Clinical trial NCT05523843: Pilot Study on the Clinical Utility of the Tulsa Life Chart
Official title: Pilot Study on the Clinical Utility of the Tulsa Life Chart: A Graphical Representation of Patient Life History
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Mental Health Issue
Mental Health Disorder
Assessment, Self
Keywords: Assessment
Life Chart
Web-based application
Clinical intake assessment
Pragmatic Clinical Pilot
Lead sponsor: Laureate Institute for Brain Research, Inc.
Sponsor class: OTHER
First posted: 2022-08-31
Enrollment: 130
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Indviduals seeking mental health treatment and their healthcare providers who have been invited to participate in the study.

Brief summary: The proposed study aims to examine the usability, utility, and feasibility of the Tulsa Life Chart (TLC) in a sample of patients seeking mental health treatment and their healthcare providers. The TLC is an interactive, web-based application used to create a graphical interface for visualizing a patient's life history.

Detailed description: Understanding the longitudinal course of mental health is critical for case conceptualization. One approach for capturing the complexity of an individual's illness course is to depict it graphically. The first attempt for this method was the National Institute of Mental Health Life Chart for Bipolar Disorder. Subsequent research indicated Life Charts are useful clinically and time- and cost-effective. Despite clinical utility and time and cost efficiency, this approach has not been widely adopted in the mental health field. Possible explanations are the prior focus on bipolar disorder, time required to collect information, and prior versions have not had automatic translation of the patient information into an image.

The Tulsa Life Chart (TLC) was developed by researchers at the Laureate Institute for Brain Research (LIBR). The TLC was developed to address weaknesses of previous life chart methods and help patients and healthcare professionals (HCPs) quickly identify patterns of mental health symptoms across diagnostic categories. To date only one formal exploration of the TLC has been conducted in a sample of individuals with mood, anxiety, eating disorders, and substance use disorders, which suggested that participants felt the TLC was helpful in understanding their mental health symptoms and was pleasant to complete. Unpublished focus groups with HCPs suggest HCPs believe the TLC could help to improve patient encounters by increasing understanding of patients and facilitating conversations. Based on these findings the goal of the proposed study is to examine clinical usability, utility, and feasibility in a pragmatic pilot trial.

The current trial will recruit individuals seeking treatment within the Laureate Psychiatric Clinic and Hospital and healthcare professionals involved with their care. Treatment-seeking patients who are invited to participate will be asked to complete the TLC soon after establishing care in a health system setting. Subsequently, the patient's HCP will review the chart during the intake process and complete several measures related to the chart and their experience (baseline assessment point). Patients and HCPs will engage in treatment as usual in between the TLC and assessment time points. Prior to or shortly following discharge/termination of treatment (approximately 4 to 12 weeks depending on the clinic), patients and HCPs will be asked to again complete questions to determine the TLC's usefulness during treatment. The overarching aim of the current study is to examine the usefulness of the Tulsa Life Chart for treatment-seeking individuals and healthcare professionals.

Eligibility criteria: Inclusion Criteria:

Treatment Seekers Inclusion Criteria:

1. Actively seeking mental health treatment at Laureate Psychiatric Clinic and Hospital
2. Provision of informed consent or if \<18 assent and parental consent
3. Age 15 to 65 years
4. Necessary resources to engage in a technology-based intervention
5. English proficiency
6. Willingness to grant access to medical records

HCPs Inclusion Criteria:

1. Employed at Laureate Psychiatric Clinic and Hospital in a patient care role
2. Informed consent
3. English proficiency
4. Access to resources to engage in technology-based intervention

Exclusion Criteria:

Treatment Seekers Exclusion Criteria:

1. Active suicidal ideation with plan or intent
2. No access to resources to participate in a technology-based intervention
3. Completed more than 2 sessions of therapy with their current provider prior to enrollment in the study
4. Not proficient in English

HCPs Exclusion Criteria:

1. No access to resources to participate in a technology-based intervention
2. Not proficient in English

Primary outcomes:
measure: mHealth App Usability Questionnaire (MAUQ) Total Usability Score (Patient)
timeFrame: Baseline assessment
measure: mHealth App Usability Questionnaire (MAUQ) Total Usability Score (Healthcare Professional)
timeFrame: Baseline assessment
Secondary outcomes:
measure: mHealth App Usability Questionnaire (MAUQ) - Ease of Use Subscale (Patient)
timeFrame: Baseline assessment
measure: mHealth App Usability Questionnaire (MAUQ) - Ease of Use Subscale (Healthcare Professional)
timeFrame: Baseline assessment
measure: mHealth App Usability Questionnaire (MAUQ) - Interface and Satisfaction Subscale (Patient)
timeFrame: Baseline assessment
measure: mHealth App Usability Questionnaire (MAUQ) - Interface and Satisfaction Subscale (Healthcare Professional)
timeFrame: Baseline assessment
measure: mHealth App Usability Questionnaire (MAUQ) - Usefulness Subscale (Patient)
timeFrame: Baseline assessment
measure: mHealth App Usability Questionnaire (MAUQ) - Usefulness Subscale (Healthcare Professional)
timeFrame: Baseline assessment
measure: Time spent to complete the Tulsa Life Chart (Patient)
timeFrame: Baseline assessment
measure: Time spent to reviewing the Tulsa Life Chart (Healthcare Professional)
timeFrame: Baseline assessment
Other outcomes:
measure: mHealth App Usability Questionnaire (MAUQ) Total Usability Score (Patient)
timeFrame: Assessment two - on average 4 to 12 weeks after baseline assessment
measure: Change in perception of usefulness
timeFrame: Change from baseline to the post-treatment timepoint, approximately 4 - 12 weeks after baseline
measure: mHealth App Usability Questionnaire (MAUQ) - Ease of Use Subscale (Patient)
timeFrame: Assessment two - on average 4 to 12 weeks after baseline assessment
measure: mHealth App Usability Questionnaire (MAUQ) - Ease of Use Subscale (Healthcare Professional)
timeFrame: Assessment two - on average 4 to 12 weeks after baseline assessment
measure: mHealth App Usability Questionnaire (MAUQ) - Interface and Satisfaction Subscale (Patient)
timeFrame: Assessment two - on average 4 to 12 weeks after baseline assessment
measure: mHealth App Usability Questionnaire (MAUQ) - Interface and Satisfaction Subscale (Healthcare Professional)
timeFrame: Assessment two - on average 4 to 12 weeks after baseline assessment
measure: mHealth App Usability Questionnaire (MAUQ) - Usefulness Subscale (Patient)
timeFrame: Assessment two - on average 4 to 12 weeks after baseline assessment
measure: mHealth App mHealth App Usability Questionnaire (MAUQ) - Usefulness Subscale (Healthcare Professional)
timeFrame: Assessment two - on average 4 to 12 weeks after baseline assessment
measure: Utility Questionnaire (Patient)
timeFrame: Baseline assessment
measure: Utility Questionnaire (Healthcare Professional)
timeFrame: Baseline assessment
measure: Utility Questionnaire (Patient)
timeFrame: Assessment two - on average 4 to 12 weeks after baseline assessment
measure: Utility Questionnaire (Healthcare Professional)
timeFrame: Assessment two - on average 4 to 12 weeks after baseline assessment
measure: Likelihood of recommending the Tulsa Life Chart to other patients (Patient)
timeFrame: Baseline assessment
measure: Likelihood of recommending the Tulsa Life Chart to other healthcare professionals (Healthcare Professional)
timeFrame: Baseline assessment
measure: Likelihood of recommending the Tulsa Life Chart to other patients (Patient)
timeFrame: Assessment two - on average 4 to 12 weeks after baseline assessment
measure: Likelihood of recommending (Healthcare Professional)
timeFrame: Assessment two - on average 4 to 12 weeks after baseline assessment
Locations:
city: Tulsa
country: United States
facility: Laureate Institute for Brain Research
state: Oklahoma
Study officials:
affiliation: Laureate Institute for Brain Research
name: Robin Aupperle, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Aupperle RL, Paulus MP, Kuplicki R, Touthang J, Victor T, Yeh HW; Tulsa 1000 Investigators; Khalsa SS. Web-Based Graphic Representation of the Life Course of Mental Health: Cross-Sectional Study Across the Spectrum of Mood, Anxiety, Eating, and Substance Use Disorders. JMIR Ment Health. 2020 Jan 28;7(1):e16919. doi: 10.2196/16919.
citation: Manderscheid RW, Ryff CD, Freeman EJ, McKnight-Eily LR, Dhingra S, Strine TW. Evolving definitions of mental illness and wellness. Prev Chronic Dis. 2010 Jan;7(1):A19. Epub 2009 Dec 15.
citation: Post RM, Roy-Byrne PP, Uhde TW. Graphic representation of the life course of illness in patients with affective disorder. Am J Psychiatry. 1988 Jul;145(7):844-8. doi: 10.1176/ajp.145.7.844.
citation: Born C, Amann BL, Grunze H, Post RM, Scharer L. Saving time and money: a validation of the self ratings on the prospective NIMH Life-Chart Method (NIMH-LCM). BMC Psychiatry. 2014 May 7;14:130. doi: 10.1186/1471-244X-14-130.
citation: Denicoff KD, Ali SO, Sollinger AB, Smith-Jackson EE, Leverich GS, Post RM. Utility of the daily prospective National Institute of Mental Health Life-Chart Method (NIMH-LCM-p) ratings in clinical trials of bipolar disorder. Depress Anxiety. 2002;15(1):1-9. doi: 10.1002/da.1078.