Ignite Creation Date:
2024-05-06 @ 2:27 PM
Last Modification Date:
2024-10-26 @ 1:31 PM
Study NCT ID:
NCT04324944
Status:
RECRUITING
Last Update Posted:
2023-08-01
First Post:
2020-03-23
Brief Title:
Adapting and Examining Collaborative Decision Skills Training Among Veterans With Serious Mental Illness
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Improving Collaborative Decision Making in Veterans With Serious Mental Illness
Status:
RECRUITING
Status Verified Date:
2024-08
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:
CDST
Brief Summary:
Recovery-oriented care is an imperative for the VA particularly in mental health programming for Veterans with serious mental illness SMI Collaborative decision-making CDM is a recovery-oriented approach to treatment decision-making that assigns equal participation and obligation to patients and providers across all aspects of decision-making thereby empowering patients and facilitating better decision-making based on patient values and preferences CDM is associated with several important outcomes including improved treatment engagement treatment satisfaction and social functioning However current levels of CDM among Veterans with SMI are low and there is not yet an evidence-based method to improve CDM Improving Veteran skill sets associated with engaging in CDM is a potential intervention strategy Collaborative Decision Skills Training CDST is a promising new intervention that was previously developed by the applicant for use in adult civilians with SMI and found to improve relevant skills and improve sense of personal recovery
The proposed study has two primary stages First a small one-armed open label trial will establish CDSTs feasibility will evaluate CDST among 12 Veterans with SMI receiving services at the VA San Diego Psychosocial Rehabilitation and Recovery Center PRRC and identify and complete any needed adaptations to CDST Stakeholder feedback from Veterans VA clinicians and VA administrators will be collected to assess Veteran needs and service context to identify any needed adaptations to the CDST manual or the delivery of CDST to maximize its impact and feasibility The developers of CDST will review all feedback and make final decisions about adaptations to ensure that CDST retains its essential components to protect against loss of efficacy For example a recommendation to adjust role-play topics to better reflect the needs of Veterans would be accepted because it would increase CDSTs relevance without impairing its integrity but a recommendation to remove all role-plays would not be accepted because it would cause loss of a key component
Second CDST will be compared to active control AC using a randomized clinical trial of 72 Veterans The primary outcome measure will be functioning within the rehabilitation context operationalized as frequency of Veteran CDM behaviors during Veteran-provider interactions Secondary outcomes are treatment attendance engagement satisfaction and motivation along with treatment outcomes ie rehabilitation goal attainment sense of personal recovery symptom severity and social functioning Three exploratory outcomes will be assessed Veteran-initiated collaborative behaviors acute service use and provider attitudes and behavior Veterans will be randomly assigned to CDST or AC conditions Veterans in the both groups will attend eight hour-long group sessions held over eight weeks All Veterans will complete an assessment battery at baseline post-intervention and at three-month post-intervention follow-up
Following the trial and adaptation phase the findings will be used to develop a CDST service delivery manual and design a logical subsequent study The results of the proposed study will inform the potential for larger trials of CDST and the utility of providing CDST broadly to Veterans with SMI The results of this study will expand current understanding of CDM among Veterans with SMI by providing data that will 1 identify adaptations needed to optimize CDST for Veterans receiving services in PRRCs 2 identify possible benefits of CDST 3 inform development of alternate interventions or methods to improve CDM and 4 further elucidate CDM and associated treatment processes among Veterans with SMI receiving VA rehabilitation services
The proposed study has two primary stages First a small one-armed open label trial will establish CDSTs feasibility will evaluate CDST among 12 Veterans with SMI receiving services at the VA San Diego Psychosocial Rehabilitation and Recovery Center PRRC and identify and complete any needed adaptations to CDST Stakeholder feedback from Veterans VA clinicians and VA administrators will be collected to assess Veteran needs and service context to identify any needed adaptations to the CDST manual or the delivery of CDST to maximize its impact and feasibility The developers of CDST will review all feedback and make final decisions about adaptations to ensure that CDST retains its essential components to protect against loss of efficacy For example a recommendation to adjust role-play topics to better reflect the needs of Veterans would be accepted because it would increase CDSTs relevance without impairing its integrity but a recommendation to remove all role-plays would not be accepted because it would cause loss of a key component
Second CDST will be compared to active control AC using a randomized clinical trial of 72 Veterans The primary outcome measure will be functioning within the rehabilitation context operationalized as frequency of Veteran CDM behaviors during Veteran-provider interactions Secondary outcomes are treatment attendance engagement satisfaction and motivation along with treatment outcomes ie rehabilitation goal attainment sense of personal recovery symptom severity and social functioning Three exploratory outcomes will be assessed Veteran-initiated collaborative behaviors acute service use and provider attitudes and behavior Veterans will be randomly assigned to CDST or AC conditions Veterans in the both groups will attend eight hour-long group sessions held over eight weeks All Veterans will complete an assessment battery at baseline post-intervention and at three-month post-intervention follow-up
Following the trial and adaptation phase the findings will be used to develop a CDST service delivery manual and design a logical subsequent study The results of the proposed study will inform the potential for larger trials of CDST and the utility of providing CDST broadly to Veterans with SMI The results of this study will expand current understanding of CDM among Veterans with SMI by providing data that will 1 identify adaptations needed to optimize CDST for Veterans receiving services in PRRCs 2 identify possible benefits of CDST 3 inform development of alternate interventions or methods to improve CDM and 4 further elucidate CDM and associated treatment processes among Veterans with SMI receiving VA rehabilitation services
Detailed Description:
The proposed study has three phases each associated with an Aim First a small one-arm open-label trial will establish feasibility of Collaborative Decision Skills Training CDST for Veterans receiving care in Psychosocial Rehabilitation and Recovery Centers PRRCs identify and complete adaptations and pilot the assessment strategy Stakeholder feedback will be collected via the Dynamic Adaptation Process in order to identify whether aspects of CDST or service delivery need to be adapted before conducting the RCT Second an RCT will compare CDST with an active control AC among 72 Veterans with serious mental illness SMI These two phases will address two key aspects of evaluating promising interventions 1 whether CDST could feasibly be integrated into usual care practices in the VA San Diego Healthcare System VASHDS PRRC and other PRRCs nationwide and 2 whether CDST leads to significant improvements in important domains for the target population Third findings from the first two phases will inform the design of a subsequent merit study and the completion of two primary products a CDST Clinician Manual and CDST Service Delivery Manual
Aim 1 Conduct a small one-arm open-label trial to identify and complete any adaptations needed to successfully integrate CDST into PRRC settings The Dynamic Adaptation Process will be used to produce a CDST Clinician Manual and a CDST Service Delivery Manual The existing CDST Clinical Manual from the pilot study will be modified as needed during Aim 1 based on findings from this project A new CDST Service Delivery Manual will be developed during Aim 1 and honed during Aim 1 and Aim 2 study activities
An Adaptation Resource Team ART will be formed including 2 Veterans with SMI currently receiving services in the VASDHS PRRC 2 clinicians who provide treatment in the VASDHS PRRC and 2 administrators whose duties include administration of the VASDHS PRRC Veterans will be enrolled via 1 referrals from clinicians and 2 print advertisements in the PRRC waiting room Clinicians and administrators will be solicited directly Written informed consent will be obtained from each participant
Each ART member will receive a copy of the Clinician Manual and a description of the purpose of the Service Delivery Manual They will be asked to review these materials and make notes of their perceptions including components that are not relevant may not resonate with the Veteran population or would not be feasible within the PRRC context Approximately 2 weeks later each participant will complete an individual interview accompanied by the research assistant using a semi-structured interview approach These interviews will systematically work through the CDST content and service delivery aspects of the intervention These interviews will be analyzed compiled and presented back to the ART for discussion The ART will come to consensus about adaptations with supervision from the CDST developers to ensure fidelity to CDSTs active ingredients
The open trial will occur following initial adaptation Twelve Veterans will participate There will not be a comparison group for the open trial
During the open trial and RCT there will be three assessment time points baseline post-intervention and follow-up at 3 months postintervention completion One measure will also be completed at the midpoint but this will be done by recovery coaches and does not require Veteran time Veterans will receive compensation for assessment completion but not for intervention attendance to minimize the potential impact of compensation on treatment engagement
Veteran clinician and administrator ART participants will all be encouraged to continue in the ART during RCT RCT Veterans will be enrolled on a cohort bases in tandem with the trial Specifically after each RCT cohort has completed data collection two Veterans who were assigned to the CDST group will be recruited to join the adaptation process Therefore this will equal 10 Veterans total 2 non-trial 2 open trial 2from RCT cohort 1 2 from RCT cohort 2 2 from RCT cohort 3 If more than 2 Veterans from a given cohort wish to join all Veterans will be admitted 4 Veterans per cohort have been budgeted for to account for this If Aim 1 ART members choose not to continue efforts will be made to replace them by a person with a similar role eg another provider another non-trial Veteran The ART will meet twice before each new RCT cohort to review and approve additions and changes to the Service Delivery Manual and will meet once following completion of data collection for each cohort to discuss lessons learned from that cohort to inform the Service Delivery Manual Following the end of all RCT data collection in Year 5 ART clinicians and administrators will complete one semi-structured interview to assess implementation and sustainability feasibility of CDST for the VASDHS PRRC
