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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Enhanced PVP |
|
| Standard | Active Comparator | Standard PVP |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CI-PVP (context-informed pre-visit planning) | Other | 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Patients:
PCPs:
-sees patients as a primary care physician at the study clinic site
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Magnan, MD | UCDavis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Davis | Sacramento | California | 95817 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34881189 | Derived | Magnan E, Gosdin M, Tancredi D, Jerant A. Pilot randomized controlled trial Protocol: Life context-informed pre-visit planning to improve care plans for primary care patients with multiple chronic conditions including diabetes. J Multimorb Comorb. 2021 Dec 1;11:26335565211062387. doi: 10.1177/26335565211062387. eCollection 2021 Jan-Dec. |
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Plan to share anonymized or de-identified data per IRB approval to researchers at my institution.
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D000071069 | Multiple Chronic Conditions |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Standard PVP (pre-visit planning) | Other | standard clinic staff chart review, email and/or phone call prior to diabetes office 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 |
| 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 |
| D004700 | Endocrine System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |