GrandAides; a Workforce Innovation to Address Post Acute Care

Randomized controlled trial with two groups looking at post hospital care for patients who were admitted with congestive heart failure. The control group includes standard of care provided to the patients after discharge including a hospital employed community health worker. The intervention group receives a specially trained GrandAide following the GrandAide model for post acute care. Difference in ER visits and readmissions was measured.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Behavioral: GrandAides

Detailed Description

GrandAides program is a credible messenger community health worker based program that assumes a community health worker from the community who has specialized education around a certain chronic condition will be able to support patients in the outpatient setting more effectively than current standard of care. In this study a GrandAide visited a patient discharged from the hospital in their home for 4 weeks providing education, checking vital signs, and assisting with communication with the cardiologist. The study measured the difference in hospital admissions and ER visits between the group that was assigned a GrandAid and the group that took part in standard care. The groups were assigned randomly. The difference was calculated using one and two tailed t-test results.

• Study Type: Interventional
• Enrollment (Actual): 98
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Clinical diagnosis of heart failure Lives in 6 zipcode catchment area of Temple University Hospital Is followed by Temple Cardiology

Exclusion Criteria:

End Stage Renal Disease Housed in a Skilled Nursing Facility Substance Use Disorder Unable to give consent Doesn't speak English Under age 18

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GrandAides; Patients randomized to this arm of the trial received access to a specially trained GrandAide to work as a credible messenger community health worker. This GrandAide received 6 weeks of education around congestive heart failure to support the patient in the outpatient setting.	Behavioral: GrandAides; Enhanced post acute care for patients recently admitted for congestive heart failure
No Intervention: Standard of Care; This arm served as the control and included standard of care outpatient support for patients with heart failure.This support was done telephonically.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ER visits	number of ER visits	3 years

Collaborators and Investigators

• Sponsor: Temple University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2014
• Primary Completion (Actual): March 31, 2017
• Study Completion (Actual): March 31, 2017

Study Registration Dates

• First Submitted: June 7, 2021
• First Submitted That Met QC Criteria: July 14, 2021
• First Posted (Actual): July 19, 2021

Study Record Updates

• Last Update Posted (Actual): July 19, 2021
• Last Update Submitted That Met QC Criteria: July 14, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: Temple University

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No