening Trials (SATs) & Spontaneous Breathing Trials (SBTs), Choice of analgesia and sedation, Delirium assess, prevent, and manage, Early mobility and exercise, and Family engagement and empowerment).27 Congruent with the Society of Critical Care Medicine's Clinical Practice Guidelines for the Management of Pain, Agitation, and Delirium and endorsed by a number of patient safety and quality organizations including the Institute for Healthcare Improvement and the Gordon and Betty Moore Foundation, the ABCDEF bundle is being actively implemented in ICUs throughout the world. The strength of evidence supporting the ABCDEF bundle, coupled with this strong implementation momentum, has prompted interest in the LTACH in applying the bundle into the everyday care of chronically critically ill patients who require mechanical ventilation.

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. Specifically the study's aims are to:

Aim 1: Identify facilitators and barriers to successful ABCDEF bundle implementation in the LTACH setting.

Aim 2: Compare the symptom experience (e.g., pain, agitation, anxiety, fatigue, shortness of breath, restlessness, sadness, hunger, fear, thirst, confusion sedative medication exposure) of patients receiving usual LTACH care (during months 1-4.5) to those treated with the ABCDEF bundle (during months 4.5-9).

Aim 3. Evaluate the impact ABCDEF bundle implementation has on safety (i.e., new pneumonias, device self-removal) and patient-centered outcomes (i.e., delirium/coma free days, weaning duration, tracheostomy removal , mortality, depression, post-traumatic stress disorder, functional and cognitive ability, discharge disposition, opioid and benzodiazepine withdrawal rates, and quality of life) of patients receiving usual LTACH care (during months 1-4.5) to those treated with the ABCDEF bundle (during months 4.5-9).

To complete these aims the investigators will administer an on-line survey and conduct focus group interviews with LTACH staff before and after the ABCDEF bundle is implemented into everyday care. Over the course of a nine month period, the investigators will also consent and enroll 81 patients who require mechanical ventilation at the time of LTACH admission. These patients will undergo daily, in-person symptom assessment using valid and reliable screening tools. Finally, medical record reviews and brief patient interviews will be conducted to obtain data on our outcomes of interest.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: July 1, 2017
• Est. primary completion date: July 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Aim 1:

Inclusion • All full and part-time Registered Nurses, attending physicians, respiratory therapists, pharmacists, and physical/occupational/speech therapists who regularly care for patients requiring prolonged mechanical ventilation in the LTACH setting

Exclusion

• None

Aims 2 and 3:

Inclusion

• >18 years old

• Admitted to the LTACH with a tracheostomy

• Require mechanical ventilation > 8 hours a day upon LTACH admission

• English speaking

Exclusion Criteria:

• 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)

• Inability to obtain informed consent from the patient's legally authorized representative (LAR) within 72 hours of meeting all inclusion criteria

• Chronic ventilator dependence that is deemed "not weanable" by admitting LTACH physician.

Related Conditions & MeSH terms

• Agitation
• Anxiety
• Delirium
• Pain
• Ventilators

Intervention

Other:
• Survey
Administered to healthcare providers
• interview
Administered to patients and LAR (i.e., interviews)

Locations

Country	Name	City	State
United States	The Ohio State University College of Nursing	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University	Select Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Facilitators/Barriers to successful ABCDEF bundle implementation in the LTACH setting	Achieved through surveys and focus groups of LTACH providers	9 months
Primary	Pain	As measured by numeric rating scale of behavioral pain sclae	9 months
Primary	All cause mortality		9 months
Secondary	Level of Arousal	As measured by Richmond Agitation and Sedation Scale (RASS)	9 months
Secondary	Delirium	As measured by Confusion Assessment Method ICU (CAM-ICU)	9 months
Secondary	Anxiety Anxiety	As measured by Visual Analog Scale	9 months
Secondary	Other Symptoms	As measured by Patient Symptom Survey	9 month
Secondary	Opioid Withdrawal	As measured by Clinical Opiate WIthdrawl Scale	9 months
Secondary	Benzodiazepine Withdrawal	As measured by Clinical Institute Withdrawal Assessment Scale-Benzodiazepines	9 months
Secondary	Delirium/Coma free days	As measured by CAM ICU and RASS	9 months
Secondary	Weaning duration		9 months
Secondary	New Pneumonia		9 months
Secondary	Device self-removal		9 months
Secondary	Tracheostomy removal		90 months
Secondary	Depression	As measured by Hospital Anxiety and Depression Scale	90 months
Secondary	Post Traumatic Stress Disorder	As measured by Impact of Event Scale	9 months
Secondary	Functional ability	As measured by Functional Status Score ICU, KATZ ADL, LAWTON IADL	9 months
Secondary	Cognitive ability	As measure by Mini Mental State Exam	9 months
Secondary	Quality of Life	As measured by SF 36	9 months