Home Based Care Transitions Tailored by Cognition and Patient Activation

Chronic Disease Clinical Trial

Official title:

Home Based Care Transitions Tailored by Cognition and Patient Activation: A Prudent Use of Transitional Care Resources

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02045147
• Other study ID #: 336-13-EP
• Status: Completed
• Phase: N/A
• First received: January 22, 2014
• Last updated: May 11, 2017
• Start date: October 2013
• Est. completion date: December 2014

Study information

• Verified date: May 2017
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 examine the effects of 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) on the outcomes of health care utilization (HCU) and health outcomes: patient-reported health status, assessment of care for chronic conditions, and 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 group will have lower HCU and improved outcomes (patient-reported health status, assessment of care for chronic conditions, and quality of life).

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 effects of 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) on the outcomes of health care utilization (HCU) and health outcomes: patient-reported health status, assessment of care for chronic conditions, and 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 effects of HBCTI on health care utilization. We will measure HCU (number of emergency department(ED) visits, number of unplanned clinic visits, and number of readmissions) at 1, 2, and 6 months after discharge. Our working hypothesis is that patients in the HBCTI groups compared to the UC group will have lower HCU over time (at 1, 2 and 6 months); Aim 2. To evaluate the effects of HBCTI 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 1, 2, and 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 222
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Chronic Disease

Intervention

Behavioral:
• Grp 1 Low Cognition, Low Activation
The intervention is focused on knowledge, skills, confidence and creating a partnership with the health care provider. Education is provided at a 5th grade reading level. The "teach back" method is used to validate knowledge, skills and confidence. Once knowledge is validated, the interventions focused on motivation.
• Grp 2 Low Cognition, High Activation
The intervention is focused on knowledge, skills, confidence and creating a partnership with the health care provider. Education is provided at a 5th grade reading level. The "teach back" method is used to validate knowledge, skills and confidence. Once knowledge is validated, the interventions focused on motivation and handling stressful situations.
• Grp 3 Normal Cognition, Low Activation
The intervention is focused on knowledge, skills, confidence and creating a partnership with the health care provider. Education is provided for areas of misunderstanding. The "teach back" method is used to validate knowledge, skills and confidence. Interventions are focused on motivation and developing personal behavioral goals.
• Grp 4 Normal Cognition, High Activation
The intervention is focused on knowledge, skills, confidence and creating a partnership with the health care provider. Focus is on maintaining behaviors during hardship and stress. Empowering, motivating and validating are strategies utilized.

Locations

Country	Name	City	State
United States	Saint Elizabeth Regional Medical Center	Lincoln	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
University of Nebraska

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health Care Utilization	Number of Emergency Department Visits and number of re-admissions to the hospital within a 6 month time period will be measured. Validation data will be obtained from the clinical sites.	6 months
Secondary	Patient reported health status.	Data from the patient-reported health status (PROMIS measure), assessment of care for chronic conditions, and quality of life (EQ-5D) at 1, 2, and 6 months after discharge will be measured and compared for group differences.	1 month, 2 months and 6 months