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Diabetes Communication and Treatment Burden

Primary Purpose

Diabetes Mellitus, Type 2, Multiple Chronic Conditions

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CI-PVP (context-informed pre-visit planning)
Standard PVP (pre-visit planning)
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California, Davis

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Standard

Arm Description

Enhanced PVP

Standard PVP

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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
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
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
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
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
SF-12, Short Form 12 questions Health Survey
a validated 12 question survey on patient's physical and mental health
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
HgbA1c value
change in A1c level from baseline to post-study, using values nearest to study start and end dates
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.
Body Mass Index
Body Mass Index change from beginning of study to the end of the study, using most recent height available
Physician Job Satisfaction Scale
validated survey on elements of physician job satisfaction
Maslach Burnout Inventory Human Services Survey for Medical Personnel
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
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

Full Information

First Posted
September 11, 2020
Last Updated
November 15, 2022
Sponsor
University of California, Davis
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1. Study Identification

Unique Protocol Identification Number
NCT04568382
Brief Title
Diabetes Communication and Treatment Burden
Official Title
The Impact of Life Context and Social Determinants of Health on Treatment Burden in Diabetes and Multiple Chronic Conditions
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 12, 2020 (Actual)
Primary Completion Date
November 30, 2021 (Actual)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Davis

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Multiple Chronic Conditions

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Enhanced PVP
Arm Title
Standard
Arm Type
Active Comparator
Arm Description
Standard PVP
Intervention Type
Other
Intervention Name(s)
CI-PVP (context-informed pre-visit planning)
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Standard PVP (pre-visit planning)
Intervention Description
standard clinic staff chart review, email and/or phone call prior to diabetes office visit
Primary Outcome Measure Information:
Title
Pilot feasibility
Description
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
Time Frame
at completion of study, 4 months after last study visit
Title
Pilot acceptability)
Description
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
Time Frame
after each clinic visit, within 2 weeks; at end of study
Secondary Outcome Measure Information:
Title
Treatment Burden of Diabetes Care Questionnaire (TBQ)
Description
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
Time Frame
change from baseline to 4 months post visit
Title
Patient Experience with Treatment and Self-Management (PETS) Questionnaire Medical Expenses Subsection
Description
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
Time Frame
change from baseline to 4 months post visit
Title
Healthcare Climate Questionnaire (HCQ)
Description
a validated survey of patient experience with their healthcare; 6 items on a 7 point Likert scale, 6-42, higher score is better
Time Frame
change from baseline to 4 months post visit
Title
Patient Self-Activation Measure (PAM-13) short form
Description
a validated measure of patient participation in their own healthcare; 13 items on a 4 point Likert scale, 13-52, higher score is better
Time Frame
change from baseline to 4 months post visit
Title
Perceived Diabetes Self-Management Scale
Description
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
Time Frame
change from baseline to 4 months post visit
Title
SF-12, Short Form 12 questions Health Survey
Description
a validated 12 question survey on patient's physical and mental health
Time Frame
change from baseline to 4 months post visit
Title
Discussion of social determinants of health (SDH) during clinic visit, self-reported
Description
a single question survey, self-reporting by the participant, if SDH were discussed between the doctor and the patient during the visit
Time Frame
after each clinic visit, within 2 weeks
Title
HgbA1c value
Description
change in A1c level from baseline to post-study, using values nearest to study start and end dates
Time Frame
change from baseline to 4 months post visit
Title
Blood pressure measurement
Description
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.
Time Frame
change from baseline to 4 months post visit
Title
Body Mass Index
Description
Body Mass Index change from beginning of study to the end of the study, using most recent height available
Time Frame
change from baseline to 4 months post visit
Title
Physician Job Satisfaction Scale
Description
validated survey on elements of physician job satisfaction
Time Frame
change from baseline to 4 months post visit
Title
Maslach Burnout Inventory Human Services Survey for Medical Personnel
Time Frame
change from baseline to 4 months post visit
Title
Depression symptoms
Description
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
Time Frame
change from baseline to 4 months post visit
Title
Anxiety Symptoms
Description
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
Time Frame
change from baseline to 4 months post visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Magnan, MD
Organizational Affiliation
UCDavis
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Plan to share anonymized or de-identified data per IRB approval to researchers at my institution.
Citations:
PubMed Identifier
34881189
Citation
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.
Results Reference
derived

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Diabetes Communication and Treatment Burden

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