Diabetes Mellitus
Conditions
Keywords
Diabetes, Telemedicine, Shared Medical Appointments
Brief summary
The investigators' study focuses on improving the care of diabetes, a complex chronic illness, by providing important insights into interprofessional training and its potential role in fostering the necessary interdisciplinary management needed for chronic conditions and in addressing the gap between best practice and actual care provided.
Detailed description
The complexity of diabetes management challenges the acute care-oriented healthcare system. Some experts suggest part of the problem is that the healthcare system fosters a separate silos decision making model. While there is increasing recognition that quality diabetes care is best provided in an interdisciplinary manner, interprofessional training models are limited, as is understanding of the links between interprofessional training, actual practice, and patient outcomes. Advancing our understanding of interprofessional training models is critical because most of the complications associated with diabetes (e.g., amputations, renal failure, strokes) can be prevented or delayed with proper management. The investigators' objective is to better understand the processes and mechanisms by which interprofessional training impacts on chronic care management (practice patterns) and the ways it translates into improved patient outcomes.
Interventions
BEHAVIORALRole modeling in Shared medical appointments to Promote Establishing Collaborative Teams (ReSPECT)
The intervention is designed to educate the clinicians at intervention CBOCs by modeling interprofessional team practices during SMAs for diabetes mellitus (DM) patients from each CBOC primary care provider's (PCP) patient panel. We hypothesize that this education at intervention CBOCs will improve interprofessional practices and overall quality care delivered to veterans.
Sponsors
Case Western Reserve University
The Cleveland Clinic
US Department of Veterans Affairs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
CLINICIANS * All clinicians in all of Ohio's CBOCs (except for the Georgetown CBOC) will be eligible for the study (all PCPs have patients with DM in their panel of patients). PATIENTS * All diabetic patients who are seen in Ohio's CBOCs (except for the Georgetown CBOC) will be eligible for the study.
Exclusion criteria
CLINICIANS * Any clinician who does not have diabetic patients on their panel, who aren't apart of Ohio's CBOC's, or see patients at the Georgetown CBOC will not be eligible to participate. PATIENTS * Patients who don't have a diagnosis of diabetes, who aren't seen at one of Ohio's CBOC's, or is seen for their medical care at the Georgetown CBOC will not be eligible to participate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Provider Abilities Scale - Subscale From the Midwest (MW) Clinicians' Network | Baseline | Providers asked to indicate their level of confidence on an 11-point scale, with 0 indicating 'not at all confident' and 10 indicating 'extremely confident' for the following activities: 1. Instruct patients on home glucose monitoring 2. Teach foot care 3. Teach insulin administration 4. Instruct patients about diet 5. Help patients make changes in their diets that you have recommended 6. Instruct patients about regular exercise 7. Help patients make changes in their exercise habits that you have recommended 8. Identify candidates for long-acting insulin 9. Interpret glucose patterns 10. Adjust insulin in insulin-treated patients with poor glycemic control 11. Do you feel comfortable knowing whether to titrate basal insulin versus bolus insulin 12. Manage patients with poor glycemic control 13. Initiate insulin therapy (NPH or insulin glargine and aspart) 14. Apply principles of diabetes care in a team setting Averages of provider efficacy were calculated across all activities. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Attitudes Toward Healthcare Teams Scale and Subscales | Baseline | A validated scale developed to assess attitudes towards teams in a healthcare setting with three subscales to assess attitudes toward team value, attitudes toward team efficiency, and attitudes towards physician's shared role on a team. Each of the 21 items is rated 1 to 6, ranging from 'Strongly Disagree' to 'Strongly Agree'. The scale was considered 'complete' for analysis among providers who answered at least 7 of the 21 items. Items were reverse-coded as specified in the subscale development publication. Averages across completed items were calculated within provider. Higher values corresponded with more positive attitudes towards teams. |
Countries
United States
Participant flow
Pre-assignment details
Cleveland and Cincinnati CBOCs (excluding Georgetown; n = 18 CBOCs) were the study sites randomized to the two study arms. Providers within site were subject to the intervention to which the site was randomized and the questionnaire responses were collected at the provider level.
Participants by arm
| Arm | Count |
|---|---|
| Control Control sites will receive the baseline measures pre and post. These sites will receive traditional diabetes education, which includes teleconsultation. | 48 |
| ReSPECT Intervention Intervention sites will receive baseline measures pre and post, but also in-depth Shared Medical Appointments (SMA)(The Role modeling in Shared medical appointments to Promote Establishing Collaborative Teams (ReSPECT) intervention) and at 15 months SMA video conferences. At the end of the 18 months the randomly selected patients and providers will be asked to take part in a qualitative interview.
