In-person vs. Remote Wellness Support

Study Overview
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Brief Summary
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The study team will use components of the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework to compare Cognitive Adaptation Training (CAT) to Remotely delivered Cognitive Adaptation Training (R-CAT) 1-9 within a managed care organization (MCO), targeting members with serious mental illness (SMI) needing assistance with the regular taking of medication.

Detailed Description
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Individuals choosing or assigned to R-CAT will continue treatment as usual with their health care team and R-CAT will be added. R-CAT is a remotely delivered version of CAT focused on medication adherence using a series of manual-driven compensatory strategies and environmental supports (signs, checklists, electronic cueing devices) based upon a streamlined assessment of executive function impairment and barriers to habit formation including forgetfulness, difficulties in problem-solving, disorganization, apathy or amotivation, disinhibition. and home environment. Initial R-CAT goals are to 1) ensure that medications listed as prescribed are available 2) to assess current cognitive, behavioral and environmental facilitators and barriers to habit-formation 3) to set up customized CAT supports to address the barriers and use facilitators to build habits to take medication. Rare home visits may occur if issues cannot be resolved remotely. Based upon the pilot, the study team don't anticipate any more than 5-10% of individuals to need face-to-face visits. No one had home visits as part of the pilot intervention. A structured R-CAT treatment note with places for pictures of CAT interventions is used for home visits. Support and reminder calls use a brief checklist modified from the Healthy Habits Program to address issues in use of supports, placement of supports and habit formation. Examples of CAT interventions to promote taking medication regularly appear above. All home visits and phone calls will be audio-taped (with consent) for quality assurance.

Official Title
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In-person vs. Remote Wellness Support (Study Sub-title: Remote Cognitive Adaptation Training to Improve Medication Follow Through in Managed Care (R-CAT))

Conditions
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Depressive Disorder, Major, Bipolar Disorder, Schizo Affective Disorder, Schizophrenia

Intervention / Treatment
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* Behavioral: CAT
* Behavioral: R-CAT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to give informed consent. Between the ages of 18 and 65. Clinical Diagnosis of Major Depressive Disorder, Bipolar disorder, Schizophrenia, or Schizoaffective Disorder Receiving treatment with oral psychiatric medications. Have had a hospitalization or emergency department visit in the past year Have a Medication Possession Ratio (MPR) based upon electronic refill data below 80% at least 1 of the past 4 quarters with at least 1 psychiatric medication Responsible for taking their own medications Report on telephone prescreen call with researcher team that they have missed at least 2 doses of medication in the past 3 weeks, that they are willing to take medication and would like remote assistance to take medication more regularly Report on telephone prescreen call with research team that they have a stable living environment (individual apartment, family home, board and care facility) within the last three months and no plans to move in the next year Report on prescreen research call with research team that they have no plans to change their MCO in the next 12 months Have a working smart phone Able to understand and complete rating scales and assessments. Agree to home visits for intervention and to count pills and conduct assessments Exclusion Criteria: Substance dependence within the past 2 months Currently being treated by an ACT team Documented history of violence or threatening behavior on initial assessment Receive home visits to assist with medication adherence Unable to complete baseline assessments

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized parallel design
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cognitive Adaptation Training (CAT)<br>A home delivered adherence intervention used by managed care used to improve outcomes across multiple conditions. | Behavioral: CAT<br>* An evidence-based psychosocial treatment using environmental supports such as signs, alarms, pill containers, and the organization of belongings established in a person's home on weekly visits to cue adaptive behaviors and establish healthy habits.<br>* Other names: Cognitive Adaptation Training;|
| Active Comparator: Remote Cognitive Adaptation Training (R-CAT)<br>A primarily remotely delivered workable adherence intervention used by managed care used to improve outcomes across multiple conditions. | Behavioral: R-CAT<br>* An evidence-based psychosocial treatment using environmental supports such as signs, alarms, pill containers, and the organization of belongings established in a person's home using remote weekly visits to cue adaptive behaviors and establish healthy habits.<br>* Other names: Remote Cognitive Adaptation Training;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptance of intervention | Proportion of subjects who dropped out of treatment | Baseline to 6 months | 
| Medication Adherence | Adherence percent is calculated as the number of pills missing and presumed taken/ the number of pills prescribed for the time period X100. Monthly checks will be performed. | Baseline to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost of treatment | Cost to include mail, supports, provider time in visit, preparation time and mileage | Baseline to 6 months | 
| Pill count percent | Medication possession ratio from prescription refill data | Baseline to 6 months | 
| Self-Report Habit Index (SRHI) | A 12-item scale assessing three proposed characteristics of habit;1) automaticity , 2) frequency, and 3) relevance to self-identity. Four items of this scale, items 2,3,5 and 8 represent the Self-Reported Behavioral Automaticity Index (SRBAI). Lower scores indicate greater habit strength and greater automaticity. A mean Habit score will be computed using the entire scale. | Baseline and at month 2, 4 and 6 | 
| Symptomatology | Change in symptoms assess by a trained rater using the Brief Psychiatric Rating Scale-Expanded Version (BPRS-E). The scale is used to rate the subjects using 24 items, each to be rated in a 7-point scale of severity ranging from NA (not assessed), then 1-7, with 7 being the most severe. A total score reflects an overall level of symptomology, with 164, being the maximum score, with the most symptoms present. | Baseline and at month 2, 4 and 6 | 
| Functional Outcome | Functional outcome will be rated using the Social and Occupational Functioning Scale (SOFAS).70 The SOFAS rates functioning on a scale from 0 to 100 based upon all the data collected in the assessment. Higher scores reflect better functional outcome. | Baseline and month 2, 4 and 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Serious mental illness