Ignite Creation Date:
2024-05-06 @ 4:06 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04874116
Status:
RECRUITING
Last Update Posted:
2022-08-25
First Post:
2021-03-01
Brief Title:
Decreasing Cardiovascular Risk for Patients With Diabetes
Sponsor:
Michigan State University
Organization:
Michigan State University
Study Overview
Official Title:
Improving Diabetic Patients Adherence to Treatment and Prevention of Cardiovascular Disease
Status:
RECRUITING
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Cardiovascular disease CVD complications are the leading cause of diabetes mellitus DM-related morbidity and mortality creating a significant burden on the public health system This burden is in part attributable to poor medication adherence with 21-42 of patients failing to properly adhere to their care Importantly this issue is especially pronounced in minority and low-income populations which show higher rates of chronic illness and lower medication adherence Interventions that foster and reinforce patient-centered communication between clinicians and patients show promise in improving health outcomes However they have not been widely implemented in part due to a lack of compelling evidence for their effectiveness in primary care settings Project Objective The investigators propose to evaluate the impact of a patient activation program Office Guidelines Applied to Practice Office-GAP combined with mobile text messaging reinforcement Way to Health W2H on medication adherence in patients with DM compared to mobile texting alone Office-GAP incorporates shared decision-making and a decisionsupport checklist to be completed during office visits to foster patients investment in their own care W2H is a texting service that informs and encourages patients to adhere to goals and improve communication The long-term goal is to develop a model that can reliably improve and sustain adherence and can be successfully implemented in primary care clinics to close the morbidity and mortality gap for minoritylow-income DM patients The hypothesis is that the combined face-to-face patient activation and texting- delivered reinforcement methods will facilitate communication between patients and providers improving the frequency accuracy and timeliness of communication while reinforcing shared goals and engendering mutual respect more than texting alone Improved communication between patients and providers may improve medication adherence blood sugar cholesterol blood pressure control and patient satisfaction with providers and ultimately decrease burden of illness
Research Strategy The investigators will conduct a randomized community-based clinical trial in Federally-Qualified Health Centers FQHCs in Michigan enrolling 378 patients in 17 teams All patients will receive usual care and medication for DM and CVD prevention Eight teams will use W2H alone and 9 teams will combine Office-GAP with WTH The investigators will evaluate the impact of shared decision-making strategies for patients and providers
Impact If successfully translated to clinical practice these interventions have the potential to significantly impact patient care in FQHCs improving outcomes for DM and CVD This research also paves the way for shifting clinical practice across a spectrum of chronic disease where medication non-adherence is an issue
Research Strategy The investigators will conduct a randomized community-based clinical trial in Federally-Qualified Health Centers FQHCs in Michigan enrolling 378 patients in 17 teams All patients will receive usual care and medication for DM and CVD prevention Eight teams will use W2H alone and 9 teams will combine Office-GAP with WTH The investigators will evaluate the impact of shared decision-making strategies for patients and providers
Impact If successfully translated to clinical practice these interventions have the potential to significantly impact patient care in FQHCs improving outcomes for DM and CVD This research also paves the way for shifting clinical practice across a spectrum of chronic disease where medication non-adherence is an issue
Detailed Description:
Study design and overview The investigators will conduct this study with 17 teams in 12 clinics that serve low-income patients Federally Qualified Health Centers FQHCs The goal of the study is to evaluate how well the approach to improving patient outcomes with a blend of communication strategies works in real-world settings compared to mobile phone texting alone Each team will be randomly assigned to one of two groups the Intervention Group 1 includes a patient group meeting a checklist used during each medical visit together called Office-GAP along with text messaging in between visits the Control Group 2 includes only the text messages
Randomization The investigators will recruit 22 diabetes DM patients per team All patients at a particular team will participate in the same group intervention or control The investigators chose this approach because it is realistic for providers and patients at a team to follow a similar approach This also helps the comparison of control and intervention groups to be more accurate because there is less chance of mixing between the two groups In Michigan FQHCs have similar numbers and types of providers internal and family medicine and nurse practitioners
