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GrandAides; a Workforce Innovation to Address Post Acute Care

Sponsor
Temple University (Other)
Overall Status
Completed
CT.gov ID
NCT04966442
Collaborator
(none)
98
Enrollment
2
Arms
36
Actual Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: GrandAides
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
98 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
GrandAides; a Workforce Innovation to Address Post Acute Care
Actual Study Start Date :
Apr 1, 2014
Actual Primary Completion Date :
Mar 31, 2017
Actual Study Completion Date :
Mar 31, 2017

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. ER visits [3 years]

    number of ER visits

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Temple University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Temple University
ClinicalTrials.gov Identifier:
NCT04966442
Other Study ID Numbers:
  • Temple University
First Posted:
Jul 19, 2021
Last Update Posted:
Jul 19, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Heart Failure

Study Results

No Results Posted as of Jul 19, 2021