In order to have a final sample of 58 Veterans combined across conditions in the RCT the investigators will recruit 72 Veterans estimating 20 attrition There will be three cohorts with 24 Veteran per cohort In years 2-4 there will be one cohort recruited annually Veterans will be randomized by cohort with 12 Veterans randomized to CDST and 12 randomized to AC There will be two CDST groups per cohort and two AC groups per cohort and therefore there will be six total groups of each type
Veterans will be randomly assigned to either the CDST condition or to AC after completing baseline assessments To maximize power for between-group comparisons randomization will be 11 resulting in 36 participants per group Participants will be randomly assigned by cohort so that for each cohort there are 12 participants each in CDST and AC Randomization procedure may be adjusted if necessary to fix uneven group sizes or demographics eg due to attrition for example by introducing a stratification variable The research assistant who completes the assessments will be blind to condition and will not attend any clinical team meetings or otherwise participate in any non-study related PRRC activities to maintain blindness
The final aim of this study is to 1 design a follow-up study based on the conclusions of the proposed study and 2 develop a CDST Service Delivery Manual that will facilitate delivery of CDST in VA PRRCs The specific study design and aims will be determined based on the outcomes of the proposed study and will be responsive to possible changes in the VASDHS PRRC PRRCs nationwide and the broader VA context There are three general possibilities for this follow-up study based on three potential outcomes First if this study supports CDSTs effectiveness among Veterans with SMI and implementation viability for the VASDHS PRRC the follow-up study is likely to be a larger multisite clinical trial that will allow for confirmation of CDSTs effectiveness and work towards broad application of CDST in PRRCs throughout the VA system In this case the investigators plan to collaborate with other Desert Pacific PRRCs to conduct a larger trial This trial may also include maintenance of effects after a 6- or 12- month follow-up period and ability to personalize CDST service delivery for individual PRRCs Second if this study supports CDSTs effectiveness among Veterans with SMI but not its implementation viability for VASDHS PRRCs or vice versa the follow-up study will use data from this study to inform potential ways to resolve this issue so that CDST can become an effective and viable intervention For example if effectiveness was supported but viability was not and results indicated that CDST was too many sessions then a follow-up study could develop a shorter version of CDST and test it in the VASDHS PRRC Third if this study does not support CDSTs effectiveness among Veterans with SMI nor its implementation viability in PRRCs then the follow-up study will pursue other mechanisms to increase collaborative decision-making among Veterans with SMI
The Service Delivery Manual will be developed and refined throughout Aims 1 and 2 This manual is intended to be an accompaniment to the Clinician Manual to help clinicians deliver CDST in their own service contexts The Service Delivery Manual will include discussion of approved adaptations to the manual that will not dilute or remove CDSTs active ingredients The manual will also include tips from CDST providers and participants that could assist future providers in effective delivery These approved adaptations and tips could include recommendations for managing dynamics in the group deciding upon role plays to suit Veteran priorities and approved service approach variations that will not impact fidelity eg number of meetings per week In the event that data from this study refutes CDSTs viability for Veterans with SMI a CDST-specific service delivery manual is unlikely to be a useful product In that case a more general service delivery product will be developed for example a set of collaborative decision-making guidelines for PRRC administrators and providers based on data collected Products from this study will be disseminated in the VA and outside the VA
Aim 1 Conduct a small one-arm open-label trial to identify and complete any adaptations needed to successfully integrate CDST into PRRC settings The Dynamic Adaptation Process will be used to produce a CDST Clinician Manual and a CDST Service Delivery Manual The existing CDST Clinical Manual from the pilot study will be modified as needed during Aim 1 based on findings from this project A new CDST Service Delivery Manual will be developed during Aim 1 and honed during Aim 1 and Aim 2 study activities
An Adaptation Resource Team ART will be formed including 2 Veterans with SMI currently receiving services in the VASDHS PRRC 2 clinicians who provide treatment in the VASDHS PRRC and 2 administrators whose duties include administration of the VASDHS PRRC Veterans will be enrolled via 1 referrals from clinicians and 2 print advertisements in the PRRC waiting room Clinicians and administrators will be solicited directly Written informed consent will be obtained from each participant
Each ART member will receive a copy of the Clinician Manual and a description of the purpose of the Service Delivery Manual They will be asked to review these materials and make notes of their perceptions including components that are not relevant may not resonate with the Veteran population or would not be feasible within the PRRC context Approximately 2 weeks later each participant will complete an individual interview accompanied by the research assistant using a semi-structured interview approach These interviews will systematically work through the CDST content and service delivery aspects of the intervention These interviews will be analyzed compiled and presented back to the ART for discussion The ART will come to consensus about adaptations with supervision from the CDST developers to ensure fidelity to CDSTs active ingredients
The open trial will occur following initial adaptation Twelve Veterans will participate There will not be a comparison group for the open trial
During the open trial and RCT there will be three assessment time points baseline post-intervention and follow-up at 3 months postintervention completion One measure will also be completed at the midpoint but this will be done by recovery coaches and does not require Veteran time Veterans will receive compensation for assessment completion but not for intervention attendance to minimize the potential impact of compensation on treatment engagement
Veteran clinician and administrator ART participants will all be encouraged to continue in the ART during RCT RCT Veterans will be enrolled on a cohort bases in tandem with the trial Specifically after each RCT cohort has completed data collection two Veterans who were assigned to the CDST group will be recruited to join the adaptation process Therefore this will equal 10 Veterans total 2 non-trial 2 open trial 2from RCT cohort 1 2 from RCT cohort 2 2 from RCT cohort 3 If more than 2 Veterans from a given cohort wish to join all Veterans will be admitted 4 Veterans per cohort have been budgeted for to account for this If Aim 1 ART members choose not to continue efforts will be made to replace them by a person with a similar role eg another provider another non-trial Veteran The ART will meet twice before each new RCT cohort to review and approve additions and changes to the Service Delivery Manual and will meet once following completion of data collection for each cohort to discuss lessons learned from that cohort to inform the Service Delivery Manual Following the end of all RCT data collection in Year 5 ART clinicians and administrators will complete one semi-structured interview to assess implementation and sustainability feasibility of CDST for the VASDHS PRRC
In order to have a final sample of 58 Veterans combined across conditions in the RCT the investigators will recruit 72 Veterans estimating 20 attrition There will be three cohorts with 24 Veteran per cohort In years 2-4 there will be one cohort recruited annually Veterans will be randomized by cohort with 12 Veterans randomized to CDST and 12 randomized to AC There will be two CDST groups per cohort and two AC groups per cohort and therefore there will be six total groups of each type
Veterans will be randomly assigned to either the CDST condition or to AC after completing baseline assessments To maximize power for between-group comparisons randomization will be 11 resulting in 36 participants per group Participants will be randomly assigned by cohort so that for each cohort there are 12 participants each in CDST and AC Randomization procedure may be adjusted if necessary to fix uneven group sizes or demographics eg due to attrition for example by introducing a stratification variable The research assistant who completes the assessments will be blind to condition and will not attend any clinical team meetings or otherwise participate in any non-study related PRRC activities to maintain blindness
The final aim of this study is to 1 design a follow-up study based on the conclusions of the proposed study and 2 develop a CDST Service Delivery Manual that will facilitate delivery of CDST in VA PRRCs The specific study design and aims will be determined based on the outcomes of the proposed study and will be responsive to possible changes in the VASDHS PRRC PRRCs nationwide and the broader VA context There are three general possibilities for this follow-up study based on three potential outcomes First if this study supports CDSTs effectiveness among Veterans with SMI and implementation viability for the VASDHS PRRC the follow-up study is likely to be a larger multisite clinical trial that will allow for confirmation of CDSTs effectiveness and work towards broad application of CDST in PRRCs throughout the VA system In this case the investigators plan to collaborate with other Desert Pacific PRRCs to conduct a larger trial This trial may also include maintenance of effects after a 6- or 12- month follow-up period and ability to personalize CDST service delivery for individual PRRCs Second if this study supports CDSTs effectiveness among Veterans with SMI but not its implementation viability for VASDHS PRRCs or vice versa the follow-up study will use data from this study to inform potential ways to resolve this issue so that CDST can become an effective and viable intervention For example if effectiveness was supported but viability was not and results indicated that CDST was too many sessions then a follow-up study could develop a shorter version of CDST and test it in the VASDHS PRRC Third if this study does not support CDSTs effectiveness among Veterans with SMI nor its implementation viability in PRRCs then the follow-up study will pursue other mechanisms to increase collaborative decision-making among Veterans with SMI
The Service Delivery Manual will be developed and refined throughout Aims 1 and 2 This manual is intended to be an accompaniment to the Clinician Manual to help clinicians deliver CDST in their own service contexts The Service Delivery Manual will include discussion of approved adaptations to the manual that will not dilute or remove CDSTs active ingredients The manual will also include tips from CDST providers and participants that could assist future providers in effective delivery These approved adaptations and tips could include recommendations for managing dynamics in the group deciding upon role plays to suit Veteran priorities and approved service approach variations that will not impact fidelity eg number of meetings per week In the event that data from this study refutes CDSTs viability for Veterans with SMI a CDST-specific service delivery manual is unlikely to be a useful product In that case a more general service delivery product will be developed for example a set of collaborative decision-making guidelines for PRRC administrators and providers based on data collected Products from this study will be disseminated in the VA and outside the VA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None