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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02395588
Other study ID # HP-00055798
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 2014
Est. completion date June 2015

Study information

Verified date May 2021
Source University of Maryland, Baltimore
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study will test if standardized care helps patients feel better, if it can be implemented in rural hospitals, and find out which healthcare processes and outcomes are most important to heart failure patients.


Description:

The aims of this research are to: 1) Conduct a quasi-experimental study of rural hospitals to test if guideline-based care (standardized patient education, making a post discharge appointment with the patient's provider and calling the patient at 48 hours to reinforce HF education) improves patient outcomes (better self-care, and lower readmissions at 7 and 30 days post discharge); 2) Identify hospital (staffing, practice environment, costs) and provider (evidence-based practices) characteristics associated with better implementation of heart failure patient care processes; and 3) Determine which healthcare processes and outcomes are most important to heart failure patients. A quasi-experimental study with mixed methods will be used. The sample consists of HF patients (N=40, 20 each hospital) and nurses who care for HF patients on study units (N=90, 45 each hospital) from 2 rural hospitals. Survey data will be collected from patients (baseline, discharge, 48 hours and 7 days post discharge) and nurses (baseline, during patient education, on patient discharge). Secondary data will be collected quarterly on nurse staffing and once for patient readmission within 30 days of discharge. Structured patient interviews will be conducted with 10 HF patients in person to determine which health care processes and outcomes are most important to them. Both patients and nurses will be engaged to inform study procedures and outcomes consistent with the tenants of patient-centered outcomes research.


Recruitment information / eligibility

Status Completed
Enrollment 26
Est. completion date June 2015
Est. primary completion date June 2015
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility Inclusion Criteria: - Admitted to hospital with a diagnosis of heart failure - Age > 20 - Cognitively intact - English speaking - Plan for discharge to home, assisted living or intermediate care Exclusion Criteria: - Patients with planned discharge to sub-acute or nursing home facilities - Patients enrolled in another research study to test interventions to improve heart failure knowledge, self-management or reduce readmission to the hospital within 30 days post discharge - Patients that are cognitively impaired - Patients that are transferred to another unit in the hospital, and will be discharged from that unit - Patients who undergo or have a planned surgical intervention during their hospital stay

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Guideline based care
Patient education using guideline based teaching guides

Locations

Country Name City State
United States Riverside Shore Memorial Hospital Nassawadox Virginia
United States Riverside Tappahannock Hospital Tappahannock Virginia

Sponsors (1)

Lead Sponsor Collaborator
University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Self-management Self-care of Heart Failure Index 7 Days
Secondary Readmission Readmission to the hospital (all cause and heart failure related) 7 and 30 days post discharge
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