Pilot Study on the Clinical Utility of the Tulsa Life Chart

Mental Health Issue Clinical Trial

Official title:

Pilot Study on the Clinical Utility of the Tulsa Life Chart: A Graphical Representation of Patient Life History

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05523843
• Other study ID #: 2022-004
• Status: Enrolling by invitation
• Start date: September 12, 2022
• Est. completion date: August 2024

Study information

• Verified date: November 2023
• Source: Laureate Institute for Brain Research, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 Unpublished focus groups with HCPs suggest HCPs believe the TLC could help to improve patient encounters by increasing understanding of patients and facilitating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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 130
• Est. completion date: August 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Assessment, Self
• Mental Disorders
• Mental Health Disorder
• Mental Health Issue

Intervention

Other:
• Tulsa Life Chart (TLC)
The TLC is a self-administered, interactive assessment of patient history. Participants are asked to provide information from birth to their current age in developmental epochs (i.e., ages 0 to 5; 6 to 10; 11 to 14; 15 to 18; 19 to 25; 26 to 35; and so on in 10-year increments). Participants are first asked to rate their average mood during the epoch. They are then asked about locations lived, schools attended, people they were close to, hobbies, medical conditions, medications, hospitalizations, direct and indirect substance use exposure, mental health symptoms, mental health treatment, and important life events. The information is then displayed in an interactive, graphic of the individual's life that is reviewable by the patient and the healthcare providers enrolled in the study that the patient consents to having access.

