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出境医 / 临床实验 / GrandAides; a Workforce Innovation to Address Post Acute Care

GrandAides; a Workforce Innovation to Address Post Acute Care

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
Heart Failure Behavioral: GrandAides Not Applicable

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
Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : April 1, 2014
Actual Primary Completion Date : March 31, 2017
Actual Study Completion Date : March 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 [ Time Frame: 3 years ]
    number of ER visits


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

No Contacts or Locations Provided

Tracking Information
First Submitted Date  ICMJE June 7, 2021
First Posted Date  ICMJE July 19, 2021
Last Update Posted Date July 19, 2021
Actual Study Start Date  ICMJE April 1, 2014
Actual Primary Completion Date March 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 14, 2021) 		ER visits [ Time Frame: 3 years ]
number of ER visits
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE GrandAides; a Workforce Innovation to Address Post Acute Care
Official Title  ICMJE GrandAides; a Workforce Innovation to Address Post Acute Care
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Heart Failure
Intervention  ICMJE Behavioral: GrandAides
Enhanced post acute care for patients recently admitted for congestive heart failure
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: GrandAides
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 14, 2021) 		98
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 31, 2017
Actual Primary Completion Date March 31, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04966442
Other Study ID Numbers  ICMJE Temple University
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Temple University
Study Sponsor  ICMJE Temple University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Temple University
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP