Enhancing Self-Management Support in Diabetes Through Patient Engagement
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 12/15/2018 |
| Start Date: | October 2016 |
| End Date: | September 2020 |
The Patient Centered Medical Home (PCMH) and the Chronic Care Model (CCM) are complementary
clinical intervention frameworks that are commonly invoked to support better type 2 diabetes
(T2DM) outcomes in primary care. Self-management Support (SMS) is a core component of both
the PCMH and CCM, and focuses on the central role of patients in managing their illness by
engaging with and adopting healthy behaviors that promote optimal clinical outcomes. Despite
its recognized importance, SMS programs for diabetes continue to demonstrate limited
effectiveness in the real-world of primary care.
SMS is comprised of two complementary and interactive components: (1) patient engagement
(e.g., the process of eliciting and responding to patients emotions and motivations related
to health behaviors), and (2) behavioral change tools (e.g., selecting specific goals,
creating action plans). While several sophisticated SMS programs have been developed for
T2DM, the vast majority are designed with a narrow focus on behavioral change tools, largely
ignoring unique aspects of the patient context that drive and maintain health behavior.
Considerable clinical research suggests that the addition of a structured, evidenced-based
program of patient engagement can maximize the effectiveness of SMS programs for patients
with T2DM in primary care.
To date there has been no systematic study of the degree to which fully integrating enhanced
patient engagement as part of SMS will increase the initiation and maintenance of behavior
change over time, and for which kinds of patients enhanced patient engagement is essential.
To address this gap, the investigators will compare a state-of-the-art, evidence-based SMS
behavior change tool program, called Connection to Health (CTH), with an enhanced CTH program
that includes a practical, time-efficient patient engagement protocol, to create a program
with an integrated and comprehensive approach to SMS, called "Enhanced Engagement CTH"
(EE-CTH). The current study will directly test the added benefit of EE-CTH to CTH with regard
to self-management behaviors and glycemic control in resource-limited community health
centers, where vast numbers of patients with T2DM from ethnically diverse and medically
vulnerable populations receive their care. The investigators will use an
effectiveness-implementation hybrid design, employing the "Reach Effectiveness Adoption
Implementation Maintenance" (RE-AIM) framework to test these two SMS programs for T2DM. This
will provide critical information that will support dissemination and implementation of
effective SMS programs in resource-limited primary care settings, serving diverse and
medically vulnerable populations with much to gain from improved SMS.
clinical intervention frameworks that are commonly invoked to support better type 2 diabetes
(T2DM) outcomes in primary care. Self-management Support (SMS) is a core component of both
the PCMH and CCM, and focuses on the central role of patients in managing their illness by
engaging with and adopting healthy behaviors that promote optimal clinical outcomes. Despite
its recognized importance, SMS programs for diabetes continue to demonstrate limited
effectiveness in the real-world of primary care.
SMS is comprised of two complementary and interactive components: (1) patient engagement
(e.g., the process of eliciting and responding to patients emotions and motivations related
to health behaviors), and (2) behavioral change tools (e.g., selecting specific goals,
creating action plans). While several sophisticated SMS programs have been developed for
T2DM, the vast majority are designed with a narrow focus on behavioral change tools, largely
ignoring unique aspects of the patient context that drive and maintain health behavior.
Considerable clinical research suggests that the addition of a structured, evidenced-based
program of patient engagement can maximize the effectiveness of SMS programs for patients
with T2DM in primary care.
To date there has been no systematic study of the degree to which fully integrating enhanced
patient engagement as part of SMS will increase the initiation and maintenance of behavior
change over time, and for which kinds of patients enhanced patient engagement is essential.
To address this gap, the investigators will compare a state-of-the-art, evidence-based SMS
behavior change tool program, called Connection to Health (CTH), with an enhanced CTH program
that includes a practical, time-efficient patient engagement protocol, to create a program
with an integrated and comprehensive approach to SMS, called "Enhanced Engagement CTH"
(EE-CTH). The current study will directly test the added benefit of EE-CTH to CTH with regard
to self-management behaviors and glycemic control in resource-limited community health
centers, where vast numbers of patients with T2DM from ethnically diverse and medically
vulnerable populations receive their care. The investigators will use an
effectiveness-implementation hybrid design, employing the "Reach Effectiveness Adoption
Implementation Maintenance" (RE-AIM) framework to test these two SMS programs for T2DM. This
will provide critical information that will support dissemination and implementation of
effective SMS programs in resource-limited primary care settings, serving diverse and
medically vulnerable populations with much to gain from improved SMS.
This is a two-arm, 14 month pragmatic cluster randomized trial to evaluate the added benefit
of EE-CTH relative to CTH for patients with T2DM in primary care.
Primary care practices (not patients) will be randomly assigned to receive and deliver CTH or
EE-CTH in an innovative effectiveness-implementation hybrid design. Using the RE-AIM
framework, the investigators will evaluate program effectiveness in a real world setting,
while at the same time gathering information on program reach, adoption, implementation and
maintenance. CTH and EE-CTH practice trainings and delivery will each follow separate and
standardized protocols, with support provided to practices through staff training, ongoing
supervision and case presentations, and a practice improvement team assisted by a practice
facilitator to address issues of staffing and patient flow. Practice training and
facilitation notes, in conjunction with feedback from patient advisory councils, will be
captured and integrated to identify barriers and facilitators to the implementation process
and inform dissemination efforts. Beyond the requirements of the study, practices will be
permitted to use EE-CTH or CTH with other patients as wished, which will enable the
investigators to document the program's reach within the practice. Patients in both study
arms will receive the intervention at a minimum of two primary care appointments (baseline
and follow-up between 6 and 12 months).
of EE-CTH relative to CTH for patients with T2DM in primary care.
Primary care practices (not patients) will be randomly assigned to receive and deliver CTH or
EE-CTH in an innovative effectiveness-implementation hybrid design. Using the RE-AIM
framework, the investigators will evaluate program effectiveness in a real world setting,
while at the same time gathering information on program reach, adoption, implementation and
maintenance. CTH and EE-CTH practice trainings and delivery will each follow separate and
standardized protocols, with support provided to practices through staff training, ongoing
supervision and case presentations, and a practice improvement team assisted by a practice
facilitator to address issues of staffing and patient flow. Practice training and
facilitation notes, in conjunction with feedback from patient advisory councils, will be
captured and integrated to identify barriers and facilitators to the implementation process
and inform dissemination efforts. Beyond the requirements of the study, practices will be
permitted to use EE-CTH or CTH with other patients as wished, which will enable the
investigators to document the program's reach within the practice. Patients in both study
arms will receive the intervention at a minimum of two primary care appointments (baseline
and follow-up between 6 and 12 months).
Inclusion Criteria:
- Type 2 diabetes;
- Diagnosed and receiving care at participating practices for at least 12 months;
- Able to read in English or Spanish (at least 6th grade level).
Exclusion Criteria:
- Not meeting all inclusion criteria
We found this trial at
1
site
San Francisco, California 94143
Principal Investigator: Danielle M Hessler, Ph.D.
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