Ignite Creation Date:
2024-05-06 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06231407
Status:
COMPLETED
Last Update Posted:
2024-01-30
First Post:
2023-07-19
Brief Title:
Increasing Medication Check Participation Through Applying CT-r
Sponsor:
Vanderbilt University Medical Center
Organization:
Vanderbilt University Medical Center
Study Overview
Official Title:
Recovery Oriented Cognitive Therapy CT-R Medication Checks An Acceptability and Feasibility Trial Standard Operating Procedure
Status:
COMPLETED
Status Verified Date:
2024-01
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:
IMPACT
Brief Summary:
The goal of this feasibility and acceptability trial is to learn about the acceptability of adding a recovery-oriented psychological framework to a standard medication management appointment with a psychiatrist and any impact on attendance and functioning The main questions it aims to answer are
1 Will CT-R medication checks will be acceptable to the patient and feasible to deliver and receive as measured by asking patients how they like the CT-R med checks and our ability to do this study in addition to number of patient drop-outs
2 Will CT-R medication checks will be related to significantly greater engagement with treatment as measured by lower no-show rates greater self-reported working alliance and better treatment adherence
3 Will CT-R medication checks will be related to greater activity and increase in functioning as measured by time use survey GAF skill use
4 Will CT-R medication checks will be related to a trend in improved defeatist beliefs negative symptoms paranoia and self-esteem
Researchers will compare the group assigned to the trial psychiatrists to a small group who were assigned to non-trial psychiatrists to see if the intervention impacted any of the above questions beyond TAU
1 Will CT-R medication checks will be acceptable to the patient and feasible to deliver and receive as measured by asking patients how they like the CT-R med checks and our ability to do this study in addition to number of patient drop-outs
2 Will CT-R medication checks will be related to significantly greater engagement with treatment as measured by lower no-show rates greater self-reported working alliance and better treatment adherence
3 Will CT-R medication checks will be related to greater activity and increase in functioning as measured by time use survey GAF skill use
4 Will CT-R medication checks will be related to a trend in improved defeatist beliefs negative symptoms paranoia and self-esteem
Researchers will compare the group assigned to the trial psychiatrists to a small group who were assigned to non-trial psychiatrists to see if the intervention impacted any of the above questions beyond TAU
Detailed Description:
The current study aims to test whether adapting a psychological treatment for schizophrenia to medication appointments with psychiatry residents is acceptable and feasible and whether it improves treatment engagement functioning and symptom burden particularly negative symptoms In addition to providing psychiatry residents with a framework for conducting medication appointments it will also give patients with psychotic disorders access to empirically-supported psychological interventions that they may not otherwise have access to We will test the acceptability and feasibility of this adapted intervention and examine whether effect sizes of change with intervention in this sample size warrant testing in a larger study
Only patients who consent to being in the study will receive CT-R medication appointments CT-R is a therapy process that is being implemented within the medication appointments The provided measures and tasks are outcomes to be measured throughout the study For instance we are interested in how clinical symptoms subjective well-being and treatment engagement change with the implementation of CT-R in medication appointments
1 CT-R medication checks will be acceptable to the patient and feasible to deliver and receive as measured by asking patients how they like the CT-R med checks and our ability to do this study in addition to number of patient drop-outs
2 CT-R medication checks will be related to significantly greater engagement with treatment as measured by lower no-show rates greater self-reported working alliance and better treatment adherence
3 CT-R medication checks will be related to greater activity and increase in functioning as measured by time use survey GAF skill use
4 CT-R medication checks will be related to a trend in improved defeatist beliefs negative symptoms paranoia and self-esteem
5 Exploratory analyses will include
1 CT-R med checks will be related to greater improvement on a cognitive motivation task EEfRTBalloon task
2 Improvement in Defeatist Belief Scale DBS and Neg Symptoms will be mediated by increased treatment adherence engagement and activity
Expected study duration 3 years
3 Procedures_________________________________________________________________
41 Recruitment Vanderbilt Adult Psychiatry Outpatient Clinic VAPOC Individuals who are currently being seen for medication management through VAPOC and who meet eligibility criteria will be identified by the treating providers and study staff through review of medical records and consultation with providing clinicians Potential participants will only be approached with the approval of the treating provider who will determine whether that individual is likely to have the capacity to consider the research study and provide consent If appropriate their provider will ensure that the patient is agreeable to being approached about a research study or introduce the patient to the research team Potential participants will be approached by research staff after their appointment for a brief screening visit
Recruitment may occur in person over telehealth or over the phone VAPOC accommodates both in-person and telehealth appointments depending on the patients preference Therefore for eligible patients who are seen regularly over telehealth recruitment may occur by joining the telehealth appointment at the end of the visit Additionally potential participants may not be available to stay after their appointment despite interest in the study Therefore individuals identified as a good fit who cannot be connected with in-person will be called on the phone for a screening with the providers consent and after the provider has ensured that the patient is agreeable to being called about a research study
Resident subjects will be recruited from Vanderbilt Adult Psychiatry Outpatient Clinic Residents who are involved with the study will be contacted either by email or in-person to assess their interest in being enrolled and consented as a participant in order for the research team to gather information about the acceptability and feasibility of carrying out the intervention
43 Planned enrollment We plan to recruit up to 40 subjects for the study
44 Screening and Consent Potential research subjects will be asked if they would like to participate in the current study If they report potential interest a pre-screening will occur This screening will occur in person over the phone or over telehealth Zoom using the Screening Form or Phone Script Informed consent will be obtained by study personnel directly involved in the research ie research staff or PI Personnel have completed IRB training and have considerable experience running studies in clinical populations
Informed consent will be obtained either 1 in the research offices at the Psychiatric Neuroimaging Program or 2 over Zoom during a virtual study visit A research staff member will explain the applicable procedures and the possible risks and benefits to the subjects The details of the informed consent procedure are as follows
1 The investigator or research staff and the subject will read together the entire consent form
2 The subject will be asked details about the study To document that the subject has read the consent form and has the capacity to understand the most important details the investigator will use the appropriate Informed Consent Survey The questions will be read by the investigator or research staff and the answers will be recorded If the subject is unable to answer any of the questions or if the subject demonstrates a lack of understanding the investigator or research staff member will then review the details of the study again Subjects who are unable to answer the questions even after additional information is provided will be excluded from the study
3 The subject will be informed that regardless of whether or not they take part in this research study it will not affect their treatment payment or enrollment in any health plans or affect their ability to get benefits or care in any way
4 The subject will be provided with copies of the signed consent form and the Informed Consent Survey including the answers given at the time of the initial visit If completed virtually this will be emailed using secure email methods to the subject with their consent
5 At each visit we will 1 remind participants that the research visit is voluntary no matter how many previous visits they have done and 2 ask them to tell us what they believe the purpose of the study is and repeat back what they will be doing that day eg cognitive tasks self-reports
It will be emphasized to all subjects that their participation is completely voluntary and that even after signing the consent document they are still free to withdraw from the study at any time It will also be emphasized that if they choose to leave the study their medication management at VAPOC will not be impacted and they can continue seeing their medication provider as usual
45 Intervention Assignment
Participants will not be randomized Instead they will serve as their own controls Individuals will be recruited during Spring 2022 as described in section 31 Following their baseline assessment participants will continue treatment as usual TAU with their current provider The amount of time they are in the TAU branch of the study will depend on their date of recruitment The intervention phase of the study will occur between August 2022- June 2023 after the patient has established care with their new provider Therefore a participant who was recruited in April 2021 may have a TAU duration of 5 months whereas a participant who was recruited in June 2021 may only have TAU of 2 months Participants not assigned to a resident associated with the study will continue in the study as controls given their re-consent
47 Medication appointments
Resident physicians will provide medication appointments supervised by their attending physician Stovall and CT-R supervisor Brinen They will conduct their appointment per protocol see below No additionalspecial information needs to be recorded in medical record beyond the clinical notes expected per VAPOC policy Appointments will be a standard length
No-shows and hospitalizations will be recorded in the chart per clinic procedures and will be monitored and recorded by study staff with additional support from the Informatics team
48 VideoAudio Recording
In order to ensure treatment fidelity medication appointments will be video andor audio recorded Further the qualitative interviews will be audio-recorded for later analyses All recordings will be included in the Informed Consent document and described to the participants prior to study enrollment Physicians will upload their sessions to a folder on Vanderbilt University Medical Center VUMC Box which will only be available to necessary study staff for review Additionally qualitative interview recordings will be uploaded to a folder on VUMC Box which will only be available to necessary study staff for review
Only patients who consent to being in the study will receive CT-R medication appointments CT-R is a therapy process that is being implemented within the medication appointments The provided measures and tasks are outcomes to be measured throughout the study For instance we are interested in how clinical symptoms subjective well-being and treatment engagement change with the implementation of CT-R in medication appointments
1 CT-R medication checks will be acceptable to the patient and feasible to deliver and receive as measured by asking patients how they like the CT-R med checks and our ability to do this study in addition to number of patient drop-outs
2 CT-R medication checks will be related to significantly greater engagement with treatment as measured by lower no-show rates greater self-reported working alliance and better treatment adherence
3 CT-R medication checks will be related to greater activity and increase in functioning as measured by time use survey GAF skill use
4 CT-R medication checks will be related to a trend in improved defeatist beliefs negative symptoms paranoia and self-esteem
5 Exploratory analyses will include
1 CT-R med checks will be related to greater improvement on a cognitive motivation task EEfRTBalloon task
2 Improvement in Defeatist Belief Scale DBS and Neg Symptoms will be mediated by increased treatment adherence engagement and activity
Expected study duration 3 years
3 Procedures_________________________________________________________________
41 Recruitment Vanderbilt Adult Psychiatry Outpatient Clinic VAPOC Individuals who are currently being seen for medication management through VAPOC and who meet eligibility criteria will be identified by the treating providers and study staff through review of medical records and consultation with providing clinicians Potential participants will only be approached with the approval of the treating provider who will determine whether that individual is likely to have the capacity to consider the research study and provide consent If appropriate their provider will ensure that the patient is agreeable to being approached about a research study or introduce the patient to the research team Potential participants will be approached by research staff after their appointment for a brief screening visit
Recruitment may occur in person over telehealth or over the phone VAPOC accommodates both in-person and telehealth appointments depending on the patients preference Therefore for eligible patients who are seen regularly over telehealth recruitment may occur by joining the telehealth appointment at the end of the visit Additionally potential participants may not be available to stay after their appointment despite interest in the study Therefore individuals identified as a good fit who cannot be connected with in-person will be called on the phone for a screening with the providers consent and after the provider has ensured that the patient is agreeable to being called about a research study
Resident subjects will be recruited from Vanderbilt Adult Psychiatry Outpatient Clinic Residents who are involved with the study will be contacted either by email or in-person to assess their interest in being enrolled and consented as a participant in order for the research team to gather information about the acceptability and feasibility of carrying out the intervention
43 Planned enrollment We plan to recruit up to 40 subjects for the study
44 Screening and Consent Potential research subjects will be asked if they would like to participate in the current study If they report potential interest a pre-screening will occur This screening will occur in person over the phone or over telehealth Zoom using the Screening Form or Phone Script Informed consent will be obtained by study personnel directly involved in the research ie research staff or PI Personnel have completed IRB training and have considerable experience running studies in clinical populations
Informed consent will be obtained either 1 in the research offices at the Psychiatric Neuroimaging Program or 2 over Zoom during a virtual study visit A research staff member will explain the applicable procedures and the possible risks and benefits to the subjects The details of the informed consent procedure are as follows
1 The investigator or research staff and the subject will read together the entire consent form
2 The subject will be asked details about the study To document that the subject has read the consent form and has the capacity to understand the most important details the investigator will use the appropriate Informed Consent Survey The questions will be read by the investigator or research staff and the answers will be recorded If the subject is unable to answer any of the questions or if the subject demonstrates a lack of understanding the investigator or research staff member will then review the details of the study again Subjects who are unable to answer the questions even after additional information is provided will be excluded from the study
3 The subject will be informed that regardless of whether or not they take part in this research study it will not affect their treatment payment or enrollment in any health plans or affect their ability to get benefits or care in any way
4 The subject will be provided with copies of the signed consent form and the Informed Consent Survey including the answers given at the time of the initial visit If completed virtually this will be emailed using secure email methods to the subject with their consent
5 At each visit we will 1 remind participants that the research visit is voluntary no matter how many previous visits they have done and 2 ask them to tell us what they believe the purpose of the study is and repeat back what they will be doing that day eg cognitive tasks self-reports
It will be emphasized to all subjects that their participation is completely voluntary and that even after signing the consent document they are still free to withdraw from the study at any time It will also be emphasized that if they choose to leave the study their medication management at VAPOC will not be impacted and they can continue seeing their medication provider as usual
45 Intervention Assignment
Participants will not be randomized Instead they will serve as their own controls Individuals will be recruited during Spring 2022 as described in section 31 Following their baseline assessment participants will continue treatment as usual TAU with their current provider The amount of time they are in the TAU branch of the study will depend on their date of recruitment The intervention phase of the study will occur between August 2022- June 2023 after the patient has established care with their new provider Therefore a participant who was recruited in April 2021 may have a TAU duration of 5 months whereas a participant who was recruited in June 2021 may only have TAU of 2 months Participants not assigned to a resident associated with the study will continue in the study as controls given their re-consent
47 Medication appointments
Resident physicians will provide medication appointments supervised by their attending physician Stovall and CT-R supervisor Brinen They will conduct their appointment per protocol see below No additionalspecial information needs to be recorded in medical record beyond the clinical notes expected per VAPOC policy Appointments will be a standard length
No-shows and hospitalizations will be recorded in the chart per clinic procedures and will be monitored and recorded by study staff with additional support from the Informatics team
48 VideoAudio Recording
In order to ensure treatment fidelity medication appointments will be video andor audio recorded Further the qualitative interviews will be audio-recorded for later analyses All recordings will be included in the Informed Consent document and described to the participants prior to study enrollment Physicians will upload their sessions to a folder on Vanderbilt University Medical Center VUMC Box which will only be available to necessary study staff for review Additionally qualitative interview recordings will be uploaded to a folder on VUMC Box which will only be available to necessary study staff for review
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?:
None
Is an FDA AA801 Violation?:
None