Bipolar Disorder, Major Depression, Schizophrenia
Conditions
Keywords
serious mental illness, mental health services research, measurement-based care, shared decision making, psychiatric medication management, community psychiatry, comparative effectiveness research, mixed methods research
Brief summary
Fifteen minutes is the typical length of an outpatient medication management appointment for people with serious mental health conditions. These brief interactions with prescribers are frequently provider-driven with insufficient time focused on the patient's needs and personal recovery. Shared decision making is a strategy that could improve this interaction. This study examines how technology can be used in the care process to amplify the voice of the patient, support shared decisions, and improve treatment outcomes. Investigators will compare the effectiveness of Measurement-Based vs. Person-Centered Care on two primary patient-centered outcomes: the patient experience of care with medication treatment and the level of shared decision making. Investigators hypothesize that: 1. Person-Centered Care will result in greater improvement in patient experience of care with medication treatment than Measurement-Based Care. 2. Person-Centered Care will result in a greater level of shared decision making during the medication visit than Measurement-Based Care. The study team will collect information from patients, caregivers, and clinic staff at different points in time during the study. Patients will be asked to complete questionnaires, and additional data on their service use will be gathered. Some patients and providers will also be interviewed about their experiences with care. Investigators are especially interested to learn if and how these two approaches are perceived to change medication treatment, if patients are more satisfied and empowered in their care, and why and how providers perceive and adopt changes to their clinical care.
Detailed description
An important attribute of patient-centered care is the active engagement of patients in making health care decisions. Despite advances in health care to support shared decision making, the patient experience of mental health care remains provider-driven. For individuals with serious mental illness (SMI), important decisions involve the choice of medications and how best to use medications to support individualized, person-centered recovery goals. By comparing the effectiveness of two approaches for promoting shared decision making around medication treatment on outcomes that matter most to individuals with SMI, the proposed study will advance ongoing and much-needed efforts to evolve toward a more personalized, recovery-oriented system of mental health care. Building on the work of a multi-stakeholder collaboration, investigators will compare two interventions, Person-Centered Care and Measurement-Based Care, both focused on patient-prescriber interactions around medication treatment. The investigators' study will address three questions that patients have identified as important to them: 1. Are there ways I can be more involved in my care that will result in better outcomes? 2. How likely am I to benefit from improved communication with my prescriber? 3. How will shared decision making support my personal recovery and overall wellness? Study aims will compare the effectiveness of measurement-based vs. person-centered care on the patient experience of care and on shared decision making. Investigators hypothesize that: 1. Person-Centered Care will result in greater improvement in patient experience of care with medication treatment than Measurement-Based Care. 2. Person-Centered Care will result in a greater level of shared decision making during the medication visit than Measurement-Based Care. In addition, investigators will compare the effectiveness of the two approaches on seven secondary patient-centered outcomes, and examine differences in outcomes within the two approaches for subgroups of patients based on their: (1) current status regarding psychiatric medication, (2) engagement with the interventions, and (3) illness severity. The target population is 2,460+ Medicaid-enrolled adults with SMI who receive medication treatment at one of 15 community mental health centers (CMHC). Using a prospective cluster-randomized design with a mixed-methods approach, investigators will randomly assign CMHCs to one of the two interventions. Quantitative (self-report, claims, process) and qualitative (interviews) data will be gathered at multiple time points across the two-year intervention period (baseline, 8 months, 16 months, and 24 months). Multi-level longitudinal analyses will examine the impact of the interventions on outcomes and explore the role of moderating variables. Qualitative data will be used to understand patient and stakeholder perspectives and to promote dissemination and sustainability.
Interventions
BEHAVIORALPerson-Centered Care
Decision support center staffed by peers. Patient uses the CommonGround program prior to medication visit to prepare a personal report, with support from peer(s). The CommonGround report expresses goals for medication, how other strategies help with functioning, current problems, and medication side effects. Patient brings report into the medication visit. Prescriber and patient discuss medication options, and prescriber enters the shared decision into CommonGround during the visit.
BEHAVIORALMeasurement-Based Care
Clinic staff asks each patient to use a tablet computer to complete a brief assessment of symptoms and problems prior to medication visit. Prescriber views assessment results on office computer and discusses next steps in medication management with the patient.
