Diabetes Mellitus, Type 2, Multiple Chronic Conditions
Conditions
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.
Interventions
OTHERCI-PVP (context-informed pre-visit planning)
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
OTHERStandard PVP (pre-visit planning)
standard clinic staff chart review, email and/or phone call prior to diabetes office visit
Sponsors
University of California, Davis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Maslach Burnout Inventory Human Services Survey for Medical Personnel | change from baseline to 4 months post visit | — |
| 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 |
| 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 |
| 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 |
Countries
United States
Outcome results
None listed