An interventional study of Care Manager CM) and ADHD Portal in Attention-Deficit/Hyperactivity Disorder, sponsored by Children's Hospital of Philadelphia. Completed at 1 site in United States. Open to participants aged 5 Years to 12 Years. Per ClinicalTrials.gov, last updated 2019-11-25.
Sponsored by Children's Hospital of Philadelphia · Not applicable, Interventional, and Treatment
The purpose of this study was to explore whether using an online patient portal plus a Care Manager is more effective than using an online portal alone in managing care for children with ADHD. Doctors at The Children's Hospital of Philadelphia currently use the online patient portal to help gather information from parents and teachers on ADHD symptoms, treatment, and medication side effects. The Care Manager is a person who meets with participants during the study to discuss their child's ADHD care. The Care Manager communicates with the child's doctor and teacher to communicate a parent's goals and preferences for their child's ADHD care.
Fragmentation in health care and poor communication across systems adversely impact engagement and adherence to treatment by children with ADHD and their families. Fragmentation of services for ADHD impairs communication and collaboration between families and primary care providers, mental health providers, and educators, and leads to suboptimal outcomes for children. Prior studies have documented that little communication and coordination exist among providers across different systems despite calls for better system integration.
Fragmentation in communication between providers has the potential to impair shared decision-making. To promote shared decision-making, we developed an electronic health record (EHR)-linked portal to collect information from parents, teachers and clinicians on children's ADHD symptoms and treatment-related preferences and goals. This has become standard of care at our institution. We also developed and pilot tested a ADHD Care Manager intervention which will be employed in this comparative effectiveness study.
303 participants were recruited from 11 primary care pediatric practices. Participants were randomly assigned to either the EHR portal alone, or the EHR portal plus a Care Manager. For those assigned to the EHR portal plus Care Manager, the Care Manager met with families at the beginning of the study to confirm their treatment preferences and goals, provide additional education on ADHD treatment, and distribute handouts on common concerns among ADHD patients and families. The Care Manager contacted families every 3 months or more frequently if needed by phone, email, or in-person to assess treatment use, identify new concerns, and assist families with problem-solving. The Care Manager also communicated with primary care clinicians, mental health providers, and teachers to clarify family treatment preferences and goals and address emerging treatment issues. Participants completed surveys that assessed ADHD symptoms, goal attainment, patient-reported outcomes, patient and family engagement, and treatment initiation and adherence.
729 studies on the registry are indexed under Hyperkinesis; 25 are open to participants now.
This study's enrollment of 303 is above the median of 80 across 583 interventional studies indexed under Hyperkinesis.
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Exclusion Criteria:
In this arm, the ADHD Portal was used alone as an electronic communication tool.The ADHD portal is considered standard of care at our institution for communicating information between clinicians, teachers, and parents.
Other: ADHD Portal
In this arm, the ADHD Portal was combined with the CM. Clinicians, teachers, and parents used the ADHD Portal as standard of care. In addition, clinicians, teachers, parents, and any external mental health providers interacted with a CM, who had access to information contained in the ADHD Portal.
Behavioral: Care Manager CM) · Other: ADHD Portal
The CM was an individual responsible for communicating and coordinating ADHD care. The CM established rapport with families and communicated with them every 3 months or more frequently if needed to assess treatment use, identify new concerns, and help problem-solve. The CM also communicated with the patient's ADHD care team (pediatrician, teacher, mental health providers) to clarify family goals, communicate information, and coordinate treatment.
The ADHD portal was a web-based platform that permits access to parts of the hospital's electronic health record. The portal permits (1) capture and sharing of patient and family treatment preferences and goals, (2) monitoring of ADHD symptoms, treatment receipt, and side effects, and (3) assessing goal attainment. The system prompts for completion of periodic check-in surveys (bi-weekly to 3 months) with parents and teachers. Within the portal, preferences and goals for ADHD treatment were measured using the ADHD Preference Goal Instrument (PGI) (Fiks et al., 2012). Parents were encouraged to consult with their children when completing the tool.
Change in Vanderbilt Parent Rating Scales (VPRS)
The VPRS is a public domain tool that consists of forms completed by the child's parent and includes 18 items corresponding to the DSM-5 ADHD symptom criteria, 8 performance items, and 12 items assessing side effects. The VPRS items are scaled on a 4-point Likert rating ("never" to "very often"), and the scales used in this study were restricted to the 18 ADHD symptom items. Total scores were used to measure ADHD Symptoms. Higher scores indicated worse outcome. VPRS were measured at baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4). The time range given for Visit 4 reflects the time range counted as a single value. The VPRS measures ADHD symptoms and is scaled on a 4-point Likert rating ("never" to "very often"). The scale includes 18 ADHD symptom items with total scores ranges from 0-54.
Time frame: Baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4)
Mean Goal Attainment Scale (GAS) Score by Timepoint
The GAS is a 5-point likert scale that assesses the degree to which parents' goals (obtained from the ADHD Preferences and Goals Instrument) are attained from none to completely. The GAS response categories are ordered from 0 ("no change") to 6 ("goal completely met"). Higher scores indicate greater goal attainment. The GAS was measured at baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4). The time range given for Visit 4 reflects the time range counted as a single value.
Time frame: Baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4)
Treatment Initiation and Use of Services
Using responses from the Services Assessment for Children and Adolescents (SACA), a well-validated client-reported tool and provides information on any mental health services use, ambulatory services use, and inpatient service use, we determined (yes/no) whether participants ever received educational services, mental health services, or medications for ADHD. Parents reported whether their children used services ever or within the last nine months. Treatment initiation was measured by use of services ever. Categorizations include any service use, ambulatory service use (any community mental health or outpatient clinic, private professional, or in-home provider), and overnight stay (psychiatric or medical unit, residential treatment center, group home, or foster home). The time range of 9-12 given for Visit 4 reflects the time range counted as a single value.
Time frame: 9-12 months (Visit 4)
Treatment Adherence and Use of Services
Using responses from the Services Assessment for Children and Adolescents (SACA), a well-validated client-reported tool and provides information on any mental health services use, ambulatory services use, and inpatient service use, we determined (yes/no) whether participants ever received educational services, mental health services, or medications for ADHD. Parents reported whether their children used services ever or within the last nine months. Treatment adherence was measured by use of services in the past nine months. Categorizations include any service use, ambulatory service use (any community mental health or outpatient clinic, private professional, or in-home provider), and overnight stay (psychiatric or medical unit, residential treatment center, group home, or foster home). The time range of 9-12 given for Visit 4 reflects the time range counted as a single value.
Time frame: 9-12 months (Visit 4)
School Performance
School Performance is a 5-item domain (minimum score=1, maximum score=5 on a 5 point Likert scale) of the of 30-item Child- (age 8-12) and 17-item Parent Patient Reported Outcomes Scores (PROS). The minimum total score for the School Performance domain is 5 and the maximum total score is 25 (total scores are not shown below). Values in the table below are reported as mean scores at each time point and therefore fall between the minimum score of 1 and maximum score of 5. Higher scores indicate better outcomes. Parent-reported PRO and child-reported PRO measures were averaged for each domain for each time point. School performance PRO scores were measured at baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4). The time range given for Visit 4 reflects the time range counted as a single value.
Time frame: Baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4)
Student Engagement
Student Engagement is a 4-item domain (minimum score=1, maximum score=5 on a 5 point Likert scale) of the of 30-item Child- (age 8-12) and 17-item Parent Patient Reported Outcomes Scores (PROS). The minimum total score for the Student Engagement domain is 4 and the maximum total score is 20 (total scores are not shown below). Values in the table below are reported as means at each time point and therefore fall between the minimum score of 1 and maximum score of 5. Higher scores indicate better outcomes. Parent-reported PRO and child-reported PRO measures were averaged for each domain for each time point. Student Engagement PRO scores were measured at baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4). The time range given for Visit 4 reflects the time range counted as a single value.
Time frame: Baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4)
Teacher Connectedness
Teacher Connectedness is a 9-item domain (minimum=1, maximum=5 on a 5 point Likert scale) of the of 30-item Child- (age 8-12) and 17-item Parent Patient Reported Outcomes Scores (PROS). The minimum total score for the Teacher Connectedness domain is 9 and the maximum total score is 45 (total scores not shown below). Values in the table below are reported as means at each time point and therefore fall between the minimum score of 1 and maximum score of 5. Higher scores indicate better outcomes. Parent-reported PRO and child-reported PRO measures were averaged for each domain for each time point. Teacher Connectedness PRO scores were measured at baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4). The time range given for Visit 4 reflects the time range counted as a single value.
Time frame: Baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4)
Peer Relationships
Peer Relationships is a 6-item domain (minimum=1, maximum=5, on a 5 point Likert scale) of the of 30-item Child- (age 8-12) and a 7-item domain (minimum=1, maximum=5 on a 5 point Likert scale) of the 17-item Parent Patient Reported Outcomes Scores (PROS). The minimum total score is 6 and the maximum total score is 30 on the Child PROs. The minimum total score for the Peer Relationships domain is 7 and the maximum total score is 35 on the Parent PROs. Total scores not shown below. Values in the table below are reported as means at each time point and therefore fall between the minimum score of 1 and maximum score of 5. Parent-reported PRO and child-reported PRO measures were averaged for each domain for each time point. Higher scores indicate better outcomes. Peer Relationships PRO scores were measured at baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4). The time range given for Visit 4 reflects the time range counted as a single value.
Time frame: Baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4)
Family Relationships
Family Relationships is a 6-item domain (minimum=1, maximum=5 on a 5 point Likert scale) of the 30-item Child- (age 8-12) Patient Reported Outcomes Measures of relationships with other family members over the past 4 weeks. The minimum total score for the Family Relationships domain is 6 and the maximum total score is 30 (total scores not shown below). Values in the table below are reported as means at each time point and therefore fall between the minimum score of 1 and maximum score of 5. Child-reported PRO measures were averaged for each domain for each time point. Higher scores indicate better outcomes. Family Relationships PRO scores were measured at baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4). The time range given for Visit 4 reflects the time range counted as a single value.
Time frame: Baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4)
Engagement Measure Scores
The Engagement Measure is a 28-item parent self-report measure comprised of four domains: Access (5-items, total score range 5-25), Patient Family Centered Care or PFCC (6-items, total score range 6-30), Communication (3-items, total score range 3-15), and Understanding (5-items, total score range 5-25). Total scores are not reported below. Scores for each individual item and therefore the mean for each domain (means reported in the table below) ranged from 1-5 with higher scores indicating greater engagement. The time range given for Visit 4 reflects the time range counted as a single value.
Time frame: Visit 4 (9-12 months)
From 3/2016-7/2017, primary care clinicians at participating pediatric practices nominated eligible patients for recruitment. Eligible patients were contacted by phone and then underwent in-person informed consent. Participants were stratified by practice, age group (5-7 or 8-12 years old), and sex and randomized 1:1 to the two study arms.
| Milestone | ADHD Portal | ADHD Portal Plus Care Manager |
|---|---|---|
| Started | 149 | 154 |
| Completed | 130 | 143 |
| Not completed | 19 | 11 |
The VPRS is a public domain tool that consists of forms completed by the child's parent and includes 18 items corresponding to the DSM-5 ADHD symptom criteria, 8 performance items, and 12 items assessing side effects. The VPRS items are scaled on a 4-point Likert rating ("never" to "very often"), and the scales used in this study were restricted to the 18 ADHD symptom items. Total scores were used to measure ADHD Symptoms. Higher scores indicated worse outcome. VPRS were measured at baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4). The time range given for Visit 4 reflects the time range counted as a single value. The VPRS measures ADHD symptoms and is scaled on a 4-point Likert rating ("never" to "very often"). The scale includes 18 ADHD symptom items with total scores ranges from 0-54.
| score on a scale | ADHD Portal | ADHD Portal Plus Care Manager |
|---|---|---|
| Visit 1 | 32.6 ± 11.8 | 31.3 ± 10.8 |
| Visit 2 | 28.7 ± 12.2 | 29.0 ± 11.4 |
| Visit 3 | 28.1 ± 12.1 | 26.3 ± 11.6 |
| Visit 4 | 27.2 ± 12.1 | 25.7 ± 11.1 |
The GAS is a 5-point likert scale that assesses the degree to which parents' goals (obtained from the ADHD Preferences and Goals Instrument) are attained from none to completely. The GAS response categories are ordered from 0 ("no change") to 6 ("goal completely met"). Higher scores indicate greater goal attainment. The GAS was measured at baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4). The time range given for Visit 4 reflects the time range counted as a single value.
