Diabetes, Diabetes Mellitus
Conditions
Brief summary
The purpose of this study is to co-develop a toolkit (known as the QBSAfe toolkit) with patients, family caregivers, and clinicians that focuses on palliating symptoms, alleviating burden of treatment, facilitating social connections, and optimizing treatment safety for patients with diabetes mellitus.
Interventions
OTHERQBSAfe Toolkit
The QBSAfe toolkit focuses on palliating symptoms, alleviating burden of treatment, facilitating social connections, and optimizing treatment safety.
Sponsors
National Institutes of Health (NIH)
Trinity Health Of New England
National Institute on Aging (NIA)
Yale University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
-Existing diagnosis of diabetes mellitus; have an existing appointment with a participating clinician
Exclusion criteria
* Do not speak English * Severe vision/hearing impairment * Unable to give informed consent for any reason
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability - Patients | Baseline [Post Clinical Encounter] | Patient responses to post-visit questionnaires. |
| Acceptability - Clinicians | Baseline [Post Clinical Encounter] | Clinician responses to post-visit questionnaires. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility 1 | Baseline [Post Clinical Encounter] | Percentage of participants who completed the study procedures. |
| Feasibility 2 | Baseline [Post Clinical Encounter] | Percentage of recorded visits in which the QBSAFE toolkit was used assessed by Number of visits QBSAFE was used/Number of recorded visits. |
| Feasibility 3 | Baseline [Post Clinical Encounter] | Time to recruit 84 subjects across 3 sites. |
Countries
United States
Participant flow
Recruitment details
84 participants and 7 clinicians
Participants by arm
| Arm | Count |
|---|---|
| Implementation Arm QBSAfe Toolkit: The QBSAfe toolkit focuses on palliating symptoms, alleviating burden of treatment, facilitating social connections, and optimizing treatment safety. | 84 |
| Clinicians Clinicians who participated in the study | 7 |
| Total | 91 |
Baseline characteristics
| Characteristic | Implementation Arm | Total |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 45 Participants | 45 Participants |
| Age, Categorical Between 18 and 65 years | 39 Participants | 39 Participants |
| Age, Continuous | 74.4 years STANDARD_DEVIATION 15.4 | 74.4 years STANDARD_DEVIATION 15.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants | 14 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 4 Participants |
| Race (NIH/OMB) White | 66 Participants | 66 Participants |
| Region of Enrollment United States | 84 participants | 84 participants |
| Sex: Female, Male Female | 39 Participants | 39 Participants |
| Sex: Female, Male Male | 45 Participants | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 84 | 0 / 0 |
| other Total, other adverse events | 0 / 84 | 0 / 0 |
| serious Total, serious adverse events | 0 / 84 | 0 / 0 |
Outcome results
Primary
Acceptability - Clinicians
Clinician responses to post-visit questionnaires.
Time frame: Baseline [Post Clinical Encounter]
Population: Questionnaires completed by clinicians after each patient encounter
| Arm | Measure | Group | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|---|
| Single-Arm Intervention Group | Acceptability - Clinicians | I felt confident in responding to issues raised by the patient | Strongly Agree | 48 Questionnaires after each encounter |
| Single-Arm Intervention Group | Acceptability - Clinicians | I felt confident in responding to issues raised by the patient | Agree | 14 Questionnaires after each encounter |
| Single-Arm Intervention Group | Acceptability - Clinicians | I felt confident in responding to issues raised by the patient | Neutral | 4 Questionnaires after each encounter |
| Single-Arm Intervention Group | Acceptability - Clinicians | I felt confident in responding to issues raised by the patient | Disagree | 3 Questionnaires after each encounter |
| Single-Arm Intervention Group | Acceptability - Clinicians | I felt confident in responding to issues raised by the patient | Strongly Disagree | 0 Questionnaires after each encounter |
| Single-Arm Intervention Group | Acceptability - Clinicians | I would like to use these cards with a patient like this next time | Strongly Agree | 43 Questionnaires after each encounter |
| Single-Arm Intervention Group | Acceptability - Clinicians | I would like to use these cards with a patient like this next time | Agree | 11 Questionnaires after each encounter |
| Single-Arm Intervention Group | Acceptability - Clinicians | I would like to use these cards with a patient like this next time | Neutral | 14 Questionnaires after each encounter |
| Single-Arm Intervention Group | Acceptability - Clinicians | I would like to use these cards with a patient like this next time | Disagree | 1 Questionnaires after each encounter |
| Single-Arm Intervention Group | Acceptability - Clinicians | I would like to use these cards with a patient like this next time | Strongly Disagree | 0 Questionnaires after each encounter |
| Single-Arm Intervention Group | Acceptability - Clinicians | I would recommend these cards to my colleagues | Strongly Agree | 46 Questionnaires after each encounter |
| Single-Arm Intervention Group | Acceptability - Clinicians | I would recommend these cards to my colleagues | Agree | 10 Questionnaires after each encounter |
| Single-Arm Intervention Group | Acceptability - Clinicians | I would recommend these cards to my colleagues | Neutral | 11 Questionnaires after each encounter |
| Single-Arm Intervention Group | Acceptability - Clinicians | I would recommend these cards to my colleagues | Disagree | 1 Questionnaires after each encounter |
| Single-Arm Intervention Group | Acceptability - Clinicians | I would recommend these cards to my colleagues | Strongly Disagree | 0 Questionnaires after each encounter |
Primary
Acceptability - Patients
Patient responses to post-visit questionnaires.
Time frame: Baseline [Post Clinical Encounter]
Population: Patients who had their visit recorded and answered post visit questionnaires
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Single-Arm Intervention Group | Acceptability - Patients | These cards helped me talk about my situation during my visit | Strongly Agree | 16 Participants |
| Single-Arm Intervention Group | Acceptability - Patients | These cards helped me talk about my situation during my visit | Agree | 21 Participants |
| Single-Arm Intervention Group | Acceptability - Patients | These cards helped me talk about my situation during my visit | Disagree | 6 Participants |
| Single-Arm Intervention Group | Acceptability - Patients | These cards helped me talk about my situation during my visit | Strongly Disagree | 3 Participants |
| Single-Arm Intervention Group | Acceptability - Patients | I would like to have these cards available to me at my next visit | Strongly Agree | 12 Participants |
| Single-Arm Intervention Group | Acceptability - Patients | I would like to have these cards available to me at my next visit | Agree | 10 Participants |
| Single-Arm Intervention Group | Acceptability - Patients | These cards helped me talk about my situation during my visit | Neutral | 12 Participants |
| Single-Arm Intervention Group | Acceptability - Patients | I would like to have these cards available to me at my next visit | Neutral | 21 Participants |
| Single-Arm Intervention Group | Acceptability - Patients | I would like to have these cards available to me at my next visit | Disagree | 12 Participants |
| Single-Arm Intervention Group | Acceptability - Patients | I would like to have these cards available to me at my next visit | Strongly Disagree | 3 Participants |
| Single-Arm Intervention Group | Acceptability - Patients | I believe other patients like me would benefit from these cards | Strongly Agree | 19 Participants |
| Single-Arm Intervention Group | Acceptability - Patients | I believe other patients like me would benefit from these cards | Agree | 26 Participants |
| Single-Arm Intervention Group | Acceptability - Patients | I believe other patients like me would benefit from these cards | Neutral | 9 Participants |
| Single-Arm Intervention Group | Acceptability - Patients | I believe other patients like me would benefit from these cards | Disagree | 3 Participants |
| Single-Arm Intervention Group | Acceptability - Patients | I believe other patients like me would benefit from these cards | Strongly Disagree | 1 Participants |
Secondary
Feasibility 1
Percentage of participants who completed the study procedures.
Time frame: Baseline [Post Clinical Encounter]
Population: Number of patients and number of clinicians in the study
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single-Arm Intervention Group | Feasibility 1 | 58 Participants |
| Single-Arm Intervention Group - Clinicians | Feasibility 1 | 7 Participants |
Secondary
Feasibility 2
Percentage of recorded visits in which the QBSAFE toolkit was used assessed by Number of visits QBSAFE was used/Number of recorded visits.
Time frame: Baseline [Post Clinical Encounter]
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Single-Arm Intervention Group | Feasibility 2 | 58 percentage of visits QBSAFE was used |
Secondary
Feasibility 3
Time to recruit 84 subjects across 3 sites.
Time frame: Baseline [Post Clinical Encounter]
Population: Number of recruited patients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Single-Arm Intervention Group | Feasibility 3 | 145 Days |