A Study of Cognitive Adaptation Training in Inpatient Forensic Environments (finCAT)

The proposed project will be a mixed-methods feasibility study of modified Cognitive Adaptation Training for an inpatient forensic mental health population (finCAT). Cognitive Adaptation Training (CAT) is an evidence-based compensatory cognitive intervention that focuses on improving functioning through the provision of environmental supports and cues. CAT is typically applied in outpatient care but has been successfully modified for inpatient service contexts in a Netherlands trial and at CAMH in previous pilots for both forensic and non-forensic inpatient populations.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Other: Cognitive Adaptation Training (CAT)

Detailed Description

The proposed project will expand the investigators knowledge of the role of compensatory cognitive interventions for forensic inpatient populations with schizophrenia. Over the course of 6 months, the investigators will conduct a feasibility study of the delivery of a modified forensic inpatient version of Cognitive Adaptation Training. The objective of this single group study with pre-post and follow up assessments is to determine if preliminary outcomes and follow up findings support the feasibility of a modified version CAT within a forensic inpatient setting. Feasibility data will be used to inform (i) any necessary adjustments to the intervention, (ii) any necessary adjustments to the optimal time of study for outcomes to be observed, and (iii) to inform future trials with respect to anticipated recruitment and drop-out rates and optimal powering.

This study would be among the few examinations of CAT as an inpatient intervention to date, as well as the first to examine a modified cognitive adaptation training approach in both a North American and forensic inpatient setting, and would make a substantial contribution to the evidence-based intervention literature. This intervention will be referred to as forensic inpatient CAT or finCAT.

The questions for this project are:

1. Is finCAT feasible for forensic inpatient populations with a schizophrenia spectrum diagnosis? Based on preliminary work the investigators hypothesize that finCAT will prove acceptable to patients and inpatient staff and will demonstrate positive outcomes with respect to functioning and inpatient room organization.
2. What are the attitudes of inpatient forensic occupational therapists and clinical teams towards implementing finCAT on their units?

This study will expand on the preliminary work of the investigators at CAMH. The study will be implemented on four CAMH general security forensic inpatient units. There will be four weeks of CAT Clinician--delivered treatment focusing on two goal areas - room organization and personal hygiene, followed by two months of maintenance by CAT Unit Champions with pre, post, and two-month follow-up, as well as project-end evaluations. In the first four weeks, the investigators will conduct a trial of finCAT for two of the four inpatient general forensic units, followed by two months of finCAT maintenance with Unit CAT Champions supported by the CAT Clinician. This process would then be repeated on the remaining two general units at CAMH. Previous implementation of CAT has demonstrated gains within one-month; however, follow-up assessments were not conducted to determine if gains were maintained over time. While brief, this time period (i) reflects the intent of this study as a pilot test of feasibility and, (ii) aligns with this circumscribed version of CAT (as compared to the more comprehensive community version with broader outcome domains). Data will be collected from both primary participants (inpatients) and the clinical team.

• Study Type: Observational
• Enrollment (Actual): 24

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M6J 1H4
      • Centre for Addiction and Mental Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All participants will be recruited through CAMH Complex Care & Recovery inpatient forensic services.

Description

Inclusion Criteria:

1. A chart diagnosis of a schizophrenia spectrum illness.
2. Capacity to consent or availability of a substitute decision-maker to consent with the assent of the participant.
3. Participant residing on a CAMH inpatient forensic unit (general security)

Exclusion Criteria

1. High paranoia
2. Primary issue of hoarding

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Inpatient Clients; Have a chart diagnosis of a schizophrenia spectrum illness, capacity to consent or availability of a substitute decision-maker to consent with the assent of the participant and is residing on a CAMH inpatient forensic unit (general security)

Other: Cognitive Adaptation Training (CAT); Cognitive Adaptation Training (CAT) is a standardized implementation of environmental supports for improving adaptive functioning including medication adherence, grooming, and daily activities in patients with schizophrenia. Environmental supports (signs, checklists) are manual-driven and grounded upon an assessment of neurocognitive function and behaviour. Assessment results yield one of six CAT classifications (Apathy/Poor Executive Functioning, Disinhibited/Poor EF, Mixed/Poor EF, Apathy/Fair EF, Disinhibited/Fair EF, Mixed/Fair EF).The goal will be to improve organization and self-care, modifying the intervention to be more relevant for an inpatient setting. Once an individual's CAT classification has been determined, strategies for specific functional problems are chosen from a series of tables. CAT interventions are maintained in the client's living space during weekly visits. CAT clinicians will encourage team members to assist with the reinforcement of CAT tools and strategies.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clutter Image Rating Scale (CIRS) - Blind-rated	Room organization will be measured by ratings on the Clutter Image Rating Scale (CIRS; Frost et al., 2008). The CIRS is a 9-picture visual analogue scale used to quantify and standardize the amount of clutter in 3 different living spaces (kitchen, living room, and bedroom). Min is 1 and Max is 9. Higher ratings indicate more clutter. For this project, only the bedroom rating scale will be utilized. The CIRS is used to measure the severity of clutter in compulsive hoarding. Before and after photos will be taken of each participant's room. These photos will be rated by 2 blinded student investigators with the mean rating taken.	Baseline
Clutter Image Rating Scale (CIRS) - Blind-rated	Room organization will be measured by ratings on the Clutter Image Rating Scale (CIRS; Frost et al., 2008). The CIRS is a 9-picture visual analogue scale used to quantify and standardize the amount of clutter in 3 different living spaces (kitchen, living room, and bedroom). Min is 1 and Max is 9. Higher ratings indicate more clutter. For this project, only the bedroom rating scale will be utilized. The CIRS is used to measure the severity of clutter in compulsive hoarding. Before and after photos will be taken of each participant's room. These photos will be rated by 2 blinded student investigators with the mean rating taken.	4-Weeks Post-Intervention
Clutter Image Rating Scale (CIRS) - Blind-rated	Room organization will be measured by ratings on the Clutter Image Rating Scale (CIRS; Frost et al., 2008). The CIRS is a 9-picture visual analogue scale used to quantify and standardize the amount of clutter in 3 different living spaces (kitchen, living room, and bedroom). Min is 1 and Max is 9. Higher ratings indicate more clutter. For this project, only the bedroom rating scale will be utilized. The CIRS is used to measure the severity of clutter in compulsive hoarding. Before and after photos will be taken of each participant's room. These photos will be rated by 2 blinded student investigators with the mean rating taken.	2-Month Follow-Up
Clutter Image Rating Scale (CIRS) - Patient-rated	Room organization will be measured by ratings on the Clutter Image Rating Scale (CIRS; Frost et al., 2008). The CIRS is a 9-picture visual analogue scale used to quantify and standardize the amount of clutter in 3 different living spaces (kitchen, living room, and bedroom). Min is 1 and Max is 9. Higher ratings indicate more clutter. For this project, only the bedroom rating scale will be utilized. The CIRS is used to measure the severity of clutter in compulsive hoarding. Before and after photos will be taken of each participant's room. These photos will be rated by 2 blinded student investigators with the mean rating taken.	Baseline
Clutter Image Rating Scale (CIRS) - Patient-rated	Room organization will be measured by ratings on the Clutter Image Rating Scale (CIRS; Frost et al., 2008). The CIRS is a 9-picture visual analogue scale used to quantify and standardize the amount of clutter in 3 different living spaces (kitchen, living room, and bedroom). Min is 1 and Max is 9. Higher ratings indicate more clutter. For this project, only the bedroom rating scale will be utilized. The CIRS is used to measure the severity of clutter in compulsive hoarding. Before and after photos will be taken of each participant's room. These photos will be rated by 2 blinded student investigators with the mean rating taken.	4-Weeks Post-Intervention
Life Skills Profile (LSP) - Self-Care Subscale	Personal hygiene will be measured by scores on the Life Skills Profile (LSP; Rosen, Hadzi-Pavlovic, & Parker, 1989). The LSP consists of 39 clinician-rated questions on a four-point scale and measures various aspects related to daily life activities: self-care; non-turbulence; social contact; communication; responsibility. For this project, only the self-care ratings from the full LSP-39 will be completed by service providers (items 10, 12, 13, 14, 15, 16, 23, 24, 26, and 30). While each item consists of 4 responses, the content of each response is different for each item. Overall, higher scores indicate better functioning. Max total score is 40. Min total score is 10. Current inpatient research on the use of CAT also uses this scale as a primary measure of the effectiveness of CAT. Scores will be obtained from the nursing staff not directly involved in the delivery of the finCAT intervention.	Baseline
Life Skills Profile (LSP) - Self-care Subscale	Personal hygiene will be measured by scores on the Life Skills Profile (LSP; Rosen, Hadzi-Pavlovic, & Parker, 1989). The LSP consists of 39 clinician-rated questions on a four-point scale and measures various aspects related to daily life activities: self-care; non-turbulence; social contact; communication; responsibility. For this project, only the self-care ratings from the full LSP-39 will be completed by service providers (items 10, 12, 13, 14, 15, 16, 23, 24, 26, and 30). While each item consists of 4 responses, the content of each response is different for each item. Overall, higher scores indicate better functioning. Max total score is 40. Min total score is 10. Current inpatient research on the use of CAT also uses this scale as a primary measure of the effectiveness of CAT. Scores will be obtained from the nursing staff not directly involved in the delivery of the finCAT intervention.	4-Weeks Post-Intervention
Life Skills Profile (LSP) - Self-care Subscale	Personal hygiene will be measured by scores on the Life Skills Profile (LSP; Rosen, Hadzi-Pavlovic, & Parker, 1989). The LSP consists of 39 clinician-rated questions on a four-point scale and measures various aspects related to daily life activities: self-care; non-turbulence; social contact; communication; responsibility. For this project, only the self-care ratings from the full LSP-39 will be completed by service providers (items 10, 12, 13, 14, 15, 16, 23, 24, 26, and 30). While each item consists of 4 responses, the content of each response is different for each item. Overall, higher scores indicate better functioning. Max total score is 40. Min total score is 10. Current inpatient research on the use of CAT also uses this scale as a primary measure of the effectiveness of CAT. Scores will be obtained from the nursing staff not directly involved in the delivery of the finCAT intervention.	2-Month Follow-Up
Goal Attainment Scaling (GAS) - Goal 1	Goal Attainment Scaling (GAS) will be employed as a sensitive measure of progress on individually defined goals. Goal attainment scaling involves the setting of 3-5 goals, each operationalized on a 5-point scale. Min is -2. Max is 2. Higher scores indicate greater attainment of the goal. Goals are individualized to the client and assessment of progress is determined through consensus of the clinician and case manager.	Baseline
Goal Attainment Scaling (GAS) - Goal 1	Goal Attainment Scaling (GAS) will be employed as a sensitive measure of progress on individually defined goals. Goal attainment scaling involves the setting of 3-5 goals, each operationalized on a 5-point scale. Min is -2. Max is 2. Higher scores indicate greater attainment of the goal. Goals are individualized to the client and assessment of progress is determined through consensus of the clinician and case manager.	4-Week Post-Intervention
Goal Attainment Scaling (GAS) - Goal 1	Goal Attainment Scaling (GAS) will be employed as a sensitive measure of progress on individually defined goals. Goal attainment scaling involves the setting of 3-5 goals, each operationalized on a 5-point scale. Min is -2. Max is 2. Higher scores indicate greater attainment of the goal. Goals are individualized to the client and assessment of progress is determined through consensus of the clinician and case manager.	2-Month Follow-Up
Goal Attainment Scaling (GAS) - Goal 2	Goal Attainment Scaling (GAS) will be employed as a sensitive measure of progress on individually defined goals. Goal attainment scaling involves the setting of 3-5 goals, each operationalized on a 5-point scale. Min is -2. Max is 2. Higher scores indicate greater attainment of the goal. Goals are individualized to the client and assessment of progress is determined through consensus of the clinician and case manager.	Baseline
Goal Attainment Scaling (GAS) - Goal 2	Goal Attainment Scaling (GAS) will be employed as a sensitive measure of progress on individually defined goals. Goal attainment scaling involves the setting of 3-5 goals, each operationalized on a 5-point scale. Min is -2. Max is 2. Higher scores indicate greater attainment of the goal. Goals are individualized to the client and assessment of progress is determined through consensus of the clinician and case manager.	4-Week Post-Intervention
Goal Attainment Scaling (GAS) - Goal 2	Goal Attainment Scaling (GAS) will be employed as a sensitive measure of progress on individually defined goals. Goal attainment scaling involves the setting of 3-5 goals, each operationalized on a 5-point scale. Min is -2. Max is 2. Higher scores indicate greater attainment of the goal. Goals are individualized to the client and assessment of progress is determined through consensus of the clinician and case manager.	2-Month Follow-Up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evidence-Based Practice Attitude Scale (EBPAS)	The attitudes of the team members towards finCAT will be measured using the Evidence-Based Practice Attitude Scale (EPBAS; Aarons, 2004) adapted to specifically target attitudes towards CAT. The EPBAS is a self-report questionnaire consisting of 36 items measured on a 5-point Likert scale ranging from 0 ('Not at all') to 4 ('To a very great extent') and consists of 12 subscales. Maximum is 4. Minimum is 0. Higher scores indicate a more open attitude towards new types of therapy, interventions or treatments including manualized therapy.	Baseline
Evidence-Based Practice Attitude Scale (EBPAS)	The attitudes of the team members towards finCAT will be measured using the Evidence-Based Practice Attitude Scale (EPBAS; Aarons, 2004) adapted to specifically target attitudes towards CAT. The EPBAS is a self-report questionnaire consisting of 36 items measured on a 5-point Likert scale ranging from 0 ('Not at all') to 4 ('To a very great extent') and consists of 12 subscales. Maximum is 4. Minimum is 0. Higher scores indicate a more open attitude towards new types of therapy, interventions or treatments including manualized therapy.	2-Month Follow-Up
Essen Climate Evaluation Schema (Essen CES)	The therapeutic alliance on the unit will be measured by clinician and client ratings on the Essen Climate Evaluation Schema (Essen CES; Schalast et al., 2008). The Essen CES is a 15-item questionnaire measured on a 5-point Likert scale ranging from 'Not at all' to 'Very Much' and consists of three subscales: (1) Patient's Cohesion, (2) Experienced Safety, and (3) Therapeutic Hold. For this study, client and clinician ratings on the Therapeutic Hold and Experienced safety subscales will be collected. For each sub-scale, the max is 20 and minimum is 0. Higher scores indicate greater experienced safety and therapeutic hold.	Baseline
Essen Climate Evaluation Schema (Essen CES)	The therapeutic alliance on the unit will be measured by clinician and client ratings on the Essen Climate Evaluation Schema (Essen CES; Schalast et al., 2008). The Essen CES is a 15-item questionnaire measured on a 5-point Likert scale ranging from 'Not at all' to 'Very Much' and consists of three subscales: (1) Patient's Cohesion, (2) Experienced Safety, and (3) Therapeutic Hold. For this study, client and clinician ratings on the Therapeutic Hold and Experienced safety subscales will be collected. For each sub-scale, the max is 20 and minimum is 0. Higher scores indicate greater experienced safety and therapeutic hold.	2-Month Follow-Up
Qualitative Care Provider Attitudes	The attitudes of the team members towards finCAT will also be measured using a qualitative feedback form created for this study. Questions will target attitudes towards finCAT, perceptions of the impact of finCAT, and perceptions of team tension or conflict arising or abating during the implementation of finCAT. Small focus groups with healthcare providers will be facilitated by student investigators. Interviews will be audio-recorded and transcribed verbatim.	2 months after month of service implementation
Qualitative Participant Attitudes	The attitudes of the participants towards finCAT will also be measured using a qualitative feedback form created for this study. Questions will target attitudes towards finCAT, perceptions of the impact of finCAT. Individual interviews with interested clients will be facilitated by student investigators. Interviews will be audio-recorded and transcribed verbatim.	2 months after month of service implementation

Collaborators and Investigators

• Sponsor: Centre for Addiction and Mental Health
• Investigators: Principal Investigator: Sean Kidd, Centre for Addiction and Mental Health

Publications and helpful links

General Publications

• Goeree R, Farahati F, Burke N, Blackhouse G, O'Reilly D, Pyne J, Tarride JE. The economic burden of schizophrenia in Canada in 2004. Curr Med Res Opin. 2005 Dec;21(12):2017-28. doi: 10.1185/030079905X75087.
• Green MF. What are the functional consequences of neurocognitive deficits in schizophrenia? Am J Psychiatry. 1996 Mar;153(3):321-30. doi: 10.1176/ajp.153.3.321.
• Aarons GA. Mental health provider attitudes toward adoption of evidence-based practice: the Evidence-Based Practice Attitude Scale (EBPAS). Ment Health Serv Res. 2004 Jun;6(2):61-74. doi: 10.1023/b:mhsr.0000024351.12294.65.
• Hsieh HF, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res. 2005 Nov;15(9):1277-88. doi: 10.1177/1049732305276687.
• Velligan DI, Diamond PM, Mintz J, Maples N, Li X, Zeber J, Ereshefsky L, Lam YW, Castillo D, Miller AL. The use of individually tailored environmental supports to improve medication adherence and outcomes in schizophrenia. Schizophr Bull. 2008 May;34(3):483-93. doi: 10.1093/schbul/sbm111. Epub 2007 Oct 10.
• Velligan DI, Prihoda TJ, Ritch JL, Maples N, Bow-Thomas CC, Dassori A. A randomized single-blind pilot study of compensatory strategies in schizophrenia outpatients. Schizophr Bull. 2002;28(2):283-92. doi: 10.1093/oxfordjournals.schbul.a006938.
• Velligan DI, Bow-Thomas CC, Huntzinger C, Ritch J, Ledbetter N, Prihoda TJ, Miller AL. Randomized controlled trial of the use of compensatory strategies to enhance adaptive functioning in outpatients with schizophrenia. Am J Psychiatry. 2000 Aug;157(8):1317-23. doi: 10.1176/appi.ajp.157.8.1317.
• Torrey WC, Drake RE, Dixon L, Burns BJ, Flynn L, Rush AJ, Clark RE, Klatzker D. Implementing evidence-based practices for persons with severe mental illnesses. Psychiatr Serv. 2001 Jan;52(1):45-50. doi: 10.1176/appi.ps.52.1.45.
• Alphs LD, Summerfelt A, Lann H, Muller RJ. The negative symptom assessment: a new instrument to assess negative symptoms of schizophrenia. Psychopharmacol Bull. 1989;25(2):159-63. No abstract available.
• Brown S, Inskip H, Barraclough B. Causes of the excess mortality of schizophrenia. Br J Psychiatry. 2000 Sep;177:212-7. doi: 10.1192/bjp.177.3.212.
• Chen S, Collins A, Anderson K, McKenzie K, Kidd S. Patient Characteristics, Length of Stay, and Functional Improvement for Schizophrenia Spectrum Disorders: A Population Study of Inpatient Care in Ontario 2005 to 2015. Can J Psychiatry. 2017 Dec;62(12):854-863. doi: 10.1177/0706743716680167. Epub 2016 Dec 14.
• Draper ML, Stutes DS, Maples NJ, Velligan DI. Cognitive adaptation training for outpatients with schizophrenia. J Clin Psychol. 2009 Aug;65(8):842-53. doi: 10.1002/jclp.20612.
• Frost, R. O., Steketee, G., Tolin, D. F., & Renaud, S. (2008). Development and validation of the clutter image rating. Journal of Psychopathology and Behavioral Assessment, 30(3), 193-203.
• Harvey, P. D. (Ed.). (2013). Cognitive impairment in schizophrenia: Characteristics, assessment and treatment. Cambridge University Press.
• Kidd SA, Herman Y, Barbic S, Ganguli R, George TP, Hassan S, McKenzie K, Maples N, Velligan D. Testing a modification of cognitive adaptation training: streamlining the model for broader implementation. Schizophr Res. 2014 Jun;156(1):46-50. doi: 10.1016/j.schres.2014.03.026. Epub 2014 Apr 29.
• Maples, N. J., & Velligan, D. I. (2008). Cognitive adaptation training: establishing environmental supports to bypass cognitive deficits and improve functional outcomes. American Journal of Psychiatric Rehabilitation, 11(2), 164-180.
• Rosen A, Hadzi-Pavlovic D, Parker G. The life skills profile: a measure assessing function and disability in schizophrenia. Schizophr Bull. 1989;15(2):325-37. doi: 10.1093/schbul/15.2.325.
• Schalast N, Redies M, Collins M, Stacey J, Howells K. EssenCES, a short questionnaire for assessing the social climate of forensic psychiatric wards. Crim Behav Ment Health. 2008;18(1):49-58. doi: 10.1002/cbm.677.
• Stiekema AP, Quee PJ, Dethmers M, van den Heuvel ER, Redmeijer JE, Rietberg K, Stant AD, Swart M, van Weeghel J, Aleman A, Velligan DI, Schoevers RA, Bruggeman R, van der Meer L. Effectiveness and cost-effectiveness of cognitive adaptation training as a nursing intervention in long-term residential patients with severe mental illness: study protocol for a randomized controlled trial. Trials. 2015 Feb 12;16:49. doi: 10.1186/s13063-015-0566-8.
• van Dam, M., Stiekema, A., Islam, A., Swart, M., Redmeyer, J., Dethmers, M., ... & Bruggeman, R. (2017). SU15. Implementation of Cognitive Adaptation Training in a Hospital Setting: Facilitating and Hampering Factors. Schizophrenia bulletin, 43(Suppl 1), S166.
• van der Meer, L., Stiekema, A., van Dam, M., Swart, M., Redmeyer, J., Dethmers, M., ... & Pijnenborg, G. M. (2017). SU13. Cognitive Adaptation Training: Is It Effective as a Nursing Intervention in a Hospital Setting?. Schizophrenia bulletin, 43(Suppl 1), S165.
• Velligan, D. I., Mahurin, R. K., Eckert, S. L., Miller, A. L., & Bow-Thomas, C. C. (1997). Cognitive adaptation training: The use of compensatory strategies for inpatients and outpatients with schizophrenia. Schizophrenia Research, 1(24), 229.
• Velligan DI, Lam F, Ereshefsky L, Miller AL. Psychopharmacology: Perspectives on medication adherence and atypical antipsychotic medications. Psychiatr Serv. 2003 May;54(5):665-7. doi: 10.1176/appi.ps.54.5.665. No abstract available.
• Velligan DI, Diamond PM, Maples NJ, Mintz J, Li X, Glahn DC, Miller AL. Comparing the efficacy of interventions that use environmental supports to improve outcomes in patients with schizophrenia. Schizophr Res. 2008 Jul;102(1-3):312-9. doi: 10.1016/j.schres.2008.02.005. Epub 2008 Apr 18.
• Williams, R.S. (June 2017). Occupational Therapists' Perspectives on Cognitive Adaptation Training. Poster presented at the Canadian Association of Occupational Therapists Conference, Charlottetown, PE, Canada.

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2019
• Primary Completion (Actual): June 20, 2020
• Study Completion (Actual): June 30, 2020

Study Registration Dates

• First Submitted: February 11, 2020
• First Submitted That Met QC Criteria: March 2, 2020
• First Posted (Actual): March 4, 2020

Study Record Updates

• Last Update Posted (Estimate): January 26, 2023
• Last Update Submitted That Met QC Criteria: April 21, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Schizophrenia; Cognition; Inpatient; Cognitive Adaptation Training; Forensic; Environmental Supports
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: 115-2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Client-specific research data gathered as part of this study may be shared and provided to the paticipant's unit treatment team for client care. All client data gathered will be kept confidential within the participant's treatment team and the research project team. All other gathered data (i.e. staff data) will be kept de-identified, confidential, and anonymous.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No