Clinical trial NCT02045147: Home Based Care Transitions Tailored by Cognition and Patient Activation
Official title: Home Based Care Transitions Tailored by Cognition and Patient Activation: A Prudent Use of Transitional Care Resources
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Disease
Keywords: Home Bound Care Transitions
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2014-01-24
Enrollment: 263
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There is overwhelming evidence that patients with multiple chronic illnesses need better self-management skills. Discharge from the hospital may not be the most opportune time to be teaching patients these self-management skills. There are several different care transition models being used across the country; however we know that not every patient needs the same type or amount of an intervention. The purpose of this pilot study is to study the impact delivering a home based care transitions intervention (HBCTI) with four different groups tailored on cognition and level of patient activation compared to usual care (UC) resulting in 8 study arms on the outcomes of health care utilization (HCU) and health outcomes: patient-reported health status, assessment of care for chronic conditions, and health related quality of life in adult patients with multiple chronic diseases dismissed to home from an acute care facility. Our working hypothesis is that patients in the HBCTI groups compared to the UC groups will have lower HCU and improved outcomes (patient-reported health status, assessment of care for chronic conditions, and health related quality of life).

Detailed description: One in five Medicare patients discharged from the hospital experience readmission within 30 days. Too often, hospital readmissions result from inadequate transition from hospital to home at discharge. Care transitions are complicated because of high patient acuity, multiple comorbidities, decreased length of stay, and multiple clinician involvement increasing the number of handoffs. With decreased length of stay, many patients do not comprehend or feel confident with instructions for discharge, thus management of their chronic illnesses are difficult. Most formal care transition programs are standardized and every patient receives similar strategies or interventions. However, it has been well documented that patients with cognitive problems and decreased activation are at high risk for re-hospitalization related to impaired self-management. We believe that assessment of cognition and patient activation during the patient's hospitalization will provide valuable information for discharge interventions. Data related to cognition and activation can be used to tailor discharge planning and help determine what type and how many resources are needed for individual patients after hospital discharge. The purpose of this feasibility study is to examine the impact of delivering a home based care transitions interventions (HBCTIs) with four different groups tailored on cognition and level of patient activation compared to usual care (UC) on the outcomes of health care utilization (HCU) and health outcomes: patient-reported health status, assessment of care for chronic conditions, and health related quality of life in adult patients with multiple chronic diseases discharged to home from the hospital.

We will test our intervention with the following aims: Aim 1.To evaluate the impact of HBCTIs on health care utilization. We will measure HCU (number of emergency department(ED) visits and number of readmissions) at 6 months after discharge. Our working hypothesis is that patients in the HBCTI groups compared to the UC groups will have lower HCU over time (6 months); Aim 2. To evaluate the impact of HBCTIs on the following health outcomes: patient-reported health status (PROMIS-29), assessment of care for chronic conditions (PACIC), and quality of life (EuroQol). Our working hypothesis is that patients in the HBCTI groups compared to the UC group will have improved patient-reported health status, assessment of care for chronic conditions, and quality of life (EuroQol) at 6 months after discharge.

The findings from this study have the potential to change this paradigm in three ways: 1) we will gain a better understanding of the role of cognition and patient activation in promoting self-management to enhance outcomes; 2). our innovative approach, which considers the unique needs of patients based on their level of cognition and patient activation will advance new concepts in care transition programs; 3) we will have a better understanding of varying intensities of visits, level of providers, and type and amount of strategies administered. This practical model for care transitions could serve as a model within the larger health care delivery system that could result in significant cost savings.

Eligibility criteria: Inclusion Criteria:

* Adult Patients (age 19 and older) being discharged from the hospital with three or more chronic diseases;
* Have a score greater than 17 on the Montreal Cognitive Assessment (dementia);
* Reside within a 35 mile radius of Lincoln, Ne.; and
* Able to hear, speak and read English.

Exclusion Criteria:

Patients will be excluded if they:

* have a terminal illness;
* have a score of less than 17 on the Montreal Cognitive Assessment (dementia);
* are under the care of The Physicians Network (TPN) at St. Elizabeth Regional Medical Center (SERMC).

Primary outcomes:
measure: Health Care Utilization
timeFrame: 6 months
Secondary outcomes:
measure: Patient-Reported Outcomes Measurement Information System - Pain Interference
timeFrame: 6 months
measure: Patient-Reported Outcomes Measurement Information System-Physical Functioning
timeFrame: 6 months after intervention
measure: Patient-Reported Outcomes Measurement Information System-Satisfaction With Social Roles
timeFrame: 6 months
measure: Patient-Reported Outcomes Measurement Information System- Anxiety
timeFrame: 6 months
measure: Patient-Reported Outcomes Measurement Information System-Fatigue
timeFrame: 6 months
measure: Patient-Reported Outcomes Measurement Information System- Depression
timeFrame: 6 months
measure: Patient-Reported Outcomes Measurement Information System-Sleep Deprivation
timeFrame: 6 months
measure: Patient Assessment of Chronic Illness Care
timeFrame: 6 months
measure: Health Related Quality of Life EuroQol-5D (EQ-5D)
timeFrame: 6 months
measure: EQ-5D Visual Analog Scale (VAS)
timeFrame: 6 months
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: Saint Elizabeth Regional Medical Center
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Lani M Zimmerman, PhD
role: PRINCIPAL_INVESTIGATOR
References: