Ignite Creation Date:
2024-05-06 @ 8:45 AM
Last Modification Date:
2024-10-26 @ 12:04 PM
Study NCT ID:
NCT02815020
Status:
COMPLETED
Last Update Posted:
2016-06-28
First Post:
2016-05-31
Brief Title:
Implementing Networks Self-management Tools Through Engaging Patients and Practices
Sponsor:
Oregon Health and Science University
Organization:
Oregon Health and Science University
Study Overview
Official Title:
Implementing Networks Self-management Tools Through Engaging Patients and Practices
Status:
COMPLETED
Status Verified Date:
2016-06
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:
INSTTEPP
Brief Summary:
The purpose of this project is to use the Agency for Healthcare Research and Quality patient self-management support tools and resources across four practice-based research networks and 16 member practices using a community-based participatory intervention called Boot Camp Translation
Detailed Description:
Specific Aim 1 Implement the Agency for Healthcare Research and Quality SMS Resources and Tools SMS LibraryToolkit across four participating networks and 16 practices using Boot Camp Translation in a stepped-wedge design
Specific Aim 2 Assess the impact of implementation on practice staff and patients engaged in chronic care management
Specific Aim 3 Identify the factors related to successful implementation
Background and Significance
With almost one-half of Americans projected to have at least one chronic condition before 2020 it will be paramount that the health care system reduce the burden to primary care for disease management by facilitating the development of activated informed individuals who are proficient in self-management skills This represents a significant cultural shift in health management and clinicians and staff may lack confidence introducing and promoting self-management support SMS In fact SMS is the area of disease management least often implemented and most challenging to integrate into usual care This difficulty occurs at the patient and clinician level Using the Patient Activation Measure PAM Hibbard and colleagues found that 60 of patients feel passive about managing their own health and a third of patients had barriers in knowledge and confidence in caring for themselves
The chronic care model describes SMS as one of six key pillars for providing effective primary care A systematic review of the Chronic Care Model applied to diabetes care found that although not a single component of the care model emerged as essential 19 of 20 interventions that included a self-management component resulted in improved processes or outcomes of care Under the patient-centered medical home PCMH model primary care practices have moved to team-based care and care coordination putting the patient in the center of care model Primary care practices are beginning to provide care coordination services identifying and training care managers to deliver care to complex patients with chronic illnesses This has been shown to be cost-effective with a high degree of patient acceptance
The four Practice-Based Research Networks PBRNs participating in this protocol are part of the Meta-network Learning And Research Center Meta-LARC In 2012 AHRQ awarded the Oregon Rural Practice-based Research Network ORPRN a 5-year award as a Center of Excellence in Primary Care Practice-based Research and Learning This support enabled ORPRN to establish a collaborative center with the participating PBRNs using center infrastructure for data collection and management
Patient involvement has progressed to informing approaches for knowledge transfer with Boot Camp Translation BCT BCT provides a partnership model where patients are at the elbow with primary care clinicians and staff to refine best practices of care at the local level The study uses BCT to increase patient skills and engagement in improving their health It incorporates the BCT model and findings through the interpretive- and theory-based lenses of the Consolidation Framework for Implementation Research and the Theory of Planned Behavior as well as intermediate outcome measures of the Patient Activation Measure PAM and Clinician Support for Patient Activation Measure CS-PAM to provide the foundation for clinicians care managers patients practice facilitators and researchers to develop optimal strategies to make the case for self-management skills and to implement and evaluate the SMS LibraryToolkit Using a stepped wedge study design these strategies will be replicated and improved across all four PBRNs resulting in tools and a process that can be readily reproduced in other primary care practices
Primary outcomes will include the CS-PAM scores at baseline and the end of T2 T3 T4 and T5 implementation periods The structure of the data is hierarchical individuals nested within practices and longitudinal repeated measures on individuals over time
This specific aim and hypotheses will be approached using a mixed methods evaluation Theory of Planned Behavior TPB constructs will be assessed among practice staff in each study time period using a survey instrument to measure intention attitude social norm and perceived behavior control towards use of the SMS LibraryToolkit The direct measure of attitude will be assessed by means of six items using a semantic differential 7-point scale Six pairs of adjectives will be used to assess Aact for example not very usefulvery useful or not very responsiblevery responsible These adjectives will follow sentence In the context of chronic care management for me using items from the SMS LibraryToolkit would be Direct measure of the social norm SN will be assessed by means of three items each assessed on a 7-point scale Three items will be included to assess a direct measure of the perceived behavioral control PBC each on a 7-point response scale Finally intention to use the SMS librarytoolkit will be assessed by means of three items The mean composite scores of the items assessing each TPB construct will be computed For all above variables a positive score indicates that the respondent expressed a positive evaluation of the construct
The assessment of SMS LibraryToolkit implementation will rely on multiple data sources to fully evaluate what works and where across different practice settings Semi-structured key informant interviews and guided practice observation comprise the primary data sources Interview and observation guides will use open-ended question probes and cues to elicit responses and data about key implementation domains intervention characteristics outer setting external influences internal setting individual characteristics and implementation processes
The semi-structured data will be supplemented with closed-ended survey questions asked in-person or self-administered for questions that can efficiently provide descriptive results using categorical or numeric responses This includes items related to practice demographics eg number of providers and staff patient population payer mix individual characteristics eg level of training years in practice age This data will be analyzed using Qualitative Comparative Analysis to identify the specific components within the Consolidated Framework for Implementation Research CFIR domains that are important for successful implementation of the LibraryToolkit
