Addressing Uncontrolled Diabetes in Primary Care: A Lifestyle Redesign Approach
- Conditions
- Diabetes Mellitus
- Interventions
- Behavioral: Lifestyle Redesign
- Registration Number
- NCT03293914
- Lead Sponsor
- University of Southern California
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 143
- 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
- Active, untreated substance use or behavioral health disorder which interferes with participation in major life activities
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Lifestyle Redesign 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.
- Primary Outcome Measures
Name Time Method 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 all measures taken from one year prior to baseline, to immediately post-intervention (an average of 4 months) Measure of average blood glucose concentration over approximately the previous 12 weeks. HbA1C is measured periodically, as prescribed by study-independent provider.
- Secondary Outcome Measures
Name Time Method Acceptability Months 11-12 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.
Change from baseline in Audit of Diabetes-Dependent Quality of Life (ADD-QoL) at post-intervention Baseline, an average of 4 months 19-item survey measure assessing impact of diabetes on social, physical, and emotional functioning.
Change from baseline in Medication adherence scale at post-intervention Baseline, an average of 4 months 3-item self-report medication adherence scale designed by Ira B. Wilson, Yoojin Lee, Joanne Michaud, Floyd J. FowlerJr., and William H. Rogers
Appropriateness Months 0-2, 3-10, and 11-12 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.
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 all measures taken from one year prior to baseline, to immediately post-intervention (an average of 4 months) 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).
Change from baseline in Summary of Diabetes Self-Care Activities (SDSCA) at post-intervention Baseline, an average of 4 months 14 items assessing diet, physical activity, medication adherence and other self-care behaviors relevant to diabetes.
Change from baseline in Appraisal of Diabetes Scale at post-intervention Baseline, an average of 4 months 7-item self-report scale assessing the individual's appraisal of his or her diabetes
Feasibility Months 0-2, and 11-12 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.
Timeliness Months 11-12 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.
Change from baseline RAND 20-Item Short Form Survey (SF-20) at post-intervention Baseline, an average of 4 months The SF-20 is a 20-item set of generic, coherent, and easily administered quality-of-life measures.
Fidelity Months 0-2, 3-10, and 11-12 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.
Efficiency Months 0-2 and 11-12 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.
Trial Locations
- Locations (1)
LAC+USC Primary Care Adult West Clinic
🇺🇸Los Angeles, California, United States