Locations

Country	Name	City	State
United States	Laureate Institute for Brain Research	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Laureate Institute for Brain Research, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	mHealth App Usability Questionnaire (MAUQ) Total Usability Score (Patient)	Validated self-report survey in which participants indicate how usable the assessment tool was, with scores ranging from 18 to 126. Higher scores indicate greater usability.	Assessment two - on average 4 to 12 weeks after baseline assessment
Other	Change in perception of usefulness	Change in mHealth App Usability Questionnaire (MAUQ) score from first assessment time point to second assessment time point. Scores on the MAUQ range from 18 to 126. Higher scores indicate greater usability.	Change from baseline to the post-treatment timepoint, approximately 4 - 12 weeks after baseline
Other	mHealth App Usability Questionnaire (MAUQ) - Ease of Use Subscale (Patient)	Subscale of a validated self-report survey in which patient participants report how easy the assessment tool was to use. Ease of use scores range from 5 to 35 with higher scores indicating greater ease of use.	Assessment two - on average 4 to 12 weeks after baseline assessment
Other	mHealth App Usability Questionnaire (MAUQ) - Ease of Use Subscale (Healthcare Professional)	Subscale of a validated self-report survey in which healthcare professional participants report how easy the assessment tool was to use. Ease of use scores range from 5 to 35 with higher scores indicating greater ease of use.	Assessment two - on average 4 to 12 weeks after baseline assessment
Other	mHealth App Usability Questionnaire (MAUQ) - Interface and Satisfaction Subscale (Patient)	Subscale of a validated self-report survey in which patients rate their satisfaction with the assessment tool and the interface of the tool. Interface and satisfaction scores range from 7 to 49 with higher scores indicating greater satisfaction.	Assessment two - on average 4 to 12 weeks after baseline assessment
Other	mHealth App Usability Questionnaire (MAUQ) - Interface and Satisfaction Subscale (Healthcare Professional)	Subscale of a validated self-report survey in which healthcare professionals rate their satisfaction with the assessment tool and the interface of the tool. Interface and satisfaction scores range from 7 to 49 with higher scores indicating greater satisfaction.	Assessment two - on average 4 to 12 weeks after baseline assessment
Other	mHealth App Usability Questionnaire (MAUQ) - Usefulness Subscale (Patient)	Subscale of a validated self-report survey in which patients rate the usefulness of the assessment tool. Usefulness scores range from 6 to 42 with higher scores indicating greater usefulness.	Assessment two - on average 4 to 12 weeks after baseline assessment
Other	mHealth App mHealth App Usability Questionnaire (MAUQ) - Usefulness Subscale (Healthcare Professional)	Subscale of a validated self-report survey in which healthcare professionals rate the usefulness of the assessment tool. Usefulness scores range from 6 to 42 with higher scores indicating greater usefulness.	Assessment two - on average 4 to 12 weeks after baseline assessment
Other	Utility Questionnaire (Patient)	This measure was created for the purpose of the current study to measure how useful the assessment tool was in multiple domains. This measure asks treatment seekers questions pertaining to their experience using the Tulsa Life Chart including: ease of understanding and impact of completing the Tulsa Life Chart on remembering life events, understanding of mental health patterns, communication with their provider, and motivation for treatment engagement. Scores range from 6 to 28 with higher scores indicating greater utility for patients.	Baseline assessment
Other	Utility Questionnaire (Healthcare Professional)	This measure was created for the purpose of the current study to measure how useful the assessment tool was in multiple domains. This measure asks healthcare professionals questions pertaining to their experience viewing their patient's Tulsa Life Chart. Domains include ease of understanding the chart; usefulness in diagnosing their patient; and impact on understanding patient's psychosocial history, understanding patterns in their patient's mental health, and facilitating conversations. Scores range from 7 to 35 with higher scores indicating greater utility for healthcare professionals.	Baseline assessment
Other	Utility Questionnaire (Patient)	This measure was created for the purpose of the current study to measure how useful the assessment tool was in multiple domains. This measure asks treatment seekers questions pertaining to their experience using the Tulsa Life Chart including: ease of understanding and impact of completing the Tulsa Life Chart on remembering life events, understanding of mental health patterns, communication with their provider, and motivation for treatment engagement. Scores range from 5 to 23 with higher scores indicating greater utility for patients.	Assessment two - on average 4 to 12 weeks after baseline assessment
Other	Utility Questionnaire (Healthcare Professional)	This measure was created for the purpose of the current study to measure how useful the assessment tool was in multiple domains. This measure asks healthcare professionals questions pertaining to their experience viewing their patient's Tulsa Life Chart. Domains include impact on therapy; ease of understanding the chart; usefulness in diagnosing their patient; and impact on understanding patient's psychosocial history, understanding patterns in their patient's mental health, and facilitating conversations. Scores range from 8 to 35 with higher scores indicating greater utility for healthcare professionals.	Assessment two - on average 4 to 12 weeks after baseline assessment
Other	Likelihood of recommending the Tulsa Life Chart to other patients (Patient)	One question will be used to assess the patient's likelihood of recommending the Tulsa Life Chart. "How likely are you to recommend the Tulsa Life Chart to someone else who may be experiencing mental health symptoms?" Scores range from 1 to 5, with higher scores indicating greater likelihood of recommending to the chart.	Baseline assessment
Other	Likelihood of recommending the Tulsa Life Chart to other healthcare professionals (Healthcare Professional)	One question will be used to assess the patient's likelihood of recommending the Tulsa Life Chart to other healthcare professionals. "Based on this experience, how likely are you to recommend the Tulsa Life Chart to other providers?" Scores range from 1 to 5, with higher scores indicating greater likelihood of recommending to the chart.	Baseline assessment
Other	Likelihood of recommending the Tulsa Life Chart to other patients (Patient)	One question will be used to assess the patient's likelihood of recommending the Tulsa Life Chart. "How likely are you to recommend the Tulsa Life Chart to someone else who may be experiencing mental health symptoms?" Scores range from 1 to 5, with higher scores indicating greater likelihood of recommending to the chart.	Assessment two - on average 4 to 12 weeks after baseline assessment
Other	Likelihood of recommending (Healthcare Professional)	One question will be used to assess the patient's likelihood of recommending the Tulsa Life Chart to other healthcare professionals. "Based on this experience, how likely are you to recommend the Tulsa Life Chart to other providers?" Scores range from 1 to 5, with higher scores indicating greater likelihood of recommending to the chart.	Assessment two - on average 4 to 12 weeks after baseline assessment
Primary	mHealth App Usability Questionnaire (MAUQ) Total Usability Score (Patient)	Validated self-report survey in which participants indicate how usable the assessment tool was, with scores ranging from 18 to 126. Higher scores indicate greater usability.	Baseline assessment
Primary	mHealth App Usability Questionnaire (MAUQ) Total Usability Score (Healthcare Professional)	Validated self-report survey in which healthcare professional participants indicate how usable the assessment tool was, with scores ranging from 18 to 126. Higher scores indicate greater usability.	Baseline assessment
Secondary	mHealth App Usability Questionnaire (MAUQ) - Ease of Use Subscale (Patient)	Subscale of a validated self-report survey in which patient participants report how easy the assessment tool was to use. Ease of use scores range from 5 to 35 with higher scores indicating greater ease of use.	Baseline assessment
Secondary	mHealth App Usability Questionnaire (MAUQ) - Ease of Use Subscale (Healthcare Professional)	Subscale of a validated self-report survey in which healthcare professional participants report how easy the assessment tool was to use. Ease of use scores range from 5 to 35 with higher scores indicating greater ease of use.	Baseline assessment
Secondary	mHealth App Usability Questionnaire (MAUQ) - Interface and Satisfaction Subscale (Patient)	Subscale of a validated self-report survey in which patients rate their satisfaction with the assessment tool and the interface of the tool. Interface and satisfaction scores range from 7 to 49 with higher scores indicating greater satisfaction.	Baseline assessment
Secondary	mHealth App Usability Questionnaire (MAUQ) - Interface and Satisfaction Subscale (Healthcare Professional)	Subscale of a validated self-report survey in which healthcare professionals rate their satisfaction with the assessment tool and the interface of the tool. Interface and satisfaction scores range from 7 to 49 with higher scores indicating greater satisfaction.	Baseline assessment
Secondary	mHealth App Usability Questionnaire (MAUQ) - Usefulness Subscale (Patient)	Subscale of a validated self-report survey in which patients rate the usefulness of the assessment tool. Usefulness scores range from 6 to 42 with higher scores indicating greater usefulness.	Baseline assessment
Secondary	mHealth App Usability Questionnaire (MAUQ) - Usefulness Subscale (Healthcare Professional)	Subscale of a validated self-report survey in which healthcare professionals rate the usefulness of the assessment tool. Usefulness scores range from 6 to 42 with higher scores indicating greater usefulness.	Baseline assessment
Secondary	Time spent to complete the Tulsa Life Chart (Patient)	Treatment seekers self-report of time to complete the TLC and embedded time count from the TLC application.	Baseline assessment
Secondary	Time spent to reviewing the Tulsa Life Chart (Healthcare Professional)	Healthcare professionals' self-report of time spent reviewing the TLC and embedded time count from the TLC application.	Baseline assessment

External Links

•   Tulsa Life Chart application link