Diabetes Communication and Treatment Burden

Study Overview
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Brief Summary
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The objective of this proposal is to pilot test two types of pre-visit planning, where clinical staff reviews charts and talks to patients before their doctors appointments, to reduce the burden of diabetes care on the patient without increasing the visit workload during busy primary care clinics.

Official Title
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The Impact of Life Context and Social Determinants of Health on Treatment Burden in Diabetes and Multiple Chronic Conditions

Conditions
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Diabetes Mellitus, Type 2, Multiple Chronic Conditions

Intervention / Treatment
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* Other: CI-PVP (context-informed pre-visit planning)
* Other: Standard PVP (pre-visit planning)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients: patient at the UCD ACC family medicine residency clinic age 18+, has diabetes per Diabetes Registry (HealthyPlanet2020) PLUS at least one other chronic condition attends a primary care office visit (in-person or telehealth) during the study initial data collection period with a physician who is participating in the study speaks and writes English well enough to complete a written or oral survey consents to participate PCPs: -sees patients as a primary care physician at the study clinic site Exclusion Criteria: does not meet inclusion criteria

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Enhanced PVP | Other: CI-PVP (context-informed pre-visit planning)<br>* may experience a single additional phone call from clinic staff in addition to the standard clinic staff chart review, email and/or phone call prior to diabetes office visit<br>|
| Active Comparator: Standard<br>Standard PVP | Other: Standard PVP (pre-visit planning)<br>* standard clinic staff chart review, email and/or phone call prior to diabetes office visit<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pilot feasibility | patients reached by phone for PVP call after assigned to call; # patients recruited successfully who were eligible; # questions completed on the surveys; # calls made to each patient and to patients total per # patients reached and # patients enrolled; # patients who completed all surveys; qualitative interviews will discuss challenges, barriers, and other feasability concerns to scaling this pilot trial to a definitive multi-center trial | at completion of study, 4 months after last study visit | 
| Pilot acceptability) | a short survey measuring PCPs perception of the visit's difficulty, hassle and effort; qualittive interviews with patients, providers and those conducting the intervention PVP calls | after each clinic visit, within 2 weeks; at end of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Burden of Diabetes Care Questionnaire (TBQ) | a validated survey that measures patient self-assessment of chronic disease care burden; 13 items on a 5 point Likert scale, 13-65, higher score is worse | change from baseline to 4 months post visit | 
| Patient Experience with Treatment and Self-Management (PETS) Questionnaire Medical Expenses Subsection | a validated survey that measures patient's self-assessed ability to handle financial aspects of chronic disease care; 5 items on a 5 point Likert scale, 5-25, higher score is worse | change from baseline to 4 months post visit | 
| Healthcare Climate Questionnaire (HCQ) | a validated survey of patient experience with their healthcare; 6 items on a 7 point Likert scale, 6-42, higher score is better | change from baseline to 4 months post visit | 
| Patient Self-Activation Measure (PAM-13) short form | a validated measure of patient participation in their own healthcare; 13 items on a 4 point Likert scale, 13-52, higher score is better | change from baseline to 4 months post visit | 
| Perceived Diabetes Self-Management Scale | a validated survey on the patients perception of their ability to care for their diabetes; 8 items on a 5 point Likert scale, 8-40 higher score is worse | change from baseline to 4 months post visit | 
| SF-12, Short Form 12 questions Health Survey | a validated 12 question survey on patient's physical and mental health | change from baseline to 4 months post visit | 
| Discussion of social determinants of health (SDH) during clinic visit, self-reported | a single question survey, self-reporting by the participant, if SDH were discussed between the doctor and the patient during the visit | after each clinic visit, within 2 weeks | 
| HgbA1c value | change in A1c level from baseline to post-study, using values nearest to study start and end dates | change from baseline to 4 months post visit | 
| Blood pressure measurement | systolic and diastolic blood pressure value pre and psot study, using measures closest to study start and end date, and area-under-the-curve for blood pressure in between. | change from baseline to 4 months post visit | 
| Body Mass Index | Body Mass Index change from beginning of study to the end of the study, using most recent height available | change from baseline to 4 months post visit | 
| Physician Job Satisfaction Scale | validated survey on elements of physician job satisfaction | change from baseline to 4 months post visit | 
| Maslach Burnout Inventory Human Services Survey for Medical Personnel |  | change from baseline to 4 months post visit | 
| Depression symptoms | change in symptom score, as measured by PHQ2 (0-6, higher is worse) or PHQ9 (0-27, higher is worse), as available, done within one month of study start and after visit by study end | change from baseline to 4 months post visit | 
| Anxiety Symptoms | change in symptom score, as measured by GAD2 (0-6, higher is worse) or GAD7 (0-21, higher is worse), as available, done within one month of study start and after visit by study end | change from baseline to 4 months post visit |