Sponsors
Dartmouth College
Patient-Centered Outcomes Research Institute
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults age 18 and older * Non-SMI (anxiety, post-traumatic stress disorder, depression, dysthymia, depression NOS) or SMI (schizophrenia, bipolar disorder, major depression) * Receiving services at one of the 15 participating community mental health centers * At least three claims for medication management services in past 12 months * Insured by Community Care Behavioral Health Organization
Exclusion criteria
* Assessed by clinicians as being too ill to be treated on an outpatient basis * Unable to speak, read, or understand English at the minimum required level
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Experience of Medication Treatment (PEMM) | Baseline and every eight months during the two-year intervention phase | The PEMM is a 12-item self-report measure of mental health patient experience of medication management with prescribers .Response options for 11 questions range from 0=Never to 4=Always, and the response options for the final question range from 0=Very Dissatisfied to 4=Very Satisfied. Overall possible range was 0 to 4. PEMM scores for each time point reflect the mean score of all measures collected within that time frame. |
| Shared Decision Making Questionnaire (SDM-Q-9) | Baseline and every eight months during the two-year intervention phase | The SDM-Q-9 is a 9-item self-report measure of the degree of shared decision making in clinical encounters. There are 6 possible responses ranging from: Completely Disagree (0) to Completely Agree (5). Raw score ranges from 0 to 45. Multiplication of the raw score by 20/9 provides a score forced (transformed) to range from 0 to 100, where 0 indicates the lowest possible level of SDM and 100 indicates the highest extent of shared decision making in clinical encounters. SDM-Q-9 scores for each time point reflect the mean score of all measures collected within that time frame. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Activation Measure (PAM) | Baseline and every eight months during the two-year intervention phase | PAM is a 13-item scale that assesses the knowledge, skills, and confidence of patients essential to managing their own health and health care. Response options are: Strongly Disagree, Disagree, Agree, and Strongly Agree. The activation scale for the PAM ranges from 0 to 100. The lower values represent a poor outcome while higher values represent a better outcome. Overall possible range was 0 to 91.6. PAM scores for each time point reflect the mean score of all measures collected within that time frame. |
| Behavior and Symptom Identification Scale (BASIS-24) | Baseline and every eight months during the two-year intervention phase | The BASIS-24 identifies a wide range of symptoms and problems that occur across the psychiatric diagnostic spectrum. There are 5 ordered responses either ranging from No Difficulty to Extreme Difficulty or from None of the Time to All of the Time. Each of 24 questions is scored on a 5 point scale (from 0 to 4 where 0 is the lowest severity and 4 is the highest). The overall BASIS-24 score is a weighted sum that is computed by multiplying the rating for each question by its weight and totaling the weighted ratings for each question. Overall possible range was 0 to 3.99. BASIS-24 scores for each time point reflect the mean score of all measures collected within that time frame. |
| Sheehan Disability Scale | Baseline and every eight months during the two-year intervention phase | The Sheehan Disability Scale measures the extent to which three major sectors in the person's life are impaired by psychiatric symptoms (work/school, social/leisure life, and family/home life). The 3 items are summed together to form a single measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired). Sheehan Disability Scale scores for each time point reflect the mean score of all measures collected within that time frame. |
| Hope | Baseline and every eight months during the two-year intervention phase | Patient hopefulness will be assessed using a single question: Overall, how hopeful does the patient feel about his/her life? Responses are on a scale of 1 through 10 with 1=No Hope and 10=Filled with Hope. Hopefulness scores for each time point reflect the mean score of all measures collected within that time frame. |
| Engagement in Medication and Evaluation Visit | Baseline, 8 months, 24 months | Count of the number of medication checks and evaluation visits for each study participant for the 12 month period prior to and including the anchor date of the time point. |
| Engagement in Psychotherapy Visit | Baseline, 8 months, 24 months | Count of the number of psychotherapy visits for each study participant for the 12 month period prior to and including the anchor date of the time point. |
| Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (QLESQ-SF) | Baseline and every eight months during the two-year intervention phase | Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form is a 16-item, self-report questionnaire for assessing quality of life in multiple domains (e.g., physical health, mood, leisure time activities, social relationships, and overall). Response items are on a 5-point scale ranging from Very Poor to Very Good. The scoring of the Q-LES-Q-SF involves summing only the first 14 items to yield a raw total score. The last two items are not included in the total score but are standalone items. The raw total score ranges from 14 to 70. The raw total score was transformed into a percentage maximum possible score using the following formula. The lower values/percentages represent a poor outcome while higher values/percentages represent a better outcome. Overall possible range was 0-100. QLESQ-SF scores for each time point reflect the mean score of all measures collected within that time frame. |
| Medication Side Effects | Baseline and every eight months during the two-year intervention phase | Medication side effects will be assessed using a single question: How much is the patient troubled by medication side effects? Responses are on a scale of 1 through 10 with 1=Not Bothered at all by side effects and 10=Very Bothered by side effects. Medication side effect scores for each time point reflect the mean score of all measures collected within that time frame. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Person-Centered Care Decision support center staffed by peers. Patient uses the CommonGround program prior to medication visit to prepare a personal report, with support from peer(s). The CommonGround report expresses goals for medication, how other strategies help with functioning, current problems, and medication side effects. Patient brings report into the medication visit. Prescriber and patient discuss medication options, and prescriber enters the shared decision into CommonGround during the visit.
Person-Centered Care: Decision support center staffed by peers. Patient uses the CommonGround program prior to medication visit to prepare a personal report, with support from peer(s). The CommonGround report expresses goals for medication, how other strategies help with functioning, current problems, and medication side effects. Patient brings report into the medication visit. Prescriber and patient discuss medication options, and prescriber enters the shared decision into CommonGround during the visi | 1,201 |
| Measurement-Based Care Clinic staff asks each patient to use a tablet computer to complete a brief assessment of symptoms and problems prior to medication visit. Prescriber views assessment results on office computer and discusses next steps in medication management with the patient.
Measurement-Based Care: Clinic staff asks each patient to use a tablet computer to complete a brief assessment of symptoms and problems prior to medication visit. Prescriber views assessment results on office computer and discusses next steps in medication management with the patient. | 1,162 |
| Total | 2,363 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 12 | 16 |
| Overall Study | Lost to Follow-up | 174 | 144 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Measurement-Based Care | Total | Person-Centered Care |
|---|---|---|---|
| Age, Continuous | 41.31 years STANDARD_DEVIATION 11.88 | 41.57 years STANDARD_DEVIATION 12.15 | 41.82 years STANDARD_DEVIATION 12.41 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 14 Participants | 51 Participants | 37 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1148 Participants | 2312 Participants | 1164 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 2 Participants | 8 Participants | 6 Participants |
| Race/Ethnicity, Customized Black/African American | 104 Participants | 207 Participants | 103 Participants |
| Race/Ethnicity, Customized Native American | 2 Participants | 9 Participants | 7 Participants |
| Race/Ethnicity, Customized Other | 31 Participants | 101 Participants | 70 Participants |
| Race/Ethnicity, Customized White | 1023 Participants | 2038 Participants | 1015 Participants |
| Region of Enrollment United States | 1162 participants | 2363 participants | 1201 participants |
| Sex: Female, Male Female | 775 Participants | 1491 Participants | 716 Participants |
| Sex: Female, Male Male | 387 Participants | 872 Participants | 485 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 12 / 1,232 | 16 / 1,211 |
| other Total, other adverse events | 0 / 1,232 | 0 / 1,211 |
| serious Total, serious adverse events | 0 / 1,232 | 0 / 1,211 |
Outcome results
Primary
Patient Experience of Medication Treatment (PEMM)
The PEMM is a 12-item self-report measure of mental health patient experience of medication management with prescribers .Response options for 11 questions range from 0=Never to 4=Always, and the response options for the final question range from 0=Very Dissatisfied to 4=Very Satisfied. Overall possible range was 0 to 4. PEMM scores for each time point reflect the mean score of all measures collected within that time frame.
Time frame: Baseline and every eight months during the two-year intervention phase
Population: Multiple records can be measured from the same participant at the same time period, so overall number of surveys analyzed can be greater than the unique number of participants except for at baseline.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Person-Centered Care | Patient Experience of Medication Treatment (PEMM) | Month 3: Every record 0< month <=3 | 2.6 Units on a scale | Standard Deviation 0.91 |
| Person-Centered Care | Patient Experience of Medication Treatment (PEMM) | Month16: Every record 12< month <=16 | 3.066 Units on a scale | Standard Deviation 0.685 |
| Person-Centered Care | Patient Experience of Medication Treatment (PEMM) | Month 8: Every record 6< month <=8 | 3.015 Units on a scale | Standard Deviation 0.713 |
| Person-Centered Care | Patient Experience of Medication Treatment (PEMM) | Month 18: Every record 16< month <=18 | 3.134 Units on a scale | Standard Deviation 0.703 |
| Person-Centered Care | Patient Experience of Medication Treatment (PEMM) | Month 6: Every record 3< month <=6 | 3.056 Units on a scale | Standard Deviation 0.679 |
| Person-Centered Care | Patient Experience of Medication Treatment (PEMM) | Month 20: Every record 18< month <=20 | 3.062 Units on a scale | Standard Deviation 0.666 |
| Person-Centered Care | Patient Experience of Medication Treatment (PEMM) | Month 12: Every record 8< month <=12 | 3.055 Units on a scale | Standard Deviation 0.715 |
| Person-Centered Care | Patient Experience of Medication Treatment (PEMM) | Month 24: Every record 20< month | 3.13 Units on a scale | Standard Deviation 0.667 |
| Person-Centered Care | Patient Experience of Medication Treatment (PEMM) | Baseline | 3.009 Units on a scale | Standard Deviation 0.712 |
| Measurement-Based Care | Patient Experience of Medication Treatment (PEMM) | Month 24: Every record 20< month | 3.117 Units on a scale | Standard Deviation 0.7 |
| Measurement-Based Care | Patient Experience of Medication Treatment (PEMM) | Baseline | 3.007 Units on a scale | Standard Deviation 0.747 |
| Measurement-Based Care | Patient Experience of Medication Treatment (PEMM) | Month 3: Every record 0< month <=3 | 3.09 Units on a scale | Standard Deviation 0.18 |
| Measurement-Based Care | Patient Experience of Medication Treatment (PEMM) | Month 6: Every record 3< month <=6 | 3.068 Units on a scale | Standard Deviation 0.675 |
| Measurement-Based Care | Patient Experience of Medication Treatment (PEMM) | Month 8: Every record 6< month <=8 | 3.083 Units on a scale | Standard Deviation 0.735 |
| Measurement-Based Care | Patient Experience of Medication Treatment (PEMM) | Month 12: Every record 8< month <=12 | 3.119 Units on a scale | Standard Deviation 0.682 |
| Measurement-Based Care | Patient Experience of Medication Treatment (PEMM) | Month16: Every record 12< month <=16 | 3.112 Units on a scale | Standard Deviation 0.681 |
| Measurement-Based Care | Patient Experience of Medication Treatment (PEMM) | Month 18: Every record 16< month <=18 | 3.153 Units on a scale | Standard Deviation 0.624 |
| Measurement-Based Care | Patient Experience of Medication Treatment (PEMM) | Month 20: Every record 18< month <=20 | 3.113 Units on a scale | Standard Deviation 0.677 |
Comparison: Time-by-treatment interactionp-value: <0.0001Mixed Models Analysis
Comparison: Three-way interaction effect (treatment, polynomial time, and age group 1) where age group 1 is defined by 0 (reference) if \<=35; 1 if (35\<age\<=49); 2 if age \>49.p-value: 0.0033Mixed Models Analysis
Comparison: Three-way interaction effect (treatment, polynomial time, and SMI group). Participants with a diagnosis of major depression, schizoaffective or schizophrenia were classified into the SMI group and the reference group (Non-SMI) included diagnosis of anxiety, PTSD, depression/dysthymia/depression nos.p-value: 0.3164Mixed Models Analysis
Comparison: Three-way interaction effect of time, treatment, and the basis subgroups (no symptoms =group 1; at least 1 severe symptom = group 2)p-value: 0.0482Mixed Models Analysis
Comparison: Three-way interaction of Treatment, time, and subgroup of side effects. Subgroup of side effect= 0 if the response to the medication side effects question at baseline is 1, 2, or 3 (i.e. subgroup of participants who are minimally bothered by medication side effects at baseline); Subgroup of side effect= 1 if the response to the medication side effects question at baseline is 4-10 (i.e. subgroup of participants who are moderately or very bothered by medication side effects at baseline)p-value: 0.9928Mixed Models Analysis
Primary
Shared Decision Making Questionnaire (SDM-Q-9)
The SDM-Q-9 is a 9-item self-report measure of the degree of shared decision making in clinical encounters. There are 6 possible responses ranging from: Completely Disagree (0) to Completely Agree (5). Raw score ranges from 0 to 45. Multiplication of the raw score by 20/9 provides a score forced (transformed) to range from 0 to 100, where 0 indicates the lowest possible level of SDM and 100 indicates the highest extent of shared decision making in clinical encounters. SDM-Q-9 scores for each time point reflect the mean score of all measures collected within that time frame.
Time frame: Baseline and every eight months during the two-year intervention phase
Population: Multiple records can be measured from the same participant at the same time period, so N can be greater than the unique number of participants except for the baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Person-Centered Care | Shared Decision Making Questionnaire (SDM-Q-9) | Month 3: Every record 0< month <=3 | 72 Units on a scale | Standard Deviation 18.699 |
| Person-Centered Care | Shared Decision Making Questionnaire (SDM-Q-9) | Month16: Every record 12< month <=16 | 75.736 Units on a scale | Standard Deviation 21.823 |
| Person-Centered Care | Shared Decision Making Questionnaire (SDM-Q-9) | Month 8: Every record 6< month <=8 | 74.692 Units on a scale | Standard Deviation 22.911 |
| Person-Centered Care | Shared Decision Making Questionnaire (SDM-Q-9) | Month 18: Every record 16< month <=18 | 78.682 Units on a scale | Standard Deviation 21.648 |
| Person-Centered Care | Shared Decision Making Questionnaire (SDM-Q-9) | Month 6: Every record 3< month <=6 | 75.946 Units on a scale | Standard Deviation 22.206 |
| Person-Centered Care | Shared Decision Making Questionnaire (SDM-Q-9) | Month 20: Every record 18< month <=20 | 76.728 Units on a scale | Standard Deviation 19.737 |
| Person-Centered Care | Shared Decision Making Questionnaire (SDM-Q-9) | Month 12: Every record 8< month <=12 | 76.148 Units on a scale | Standard Deviation 23.389 |
| Person-Centered Care | Shared Decision Making Questionnaire (SDM-Q-9) | Month 24: Every record 20< month | 77.822 Units on a scale | Standard Deviation 20.898 |
| Person-Centered Care | Shared Decision Making Questionnaire (SDM-Q-9) | Baseline | 74.082 Units on a scale | Standard Deviation 24.162 |
| Measurement-Based Care | Shared Decision Making Questionnaire (SDM-Q-9) | Month 24: Every record 20< month | 77.082 Units on a scale | Standard Deviation 21.801 |
| Measurement-Based Care | Shared Decision Making Questionnaire (SDM-Q-9) | Baseline | 73.69 Units on a scale | Standard Deviation 24.271 |
| Measurement-Based Care | Shared Decision Making Questionnaire (SDM-Q-9) | Month 3: Every record 0< month <=3 | 83.703 Units on a scale | Standard Deviation 8.411 |
| Measurement-Based Care | Shared Decision Making Questionnaire (SDM-Q-9) | Month 6: Every record 3< month <=6 | 76.12 Units on a scale | Standard Deviation 21.756 |
| Measurement-Based Care | Shared Decision Making Questionnaire (SDM-Q-9) | Month 8: Every record 6< month <=8 | 74.014 Units on a scale | Standard Deviation 22.852 |
| Measurement-Based Care | Shared Decision Making Questionnaire (SDM-Q-9) | Month 12: Every record 8< month <=12 | 77.629 Units on a scale | Standard Deviation 19.988 |
| Measurement-Based Care | Shared Decision Making Questionnaire (SDM-Q-9) | Month16: Every record 12< month <=16 | 76.325 Units on a scale | Standard Deviation 22.733 |
| Measurement-Based Care | Shared Decision Making Questionnaire (SDM-Q-9) | Month 18: Every record 16< month <=18 | 76.554 Units on a scale | Standard Deviation 21.015 |
| Measurement-Based Care | Shared Decision Making Questionnaire (SDM-Q-9) | Month 20: Every record 18< month <=20 | 75.72 Units on a scale | Standard Deviation 21.73 |
Comparison: Time-by-treatment interactionp-value: 0.6243Mixed Models Analysis
Comparison: Test for change over time from baseline (Marginal Effect of Time)p-value: 0.1969Mixed Models Analysis
Comparison: Three-way interaction effect (treatment, polynomial time, and age group 1) where age group 1 is defined by 0 (reference) if \<=35; 1 if (35\<age\<=49); 2 if age \>49p-value: 0.0042Mixed Models Analysis
Comparison: Three-way interaction effect (treatment, polynomial time, and SMI group). Participants with a diagnosis of major depression, schizoaffective or schizophrenia were classified into the SMI group and the reference group (Non-SMI) included diagnosis of anxiety, PTSD, depression/dysthymia/depression nos.p-value: 0.0002Mixed Models Analysis
Comparison: Three-way interaction effect of time, treatment, and the basis subgroups (no symptoms =group 1; at least 1 severe symptom = group 2)p-value: 0.7254Mixed Models Analysis
Comparison: Three-way interaction of Treatment, time, and subgroup of side effects. Subgroup of side effect= 0 if the response to the medication side effects question at baseline is 1, 2, or 3 (i.e. subgroup of participants who are minimally bothered by medication side effects at baseline); Subgroup of side effect= 1 if the response to the medication side effects question at baseline is 4-10 (i.e. subgroup of participants who are moderately or very bothered by medication side effects at baseline)p-value: 0.058Mixed Models Analysis
Secondary
Behavior and Symptom Identification Scale (BASIS-24)
The BASIS-24 identifies a wide range of symptoms and problems that occur across the psychiatric diagnostic spectrum. There are 5 ordered responses either ranging from No Difficulty to Extreme Difficulty or from None of the Time to All of the Time. Each of 24 questions is scored on a 5 point scale (from 0 to 4 where 0 is the lowest severity and 4 is the highest). The overall BASIS-24 score is a weighted sum that is computed by multiplying the rating for each question by its weight and totaling the weighted ratings for each question. Overall possible range was 0 to 3.99. BASIS-24 scores for each time point reflect the mean score of all measures collected within that time frame.
Time frame: Baseline and every eight months during the two-year intervention phase
Population: Multiple records can be measured from the same participant at the same time period, so N can be greater than the unique number of participants except for the baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Person-Centered Care | Behavior and Symptom Identification Scale (BASIS-24) | Month 3: Every record 0< month <=3 | 1.418 Units on a scale | Standard Deviation 0.552 |
| Person-Centered Care | Behavior and Symptom Identification Scale (BASIS-24) | Month16: Every record 12< month <=16 | 1.3 Units on a scale | Standard Deviation 0.724 |
| Person-Centered Care | Behavior and Symptom Identification Scale (BASIS-24) | Month 8: Every record 6< month <=8 | 1.386 Units on a scale | Standard Deviation 0.724 |
| Person-Centered Care | Behavior and Symptom Identification Scale (BASIS-24) | Month 18: Every record 16< month <=18 | 1.179 Units on a scale | Standard Deviation 0.696 |
| Person-Centered Care | Behavior and Symptom Identification Scale (BASIS-24) | Month 6: Every record 3< month <=6 | 1.291 Units on a scale | Standard Deviation 0.776 |
| Person-Centered Care | Behavior and Symptom Identification Scale (BASIS-24) | Month 20: Every record 18< month <=20 | 1.252 Units on a scale | Standard Deviation 0.709 |
| Person-Centered Care | Behavior and Symptom Identification Scale (BASIS-24) | Month 12: Every record 8< month <=12 | 1.324 Units on a scale | Standard Deviation 0.782 |
| Person-Centered Care | Behavior and Symptom Identification Scale (BASIS-24) | Month 24: Every record 20< month | 1.245 Units on a scale | Standard Deviation 0.699 |
| Person-Centered Care | Behavior and Symptom Identification Scale (BASIS-24) | Baseline | 1.496 Units on a scale | Standard Deviation 0.737 |
| Measurement-Based Care | Behavior and Symptom Identification Scale (BASIS-24) | Month 24: Every record 20< month | 1.305 Units on a scale | Standard Deviation 0.72 |
| Measurement-Based Care | Behavior and Symptom Identification Scale (BASIS-24) | Baseline | 1.483 Units on a scale | Standard Deviation 0.726 |
| Measurement-Based Care | Behavior and Symptom Identification Scale (BASIS-24) | Month 3: Every record 0< month <=3 | 2.03 Units on a scale | Standard Deviation 0.622 |
| Measurement-Based Care | Behavior and Symptom Identification Scale (BASIS-24) | Month 6: Every record 3< month <=6 | 1.449 Units on a scale | Standard Deviation 0.666 |
| Measurement-Based Care | Behavior and Symptom Identification Scale (BASIS-24) | Month 8: Every record 6< month <=8 | 1.431 Units on a scale | Standard Deviation 0.767 |
| Measurement-Based Care | Behavior and Symptom Identification Scale (BASIS-24) | Month 12: Every record 8< month <=12 | 1.432 Units on a scale | Standard Deviation 0.739 |
| Measurement-Based Care | Behavior and Symptom Identification Scale (BASIS-24) | Month16: Every record 12< month <=16 | 1.362 Units on a scale | Standard Deviation 0.722 |
| Measurement-Based Care | Behavior and Symptom Identification Scale (BASIS-24) | Month 18: Every record 16< month <=18 | 1.357 Units on a scale | Standard Deviation 0.737 |
| Measurement-Based Care | Behavior and Symptom Identification Scale (BASIS-24) | Month 20: Every record 18< month <=20 | 1.299 Units on a scale | Standard Deviation 0.704 |
Comparison: Time-by-treatment interactionp-value: 0.0033Mixed Models Analysis
Secondary
Engagement in Medication and Evaluation Visit
Count of the number of medication checks and evaluation visits for each study participant for the 12 month period prior to and including the anchor date of the time point.
Time frame: Baseline, 8 months, 24 months
Population: Based on participants who had available claims data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Person-Centered Care | Engagement in Medication and Evaluation Visit | 24 months | 5.517 medication checks and evaluation visits | Standard Deviation 4.803 |
| Person-Centered Care | Engagement in Medication and Evaluation Visit | Baseline | 6.356 medication checks and evaluation visits | Standard Deviation 4.22 |
| Person-Centered Care | Engagement in Medication and Evaluation Visit | 8 months | 5.977 medication checks and evaluation visits | Standard Deviation 4.586 |
| Measurement-Based Care | Engagement in Medication and Evaluation Visit | Baseline | 6.785 medication checks and evaluation visits | Standard Deviation 4.006 |
| Measurement-Based Care | Engagement in Medication and Evaluation Visit | 8 months | 6.851 medication checks and evaluation visits | Standard Deviation 3.94 |
| Measurement-Based Care | Engagement in Medication and Evaluation Visit | 24 months | 5.691 medication checks and evaluation visits | Standard Deviation 4.839 |
p-value: <0.0001Mixed Models Analysis
Secondary
Engagement in Psychotherapy Visit
Count of the number of psychotherapy visits for each study participant for the 12 month period prior to and including the anchor date of the time point.
Time frame: Baseline, 8 months, 24 months
Population: Based on participants who had available claims data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Person-Centered Care | Engagement in Psychotherapy Visit | Baseline | 8.706 psychotherapy visits | Standard Deviation 12.972 |
| Person-Centered Care | Engagement in Psychotherapy Visit | 8 months | 7.825 psychotherapy visits | Standard Deviation 12.461 |
| Person-Centered Care | Engagement in Psychotherapy Visit | 24 months | 7.224 psychotherapy visits | Standard Deviation 12.728 |
| Measurement-Based Care | Engagement in Psychotherapy Visit | Baseline | 9.679 psychotherapy visits | Standard Deviation 12.313 |
| Measurement-Based Care | Engagement in Psychotherapy Visit | 8 months | 9.369 psychotherapy visits | Standard Deviation 12.279 |
| Measurement-Based Care | Engagement in Psychotherapy Visit | 24 months | 6.864 psychotherapy visits | Standard Deviation 11.397 |
p-value: 0.0003Mixed Models Analysis
Secondary
Hope
Patient hopefulness will be assessed using a single question: Overall, how hopeful does the patient feel about his/her life? Responses are on a scale of 1 through 10 with 1=No Hope and 10=Filled with Hope. Hopefulness scores for each time point reflect the mean score of all measures collected within that time frame.
Time frame: Baseline and every eight months during the two-year intervention phase
Population: Multiple records can be measured from the same participant at the same time period, so N can be greater than the unique number of participants except for the baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Person-Centered Care | Hope | Month 3: Every record 0< month <=3 | 6.5 Units on a scale | Standard Deviation 2.082 |
| Person-Centered Care | Hope | Month16: Every record 12< month <=16 | 6.166 Units on a scale | Standard Deviation 2.413 |
| Person-Centered Care | Hope | Month 8: Every record 6< month <=8 | 6.073 Units on a scale | Standard Deviation 2.471 |
| Person-Centered Care | Hope | Month 18: Every record 16< month <=18 | 6.583 Units on a scale | Standard Deviation 2.176 |
| Person-Centered Care | Hope | Month 6: Every record 3< month <=6 | 6.078 Units on a scale | Standard Deviation 2.483 |
| Person-Centered Care | Hope | Month 20: Every record 18< month <=20 | 6.225 Units on a scale | Standard Deviation 2.245 |
| Person-Centered Care | Hope | Month 12: Every record 8< month <=12 | 6.118 Units on a scale | Standard Deviation 2.409 |
| Person-Centered Care | Hope | Month 24: Every record 20< month | 6.374 Units on a scale | Standard Deviation 2.348 |
| Person-Centered Care | Hope | Baseline | 6.008 Units on a scale | Standard Deviation 2.469 |
| Measurement-Based Care | Hope | Month 24: Every record 20< month | 6.312 Units on a scale | Standard Deviation 2.196 |
| Measurement-Based Care | Hope | Baseline | 6.003 Units on a scale | Standard Deviation 2.413 |
| Measurement-Based Care | Hope | Month 3: Every record 0< month <=3 | 4 Units on a scale | Standard Deviation 1.732 |
| Measurement-Based Care | Hope | Month 6: Every record 3< month <=6 | 5.984 Units on a scale | Standard Deviation 2.303 |
| Measurement-Based Care | Hope | Month 8: Every record 6< month <=8 | 5.959 Units on a scale | Standard Deviation 2.439 |
| Measurement-Based Care | Hope | Month 12: Every record 8< month <=12 | 6.105 Units on a scale | Standard Deviation 2.338 |
| Measurement-Based Care | Hope | Month16: Every record 12< month <=16 | 6.164 Units on a scale | Standard Deviation 2.145 |
| Measurement-Based Care | Hope | Month 18: Every record 16< month <=18 | 6.185 Units on a scale | Standard Deviation 2.2 |
| Measurement-Based Care | Hope | Month 20: Every record 18< month <=20 | 6.092 Units on a scale | Standard Deviation 2.316 |
Comparison: Time-by-treatment interactionp-value: 0.4677Mixed Models Analysis
Comparison: Test for change over time from baseline (Marginal Effect of Time)p-value: 0.094Mixed Models Analysis
Secondary
Medication Side Effects
Medication side effects will be assessed using a single question: How much is the patient troubled by medication side effects? Responses are on a scale of 1 through 10 with 1=Not Bothered at all by side effects and 10=Very Bothered by side effects. Medication side effect scores for each time point reflect the mean score of all measures collected within that time frame.
Time frame: Baseline and every eight months during the two-year intervention phase
Population: Multiple records can be measured from the same participant at the same time period, so N can be greater than the unique number of participants except for the baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Person-Centered Care | Medication Side Effects | Month 18: Every record 16< month <=18 | 3.373 Units on a scale | Standard Deviation 2.674 |
| Person-Centered Care | Medication Side Effects | Baseline | 3.935 Units on a scale | Standard Deviation 2.759 |
| Person-Centered Care | Medication Side Effects | Month 3: Every record 0< month <=3 | 3.75 Units on a scale | Standard Deviation 2.217 |
| Person-Centered Care | Medication Side Effects | Month 6: Every record 3< month <=6 | 3.527 Units on a scale | Standard Deviation 2.469 |
| Person-Centered Care | Medication Side Effects | Month 8: Every record 6< month <=8 | 3.884 Units on a scale | Standard Deviation 2.726 |
| Person-Centered Care | Medication Side Effects | Month 12: Every record 8< month <=12 | 3.67 Units on a scale | Standard Deviation 2.763 |
| Person-Centered Care | Medication Side Effects | Month16: Every record 12< month <=16 | 3.728 Units on a scale | Standard Deviation 2.67 |
| Person-Centered Care | Medication Side Effects | Month 20: Every record 18< month <=20 | 3.751 Units on a scale | Standard Deviation 2.745 |
| Person-Centered Care | Medication Side Effects | Month 24: Every record 20< month | 3.531 Units on a scale | Standard Deviation 2.705 |
| Measurement-Based Care | Medication Side Effects | Month 24: Every record 20< month | 3.595 Units on a scale | Standard Deviation 2.602 |
| Measurement-Based Care | Medication Side Effects | Month 12: Every record 8< month <=12 | 3.687 Units on a scale | Standard Deviation 2.738 |
| Measurement-Based Care | Medication Side Effects | Baseline | 3.849 Units on a scale | Standard Deviation 2.746 |
| Measurement-Based Care | Medication Side Effects | Month 20: Every record 18< month <=20 | 3.72 Units on a scale | Standard Deviation 2.749 |
| Measurement-Based Care | Medication Side Effects | Month 3: Every record 0< month <=3 | 4.333 Units on a scale | Standard Deviation 3.215 |
| Measurement-Based Care | Medication Side Effects | Month16: Every record 12< month <=16 | 3.717 Units on a scale | Standard Deviation 2.609 |
| Measurement-Based Care | Medication Side Effects | Month 6: Every record 3< month <=6 | 3.878 Units on a scale | Standard Deviation 2.654 |
| Measurement-Based Care | Medication Side Effects | Month 18: Every record 16< month <=18 | 3.502 Units on a scale | Standard Deviation 2.604 |
| Measurement-Based Care | Medication Side Effects | Month 8: Every record 6< month <=8 | 3.858 Units on a scale | Standard Deviation 2.82 |
Comparison: Time-by-treatment interactionp-value: 0.8733Mixed Models Analysis
Comparison: Test for change over time from baseline (Marginal Effect of Time)p-value: 0.0113Mixed Models Analysis
Secondary
Patient Activation Measure (PAM)
PAM is a 13-item scale that assesses the knowledge, skills, and confidence of patients essential to managing their own health and health care. Response options are: Strongly Disagree, Disagree, Agree, and Strongly Agree. The activation scale for the PAM ranges from 0 to 100. The lower values represent a poor outcome while higher values represent a better outcome. Overall possible range was 0 to 91.6. PAM scores for each time point reflect the mean score of all measures collected within that time frame.
