I actually do attached in a template and a draft protocol would you be able to complete the research plan as much as you can for this protocol? I will need you to set up a timeline (maybe in the form of a gantt chart) for me to edit and also a brief Lit review on the topic.
The protocol is the study that I want to conduct. The research plan needs to be written based on the protocol. Some sections can be relatively short. Others need to be extensive like the literature review (with references). Also you have build the registry? CGM use/ diabetes interventions etc.
please read the instuctions properly and check the files .
Requirements: please complete everything properly .
Requirements: Everything is mentioned . please check carefully
Background
Blue Cross Blue Shield (BCBS) has given money to the Institute of Healthcare Improvement (IHI) to disseminate to healthcare institutions with health equity focused projects. We received this award through BMC’s health equity accelerator to launch ACclerating Equity (ACE) in Diabetes. ACE Diabetes is a multi-level initiative that aims to reduce the racial disparities among those with uncontrolled diabetes (A1c >=9) within the department of General Internal Medicine (GIM). It also aims to reduce the prevalence of those living with uncontrolled diabetes ± hypertension (HTN) within this same population. This initiative leverages three mutually reinforcing strategies to reach our goals: 1) establishment of a patient registry; 2) clinical interventions including a new, comprehensive assessment system; and 3) an improved and accessible framework for patient education.
The core elements of this intervention includes patient access to population health specialists and a pharmacy liaison, access to educational materials and resources offered at Boston Medical Center (BMC), and engagement with a pharmacist to manage diabetes and HTN-related medications and technology. Participants enrolled in this initiative will be followed for a 6-month minimum which declares that the patient has completed the program. This existing quality improvement project offers the opportunity to assess the impact of this initiative.
Objective:
This study aims to evaluate the effectiveness of a multi-level intervention on diabetes distress, diabetes treatment satisfaction health and glycemic control in patients with uncontrolled type 2 diabetes (A1c >=9) at Boston Medical Center’s General Internal Medicine department
Research Questions:
How do the scores on the Type 2 Diabetes Distress Assessment System (T2-DDAS) survey compare in those patients with uncontrolled diabetes and were enrolled in ACE Diabetes and those patients that were not enrolled?
How do the HbA1c values compare in those patients with uncontrolled diabetes and were enrolled in ACE Diabetes and those patients who did not?
How do the BMI values compare in those patients with uncontrolled diabetes and were enrolled in ACE Diabetes and those patients who did not?
Is there an association between ACE diabetes enrollment and diabetes distress?
Methods
Study Population
Participants will be recruited using the ACE Diabetes registry that consists of all patients at Boston Medical Center with uncontrolled diabetes (A1c >=9) in General Internal Medicine at a given time. Of those patients within the registry, some will be offered the resources of the ACE Diabetes Initiative and quality improvement project and others will not. Sample size estimation is 400 participants. The inclusion and exclusion criteria go as follows:
Inclusion Criteria:
BMC GIM Patient: Completed outpatient visit in a GIM location in the past 18 months.
Out-Of-Control A1c: Look back 6 months for A1c values and take the last A1c value. This last value must be >= 9.
Type 2 Diabetes: The patient has at least one of the following: a Type 2 Diabetes diagnosis on the problem list; at least two Type 2 Diabetes billing diagnoses; at least one A1c value > 6.4.
Patient is 18+ years.
Exclusion Criteria:
Patients with Type 1 Diabetes: The patient has at least one of the following: a Type 1 Diabetes diagnosis on the problem list; at least two Type 1 Diabetes billing diagnoses.
Patients with Gestational Diabetes
Patients on Hospice
Deceased Patients
Patients may only enter the cohort once, so exclude patients who otherwise meet criteria, but were already included in the cohort in the past.
Patient is younger than 18 years old.
The quality improvement (QI) project initiative consists of pharmacy visits, medication changes, accessibility to continuous glucose monitors (CGMs), access to a diabetes self-management education program (DSME) from the Department of Endocrine at BMC, access to group sessions that focuses on the mental health of patients with diabetes from the Department of Integrated Behavioral Health (IBH) at BMC. This program will take place from April 2023 to June 2024. Outstanding patient demographic information will be obtained from Epic electronic medical record.
Recruitment
Patients enrolled in the ACE diabetes registry will be outreached to by a population health specialist (PHS). A population health specialist (PHS) will call each patient and ask if they are interested in taking a survey. There will be an incentive of $10 if the patient completes the survey in its entirety. The participant can select to fill out the surveys via a REDCap link or the population health specialist can interview the patient and verbally document the patient’s responses for manual data entry. The participant will provide verbal authorization to opt-in or opt-out of participating in taking the surveys if they are engaging in an interview and if they decide to fill out the survey via REDCap authorization will be asked.
Statistical Analysis plan
Outcome Variables
BMI and HbA1c are two of our clinical outcomes, which will be measured using the EHR. To measure diabetes distress, we will be utilizing the T2-DDAS 28-item scale as shown in Appendix A. The first 8 items represent the level of diabetes distress in which a patient experiences (core items) and the remaining 20-items capture the potential sources of the diabetes-related distress (source items). All questions have the same rating scale, 1 (Not a problem at all) – 5 (A very serious problem) however the core items are scored differently from the remaining items so each participant will have one overall score for the core items (adding Q 1-8) and an individual score for the items representative of each source (management demands, hypoglycemia, interpersonal issues, healthcare provider, shame/stigma, long-term health, and healthcare access).
For descriptive analyses, we will calculate the means (standard deviations) of all A1c and BMI values for each patient in the intervention group prior to and after their enrollment in the ACE Diabetes intervention program over the last 18 months. This will be repeated for the control group. We also compared the distribution of T2DDAS Core scores for diabetes distress (mean score > 2.0)
Matching Variables
A priori differences in patient characteristics between control group and intervention group has the potential to introduce bias. In order to decrease this bias, we will use propensity score matching techniques. Using a logistic regression modelling we will estimate the propensity of participating in the intervention for both groups based on the following covariates: baseline A1c, age, gender, socio-economic status (based on postal codes), marital status, smoking, COPD, asthma, cancer, cardiovascular disease, hypertension, depression and mental illness. They will be used to generate a propensity score of all individuals and the control an intervention group participants will be matched according to that score. Matching covariates will be compared using independent t-test and chi-square and propensity score matching will be done using the appropriate statistical software.
Sample Table Shells
***THIS TABLE IS TO BE USED BEFORE AND AFTER MATCHING
Categorical
Association between ACE Diabetes registry enrollment and diabetes distress in matched sample (N =???)
Notes
Frameworks: Behavior Change and quality care, health belief model
Focus groups: CGMs, CGMs + DSME, Control group
Find a way to illicit a story
Team Members
Dedier: PI
Besson: First author
Emily: Data analyst
Liza: Qualitative
Matthew or Zimming: Biostatistician
BUSPH Student: Student Researcher
Appendix A
TYPE 2 DIABETES DISTRESS ASSESSMENT SYSTEM
Identifying the Core Level of Distress (T2-DDAS COMBINED)
Living with diabetes can be tough. Listed below are many of the stresses and worries that people with diabetes often experience. Thinking back over the past month, please indicate how much each of the following items were a problem for you by marking the appropriate column.
For example, if an item was not a problem for you over the past month, place a mark in the first column: “Not a Problem” (1). If it was a very tough problem for you, place a mark in the last column: “A Very Serious Problem” (5).
TYPE 2 DIABETES DISTRESS ASSESSMENT SYSTEM
Identifying the Sources of Distress (T2-DDAS COMBINED)
Scoring the T2-DDAS-
COMBINED Part 1
For the first 8 questions: This score reflects the degree of, intensity, or amount of core diabetes distress reported by the respondent, with higher scores indicating greater intensity.
To score, sum the scores across all eight items (1 to 5) and divide by 8:
What if all 8 items are not completed?
If only 7 items are completed, sum the scores of the items and divide by 7. If only 6 items are completed, sum the scores of the items and divide by 6.
NOTES:
A minimum of 6 completed items are required for an accurate score.
We view a total score based on fewer than 6 items to be unreliable and therefore not scorable.
Scoring the T2-DDAS-COMBINED Part 2
For questions 9-28: This scale assesses each of seven common Sources of diabetes distress for adults with type 2 diabetes. Each Source refers to a specific aspect of living with and managing diabetes that can lead or contribute to diabetes distress for a particular individual. The higher the score, the more impactful that Source is likely to be in contributing to diabetes distress for this individual.
Each Source should be scored and considered individually; summing across Sources into a single, overall score or combining scores across Sources in any way IS NOT RECOMMENDED. A review of each of the highest scored Sources will help to identify which of the different aspects of living with and managing diabetes may be having the biggest effects on the individual.
To score, sum the scores (1 to 5) across all of the items in that scale and divide by the number of contributing items as follows:
Distress About:
PROJECT MANAGEMENT PLAN
TEMPLATE
Executive summary
Use the project charter to summarize the purpose of the project. Detail goals and objectives.
Study population
DATA SOURCES
Refer to the project charter to define the project scope, or link to the scope of work document. Defining the limits of scope will aid focus and prevent scope creep. If you are a vendor or contractor, refer to the statement of work.
DELIVERABLES
Specify the deliverables or outcomes for the project.
WORK BREAKDOWN STRUCTURE (WBS)
Discuss how the work breakdown structure will be used to complete the project, and link to the WBS document and WBS dictionary, which details the work packages or tasks for the project.
STAKEHOLDER ANALYSIS
Describe how stakeholders were identified and how they will impact and be impacted by the project. If you use a stakeholder analysis matrix, attach it here.
SCHEDULE BASELINE
Provide schedule baseline so that you can gauge progress.
MILESTONE LIST
Summarize the major milestones. Then, list each milestone and its date. Describe how to update any changes to the schedule and milestones and how to communicate those changes.
CHANGE MANAGEMENT PLAN
Describe the change control process or link to a separate document. Describe who can submit changes, who approves changes, and how changes are communicated and tracked. If your organization has a standing process or a change control board, refer to any existing documentation.
PROJECT SCOPE MANAGEMENT PLAN
Detail who has the authority to manage project scope, how scope will be measured, and who will approve the final project.
COMMUNICATION MANAGEMENT PLAN
A communication plan defines who needs information and updates on the project, what information they need, how frequently those people must be updated, and how they will be updated. A communication management plan is often used in tandem with a stakeholder list. Outline the plan here or link to a separate document.
RESOURCE MANAGEMENT PLAN
Procurement management can include all resources equipment and supplies. Also, detail whether goods or services will be purchased or rented.
PROJECT STAFF LIST
RESOURCE REQUIREMENT CALENDAR
A resource calendar details key resources for the project. It describes what resources will be needed when and for how long. Note that not all resources will necessarily be required for the duration. Complete this calendar or link to an external document.
SCHEDULE MANAGEMENT PLAN
Explain methods for developing the schedule and what tools will be used to record and post the schedule and any changes.
QUALITY MANAGEMENT PLAN
Describe the processes that will ensure the quality of deliverables. Define the quality standards, continuous improvement processes, quality governance, metrics, and reporting frequency and methods.
RISK MANAGEMENT PLAN
Briefly describe how you plan to identify, analyze, and prioritize project risks. Also, describe the methods used for tracking risks. Describe contingency plans.
RISK LOG
Link to an external risk log or attach a log as an appendix.
APPENDICES
Attach or link to separate plan documents or other reference documents. Optional.
AUTHORIZATION SIGNATURES
PREPARED BY
RECOMMENDED BY
APPROVED BY
9/22/2023
Mapping out the data registry (half a page for every data source)
How do people get in it
Whose recognized
What is the inclusion and exclusion criteria
Surveys need to be described
What was the intent?
What is the current state?
Who has access
Describe each survey tool
Describe RedCap and where the original source of data
Think measurement error
Think about other errors
Be very explicit and how patients got into each of the arms
Project description
Outcome measures
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