Self-management Adherence in Heart Failure Patients (PATCH)

Promoting Self-management Through Adherence Among Heart Failure Patients

Non-adherence to self-management behaviors is prevalent and accounts for hospital readmissions in heart failure (HF) patients 65 years of age and older. The mechanism to activate and engage HF patients in managing their own care is uncertain. Yet post-acute care service that is vital to improve HF patients' self-management adherence and HF outcomes is suboptimal in rural hospitals (primarily critical access hospitals). The investigators central hypothesis is that patients with higher activation level will have significantly better self-management adherence. This study will test whether Patient AcTivated Care at Home (PATCH) will improve self-management adherence and health outcome (reduced hospital readmissions), as well as the feasibility to translate the research findings to a home based post-acute care service in rural communities.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Behavioral: PATCH intervention; Behavioral: Usual care

Detailed Description

Heart failure (HF) is among the most prevalent chronic conditions and leading cause of hospital readmission in adults 65 years of age and older. HF patients discharged from rural critical access hospitals (CAHs) had higher 30-day readmission rates compared to patients discharged from urban hospitals. Adhering to recommended self-management behaviors improves HF patients' health outcomes and reduces readmissions; however, the prevalence of adherence is low in HF patients. In rural communities, low adherence can be attributed to the fact that rural HF patients received less information about managing their chronic condition based on the investigators preliminary study. Previous studies reported inconsistent findings regarding the effectiveness of interventions designed to improve self-management adherence. The feasibility of these interventions in rural settings is unknown. Therefore, innovative programs are needed to identify the intervention to enhance self-management adherence in HF patients living in rural communities. The purpose of this prospective, two-group, repeated measures, randomized control trial is to test the efficacy and feasibility of a 12-week activation-enhancing intervention (Patient AcTivated Care at Home [PATCH]) on self-management adherence and health outcome (readmission rates) in HF patients discharged from rural hospitals (critical access hospitals). A sample size of 96 subjects with heart failure will be recruited over 14 month period. Both intervention and control groups will receive usual care. The intervention group will additionally receive 2-phase PATCH intervention: the in-hospital discharge education session (Phase I) and 12-week post-discharge education sessions delivered by telephone (Phase II). The tailored strategies are developed to activate patients engaging in self-management behaviors based on their baseline activation level. The investigators central hypothesis, based upon their preliminary data, is that patients with higher activation level will have significantly better self-management adherence. The investigators will test their hypothesis with the following Specific Aims: To evaluate the effects of the patient activation intervention on self-management adherence (Aim 1) and hospital readmissions (Aim 2) over time. To evaluate the mechanism of the patient activation intervention (Aim 3). To evaluate the feasibility of the PATCH intervention (Aim 4). The PATCH intervention is innovative because: 1) it translates patient activation theory into intervention strategies to improve self-management in a vulnerable population (rural heart failure patients living in rural community), 2) it tests the mechanism of patient activation on self-management adherence; 3) it uses the rural nursing theory to guide developing a sustainable intervention program in rural communities; and 4) it evaluates a biomarker collected by a single urine test as the indicator of self-management adherence in HF patients. This study will impact the management of heart failure by adding knowledge about the mechanism to improve self-management adherence in heart failure patient living in rural communities. Long term adherence to the recommended self-management behaviors is the foundation to realize health benefit and reduce burden on patients, their family and the healthcare system.

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Beatrice, Nebraska, United States, 68310
      • Beatrice Community Hospital & Health Center
    • Fairbury, Nebraska, United States, 68352
      • Jefferson Community Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• have HF as one of their discharge diagnoses;
• have New York Heart Association (NYHA) class II to IV symptoms or have NYHA class I symptoms
• have had at least one other HF-related hospitalization or emergency department visit in the previous year;
• are discharged to home;
• pass a mini-cog screen
• understand English;
• have access to a phone.

Exclusion Criteria:

• Have scheduled procedures and/or surgeries during hospitalization;
• Have depressive symptoms (receive a score of 3 or above on the Patient Health Questionnaire-2 (PHQ-2) have documented medical diagnosis or diagnostic evidence of liver cirrhosis;
• Have renal failure (serum creatinine greater than 2.0mg/dl)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PATCH Intervention; The intervention group will receive usual care and the PATCH intervention. The intervention is comprised of two phases in which the in-hospital discharge education session is followed by 12 weeks of post-discharge education sessions delivered by telephone. The focus of this study is to test the mechanism of the proposed patient activation intervention on HF self-management adherence and associated health outcomes.	Behavioral: PATCH intervention; The intervention group will receive usual care and the PATCH intervention. The intervention is comprised of two phases in which the in-hospital discharge education session is followed by 12 weeks of post-discharge education sessions delivered by telephone. The focus of this study is to test the mechanism of the proposed patient activation intervention on HF self-management adherence and associated health outcomes.
Active Comparator: Usual Care; The usual care group will receive standardized discharge written information and scheduled doctor appointments. Standardized discharge instruction, as recommended by CMS and the Joint Commission, includes: activity level, diet, discharge medications, follow-up doctor appointment, weight monitoring, and what to do if symptoms worsen. No further follow-ups are routinely done by the hospital and patients are told to see their primary care provider if problems occur.	Behavioral: Usual care; Usual care refers to the standardized discharge written information and scheduled doctor appointments. Standardized discharge instruction, as recommended by CMS and the Joint Commission, includes: activity level, diet, discharge medications, follow-up doctor appointment, weight monitoring, and what to do if symptoms worsen.113 No further follow-ups are routinely done by the hospital and patients are told to see their primary care provider if problems occur.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in self-management adherence at 3 and 6 months	Primary outcome of self-management adherence refers to the adherence to self-care behaviors	3 and 6 months following intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in re-hospitalization rate at 30-day, 3 and 6 months	Evaluate the immediate and extended effects of the patient activation intervention on the re-hospitalization rate in heart failure patients	30 day after intervention

Collaborators and Investigators

• Sponsor: University of Nebraska
• Investigators: Principal Investigator: Lufei Young, PhD, University of Nebraska

Publications and helpful links

General Publications

• Young L, Hertzog M, Barnason S. Effects of a home-based activation intervention on self-management adherence and readmission in rural heart failure patients: the PATCH randomized controlled trial. BMC Cardiovasc Disord. 2016 Sep 8;16(1):176. doi: 10.1186/s12872-016-0339-7.
• Young L, Barnason S, Do V. Promoting self-management through adherence among heart failure patients discharged from rural hospitals: a study protocol. F1000Res. 2014 Dec 30;3:317. doi: 10.12688/f1000research.5998.2. eCollection 2014.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2013
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: October 10, 2013
• First Submitted That Met QC Criteria: October 13, 2013
• First Posted (Estimated): October 17, 2013

Study Record Updates

• Last Update Posted (Actual): September 6, 2023
• Last Update Submitted That Met QC Criteria: August 30, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: patient activation; hospital readmission; Self-management adherence; post acute care; critical access hospitals
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 0228-13-EP