Ignite Creation Date:
2024-05-06 @ 2:55 PM
Last Modification Date:
2024-10-26 @ 1:39 PM
Study NCT ID:
NCT04461405
Status:
COMPLETED
Last Update Posted:
2023-11-14
First Post:
2020-06-26
Brief Title:
INTEGRATE-D A Pilot Test to Support Integration of Medical and Psychosocial Care for People With Type II Diabetes
Sponsor:
Oregon Health and Science University
Organization:
Oregon Health and Science University
Study Overview
Official Title:
INTEGRATE-D A Pilot Test of Implementation Strategies to Support Integration of Medical and Psychosocial Care for People With Type II Diabetes
Status:
COMPLETED
Status Verified Date:
2023-11
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:
In 2016 the American Diabetes Association ADA published its first-ever recommendations for integrating medical and psychosocial care for patients with Type II Diabetes Mellitus DMII and common mental and behavioral health MHBH problems In the United States 30 million people live with DMII and the majority receive care in primary care settings By implementing the ADA recommendations primary care practices will help patients better manage their MHBH needs meet recommended goals for DMII management and reduce the risk of adverse outcomes Making these recommendations a routine part of practice is a major change and it is critical to understand how best to implement the ADA recommendations and test its effectiveness in the real world The pilot study builds on a series of prior studies to refine and pilot test a package of implementation strategies - called INTEGRATE-D - to support practices in implementing the ADA recommendations for integrated DMII care INTEGRATE-D combines the following evidence-based implementation strategies 1 electronic health record EHR-based support - to help align EHR use with ADA recommendations and enable screening for depression anxiety diabetes distress cognitive impairment and self-management and support identifying and tracking progress on patient treatments and goals 2 Audit and feedback - which involves assisting practices in accessing clinically relevant actionable data reports to inform measurement and identification of care gaps in DMII and behavioral health care 3 Skill-building resources - including training on ADA-recommended care and 4 Facilitation - to help implement the above strategies and tailor the intervention so that practice work on the subset of areas where practices are ready to change to align care with ADA recommendations The study aims are Aim 1 Refine the INTEGRATE-D intervention by incorporating the preferences of stakeholders In partnership with patients primary care key stakeholders and experts compile and refine the package of implementation strategies in the INTEGRATE-D intervention Aim 2 Demonstrate feasibility acceptability and estimate cost Conduct a mixed-method pre-post pilot comparing two practices that receive the INTEGRATE-D intervention to two control practices that receive training materials only
Detailed Description:
The INTEGRATE-D intervention is designed to support primary care practices with implementing ADA recommendations for integrating medical and psychosocial care for patients with DMII Primary care practices will be the recipients of this support For practices the intervention will be 15 months long The first three months will be a Readiness Phase where the study team assesses practices capacity at baseline and a facilitator works with intervention practices to address capacity issues eg help the practice produce a quality report that can be barriers during active implementation Then intervention practices receive 12 months of Active Intervention with the same facilitator to align care processes with ADA recommendations Pilot study design The study team will use a randomized mixed-method pre-post design for this pilot study The goal of this randomized pilot design is to evaluate the feasibility of recruitment randomization retention assessment procedures implementation of the INTEGRATE-D intervention and provide insights into the effect of this pilot intervention on practice-level outcomes Practice Sample and eligibility criteria The sample for this pilot is four primary care practices Practices with more than 100 adult patients 18 years with a diagnosis of DM Type II not gestational are eligible Practice Recruitment Practices will be recruited from the ORPRN practice-based research network ORPRN works with 279 primary care practices in the state of Oregon including 51 that are rural and 42 clinician-owned practices ORPRN recruiters will identify 50 potential practices and conduct a faxback to assess interest capacity and eligibility Of interested practices ORPRN and the study team will select 4 practices 2 rural and 2 non-rural that vary on whether practices employ a behavioral health clinician The study team will purposefully vary practices on these characteristics based on previous work that demonstrated they influenced intervention uptake Patient Sample The study team will have three different patient samples For chart audits there will be two samples 1 Patients with a diagnosis of DMII who have been seen at least once at the practice in the 15 months prior to the intervention start date and at least once after the intervention start date will be included in the chart audit The study team will randomly select 50 patients meeting these criteria 2 Patients meeting the above criteria and screening positive for depression ie those patients who have minimally exposed to the INTEGRATE-D intervention will also be randomly selected for chart audit The study team will audit charts until there is a sample of 30 patients meeting these criteria 3 From this latter group the study team will select 5 patients at each of the two intervention practices to participate in an interview Randomization Procedure Practices will be randomized in a 11 ratio through a covariate-constrained randomization procedure This is accomplished as follows Prior to randomization the study team will collect baseline data on practice-level factors eg practice size ownership rurality patient panel demographics etc that could influence process and outcome measures These data will be collected as part of the recruitment process The study team will construct all possible combinations of eligible practices into two groups For each selected possible randomization the study team will compare the balance between study arms in the important baseline data described above through a balance criterion The study team will randomly select one randomization combination from the 2 combinations with the best balance which will yield 2 practices in each study arm with good balance in important covariates Data Collection For this pilot study the study team will collect mixed methods survey observation interview and chart audit data For control practices data collection will include the collection of survey and chart audit data These data will be collected at the same time as data collected from intervention practices Intervention practices in addition to completing surveys and participating in the chart audit will participate in practice site visits which include the study team observing the practice and how it delivers care and interviewing a varied group of practice members including those that participated in implementing the intervention These visits will happen before and after the intervention In addition during the implementation of INTEGRATE-D the study team will conduct monthly telephone calls with a key informant at the intervention practices Measures The study team will measure practice capacity for quality improvement using the Change Process Capability Questionnaire survey The study team will measure changes in care processes as follows for depression - screening for depression using the Patient Health Questionnaire PHQ-9 rates of referral to behavioral health when patients screen positive on the PHQ-9 for diabetes - the study team will use a composite measure of DMII process of clinical care eg screening for HbA1c eye and foot exams and assess discussion of and engagement in self-management activities eg healthy eating physical activity The study team will measure outcome change as a change in PHQ-9 and HbA1c All process and outcome measures will all be collected via chart audit The study team will measure feasibility and acceptability perceived and actual of INTEGRATE-D using observation semi-structured interviews survey and facilitator tracking data Surveys will use validated acceptability and feasibility measures Statistical power As this is a pilot study it is not meant to have the sample size needed to test for statistical significance Rather this pilot is designed to show the promise of the INTEGRATE-D intervention and provide the data need to do accurate power calculations for the larger subsequent pragmatic trial Data Analysis Qualitative analysis will follow a rigorous process whereby a team of experienced qualitative researchers will identify emerging patterns or findings and then analyze data again to solidify these patterns into a coherent set of findings Quantitative analyses will use standard descriptive statistical methods and the study team will utilize Generalized Linear Mixed Models to compare the effect of INTEGRATE-D intervention on process outcome measures in the context of a cluster-randomized design
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