Complete Health Improvement Program for Geisinger Health Plan Members With Type 2 Diabetes

Thomas Morland38 enrolled

Overview

The Complete Health Improvement Program (CHIP) is a lifestyle improvement program intended to prevent and/or manage cardiovascular disease, diabetes, and other health conditions. This is a pilot-scale randomized-controlled trial comparing the clinical, utilization, and financial outcomes of adult health plan members with type 2 diabetes mellitus (T2DM) offered CHIP versus those only offered standard health plan coverage. We hypothesize that Geisinger Health Plan (GHP) members with T2DM offered CHIP in addition to standard insurance coverage will have improvement in HbA1c and improvements in other biometrics, biomarkers, psychometrics and utilization/financial outcomes, including LDL-C, systolic blood pressure, body mass index, waist circumference, number of diabetes medications prescribed, Wellbeing360 survey, and total cost of healthcare.

This is a pilot prospective randomized-controlled trial of 60 patients randomized to either the intervention group; in which patients enroll in the CHIP program, or the control group, in which patients follow their usual diabetes care. We hypothesize that Geisinger Health Plan members with T2DM offered CHIP in addition to standard insurance coverage will have improvement in HbA1c and improvements in other biometrics, biomarkers, psychometrics and utilization/financial outcomes, including LDL-C, systolic blood pressure, body mass index, waist circumference, number of diabetes medications prescribed, Wellbeing360 survey, and total cost of healthcare. The intervention group will attend 18 classes covering topics such as diet, sleep, exercise instruction, stress management, and toxic substance avoidance. Biometrics (weight, BMI, waist circumference, systolic/diastolic blood pressure), biomarkers (HbA1c, LDL-C) and psychometrics (Wellbeing 360 survey) will be collected on all participants at baseline, 3-months and 6-months. The CHIP curriculum will be administered during twice weekly 1-hour classes over a 6-week period, followed by weekly 1-hour classes for an additional 6 weeks. The protocol will begin with a 1-month in-person period, with participants subsequently offered the choice between in-person and online attendance for the remaining sessions. The primary aim is to compare change in HbA1c, LDL-C, systolic blood pressure, body mass index, and waist circumference for GHP members offered CHIP versus members offered standard insurance coverage at 3- and 6-months. Through this pilot study, we hope to gain insight into whether and how such an application of CHIP could be a cost-effective tool for health plans such as GHP to achieve clinical and financial goals for adult members with T2DM.

Study Type

Interventions

CHIP ProgramBEHAVIORAL

GHP members randomized to the intervention arm will participate in the following activities: * Attend 2 group meetings per week over 6 weeks, followed by one group meeting per week for 6 weeks (12 weeks total); each meeting will last about one hour. CHIP classes for weeks 1-4 and week 12 require in-person attendance, while week 5-11 classes can be attended either virtually or in-person. * Receive a copy of The Optimal Diet, The Official CHIP Cookbook. The following data will be collected at weeks 1,12 and 26: * Biometrics: weight, BMI, waist circumference, systolic and diastolic blood pressure * Biomarkers (blood tests): HbA1c, LDL-C * Psychometrics: Wellbeing360 survey

Usual CareBEHAVIORAL

GHP members assigned to the control arm will receive the routine standard of care for GHP members. Members will receive a summary of diabetes-related benefits available to members with type 2 diabetes. The following data will be collected at weeks 1,12 and 26: * Biometrics: Weight, BMI, waist circumference, systolic and diastolic blood pressure * Biomarkers (blood tests): HbA1c, LDL-C * Psychometrics: Wellbeing360 survey

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Geisinger Health Plan member for a full year prior to enrollment in the study, with plans to remain covered for a full year after the first study visit * HbA1c resulted within a year of enrollment in the study * ≥ 18 years * Current type 2 diabetes diagnosis * Living in the five-county region served by the Miller Center (Lycoming, Montour, Northumberland, Snyder and Union) with the ability to arrange their own transportation to the Miller Center in Lewisburg at least 10 times in a 3-month period * Access to computer, phone, or tablet with sufficient internet to complete program activities. Exclusion Criteria: * Presence of medical condition requiring specific diet (e.g., Celiac disease, phenylketonuria) * Presence of medical condition contraindicating participation in CHIP, as determined by the Principal Investigator (e.g. cancer on active treatment) * Pregnancy or plan to become pregnant within one year * Inability to give informed consent due to mental or psychiatric impairment * Participation in the Fresh Food Farmacy program

Outcomes

Primary Outcomes

Change in HbA1c

Change in HbA1c after 6 months compared to baseline

Time frame: 6 months

Percentage of Patients Who Completed Biomarkers

What percentage of individuals completed biomarkers

Time frame: 3 and 6 months

Percentage of Patients Who Completed Biometrics

What percentage of individuals completed biometrics

Time frame: 3 and 6 months

Percentage of Patients Contacted Who Agreed to Participate

What percentage of individuals contacted who agreed to participate in the study

Time frame: Baseline

Secondary Outcomes

HbA1c Control at 3 Months

Change in HbA1c percentage at 3 months compared to at baseline

Time frame: 3 months

LDL-C at 3 Months

Change in LDL-C levels at 3 compared to baseline

Time frame: 3 months

Change in Weight at 3 Months

Change in weight at 3 months compared to baseline

Time frame: 3months

Change in Weight at 6 Months

Change in weight at 6 months compared to baseline

Time frame: 6 months

Health Behaviors, as Measured by CHIP Participation

Overall program completion, defined as completing the majority of study activities

Time frame: 6 months

Number of Diabetes Medications Prescribed at 6 Months

Change in number of diabetes medications at 6 months compared to baseline. Number of diabetes medications, by medication class, were collected for each responding patient at 3 and 6 months. Due to small sample size and lack of reversing changes between 3 and 6 months (i.e. all changes made by 3 months were continued at 6-month mark, whereas some additional changes were made between 3 and 6 months), changes between months 1-3 and 4-6 were pooled into a single report of cumulative change between baseline and the 6-month mark).

Time frame: 6 months

Change in LDL-C at 6 Months

Change in LDL-C at 6 months compared to baseline

Time frame: 6 months

Systolic Blood Pressure After 3 Months

Change in systolic blood pressure at 3 months compared to baseline

Time frame: 3 months

Systolic Blood Pressure at 6 Months

Change in systolic blood pressure at 6 months compared to baseline

Time frame: 6 months

Diastolic Blood Pressure at 6 Months

Change in diastolic blood pressure at 6 months compared to baseline

Time frame: 6 months

Diastolic Blood Pressure After 3 Months

Change in diastolic blood pressure at 3 months compared to baseline

Time frame: 3 months

Change in Total Cost of Care, Versus Same 6 Months Year Prior

This outcome evaluates cost of care in the 6 months beginning to the first day of the CHIP program versus the same 6 months as patient's participation in the study one year prior to enrollment

Time frame: 6 months of participation compared to same period one year prior

Change in Total Cost of Care Versus 6 Months Leading to Intervention

This outcome evaluates cost of care in the 6 months beginning to the first day of the CHIP program versus the 6 months leading up to that date

Time frame: 6 months beginning with first day of intervention versus 6 months leading up to that day

Complete Health Improvement Program for Geisinger Health Plan Members With Type 2 Diabetes

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes