Addressing Uncontrolled Diabetes in Primary Care: A Lifestyle Redesign Approach

Study Overview
=================
Brief Summary
-----------------
This study is examining the feasibility of implementing an occupational therapy intervention addressing diabetes management in a primary care clinic within the Los Angeles County Department of Health Services (LAC-DHS), as well as the impact of this intervention approach on clinical outcomes, efficiency and patient-centeredness of care. This implementation science study is evaluating two emerging trends in healthcare delivery: (1) the integration of nontraditional providers into primary care medical home (PCMH) settings to facilitate the delivery of high-quality, comprehensive primary care while reducing the burden on physicians; and (2) the potential value of using occupational therapists to address chronic disease management in this setting

Official Title
-----------------
Addressing Uncontrolled Diabetes in Primary Care: A Lifestyle Redesign Approach

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Behavioral: Lifestyle Redesign


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Current patient at Los Angeles County-USC Medical Center Adult West Primary Care clinic Diagnosed diabetes (type 1 or type 2) documented in EMR Most recent HbA1c level >9.0% OR has not had an HbA1c measurement within past 12 months Per provider judgment, would be willing to make lifestyle changes related to diabetes self-care Exclusion Criteria: Active, untreated substance use or behavioral health disorder which interferes with participation in major life activities

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Participants will be invited to enroll in an occupational therapy (OT) lifestyle redesign intervention focused on diabetes management. The intervention includes approximately 8 one-hour OT sessions over 4 months. | Behavioral: Lifestyle Redesign<br>* Individualized lifestyle intervention incorporating the following topics: Diabetes knowledge; access to healthcare; communication with healthcare providers; incorporation of diabetes self-care tasks within daily habits and routines; social support; and emotional well-being. Participants receive approximately 8 hours of intervention by a licensed occupational therapist with training in diabetes education, motivational interviewing and the intervention protocol.<br>* Other names: Resilient, Empowered, Active Living with Diabetes (REAL);|
| No Intervention: Usual Care Control<br>Participants will not be contacted; outcome data will be extracted from medical records. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in the daily rate of change of Glycated hemoglobin (HbA1C) during the year prior to baseline, compared to the period from baseline to post-intervention | Measure of average blood glucose concentration over approximately the previous 12 weeks. HbA1C is measured periodically, as prescribed by study-independent provider. | all measures taken from one year prior to baseline, to immediately post-intervention (an average of 4 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Audit of Diabetes-Dependent Quality of Life (ADD-QoL) at post-intervention | 19-item survey measure assessing impact of diabetes on social, physical, and emotional functioning. | Baseline, an average of 4 months | 
| Difference in the daily rate of change of Patient Health Questionnaire-9 (PHQ-9) during the year prior to baseline, compared to the period from baseline to post-intervention | 9-item survey measure assessing severity of depressive symptoms. PHQ-9 is measured at each study-independent clinic visit for patients who screen positive on the PHQ-2 (score >2). | all measures taken from one year prior to baseline, to immediately post-intervention (an average of 4 months) | 
| Change from baseline in Summary of Diabetes Self-Care Activities (SDSCA) at post-intervention | 14 items assessing diet, physical activity, medication adherence and other self-care behaviors relevant to diabetes. | Baseline, an average of 4 months | 
| Change from baseline in Medication adherence scale at post-intervention | 3-item self-report medication adherence scale designed by Ira B. Wilson, Yoojin Lee, Joanne Michaud, Floyd J. FowlerJr., and William H. Rogers | Baseline, an average of 4 months | 
| Change from baseline in Appraisal of Diabetes Scale at post-intervention | 7-item self-report scale assessing the individual's appraisal of his or her diabetes | Baseline, an average of 4 months | 
| Change from baseline RAND 20-Item Short Form Survey (SF-20) at post-intervention | The SF-20 is a 20-item set of generic, coherent, and easily administered quality-of-life measures. | Baseline, an average of 4 months | 
| Acceptability | Both formative and summative data will be gathered throughout the study to assess acceptability, defined herein as the perception of the intervention as agreeable/satisfactory. Acceptability will be assessed through interviews. | Months 11-12 | 
| Appropriateness | Both formative and summative data will be gathered throughout the study to assess appropriateness, defined herein as the perceived relevance or compatibility of the intervention in the practice setting. Appropriateness will be assessed through interviews. | Months 0-2, 3-10, and 11-12 | 
| Feasibility | Both formative and summative data will be gathered throughout the study to assess feasibility, defined herein as the extent to which the intervention can be successfully used in a practice setting. Feasibility will be assessed through surveys. | Months 0-2, and 11-12 | 
| Fidelity | Both formative and summative data will be gathered throughout the study to assess fidelity, defined herein as the extent to which the intervention is implemented as intended. Fidelity will be assessed through score on fidelity checklist. | Months 0-2, 3-10, and 11-12 | 
| Efficiency | Both formative and summative data will be gathered throughout the study to assess efficiency, defined herein as the degree to which providers work to the top of license. Efficiency will be assessed through interviews. | Months 0-2 and 11-12 | 
| Timeliness | Both formative and summative data will be gathered throughout the study to assess timeliness, defined herein as the availability of appointments when needed. Timeliness will be assessed through staff documentation records. | Months 11-12 |