Home Based Care Transitions Tailored by Cognition and Patient Activation

NCT ID: NCT02045147

Last Updated: 2024-10-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

263 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-01

Study Completion Date

2014-12-01

Brief Summary

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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

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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.

Conditions

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Chronic Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Grp 3a: Normal Cognition, Low Activation

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 Type EXPERIMENTAL

Grp 3a Normal Cognition, Low Activation Intervention

Intervention Type BEHAVIORAL

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 4a: Normal Cognition, High Activation

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

Group Type EXPERIMENTAL

Grp 4a Normal Cognition, High Activation Intervention

Intervention Type BEHAVIORAL

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.

Grp 1b: Low Cognition, Low Activation Usual Care

Comparison group to 1a intervention group

Group Type NO_INTERVENTION

No interventions assigned to this group

Grp 2b Low Cognition, High Activation Usual Care

Comparison group to 2a intervention group

Group Type NO_INTERVENTION

No interventions assigned to this group

Grp 3b: Normal Cognition, Low Activation Usual Care

Comparison group to 3a intervention group

Group Type NO_INTERVENTION

No interventions assigned to this group

Grp 4b: Normal Cognition, High Activation Usual Care

Comparison group to 4a intervention group

Group Type NO_INTERVENTION

No interventions assigned to this group

Grp 1a: Low Cognition, Low Activation

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 Type EXPERIMENTAL

Grp 1a Low Cognition, Low Activation Intervention

Intervention Type BEHAVIORAL

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 2a: Low Cognition, High Activation

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 Type EXPERIMENTAL

Grp 2a Low Cognition, High Activation Intervention

Intervention Type BEHAVIORAL

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.

Interventions

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Grp 1a Low Cognition, Low Activation Intervention

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

Grp 2a Low Cognition, High Activation Intervention

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

Grp 3a Normal Cognition, Low Activation Intervention

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

Grp 4a Normal Cognition, High Activation Intervention

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Nebraska

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lani M Zimmerman, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Locations

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Saint Elizabeth Regional Medical Center

Lincoln, Nebraska, United States

Site Status

Countries

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United States

Other Identifiers

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0336-13-EP

Identifier Type: -

Identifier Source: org_study_id

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