Methods Setting Because the investigators are interested in how well the interventions may address disparities in health outcomes for low-income and minority patients they are recruited from FQHCs who serve these populations in Michigan FQHC patients are mainly below federal poverty levels 92 of participants 56 are non-white 91 are uninsured or covered by Medicaid Sample A total of 378 patients men and women with Type II diabetes that is not well-controlled the standard will be a score for the HbA1c test equal to or higher than 8 will be recruited In the investigators pilot studies 80 of patients who met these criteria agreed to participate In the pilot about 10 dropped out before follow-up at 3 months and a further 3 dropped out before completion A 20 dropout rate is anticipated Recruiting 378 patients will result in 320 patients retained by the end of the 5 year study Based on the pilot study and feedback from clinics it is estimated that the enrollment goal will be reached within 4 years Each FQHC will have at least 200 DM patients who meet the criteria
Patient Intervention procedures Patients will participate either in the intervention group Office-GAP Texting or in the control group Texting only as described below All patients will receive medical treatment-as-usual from the participating clinics consisting of diabetes care usual preventive care and other medical treatment as needed
Office-GAP Intervention Patient Activation Intervention The investigators have described the Office-GAP intervention in previous peer-reviewed publications 1-3 Briefly after recruitment patients in the Office-GAP group will attend 1 one scheduled group visit 90-120 min 4-6 patients at a time 2 one follow-up visit with their providers within one month and then at 3 6 9 and 12 months after the group visit At these follow-up visits providers will complete the Office-GAP Checklist which evaluates medication prescribing behavior In addition shared decision-making SDM and goal setting occurs between patient and provider These follow-up visits are patients regularly scheduled visits with their providers and not additional to their usual care
At the group visit Research Assistants will obtain informed consentHIPAA authorization from patients after introducing them to the study Group 1 Office-GAP Texting session the group visit is a Shared Decision Making SDM activation session wherein patients learn self-management behaviors communication skills and use of decision support tools DSTs They also learn how to use the eCap electronic pill container to monitor medication adherence learn to use Way to Health Texting service and confirm set up on their mobile phone Group 2 For the texting only group participants will learn how to use Way to Health Texting service and confirm set up on their mobile phone and learn how to use the eCap electronic pill container to monitor medication adherence They will not experience the Office-GAP intervention Both groups will also complete baseline study questionnaires during the group visit
Office-GAP Follow-up visit with providers the Office-GAP Checklist The Office-GAP Checklist is the core tool of the SDM intervention A one-page checklist this SDM tool outlines all evidence-based medications for secondary prevention of cardiovascular disease CVD in T2DM patients It is an in-consultation decision support tool that helps engage the patient and provider to encourage and enhance an SDM process via discussion of medication and secondary preventionlifestyle changes during an office visit In this study the Office-GAP Checklist will be completed by the provider with direct patient involvement during the office visits at 0-1 3 6 9 and 12 months Only Group 1 patients will use this checklist during their office visits
The Office-GAP Checklist also serves as a provider reminder at the point of care because the provider records a check-mark for each medication Yes if patient is on the medication No if patient is not or Does not apply to me because A reason for exclusion of a medication is also provided patient is not eligible for the medication has a contraindication to its use or the patient and provider have identified an alternative due to side effect or cost concerns Details about the next appointment and any secondary prevention plan changes are also listed on the form At the end of the visit both patient and provider sign the form to confirm that they have reviewed the checklist The patient receives a copy of the checklist to take home and a copy is retained in the patient record All providers in the intervention teams receive a brief provider education in Office-GAP tool use and communication skills described below C415
Educational tool literacy standards Office-GAP has been rigorously adapted for use with low health literacy patients All study materials are grade 6 reading level
Mobile DM self-management texting intervention Way to Health Texting Program During group visits all patients in both groups will be taught how to send and receive text messages on their phone The Way to Health service does not require patients to use a special app Way to Health engages patients in two ways 1 Patients receive daily Way to Health messages appropriate to their diagnosis and medications eg BP blood glucose medication and appointment reminders throughout the study They also receive informational and educational texts 2 Patients respond to prompts and may contact their providers office throughout the study via texting Patients will receive additional diabetic modules that follow the standard for diabetes education for the rest of the 12 months once the initial 15 week program is complete The Way to Health texting program will be used to encourage T2DM patients to maintain communication with their providers improve medication adherence and other secondary prevention and self-care between visits Daily messages may take the form of reminders prompts education or reinforcement Sample message texts include Did you take your medications today and How many times did you check your feet for wounds this week The pilot found the program to be usable and effective for both patients and providers
