Diabetes Communication and Treatment Burden
- Conditions
- Diabetes Mellitus, Type 2Multiple Chronic Conditions
- Interventions
- Other: Standard PVP (pre-visit planning)Other: CI-PVP (context-informed pre-visit planning)
- Registration Number
- NCT04568382
- Lead Sponsor
- University of California, Davis
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
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
- does not meet inclusion criteria
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard Standard PVP (pre-visit planning) Standard PVP Intervention CI-PVP (context-informed pre-visit planning) Enhanced PVP
- Primary Outcome Measures
Name Time Method Pilot acceptability) after each clinic visit, within 2 weeks; at end of study 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
Pilot feasibility at completion of study, 4 months after last study visit 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
- Secondary Outcome Measures
Name Time Method HgbA1c value change from baseline to 4 months post visit change in A1c level from baseline to post-study, using values nearest to study start and end dates
Treatment Burden of Diabetes Care Questionnaire (TBQ) change from baseline to 4 months post visit 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
Healthcare Climate Questionnaire (HCQ) change from baseline to 4 months post visit a validated survey of patient experience with their healthcare; 6 items on a 7 point Likert scale, 6-42, higher score is better
Blood pressure measurement change from baseline to 4 months post visit 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.
Patient Experience with Treatment and Self-Management (PETS) Questionnaire Medical Expenses Subsection change from baseline to 4 months post visit 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
Patient Self-Activation Measure (PAM-13) short form change from baseline to 4 months post visit a validated measure of patient participation in their own healthcare; 13 items on a 4 point Likert scale, 13-52, higher score is better
Perceived Diabetes Self-Management Scale change from baseline to 4 months post visit 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
Body Mass Index change from baseline to 4 months post visit Body Mass Index change from beginning of study to the end of the study, using most recent height available
Physician Job Satisfaction Scale change from baseline to 4 months post visit validated survey on elements of physician job satisfaction
SF-12, Short Form 12 questions Health Survey change from baseline to 4 months post visit a validated 12 question survey on patient's physical and mental health
Discussion of social determinants of health (SDH) during clinic visit, self-reported after each clinic visit, within 2 weeks a single question survey, self-reporting by the participant, if SDH were discussed between the doctor and the patient during the visit
Maslach Burnout Inventory Human Services Survey for Medical Personnel change from baseline to 4 months post visit Anxiety Symptoms change from baseline to 4 months post visit 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
Depression symptoms change from baseline to 4 months post visit 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
Trial Locations
- Locations (1)
University of California, Davis
🇺🇸Sacramento, California, United States