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Home Based Care Transitions Tailored by Cognition and Patient Activation

Primary Purpose

Chronic Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Grp 1 Low Cognition, Low Activation
Grp 2 Low Cognition, High Activation
Grp 3 Normal Cognition, Low Activation
Grp 4 Normal Cognition, High Activation
Sponsored by
University of Nebraska
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Disease focused on measuring Home Bound Care Transitions

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Saint Elizabeth Regional Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Grp 1 Low Cognition, Low Activation

Grp 2 Low Cognition, High Activation

Grp 3 Normal Cognition, Low Activation

Grp 4 Normal Cognition, High Activation

Arm Description

Group 1: Subjects will receive an 8 week care transition intervention with an Advanced Practice Registered Nurse-Nurse Practitioner (APRN-NP) and Certified Nursing Assistant (CNA). The APRN-NP will guide the care transition intervention. This group will receive the most intense intervention.

Group 2: Subjects will receive an 8 week care transition intervention with an APRN-NP and CNA. The APRN-NP will guide the care transition intervention. This group will receive an intense intervention.

Group 3: Subjects will receive an 4 week care transition intervention with a Registered Nurse (RN) Coach. This group will be evaluated at four weeks, if the patient activation levels are still low, they will be referred to the 4 week APRN-NP and CNA.

Group 4: Subjects will receive the least intensive intervention delivered by a RN coach.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
January 22, 2014
Last Updated
May 11, 2017
Sponsor
University of Nebraska
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1. Study Identification

Unique Protocol Identification Number
NCT02045147
Brief Title
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

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nebraska

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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).
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Disease
Keywords
Home Bound Care Transitions

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
222 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Grp 1 Low Cognition, Low Activation
Arm Type
Experimental
Arm Description
Group 1: Subjects will receive an 8 week care transition intervention with an Advanced Practice Registered Nurse-Nurse Practitioner (APRN-NP) and Certified Nursing Assistant (CNA). The APRN-NP will guide the care transition intervention. This group will receive the most intense intervention.
Arm Title
Grp 2 Low Cognition, High Activation
Arm Type
Experimental
Arm Description
Group 2: Subjects will receive an 8 week care transition intervention with an APRN-NP and CNA. The APRN-NP will guide the care transition intervention. This group will receive an intense intervention.
Arm Title
Grp 3 Normal Cognition, Low Activation
Arm Type
Experimental
Arm Description
Group 3: Subjects will receive an 4 week care transition intervention with a Registered Nurse (RN) Coach. This group will be evaluated at four weeks, if the patient activation levels are still low, they will be referred to the 4 week APRN-NP and CNA.
Arm Title
Grp 4 Normal Cognition, High Activation
Arm Type
Experimental
Arm Description
Group 4: Subjects will receive the least intensive intervention delivered by a RN coach.
Intervention Type
Behavioral
Intervention Name(s)
Grp 1 Low Cognition, Low Activation
Other Intervention Name(s)
Low Cognition, Low Activation
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Grp 2 Low Cognition, High Activation
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Grp 3 Normal Cognition, Low Activation
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Grp 4 Normal Cognition, High Activation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Health Care Utilization
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Patient reported health status.
Description
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.
Time Frame
1 month, 2 months and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lani M Zimmerman, PhD
Organizational Affiliation
University of Nebraska
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saint Elizabeth Regional Medical Center
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Home Based Care Transitions Tailored by Cognition and Patient Activation

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