Home Based Care Transitions Tailored by Cognition and Patient Activation

NCT02045147 | Completed Results

• 1 other identifier: 0336-13-EP
• Study Type: interventional
• Target: 263
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Disease

Keywords

Home Bound Care Transitions

Outcome Measures

Primary Outcomes (1)

• Health Care Utilization

  Patient report of number of Emergency Department Visits and number of re-admissions to the hospital within a 6 month time period was measured. Validation data was obtained from the clinical sites.

  6 months

Secondary Outcomes (10)

• Patient-Reported Outcomes Measurement Information System - Pain Interference

  6 months

• Patient-Reported Outcomes Measurement Information System-Physical Functioning

  6 months after intervention

• Patient-Reported Outcomes Measurement Information System-Satisfaction With Social Roles

  6 months

• Patient-Reported Outcomes Measurement Information System- Anxiety

  6 months

• Patient-Reported Outcomes Measurement Information System-Fatigue

  6 months

Study Arms (8)

Grp 1a: Low Cognition, Low Activation

EXPERIMENTAL

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.

Behavioral: Grp 1a Low Cognition, Low Activation Intervention

Grp 2a: Low Cognition, High Activation

EXPERIMENTAL

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.

Behavioral: Grp 2a Low Cognition, High Activation Intervention

Grp 3a: Normal Cognition, Low Activation

EXPERIMENTAL

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.

Behavioral: Grp 3a Normal Cognition, Low Activation Intervention

Grp 4a: Normal Cognition, High Activation

EXPERIMENTAL

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

Behavioral: Grp 4a Normal Cognition, High Activation Intervention

Grp 1b: Low Cognition, Low Activation Usual Care

NO INTERVENTION

Comparison group to 1a intervention group

Grp 2b Low Cognition, High Activation Usual Care

NO INTERVENTION

Comparison group to 2a intervention group

Grp 3b: Normal Cognition, Low Activation Usual Care

NO INTERVENTION

Comparison group to 3a intervention group

Grp 4b: Normal Cognition, High Activation Usual Care

NO INTERVENTION

Comparison group to 4a intervention group

Interventions

Grp 1a Low Cognition, Low Activation Intervention 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 1a: Low Cognition, Low Activation

Grp 2a Low Cognition, High Activation Intervention 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.

Grp 2a: Low Cognition, High Activation

Grp 3a Normal Cognition, Low Activation Intervention 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 3a: Normal Cognition, Low Activation

Grp 4a Normal Cognition, High Activation Intervention 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 4a: Normal Cognition, High Activation

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

Saint Elizabeth Regional Medical Center

Lincoln, Nebraska, 68510, United States

Location

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Lani Zimmerman
• Organization: University of Nebraska Medical Center

lzimmerm@unmc.edu

402-472-3847

Study Officials

• Lani M Zimmerman, PhD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2014
• First Posted: January 24, 2014
• Study Start: October 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: October 8, 2024
• Results First Posted: October 8, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)