Pilot of Home Visitation Services for Patients With a Diabetes Diagnosis

NCT03374098 | Unknown

• 1 other identifier: 17-036
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot program will assess whether an enhanced PCMH model with more intensive management and intervention can improve chronic disease patient outcomes, improve healthcare delivery, and reduce healthcare costs. Participants in this program are current patients at Leland Medical Clinic and are either enrolled, or eligible to enroll, in Mississippi's Medicaid program. This pilot program will test the effectiveness of high-quality interventions comprising of: (1) an educational intervention focusing on chronic disease management and (2) home visits by a trained community outreach worker. This pilot program will evaluate both process measures and outcome measures. Examples of process measures include, but are not limited to, the number of patients enrolled in each intervention group, the number of educational classes attended by a unique patient, and the number of home visits a unique patient receives. Examples of outcomes measures include, but are not limited to, change in patient HbA1C levels, change in patient LDL/HDL levels, change in patient blood pressure (systolic and diastolic) levels, and a comparison of patient cost data (total expenditure, expenditures by other major categories like hospital, pharmacy, etc.) After baseline measurements, patient clinical values will be acquired every 3 months for the duration of their engagement. This pilot project has three specific goals: Goal 1: Improve healthcare delivery for chronic disease patients enrolled in Mississippi Medicaid. Goal 2: Improve clinical outcomes for chronic disease patients enrolled in Mississippi Medicaid. Goal 3: Reduce Mississippi Medicaid costs for chronic disease patients enrolled in this pilot program.

Conditions

Diabetes

Keywords

Medicaid; Mississippi

Outcome Measures

Primary Outcomes (1)

• Changes in HbA1C values

  Data recorded in electronic health records system

  Six months and three months before enrollment, at enrollment, three and six months follow-ups

Secondary Outcomes (9)

• ED visits

  Baseline and six-month follow-up

• Changes in LDL values

  Six months and three months before enrollment, at enrollment, three and six months follow-ups

• Changes in blood pressure values

  Six months and three months before enrollment, at enrollment, three and six months follow-ups

• Total medical costs

  End of enrollment in intervention and six month follow-up

• Medication adherence

  At enrollment in intervention, six month follow-up

Study Arms (2)

Education

EXPERIMENTAL

Attend an hour-long classes once per week for three weeks

Behavioral: Education

Home Visitation

EXPERIMENTAL

Receive home visits that focus on the social determinants of health and attend hour-long classes once per week for three weeks

Behavioral: Home Visitiation; Behavioral: Education

Interventions

Home Visitiation BEHAVIORAL

The home visit component of the intervention will involve a visit to participants' homes by a social worker, who will assist patients dealing with other health and social problems. Participants will be followed for a minimum of 10 weeks, and additional follow-up visits will be at the discretion of the social worker. They will work with community partners and refer patients when appropriate. Community partners could include: Domestic violence services, employment placement, benefit enrollment, community action agency (bill pay, utilities), ACA enrollment, homeless shelter, housing authority, re-housing program

Home Visitation

Education BEHAVIORAL

The education component of the intervention will include attending a class once per week for 3 weeks. Classes will be led by a dietician, and may also involve other members of an interdisciplinary team including nurse practitioners, health educators, and community members. Education sessions will be held at 5:30pm on Mondays or Tuesdays, and participants will be provided with a meal. Topics will include: * Week 1 (5:30-6:30pm): Importance of self-management of disease, glucometer testing for blood sugars and using home blood pressure monitors, diabetes medication review * Week 2 (5:30-7:00pm): Diabetes and Healthy Eating and Exercise - carbohydrate counting, portion control, lifestyle activity, and exercise demonstration activity * Week 3 (5:30-6:30pm): Grocery shopping guidelines, label reading, hands on cooking demo

Education; Home Visitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Leland Medical Clinic (LMC) patients
• Medicaid beneficiary or no insurance
• Active diabetes diagnosis
• Diagnosis of at least one other chronic condition (COPD, Hypertension, chronic kidney disease, CHF
• Baseline HbA1c 7.0 or above.

You may not qualify if:

• \- Patients with active psychoses will not be eligible.

Sponsors & Collaborators

• Delta Health Alliance: lead
• University of Tennessee: collaborator
• Emory University: collaborator

Study Sites (1)

Leland Medical Clinic

Leland, Mississippi, 38756, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Karen C Matthews

  Delta Health Alliance

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2017
• First Posted: December 15, 2017
• Study Start: January 1, 2018
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: July 23, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)