Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04461405 |
Other study ID # |
20783 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
August 1, 2020 |
Est. completion date |
June 1, 2022 |
Study information
Verified date |
November 2023 |
Source |
Oregon Health and Science University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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 (MH/BH) 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 MH/BH 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.
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 (e.g., 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 (i.e., 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 1:1 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 (e.g.,
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 (e.g., screening for HbA1c, eye, and foot exams) and assess
discussion of and engagement in self-management activities (e.g., 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.