Role modeling in Shared medical appointments to Promote Establishing Collaborative Teams (ReSPECT): The intervention is designed to educate the clinicians at intervention CBOCs by modeling interprofessional team practices during SMAs for DM patients from each CBOC primary care provider's (PCP) patient panel. We hypothesize that this education at intervention CBOCs will improve interprofessional practices and overall quality care delivered to veterans. | 69 |
| Total | 117 |
Baseline characteristics
| Characteristic | Control | Total | ReSPECT Intervention |
|---|---|---|---|
| Age, Customized 39 years or less | 7 participants | 19 participants | 12 participants |
| Age, Customized 40 to 59 years | 41 participants | 89 participants | 48 participants |
| Age, Customized 60 years or greater | 0 participants | 5 participants | 5 participants |
| Age, Customized Missing | 0 participants | 4 participants | 4 participants |
| Sex/Gender, Customized Female | 36 participants | 89 participants | 53 participants |
| Sex/Gender, Customized Male | 12 participants | 25 participants | 13 participants |
| Sex/Gender, Customized Unknown | 0 participants | 3 participants | 3 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 48 | 0 / 69 |
| serious Total, serious adverse events | 0 / 48 | 0 / 69 |
Outcome results
Primary
Provider Abilities Scale - Subscale From the Midwest (MW) Clinicians' Network
Providers asked to indicate their level of confidence on an 11-point scale, with 0 indicating 'not at all confident' and 10 indicating 'extremely confident' for the following activities: 1. Instruct patients on home glucose monitoring 2. Teach foot care 3. Teach insulin administration 4. Instruct patients about diet 5. Help patients make changes in their diets that you have recommended 6. Instruct patients about regular exercise 7. Help patients make changes in their exercise habits that you have recommended 8. Identify candidates for long-acting insulin 9. Interpret glucose patterns 10. Adjust insulin in insulin-treated patients with poor glycemic control 11. Do you feel comfortable knowing whether to titrate basal insulin versus bolus insulin 12. Manage patients with poor glycemic control 13. Initiate insulin therapy (NPH or insulin glargine and aspart) 14. Apply principles of diabetes care in a team setting Averages of provider efficacy were calculated across all activities.
Time frame: Baseline
Population: Providers within sites randomized to control and intervention arms were surveyed at baseline; 39 control arm providers and 55 intervention arm providers completed the ability items of the survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Provider Abilities Scale - Subscale From the Midwest (MW) Clinicians' Network | 6.89 units on a scale | Standard Deviation 2.17 |
| ReSPECT Intervention | Provider Abilities Scale - Subscale From the Midwest (MW) Clinicians' Network | 6.41 units on a scale | Standard Deviation 1.9 |
Comparison: Null hypothesis: pre-intervention efficacies will be equal in the two study arms.p-value: 0.26t-test, 2 sided
Primary
Provider Abilities Scale - Subscale From the Midwest (MW) Clinicians' Network
Providers asked to indicate their level of confidence on an 11-point scale, with 0 indicating 'not at all confident' and 10 indicating 'extremely confident' for the following activities: 1. Instruct patients on home glucose monitoring 2. Teach foot care 3. Teach insulin administration 4. Instruct patients about diet 5. Help patients make changes in their diets that you have recommended 6. Instruct patients about regular exercise 7. Help patients make changes in their exercise habits that you have recommended 8. Identify candidates for long-acting insulin 9. Interpret glucose patterns 10. Adjust insulin in insulin-treated patients with poor glycemic control 11. Do you feel comfortable knowing whether to titrate basal insulin versus bolus insulin 12. Manage patients with poor glycemic control 13. Initiate insulin therapy (NPH or insulin glargine and aspart) 14. Apply principles of diabetes care in a team setting Averages of provider efficacy were calculated across all activities.
Time frame: 22 months (post-intervention)
Population: Providers within sites randomized to control and intervention arms were surveyed after the intervention period; 20 control arm providers and 29 intervention arm providers completed the ability items of the survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Provider Abilities Scale - Subscale From the Midwest (MW) Clinicians' Network | 7.09 units on a scale | Standard Deviation 2.05 |
| ReSPECT Intervention | Provider Abilities Scale - Subscale From the Midwest (MW) Clinicians' Network | 6.88 units on a scale | Standard Deviation 2.14 |
Comparison: Null hypothesis: post-intervention efficacies will be equal in the two study arms.p-value: 0.74t-test, 2 sided
Secondary
Attitudes Toward Healthcare Teams Scale and Subscales
A validated scale developed to assess attitudes towards teams in a healthcare setting with three subscales to assess attitudes toward team value, attitudes toward team efficiency, and attitudes towards physician's shared role on a team. Each of the 21 items is rated 1 to 6, ranging from 'Strongly Disagree' to 'Strongly Agree'. The scale was considered 'complete' for analysis among providers who answered at least 7 of the 21 items. Items were reverse-coded as specified in the subscale development publication. Averages across completed items were calculated within provider. Higher values corresponded with more positive attitudes towards teams.
Time frame: Baseline
Population: Providers within sites randomized to control and intervention arms were surveyed at baseline; 39 control arm providers and 53 intervention arm providers complete the attitude scale of the survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Attitudes Toward Healthcare Teams Scale and Subscales | 4.42 units on a scale | Standard Deviation 0.52 |
| ReSPECT Intervention | Attitudes Toward Healthcare Teams Scale and Subscales | 4.29 units on a scale | Standard Deviation 0.55 |
Secondary
Attitudes Toward Healthcare Teams Scale and Subscales
A validated scale developed to assess attitudes towards teams in a healthcare setting with three subscales to assess attitudes toward team value, attitudes toward team efficiency, and attitudes towards physician's shared role on a team. Each of the 21 items is rated 1 to 6, ranging from 'Strongly Disagree' to 'Strongly Agree'. The scale was considered 'complete' for analysis among providers who answered at least 7 of the 21 items. Items were reverse-coded as specified in the subscale development publication. Averages across completed items were calculated within provider. Higher values corresponded with more positive attitudes towards teams.
Time frame: 22 months (post-intervention)
Population: Providers within sites randomized to control and intervention arms were surveyed after the intervention period; 20 control arm providers and 29 intervention arm providers completed the attitude scale of the survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Attitudes Toward Healthcare Teams Scale and Subscales | 4.44 units on a scale | Standard Deviation 0.52 |
| ReSPECT Intervention | Attitudes Toward Healthcare Teams Scale and Subscales | 4.24 units on a scale | Standard Deviation 0.59 |