Study Stopped
Sponsor requested termination due to low recruitment numbers
Improving Mental Health Outcomes: Building an Adaptive Implementation Strategy
1 other identifier
interventional
383
1 country
2
Brief Summary
The overarching goal of this study is to build the most cost-effective adaptive implementation intervention involving a site-level implementation intervention strategy: Replicating Effective Programs (REP), and the augmentation of REP using either External Facilitation or a combination of an External and Internal Facilitation to improve patient outcomes and the uptake of an evidence-based program for mood disorders (Life Goals-LG) in community settings.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2014
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 28, 2014
CompletedFirst Posted
Study publicly available on registry
May 30, 2014
CompletedStudy Start
First participant enrolled
August 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2017
CompletedResults Posted
Study results publicly available
December 12, 2018
CompletedDecember 12, 2018
November 1, 2018
3.3 years
May 28, 2014
October 15, 2018
November 15, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Health-related Quality of Life - Mental Health Component Score
Mental Health Quality of Life was measured using the 12-Item Short Form Survey (SF-12). The SF-12 has a scale range of 0-100 with higher values representing better outcomes.
Change from Baseline in Quality of Life at 12-months
Reduced Mood Disorder Symptoms
Mood disorder symptoms were measured using the Patient Health Questionnaire (9-question). The PHQ-9 has a scale range of 0-27 with lower values representing better outcomes.
Change from Baseline in Mood Disorder Symptoms at 12-months
Secondary Outcomes (2)
Health-related Quality of Life - Mental Health Component Score
Change from Baseline in Quality of Life at 24-months
Reduced Mood Disorder Symptoms
Change from Baseline in Mood Disorder Symptoms at 24-months
Study Arms (2)
REP + EF
EXPERIMENTALReplication Effective Programs (REP) augmented with External Facilitation (EF)
REP + EF/IF
EXPERIMENTALReplicating Effective Programs (REP) augmented with External and Internal Facilitation (EF + IF)
Interventions
Non-responding sites randomized to receive external facilitation
Non-responding sites randomized to receive both internal and external facilitation
Eligibility Criteria
You may qualify if:
- Currently being seen at one of the clinics participating in this study
- Diagnosis of or treated for a mood disorder (bipolar disorder or depression)
- Ability to speak and read English and provide informed consent
You may not qualify if:
- No active substance intoxication
- No acute medical illness or dementia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Michiganlead
- National Institute of Mental Health (NIMH)collaborator
Study Sites (2)
Colorado Access
Denver, Colorado, 80231, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Related Publications (3)
Eisman AB, Hutton DW, Prosser LA, Smith SN, Kilbourne AM. Cost-effectiveness of the Adaptive Implementation of Effective Programs Trial (ADEPT): approaches to adopting implementation strategies. Implement Sci. 2020 Dec 14;15(1):109. doi: 10.1186/s13012-020-01069-w.
PMID: 33317593DERIVEDSmith SN, Almirall D, Prenovost K, Liebrecht C, Kyle J, Eisenberg D, Bauer MS, Kilbourne AM. Change in Patient Outcomes After Augmenting a Low-level Implementation Strategy in Community Practices That Are Slow to Adopt a Collaborative Chronic Care Model: A Cluster Randomized Implementation Trial. Med Care. 2019 Jul;57(7):503-511. doi: 10.1097/MLR.0000000000001138.
PMID: 31135692DERIVEDKilbourne AM, Almirall D, Eisenberg D, Waxmonsky J, Goodrich DE, Fortney JC, Kirchner JE, Solberg LI, Main D, Bauer MS, Kyle J, Murphy SA, Nord KM, Thomas MR. Protocol: Adaptive Implementation of Effective Programs Trial (ADEPT): cluster randomized SMART trial comparing a standard versus enhanced implementation strategy to improve outcomes of a mood disorders program. Implement Sci. 2014 Sep 30;9:132. doi: 10.1186/s13012-014-0132-x.
PMID: 25267385DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Number of patients referred for study was much lower than anticipated; many sites participating in the study (N=18) did not refer any patients and therefore are not included in patient-level outcomes analysis.
Results Point of Contact
- Title
- Amy Kilbourne, PhD
- Organization
- University of Michigan
Study Officials
- PRINCIPAL INVESTIGATOR
Amy M Kilbourne, PhD, MPH
University of Michigan
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Psychiatry
Study Record Dates
First Submitted
May 28, 2014
First Posted
May 30, 2014
Study Start
August 1, 2014
Primary Completion
November 1, 2017
Study Completion
November 1, 2017
Last Updated
December 12, 2018
Results First Posted
December 12, 2018
Record last verified: 2018-11