Time frame: Baseline and every eight months during the two-year intervention phase
Population: Multiple records can be measured from the same participant at the same time period, so N can be greater than the unique number of participants except for the baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Person-Centered Care | Patient Activation Measure (PAM) | Month 3: Every record 0< month <=3 | 47.75 Units on a scale | Standard Deviation 7.932 |
| Person-Centered Care | Patient Activation Measure (PAM) | Month 12: Every record 8< month <=12 | 63.205 Units on a scale | Standard Deviation 14.945 |
| Person-Centered Care | Patient Activation Measure (PAM) | Baseline | 62.707 Units on a scale | Standard Deviation 15.321 |
| Person-Centered Care | Patient Activation Measure (PAM) | Month16: Every record 12< month <=16 | 63.741 Units on a scale | Standard Deviation 14.852 |
| Person-Centered Care | Patient Activation Measure (PAM) | Month 6: Every record 3< month <=6 | 63.979 Units on a scale | Standard Deviation 15.814 |
| Person-Centered Care | Patient Activation Measure (PAM) | Month 18: Every record 16< month <=18 | 64.73 Units on a scale | Standard Deviation 14.668 |
| Person-Centered Care | Patient Activation Measure (PAM) | Month 20: Every record 18< month <=20 | 63.664 Units on a scale | Standard Deviation 14.593 |
| Person-Centered Care | Patient Activation Measure (PAM) | Month 24: Every record 20< month | 63.952 Units on a scale | Standard Deviation 14.887 |
| Person-Centered Care | Patient Activation Measure (PAM) | Month 8: Every record 6< month <=8 | 62.978 Units on a scale | Standard Deviation 14.82 |
| Measurement-Based Care | Patient Activation Measure (PAM) | Month 24: Every record 20< month | 63.895 Units on a scale | Standard Deviation 15.289 |
| Measurement-Based Care | Patient Activation Measure (PAM) | Baseline | 62.467 Units on a scale | Standard Deviation 15.635 |
| Measurement-Based Care | Patient Activation Measure (PAM) | Month 3: Every record 0< month <=3 | 60.467 Units on a scale | Standard Deviation 7.81 |
| Measurement-Based Care | Patient Activation Measure (PAM) | Month 6: Every record 3< month <=6 | 60.908 Units on a scale | Standard Deviation 14.959 |
| Measurement-Based Care | Patient Activation Measure (PAM) | Month 8: Every record 6< month <=8 | 62.826 Units on a scale | Standard Deviation 15.275 |
| Measurement-Based Care | Patient Activation Measure (PAM) | Month 12: Every record 8< month <=12 | 64.04 Units on a scale | Standard Deviation 16.678 |
| Measurement-Based Care | Patient Activation Measure (PAM) | Month16: Every record 12< month <=16 | 63.034 Units on a scale | Standard Deviation 15.478 |
| Measurement-Based Care | Patient Activation Measure (PAM) | Month 20: Every record 18< month <=20 | 63.642 Units on a scale | Standard Deviation 15.07 |
| Measurement-Based Care | Patient Activation Measure (PAM) | Month 18: Every record 16< month <=18 | 63.413 Units on a scale | Standard Deviation 14.389 |
Comparison: Time-by-treatment interactionp-value: 0.2328Mixed Models Analysis
Comparison: Test for change over time from baseline (Marginal Effect of Time)p-value: 0.0005Mixed Models Analysis
Secondary
Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (QLESQ-SF)
Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form is a 16-item, self-report questionnaire for assessing quality of life in multiple domains (e.g., physical health, mood, leisure time activities, social relationships, and overall). Response items are on a 5-point scale ranging from Very Poor to Very Good. The scoring of the Q-LES-Q-SF involves summing only the first 14 items to yield a raw total score. The last two items are not included in the total score but are standalone items. The raw total score ranges from 14 to 70. The raw total score was transformed into a percentage maximum possible score using the following formula. The lower values/percentages represent a poor outcome while higher values/percentages represent a better outcome. Overall possible range was 0-100. QLESQ-SF scores for each time point reflect the mean score of all measures collected within that time frame.
Time frame: Baseline and every eight months during the two-year intervention phase
Population: Multiple records can be measured from the same participant at the same time period, so N can be greater than the unique number of participants except for the baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Person-Centered Care | Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (QLESQ-SF) | Month 3: Every record 0< month <=3 | 52.38 Units on a scale | Standard Deviation 16.003 |
| Person-Centered Care | Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (QLESQ-SF) | Month16: Every record 12< month <=16 | 58.018 Units on a scale | Standard Deviation 20.553 |
| Person-Centered Care | Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (QLESQ-SF) | Month 8: Every record 6< month <=8 | 57.417 Units on a scale | Standard Deviation 20.472 |
| Person-Centered Care | Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (QLESQ-SF) | Month 18: Every record 16< month <=18 | 62.754 Units on a scale | Standard Deviation 20.621 |
| Person-Centered Care | Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (QLESQ-SF) | Month 6: Every record 3< month <=6 | 57.756 Units on a scale | Standard Deviation 21.417 |
| Person-Centered Care | Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (QLESQ-SF) | Month 20: Every record 18< month <=20 | 60.396 Units on a scale | Standard Deviation 20.464 |
| Person-Centered Care | Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (QLESQ-SF) | Month 12: Every record 8< month <=12 | 59.037 Units on a scale | Standard Deviation 21.651 |
| Person-Centered Care | Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (QLESQ-SF) | Month 24: Every record 20< month | 59.881 Units on a scale | Standard Deviation 20.056 |
| Person-Centered Care | Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (QLESQ-SF) | Baseline | 54.922 Units on a scale | Standard Deviation 21.316 |
| Measurement-Based Care | Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (QLESQ-SF) | Month 24: Every record 20< month | 56.666 Units on a scale | Standard Deviation 20.068 |
| Measurement-Based Care | Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (QLESQ-SF) | Baseline | 53.51 Units on a scale | Standard Deviation 20.758 |
| Measurement-Based Care | Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (QLESQ-SF) | Month 3: Every record 0< month <=3 | 37.5 Units on a scale | Standard Deviation 14.616 |
| Measurement-Based Care | Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (QLESQ-SF) | Month 6: Every record 3< month <=6 | 52.902 Units on a scale | Standard Deviation 21.231 |
| Measurement-Based Care | Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (QLESQ-SF) | Month 8: Every record 6< month <=8 | 53.271 Units on a scale | Standard Deviation 22.152 |
| Measurement-Based Care | Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (QLESQ-SF) | Month 12: Every record 8< month <=12 | 54.383 Units on a scale | Standard Deviation 20.661 |
| Measurement-Based Care | Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (QLESQ-SF) | Month16: Every record 12< month <=16 | 54.375 Units on a scale | Standard Deviation 20.337 |
| Measurement-Based Care | Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (QLESQ-SF) | Month 18: Every record 16< month <=18 | 54.31 Units on a scale | Standard Deviation 19.872 |
| Measurement-Based Care | Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (QLESQ-SF) | Month 20: Every record 18< month <=20 | 55.192 Units on a scale | Standard Deviation 20.609 |
Comparison: Time-by-treatment interactionp-value: 0.008Mixed Models Analysis
Secondary
Sheehan Disability Scale
The Sheehan Disability Scale measures the extent to which three major sectors in the person's life are impaired by psychiatric symptoms (work/school, social/leisure life, and family/home life). The 3 items are summed together to form a single measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired). Sheehan Disability Scale scores for each time point reflect the mean score of all measures collected within that time frame.
Time frame: Baseline and every eight months during the two-year intervention phase
Population: Multiple records can be measured from the same participant at the same time period, so N can be greater than the unique number of participants except for the baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Person-Centered Care | Sheehan Disability Scale | Month 3: Every record 0< month <=3 | 13.5 Units on a scale | Standard Deviation 8.347 |
| Person-Centered Care | Sheehan Disability Scale | Month16: Every record 12< month <=16 | 9.116 Units on a scale | Standard Deviation 8.005 |
| Person-Centered Care | Sheehan Disability Scale | Month 8: Every record 6< month <=8 | 10.385 Units on a scale | Standard Deviation 8.388 |
| Person-Centered Care | Sheehan Disability Scale | Month 18: Every record 16< month <=18 | 8.209 Units on a scale | Standard Deviation 7.957 |
| Person-Centered Care | Sheehan Disability Scale | Month 6: Every record 3< month <=6 | 9.536 Units on a scale | Standard Deviation 8.776 |
| Person-Centered Care | Sheehan Disability Scale | Month 20: Every record 18< month <=20 | 9.151 Units on a scale | Standard Deviation 8.175 |
| Person-Centered Care | Sheehan Disability Scale | Month 12: Every record 8< month <=12 | 9.142 Units on a scale | Standard Deviation 8.49 |
| Person-Centered Care | Sheehan Disability Scale | Month 24: Every record 20< month | 8.837 Units on a scale | Standard Deviation 7.767 |
| Person-Centered Care | Sheehan Disability Scale | Baseline | 10.514 Units on a scale | Standard Deviation 8.727 |
| Measurement-Based Care | Sheehan Disability Scale | Month 24: Every record 20< month | 9.716 Units on a scale | Standard Deviation 8.062 |
| Measurement-Based Care | Sheehan Disability Scale | Baseline | 10.826 Units on a scale | Standard Deviation 8.761 |
| Measurement-Based Care | Sheehan Disability Scale | Month 3: Every record 0< month <=3 | 19 Units on a scale | Standard Deviation 8.185 |
| Measurement-Based Care | Sheehan Disability Scale | Month 6: Every record 3< month <=6 | 10.737 Units on a scale | Standard Deviation 8.585 |
| Measurement-Based Care | Sheehan Disability Scale | Month 8: Every record 6< month <=8 | 11.467 Units on a scale | Standard Deviation 9.167 |
| Measurement-Based Care | Sheehan Disability Scale | Month 12: Every record 8< month <=12 | 11.278 Units on a scale | Standard Deviation 9.057 |
| Measurement-Based Care | Sheehan Disability Scale | Month16: Every record 12< month <=16 | 10.226 Units on a scale | Standard Deviation 8.537 |
| Measurement-Based Care | Sheehan Disability Scale | Month 18: Every record 16< month <=18 | 10.154 Units on a scale | Standard Deviation 8.59 |
| Measurement-Based Care | Sheehan Disability Scale | Month 20: Every record 18< month <=20 | 9.662 Units on a scale | Standard Deviation 7.858 |
Comparison: Time-by-treatment interactionp-value: 0.1649Mixed Models Analysis
Comparison: Test for change over time from baseline (Marginal Effect of Time)p-value: 0.0016Mixed Models Analysis