Provider and Practice Staff Training All intervention providers will participate in an interactive orientation which has been shown to promote behavioral change among health professionals Providers will be asked to agree to participate in the study before the session ProviderStaff Educational module The training session is 90 minutes long The session is scheduled at multiple times to meet providers needs In the pilot Office-GAP study there was 100 participation by providers The training module delivered by the PI and Dr Karen Kelly-Blake includes 1 brief presentations on effectiveness and cost-effectiveness of medical therapy and behavior changes in management of T2DM blood pressure and heart disease 2 a hands-on practice session for providers to elicit patients preferences and values 3 an introduction to the Office-GAP Checklist and best practices for using it during a patient encounter 4 review of the Smith evidence-based patient-centered method for establishing trust communicating clearly and engaging in goal-setting with patients Providers will have a chance to practice skills using Braddock and Elwyns approach to role-playing to model office visits and 5 a complete pre-and post-training survey before and after the training session to determine provider attitudes about the use of DSTs SDM and mHealth in their practice and an end of study semi-structured interview The investigators are highly experienced in provider training
Analysis of outcomes The primary outcome medication adherence - how well patients adhere to their providers advice to take medications will be assessed in each individual patient by e-CAP monitoring a device that signals when patients open their prescription medication bottles The investigators will conduct preliminary analysis of study hypotheses at 6mo and 12mo using standard statistical tests A comparison of Office-GAP plus Way to Health teams Group 1 to Way to Health only teams Group 2 at baseline will be conducted to be sure the patient populations are similar in terms of health characteristics that may influence the results If substantive differences are found the investigators will be able to control for these in subsequent analyses using statistical regression techniques This method assures a degree of dissimilarity rather than assuming all of the clinical populations are identical Equivalence between the groups will be assessed based on demographic factors such as age gender education raceethnicity
Randomization The investigators will recruit 22 diabetes DM patients per team All patients at a particular team will participate in the same group intervention or control The investigators chose this approach because it is realistic for providers and patients at a team to follow a similar approach This also helps the comparison of control and intervention groups to be more accurate because there is less chance of mixing between the two groups In Michigan FQHCs have similar numbers and types of providers internal and family medicine and nurse practitioners
Methods Setting Because the investigators are interested in how well the interventions may address disparities in health outcomes for low-income and minority patients they are recruited from FQHCs who serve these populations in Michigan FQHC patients are mainly below federal poverty levels 92 of participants 56 are non-white 91 are uninsured or covered by Medicaid Sample A total of 378 patients men and women with Type II diabetes that is not well-controlled the standard will be a score for the HbA1c test equal to or higher than 8 will be recruited In the investigators pilot studies 80 of patients who met these criteria agreed to participate In the pilot about 10 dropped out before follow-up at 3 months and a further 3 dropped out before completion A 20 dropout rate is anticipated Recruiting 378 patients will result in 320 patients retained by the end of the 5 year study Based on the pilot study and feedback from clinics it is estimated that the enrollment goal will be reached within 4 years Each FQHC will have at least 200 DM patients who meet the criteria
Patient Intervention procedures Patients will participate either in the intervention group Office-GAP Texting or in the control group Texting only as described below All patients will receive medical treatment-as-usual from the participating clinics consisting of diabetes care usual preventive care and other medical treatment as needed
Office-GAP Intervention Patient Activation Intervention The investigators have described the Office-GAP intervention in previous peer-reviewed publications 1-3 Briefly after recruitment patients in the Office-GAP group will attend 1 one scheduled group visit 90-120 min 4-6 patients at a time 2 one follow-up visit with their providers within one month and then at 3 6 9 and 12 months after the group visit At these follow-up visits providers will complete the Office-GAP Checklist which evaluates medication prescribing behavior In addition shared decision-making SDM and goal setting occurs between patient and provider These follow-up visits are patients regularly scheduled visits with their providers and not additional to their usual care
At the group visit Research Assistants will obtain informed consentHIPAA authorization from patients after introducing them to the study Group 1 Office-GAP Texting session the group visit is a Shared Decision Making SDM activation session wherein patients learn self-management behaviors communication skills and use of decision support tools DSTs They also learn how to use the eCap electronic pill container to monitor medication adherence learn to use Way to Health Texting service and confirm set up on their mobile phone Group 2 For the texting only group participants will learn how to use Way to Health Texting service and confirm set up on their mobile phone and learn how to use the eCap electronic pill container to monitor medication adherence They will not experience the Office-GAP intervention Both groups will also complete baseline study questionnaires during the group visit
