Diabetes Mellitus
Conditions
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
Interventions
BEHAVIORALLifestyle Redesign
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.
Sponsors
Los Angeles County Department of Health Services (DHS)
National Center for Advancing Translational Sciences (NCATS)
University of Southern California
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
This is an implementation trial being conducted in a real-world clinical setting in which masking is not appropriate.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 |
| 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 |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
United States
Outcome results
None listed