Clinical trial NCT02395588: Improving Heart Failure Outcomes Rural
Official title: Improving Heart Failure Outcomes (IHO)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2015-03-23
Enrollment: 26
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients admitted to participating rural hospitals with a diagnosis of heart failure.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Self-management
timeFrame: 7 Days
Secondary outcomes:
measure: Readmission
timeFrame: 7 and 30 days post discharge
Other outcomes:
Locations:
city: Nassawadox
country: United States
facility: Riverside Shore Memorial Hospital
state: Virginia
city: Tappahannock
country: United States
facility: Riverside Tappahannock Hospital
state: Virginia
Study officials:
affiliation: University of Maryland, Baltimore
name: Robin P Newhouse, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: