Trial Outcomes & Findings for Reducing Emergency Diabetes Care for Older African Americans (NCT NCT03466866)

Last Updated: 2024-05-14

Results Overview

The primary efficacy analysis will consider the number of incident diabetes-related ED visits and/or hospitalizations (i.e., an "event") over 12 months after the index ED visit. Each ED visit or hospitalization is counted as a single event (although an ED visit that leads to a hospitalization is counted once). ED visits and hospitalization will be ascertained through chart reviews and subject self-report.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

156 participants

Primary outcome timeframe

12 months

Results posted on

2024-05-14

Participant Flow

Recruitment period: 1/10/2019 to 10/13/2021

Participant milestones

Participant milestones
Measure	PREVENT (Preventing and Reducing Emergency Visits in Diabetes Through Education and Telehealth) Community Health Workers (CHWs), who are race-concordant with participants, will: 1) deliver in-home DM education to increase participants' knowledge and skills; 2) use DM-specific Behavioral Activation to improve DM self-care; and 3) facilitate telehealth visits with the participant's primary care physician (PCP) and a DM nurse educator to increase access to care. PREVENT: Community Health Workers (CHWs), who are race-concordant with participants, will: 1) deliver in-home DM education to increase participants' knowledge and skills; 2) use DM-specific Behavioral Activation to improve DM self-care; and 3) facilitate telehealth visits with the participant's primary care physician (PCP) and a DM nurse educator to increase access to care.	EUC (Enhanced Usual Care) In-home diabetes education with no goal stetting or telehealth visits
Overall Study STARTED	78	78
Overall Study COMPLETED	62	62
Overall Study NOT COMPLETED	16	16

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Reducing Emergency Diabetes Care for Older African Americans

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PREVENT (Preventing and Reducing Emergency Visits in Diabetes Through Education and Telehealth) n=78 Participants Community Health Workers (CHWs), who are race-concordant with participants, will: 1) deliver in-home DM education to increase participants' knowledge and skills; 2) use DM-specific Behavioral Activation to improve DM self-care; and 3) facilitate telehealth visits with the participant's primary care physician (PCP) and a DM nurse educator to increase access to care. PREVENT: Community Health Workers (CHWs), who are race-concordant with participants, will: 1) deliver in-home DM education to increase participants' knowledge and skills; 2) use DM-specific Behavioral Activation to improve DM self-care; and 3) facilitate telehealth visits with the participant's primary care physician (PCP) and a DM nurse educator to increase access to care.	EUC (Enhanced Usual Care) n=78 Participants In-home diabetes education with no goal setting or telehealth visits EUC (Enhanced Usual Care): In-home diabetes education with no goal setting or telehealth visits	Total n=156 Participants Total of all reporting groups
Age, Continuous	56.4 years STANDARD_DEVIATION 9.5 • n=5 Participants	57.2 years STANDARD_DEVIATION 9.5 • n=7 Participants	56.8 years STANDARD_DEVIATION 9.5 • n=5 Participants
Sex: Female, Male Female	48 Participants n=5 Participants	50 Participants n=7 Participants	98 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants	28 Participants n=7 Participants	58 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	77 Participants n=5 Participants	76 Participants n=7 Participants	153 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	78 Participants n=5 Participants	78 Participants n=7 Participants	156 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	78 participants n=5 Participants	78 participants n=7 Participants	156 participants n=5 Participants
Stratification variable: Baseline HbA1c < 9.0% vs. > or equal to 9.0% Baseline HbA1c < 9.0%	40 Participants n=5 Participants	42 Participants n=7 Participants	82 Participants n=5 Participants
Stratification variable: Baseline HbA1c < 9.0% vs. > or equal to 9.0% Baseline HbA1c > or equal to 9.0%	38 Participants n=5 Participants	36 Participants n=7 Participants	74 Participants n=5 Participants
Stratification variable: Primary care physician at Jefferson Jefferson primary care physician	40 Participants n=5 Participants	40 Participants n=7 Participants	80 Participants n=5 Participants
Stratification variable: Primary care physician at Jefferson Non-Jefferson primary care physician	38 Participants n=5 Participants	38 Participants n=7 Participants	76 Participants n=5 Participants
Stratification variable: Discharge status Discharged home from index visit	38 Participants n=5 Participants	39 Participants n=7 Participants	77 Participants n=5 Participants
Stratification variable: Discharge status Admitted from index visit	40 Participants n=5 Participants	39 Participants n=7 Participants	79 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: All randomized participants

Outcome measures

Outcome measures
Measure	PREVENT (Preventing and Reducing Emergency Visits in Diabetes Through Education and Telehealth) n=78 Participants Community Health Workers (CHWs), who are race-concordant with participants, will: 1) deliver in-home DM education to increase participants' knowledge and skills; 2) use DM-specific Behavioral Activation to improve DM self-care; and 3) facilitate telehealth visits with the participant's primary care physician (PCP) and a DM nurse educator to increase access to care. PREVENT: Community Health Workers (CHWs), who are race-concordant with participants, will: 1) deliver in-home DM education to increase participants' knowledge and skills; 2) use DM-specific Behavioral Activation to improve DM self-care; and 3) facilitate telehealth visits with the participant's primary care physician (PCP) and a DM nurse educator to increase access to care.	EUC (Enhanced Usual Care) n=78 Participants In-home diabetes education with no goal setting or telehealth visits EUC (Enhanced Usual Care): In-home diabetes education with no goal setting or telehealth visits
Number of Incident Diabetes-related ED Visits and/or Hospitalizations	.88 Incidence rate ratio Interval 0.62 to 1.27	1.29 Incidence rate ratio Interval 0.93 to 1.79

SECONDARY outcome

Timeframe: 12 months

Population: Participants who provided self-reported data at 6 and 12 months

Patient Satisfaction Questionnaire scores: Mean change from baseline to 12 months. There are seven subscales, and subscale scores range from 1 to 5 with higher scores indicating greater satisfaction.

Outcome measures

Outcome measures
Measure	PREVENT (Preventing and Reducing Emergency Visits in Diabetes Through Education and Telehealth) n=54 Participants Community Health Workers (CHWs), who are race-concordant with participants, will: 1) deliver in-home DM education to increase participants' knowledge and skills; 2) use DM-specific Behavioral Activation to improve DM self-care; and 3) facilitate telehealth visits with the participant's primary care physician (PCP) and a DM nurse educator to increase access to care. PREVENT: Community Health Workers (CHWs), who are race-concordant with participants, will: 1) deliver in-home DM education to increase participants' knowledge and skills; 2) use DM-specific Behavioral Activation to improve DM self-care; and 3) facilitate telehealth visits with the participant's primary care physician (PCP) and a DM nurse educator to increase access to care.	EUC (Enhanced Usual Care) n=58 Participants In-home diabetes education with no goal setting or telehealth visits EUC (Enhanced Usual Care): In-home diabetes education with no goal setting or telehealth visits
Perceived Access to Health Care General Satisfaction	.22 units on a scale Interval -0.02 to 0.46	.11 units on a scale Interval -0.13 to 0.34
Perceived Access to Health Care Financial Aspects	.13 units on a scale Interval -0.12 to 0.39	.29 units on a scale Interval 0.04 to 0.55
Perceived Access to Health Care Communication	.2 units on a scale Interval -0.01 to 0.42	.17 units on a scale Interval -0.04 to 0.38
Perceived Access to Health Care Accessibility and Convenience	.28 units on a scale Interval 0.07 to 0.49	.21 units on a scale Interval 0.0 to 0.41
Perceived Access to Health Care Interpersonal Manner	.18 units on a scale Interval -0.01 to 0.37	.09 units on a scale Interval -0.09 to 0.28
Perceived Access to Health Care Technical Quality	.27 units on a scale Interval 0.07 to 0.46	.17 units on a scale Interval -0.02 to 0.37
Perceived Access to Health Care Time Spent with Doctor	.03 units on a scale Interval -0.19 to 0.26	.19 units on a scale Interval -0.03 to 0.41

SECONDARY outcome

Timeframe: 12 months

Population: All randomized participants

Number of received Diabetes Quality Metrics (e.g., hemoglobin A1c testing, urine screening) by 12 months. The metrics are at least 2 HbA1c tests, 1 lipid test, 1 blood pressure check, 1 diabetes foot exam, and 1 dilated fundus examination. Scores range from 0 to 6, with 6 indicating better access to care.

Outcome measures

Outcome measures
Measure	PREVENT (Preventing and Reducing Emergency Visits in Diabetes Through Education and Telehealth) n=78 Participants Community Health Workers (CHWs), who are race-concordant with participants, will: 1) deliver in-home DM education to increase participants' knowledge and skills; 2) use DM-specific Behavioral Activation to improve DM self-care; and 3) facilitate telehealth visits with the participant's primary care physician (PCP) and a DM nurse educator to increase access to care. PREVENT: Community Health Workers (CHWs), who are race-concordant with participants, will: 1) deliver in-home DM education to increase participants' knowledge and skills; 2) use DM-specific Behavioral Activation to improve DM self-care; and 3) facilitate telehealth visits with the participant's primary care physician (PCP) and a DM nurse educator to increase access to care.	EUC (Enhanced Usual Care) n=78 Participants In-home diabetes education with no goal setting or telehealth visits EUC (Enhanced Usual Care): In-home diabetes education with no goal setting or telehealth visits
Actual Access to Care	3.69 Number of quality metrics met Interval 3.39 to 4.0	3.42 Number of quality metrics met Interval 3.12 to 3.73

SECONDARY outcome

Timeframe: 12 months

Population: Participants who provided self-reported data at 6 and 12 months

Frequency of engaging in diabetes self-care behaviors; Scores range from 0 to 100 with higher scores indicating more frequent engagement in diabetes self-management behaviors.

Outcome measures

Outcome measures
Measure	PREVENT (Preventing and Reducing Emergency Visits in Diabetes Through Education and Telehealth) n=57 Participants Community Health Workers (CHWs), who are race-concordant with participants, will: 1) deliver in-home DM education to increase participants' knowledge and skills; 2) use DM-specific Behavioral Activation to improve DM self-care; and 3) facilitate telehealth visits with the participant's primary care physician (PCP) and a DM nurse educator to increase access to care. PREVENT: Community Health Workers (CHWs), who are race-concordant with participants, will: 1) deliver in-home DM education to increase participants' knowledge and skills; 2) use DM-specific Behavioral Activation to improve DM self-care; and 3) facilitate telehealth visits with the participant's primary care physician (PCP) and a DM nurse educator to increase access to care.	EUC (Enhanced Usual Care) n=60 Participants In-home diabetes education with no goal setting or telehealth visits EUC (Enhanced Usual Care): In-home diabetes education with no goal setting or telehealth visits
Change From Baseline to 12 Months on Diabetes Self-Care Inventory Scores	8.02 units on a scale Interval 4.31 to 11.73	3.57 units on a scale Interval -0.09 to 7.23

Adverse Events

PREVENT (Preventing and Reducing Emergency Visits in Diabetes Through Education and Telehealth)

Serious events: 36 serious events

Other events: 0 other events

Deaths: 0 deaths

EUC (Enhanced Usual Care)

Serious events: 39 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Adverse event data not reported

Additional Information

Barry Rovner,MD

Thomas Jefferson University

Phone: 215-503-1243

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	PREVENT (Preventing and Reducing Emergency Visits in Diabetes Through Education and Telehealth) n=78 participants at risk Community Health Workers (CHWs), who are race-concordant with participants, will: 1) deliver in-home DM education to increase participants' knowledge and skills; 2) use DM-specific Behavioral Activation to improve DM self-care; and 3) facilitate telehealth visits with the participant's primary care physician (PCP) and a DM nurse educator to increase access to care. PREVENT: Community Health Workers (CHWs), who are race-concordant with participants, will: 1) deliver in-home DM education to increase participants' knowledge and skills; 2) use DM-specific Behavioral Activation to improve DM self-care; and 3) facilitate telehealth visits with the participant's primary care physician (PCP) and a DM nurse educator to increase access to care.	EUC (Enhanced Usual Care) n=78 participants at risk In-home diabetes education with no goal stetting or telehealth visits
Gastrointestinal disorders Gastrointestinal	6.4% 5/78 • Number of events 6 • 12 months Adverse events were events that resulted in a hospitalization. Adverse Events were reported by organ system class.	12.8% 10/78 • Number of events 15 • 12 months Adverse events were events that resulted in a hospitalization. Adverse Events were reported by organ system class.
Cardiac disorders Cardiac	11.5% 9/78 • Number of events 11 • 12 months Adverse events were events that resulted in a hospitalization. Adverse Events were reported by organ system class.	20.5% 16/78 • Number of events 22 • 12 months Adverse events were events that resulted in a hospitalization. Adverse Events were reported by organ system class.
Endocrine disorders Diabetes-related	6.4% 5/78 • Number of events 5 • 12 months Adverse events were events that resulted in a hospitalization. Adverse Events were reported by organ system class.	7.7% 6/78 • Number of events 6 • 12 months Adverse events were events that resulted in a hospitalization. Adverse Events were reported by organ system class.
Metabolism and nutrition disorders metabolic-not diabetes related	1.3% 1/78 • Number of events 2 • 12 months Adverse events were events that resulted in a hospitalization. Adverse Events were reported by organ system class.	1.3% 1/78 • Number of events 1 • 12 months Adverse events were events that resulted in a hospitalization. Adverse Events were reported by organ system class.
Infections and infestations Infection	12.8% 10/78 • Number of events 11 • 12 months Adverse events were events that resulted in a hospitalization. Adverse Events were reported by organ system class.	11.5% 9/78 • Number of events 14 • 12 months Adverse events were events that resulted in a hospitalization. Adverse Events were reported by organ system class.
Nervous system disorders Stroke	2.6% 2/78 • Number of events 3 • 12 months Adverse events were events that resulted in a hospitalization. Adverse Events were reported by organ system class.	2.6% 2/78 • Number of events 2 • 12 months Adverse events were events that resulted in a hospitalization. Adverse Events were reported by organ system class.
Respiratory, thoracic and mediastinal disorders COPD	1.3% 1/78 • Number of events 1 • 12 months Adverse events were events that resulted in a hospitalization. Adverse Events were reported by organ system class.	2.6% 2/78 • Number of events 2 • 12 months Adverse events were events that resulted in a hospitalization. Adverse Events were reported by organ system class.
Musculoskeletal and connective tissue disorders musculoskeletal	11.5% 9/78 • Number of events 13 • 12 months Adverse events were events that resulted in a hospitalization. Adverse Events were reported by organ system class.	6.4% 5/78 • Number of events 5 • 12 months Adverse events were events that resulted in a hospitalization. Adverse Events were reported by organ system class.
Blood and lymphatic system disorders Blood disorders	2.6% 2/78 • Number of events 7 • 12 months Adverse events were events that resulted in a hospitalization. Adverse Events were reported by organ system class.	3.8% 3/78 • Number of events 3 • 12 months Adverse events were events that resulted in a hospitalization. Adverse Events were reported by organ system class.
Nervous system disorders Neurological (excluding stroke)	7.7% 6/78 • Number of events 6 • 12 months Adverse events were events that resulted in a hospitalization. Adverse Events were reported by organ system class.	7.7% 6/78 • Number of events 7 • 12 months Adverse events were events that resulted in a hospitalization. Adverse Events were reported by organ system class.
Psychiatric disorders psychiatric	1.3% 1/78 • Number of events 1 • 12 months Adverse events were events that resulted in a hospitalization. Adverse Events were reported by organ system class.	1.3% 1/78 • Number of events 1 • 12 months Adverse events were events that resulted in a hospitalization. Adverse Events were reported by organ system class.
Respiratory, thoracic and mediastinal disorders Respiratory	1.3% 1/78 • Number of events 1 • 12 months Adverse events were events that resulted in a hospitalization. Adverse Events were reported by organ system class.	1.3% 1/78 • Number of events 1 • 12 months Adverse events were events that resulted in a hospitalization. Adverse Events were reported by organ system class.
Respiratory, thoracic and mediastinal disorders shortness of breath	5.1% 4/78 • Number of events 4 • 12 months Adverse events were events that resulted in a hospitalization. Adverse Events were reported by organ system class.	3.8% 3/78 • Number of events 3 • 12 months Adverse events were events that resulted in a hospitalization. Adverse Events were reported by organ system class.
Renal and urinary disorders renal	2.6% 2/78 • Number of events 3 • 12 months Adverse events were events that resulted in a hospitalization. Adverse Events were reported by organ system class.	3.8% 3/78 • Number of events 6 • 12 months Adverse events were events that resulted in a hospitalization. Adverse Events were reported by organ system class.
Respiratory, thoracic and mediastinal disorders Pulmonary	2.6% 2/78 • Number of events 2 • 12 months Adverse events were events that resulted in a hospitalization. Adverse Events were reported by organ system class.	7.7% 6/78 • Number of events 7 • 12 months Adverse events were events that resulted in a hospitalization. Adverse Events were reported by organ system class.
Surgical and medical procedures Surgical	1.3% 1/78 • Number of events 1 • 12 months Adverse events were events that resulted in a hospitalization. Adverse Events were reported by organ system class.	1.3% 1/78 • Number of events 1 • 12 months Adverse events were events that resulted in a hospitalization. Adverse Events were reported by organ system class.