Office-GAP Follow-up visit with providers the Office-GAP Checklist The Office-GAP Checklist is the core tool of the SDM intervention A one-page checklist this SDM tool outlines all evidence-based medications for secondary prevention of cardiovascular disease CVD in T2DM patients It is an in-consultation decision support tool that helps engage the patient and provider to encourage and enhance an SDM process via discussion of medication and secondary preventionlifestyle changes during an office visit In this study the Office-GAP Checklist will be completed by the provider with direct patient involvement during the office visits at 0-1 3 6 9 and 12 months Only Group 1 patients will use this checklist during their office visits
The Office-GAP Checklist also serves as a provider reminder at the point of care because the provider records a check-mark for each medication Yes if patient is on the medication No if patient is not or Does not apply to me because A reason for exclusion of a medication is also provided patient is not eligible for the medication has a contraindication to its use or the patient and provider have identified an alternative due to side effect or cost concerns Details about the next appointment and any secondary prevention plan changes are also listed on the form At the end of the visit both patient and provider sign the form to confirm that they have reviewed the checklist The patient receives a copy of the checklist to take home and a copy is retained in the patient record All providers in the intervention teams receive a brief provider education in Office-GAP tool use and communication skills described below C415
Educational tool literacy standards Office-GAP has been rigorously adapted for use with low health literacy patients All study materials are grade 6 reading level
Mobile DM self-management texting intervention Way to Health Texting Program During group visits all patients in both groups will be taught how to send and receive text messages on their phone The Way to Health service does not require patients to use a special app Way to Health engages patients in two ways 1 Patients receive daily Way to Health messages appropriate to their diagnosis and medications eg BP blood glucose medication and appointment reminders throughout the study They also receive informational and educational texts 2 Patients respond to prompts and may contact their providers office throughout the study via texting Patients will receive additional diabetic modules that follow the standard for diabetes education for the rest of the 12 months once the initial 15 week program is complete The Way to Health texting program will be used to encourage T2DM patients to maintain communication with their providers improve medication adherence and other secondary prevention and self-care between visits Daily messages may take the form of reminders prompts education or reinforcement Sample message texts include Did you take your medications today and How many times did you check your feet for wounds this week The pilot found the program to be usable and effective for both patients and providers
Provider and Practice Staff Training All intervention providers will participate in an interactive orientation which has been shown to promote behavioral change among health professionals Providers will be asked to agree to participate in the study before the session ProviderStaff Educational module The training session is 90 minutes long The session is scheduled at multiple times to meet providers needs In the pilot Office-GAP study there was 100 participation by providers The training module delivered by the PI and Dr Karen Kelly-Blake includes 1 brief presentations on effectiveness and cost-effectiveness of medical therapy and behavior changes in management of T2DM blood pressure and heart disease 2 a hands-on practice session for providers to elicit patients preferences and values 3 an introduction to the Office-GAP Checklist and best practices for using it during a patient encounter 4 review of the Smith evidence-based patient-centered method for establishing trust communicating clearly and engaging in goal-setting with patients Providers will have a chance to practice skills using Braddock and Elwyns approach to role-playing to model office visits and 5 a complete pre-and post-training survey before and after the training session to determine provider attitudes about the use of DSTs SDM and mHealth in their practice and an end of study semi-structured interview The investigators are highly experienced in provider training
Analysis of outcomes The primary outcome medication adherence - how well patients adhere to their providers advice to take medications will be assessed in each individual patient by e-CAP monitoring a device that signals when patients open their prescription medication bottles The investigators will conduct preliminary analysis of study hypotheses at 6mo and 12mo using standard statistical tests A comparison of Office-GAP plus Way to Health teams Group 1 to Way to Health only teams Group 2 at baseline will be conducted to be sure the patient populations are similar in terms of health characteristics that may influence the results If substantive differences are found the investigators will be able to control for these in subsequent analyses using statistical regression techniques This method assures a degree of dissimilarity rather than assuming all of the clinical populations are identical Equivalence between the groups will be assessed based on demographic factors such as age gender education raceethnicity
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None