Stepped wedge study design Stepped wedge methods are used for testing interventions that involve communities or situations where traditional randomized controlled trial methods are not possible The investigators will randomize the order in which the BCT process is implemented within each participating PBRN Each networks participating practices will receive the BCT intervention at different points along a 10-month period This will permit the investigators to have a two-month period at the beginning of the study period where all practices are in a control state for baseline assessment and gradually implement the BCT process over the subsequent eight months
Specific Aim 2 Assess the impact of implementation on practice staff and patients engaged in chronic care management
Specific Aim 3 Identify the factors related to successful implementation
Background and Significance
With almost one-half of Americans projected to have at least one chronic condition before 2020 it will be paramount that the health care system reduce the burden to primary care for disease management by facilitating the development of activated informed individuals who are proficient in self-management skills This represents a significant cultural shift in health management and clinicians and staff may lack confidence introducing and promoting self-management support SMS In fact SMS is the area of disease management least often implemented and most challenging to integrate into usual care This difficulty occurs at the patient and clinician level Using the Patient Activation Measure PAM Hibbard and colleagues found that 60 of patients feel passive about managing their own health and a third of patients had barriers in knowledge and confidence in caring for themselves
The chronic care model describes SMS as one of six key pillars for providing effective primary care A systematic review of the Chronic Care Model applied to diabetes care found that although not a single component of the care model emerged as essential 19 of 20 interventions that included a self-management component resulted in improved processes or outcomes of care Under the patient-centered medical home PCMH model primary care practices have moved to team-based care and care coordination putting the patient in the center of care model Primary care practices are beginning to provide care coordination services identifying and training care managers to deliver care to complex patients with chronic illnesses This has been shown to be cost-effective with a high degree of patient acceptance
The four Practice-Based Research Networks PBRNs participating in this protocol are part of the Meta-network Learning And Research Center Meta-LARC In 2012 AHRQ awarded the Oregon Rural Practice-based Research Network ORPRN a 5-year award as a Center of Excellence in Primary Care Practice-based Research and Learning This support enabled ORPRN to establish a collaborative center with the participating PBRNs using center infrastructure for data collection and management
Patient involvement has progressed to informing approaches for knowledge transfer with Boot Camp Translation BCT BCT provides a partnership model where patients are at the elbow with primary care clinicians and staff to refine best practices of care at the local level The study uses BCT to increase patient skills and engagement in improving their health It incorporates the BCT model and findings through the interpretive- and theory-based lenses of the Consolidation Framework for Implementation Research and the Theory of Planned Behavior as well as intermediate outcome measures of the Patient Activation Measure PAM and Clinician Support for Patient Activation Measure CS-PAM to provide the foundation for clinicians care managers patients practice facilitators and researchers to develop optimal strategies to make the case for self-management skills and to implement and evaluate the SMS LibraryToolkit Using a stepped wedge study design these strategies will be replicated and improved across all four PBRNs resulting in tools and a process that can be readily reproduced in other primary care practices
Primary outcomes will include the CS-PAM scores at baseline and the end of T2 T3 T4 and T5 implementation periods The structure of the data is hierarchical individuals nested within practices and longitudinal repeated measures on individuals over time
This specific aim and hypotheses will be approached using a mixed methods evaluation Theory of Planned Behavior TPB constructs will be assessed among practice staff in each study time period using a survey instrument to measure intention attitude social norm and perceived behavior control towards use of the SMS LibraryToolkit The direct measure of attitude will be assessed by means of six items using a semantic differential 7-point scale Six pairs of adjectives will be used to assess Aact for example not very usefulvery useful or not very responsiblevery responsible These adjectives will follow sentence In the context of chronic care management for me using items from the SMS LibraryToolkit would be Direct measure of the social norm SN will be assessed by means of three items each assessed on a 7-point scale Three items will be included to assess a direct measure of the perceived behavioral control PBC each on a 7-point response scale Finally intention to use the SMS librarytoolkit will be assessed by means of three items The mean composite scores of the items assessing each TPB construct will be computed For all above variables a positive score indicates that the respondent expressed a positive evaluation of the construct
The assessment of SMS LibraryToolkit implementation will rely on multiple data sources to fully evaluate what works and where across different practice settings Semi-structured key informant interviews and guided practice observation comprise the primary data sources Interview and observation guides will use open-ended question probes and cues to elicit responses and data about key implementation domains intervention characteristics outer setting external influences internal setting individual characteristics and implementation processes
The semi-structured data will be supplemented with closed-ended survey questions asked in-person or self-administered for questions that can efficiently provide descriptive results using categorical or numeric responses This includes items related to practice demographics eg number of providers and staff patient population payer mix individual characteristics eg level of training years in practice age This data will be analyzed using Qualitative Comparative Analysis to identify the specific components within the Consolidated Framework for Implementation Research CFIR domains that are important for successful implementation of the LibraryToolkit
Stepped wedge study design Stepped wedge methods are used for testing interventions that involve communities or situations where traditional randomized controlled trial methods are not possible The investigators will randomize the order in which the BCT process is implemented within each participating PBRN Each networks participating practices will receive the BCT intervention at different points along a 10-month period This will permit the investigators to have a two-month period at the beginning of the study period where all practices are in a control state for baseline assessment and gradually implement the BCT process over the subsequent eight months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None