Ignite Creation Date:
2024-05-06 @ 8:07 AM
Last Modification Date:
2024-10-26 @ 11:56 AM
Study NCT ID:
NCT02675777
Status:
COMPLETED
Last Update Posted:
2019-09-13
First Post:
2016-01-28
Brief Title:
Sustaining Patient-centered Alcohol-related Care
Sponsor:
Kaiser Permanente
Organization:
Kaiser Permanente
Study Overview
Official Title:
Sustained Implementation of Patient-Centered Care for Alcohol Misuse
Status:
COMPLETED
Status Verified Date:
2019-09
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:
SPARC
Brief Summary:
Alcohol use is the third greatest cause of disability and death for US adults Care for unhealthy alcohol use is lacking in most primary care settings This project will implement two types of evidence-based care for unhealthy alcohol use in the 25 primary clinics of a regional health system-Group Health GH These include preventive care and treatment Preventive care consists of alcohol screening and for patients who screen positive brief patient-centered counseling Treatment for alcohol use disorders includes offering shared decision making and motivational counseling designed to enhance engagement in one or more treatment options counseling medications andor specialty treatment During a pilot phase the research team at Group Health Research Institute partnered with Group Health leaders and front line clinicians to design pilot test and iteratively refine an implementation strategy in 3 Group Health primary care clinics
Objective
This study uses state-of-the-art implementation strategies to integrate evidence-based alcohol-related care into 22 primary care clinics detailed below This study is a pragmatic stepped-wedge quality improvement trial to evaluate its impact on
1 The proportion of patients who have primary care visits who screen positive for unhealthy alcohol use and have documented annual brief alcohol counseling
2 The proportion of patients who have primary care visits who have AUDs identified and a initiate and b engage in care for AUDs
Secondary outcomes will include
1 The proportion of patients who have primary care visits who have documented annual alcohol screening with the AUDIT-C and
2 The proportion of patients who have primary care visits who screen positive for severe unhealthy alcohol use and have AUDs assessed andor diagnosed
Objective
This study uses state-of-the-art implementation strategies to integrate evidence-based alcohol-related care into 22 primary care clinics detailed below This study is a pragmatic stepped-wedge quality improvement trial to evaluate its impact on
1 The proportion of patients who have primary care visits who screen positive for unhealthy alcohol use and have documented annual brief alcohol counseling
2 The proportion of patients who have primary care visits who have AUDs identified and a initiate and b engage in care for AUDs
Secondary outcomes will include
1 The proportion of patients who have primary care visits who have documented annual alcohol screening with the AUDIT-C and
2 The proportion of patients who have primary care visits who screen positive for severe unhealthy alcohol use and have AUDs assessed andor diagnosed
Detailed Description:
Group Healths Behavioral Health Service leaders decided to implement alcohol-related care along with integration of population-based primary care for other behavioral health conditions including screening for depression marijuana and other substance use and use disorders Group Health leaders also decided to transition primary care social workers to become integrated behavioral health clinicians in 2015
Pilot testing of the implementation strategies in 2015 was led by Group Healths Behavioral Health Service BHS in collaboration with other Group Health departments State-of-the-art implementation methods were used to integrate evidence-based alcohol-related care into 3 pilot primary care clinics in Group Health The implementation strategies included participatory design clinical champions practice facilitation performance monitoring and feedback and clinical decision support in the electronic health record EHR The implementation strategies also included a video and handout designed explicitly to shift staff attitudes in order to make discussions of unhealthy alcohol use routine and less stigmatized in primary care Screening and follow-up assessment for symptoms of AUDs are conducted on paper and then typically entered into the EPIC EHR by medical assistants MAs The implementation strategy was refined based on ongoing formative evaluation
Group Health leaders are now prepared to roll out behavioral health integration to the remaining 22 primary care clinics All implementation will be led and conducted by Group Health clinical leaders and clinicians The timing of implementation at the 22 clinics is staggered to allow for support from practice facilitators Leaders randomized clinics to different start dates to allow a rigorous evaluation using secondary quality improvement data
The research team at Group Health Research Institute is supporting implementation and will lead the evaluation The research team will conduct a pragmatic stepped-wedge quality improvement trial in the 22 primary care clinics Implementation will be staggered in 7 waves each of which will be 4 months long 3 waves in Year 1 4 waves in Years 2-3 Randomization is stratified by study Year with 9 sites chosen by Group Health clinical leaders to start in Year 1 and the 13 remaining sites to be randomized in Year 2 Randomization is stratified primarily because Group Health clinical leaders wanted to choose the first 9 clinics In addition they may decide remove 3 or 4 facilities in Spokane a long distance from Seattle requiring air travel from the Year 2 randomization thereby omitting 1 of the 7 waves of implementation Year 2
Pilot testing of the implementation strategies in 2015 was led by Group Healths Behavioral Health Service BHS in collaboration with other Group Health departments State-of-the-art implementation methods were used to integrate evidence-based alcohol-related care into 3 pilot primary care clinics in Group Health The implementation strategies included participatory design clinical champions practice facilitation performance monitoring and feedback and clinical decision support in the electronic health record EHR The implementation strategies also included a video and handout designed explicitly to shift staff attitudes in order to make discussions of unhealthy alcohol use routine and less stigmatized in primary care Screening and follow-up assessment for symptoms of AUDs are conducted on paper and then typically entered into the EPIC EHR by medical assistants MAs The implementation strategy was refined based on ongoing formative evaluation
Group Health leaders are now prepared to roll out behavioral health integration to the remaining 22 primary care clinics All implementation will be led and conducted by Group Health clinical leaders and clinicians The timing of implementation at the 22 clinics is staggered to allow for support from practice facilitators Leaders randomized clinics to different start dates to allow a rigorous evaluation using secondary quality improvement data
The research team at Group Health Research Institute is supporting implementation and will lead the evaluation The research team will conduct a pragmatic stepped-wedge quality improvement trial in the 22 primary care clinics Implementation will be staggered in 7 waves each of which will be 4 months long 3 waves in Year 1 4 waves in Years 2-3 Randomization is stratified by study Year with 9 sites chosen by Group Health clinical leaders to start in Year 1 and the 13 remaining sites to be randomized in Year 2 Randomization is stratified primarily because Group Health clinical leaders wanted to choose the first 9 clinics In addition they may decide remove 3 or 4 facilities in Spokane a long distance from Seattle requiring air travel from the Year 2 randomization thereby omitting 1 of the 7 waves of implementation Year 2
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