| Units on a scale | ADHD Portal | ADHD Portal Plus Care Manager |
|---|---|---|
| Visit 2 | 2.92 ± 1.82 | 2.67 ± 1.68 |
| Visit 3 | 2.93 ± 1.89 | 3.01 ± 1.68 |
| Visit 4 | 3.03 ± 1.66 | 2.86 ± 1.75 |
Using responses from the Services Assessment for Children and Adolescents (SACA), a well-validated client-reported tool and provides information on any mental health services use, ambulatory services use, and inpatient service use, we determined (yes/no) whether participants ever received educational services, mental health services, or medications for ADHD. Parents reported whether their children used services ever or within the last nine months. Treatment initiation was measured by use of services ever. Categorizations include any service use, ambulatory service use (any community mental health or outpatient clinic, private professional, or in-home provider), and overnight stay (psychiatric or medical unit, residential treatment center, group home, or foster home). The time range of 9-12 given for Visit 4 reflects the time range counted as a single value.
| Participants | ADHD Portal | ADHD Portal Plus Care Manager |
|---|---|---|
| Use of any services (Ever) : Yes — Yes | 79 | 88 |
| Use of any services (Ever) : Yes — No | 40 | 49 |
| Use of ambulatory services (Ever) : Yes — Yes | 77 | 87 |
| Use of ambulatory services (Ever) : Yes — No | 42 | 49 |
| Overnight Stay for Services (Ever) : Yes — Yes | 5 | 6 |
| Overnight Stay for Services (Ever) : Yes — No | 92 | 118 |
Using responses from the Services Assessment for Children and Adolescents (SACA), a well-validated client-reported tool and provides information on any mental health services use, ambulatory services use, and inpatient service use, we determined (yes/no) whether participants ever received educational services, mental health services, or medications for ADHD. Parents reported whether their children used services ever or within the last nine months. Treatment adherence was measured by use of services in the past nine months. Categorizations include any service use, ambulatory service use (any community mental health or outpatient clinic, private professional, or in-home provider), and overnight stay (psychiatric or medical unit, residential treatment center, group home, or foster home). The time range of 9-12 given for Visit 4 reflects the time range counted as a single value.
| Participants | ADHD Portal | ADHD Portal Plus Care Manager |
|---|---|---|
| Use of any service (Past 9 months) — Yes | 48 | 51 |
| Use of any service (Past 9 months) — No | 19 | 29 |
| Use of ambulatory services (Past 9 months) — Yes | 47 | 50 |
| Use of ambulatory services (Past 9 months) — No | 18 | 29 |
| Overnight Stay for Services (Ever) — Yes | 1 | 2 |
| Overnight Stay for Services (Ever) — No | 3 | 4 |
School Performance is a 5-item domain (minimum score=1, maximum score=5 on a 5 point Likert scale) of the of 30-item Child- (age 8-12) and 17-item Parent Patient Reported Outcomes Scores (PROS). The minimum total score for the School Performance domain is 5 and the maximum total score is 25 (total scores are not shown below). Values in the table below are reported as mean scores at each time point and therefore fall between the minimum score of 1 and maximum score of 5. Higher scores indicate better outcomes. Parent-reported PRO and child-reported PRO measures were averaged for each domain for each time point. School performance PRO scores were measured at baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4). The time range given for Visit 4 reflects the time range counted as a single value.
| Score on a scale | ADHD Portal | ADHD Portal Plus Care Manager |
|---|---|---|
| Parent PROS : Visit 1 | 2.82 ± 1.00 | 2.77 ± 0.80 |
| Parent PROS : Visit 2 | 3.00 ± 1.01 | 2.91 ± 0.80 |
| Parent PROS : Visit 3 | 3.03 ± 0.89 | 3.04 ± 0.92 |
| Parent PROS : Visit 4 | 3.08 ± 0.96 | 3.03 ± 0.90 |
| Child PROS : Visit 1 | 3.53 ± 0.77 | 3.42 ± 0.79 |
| Child PROS : Visit 2 | 3.22 ± 0.93 | 3.30 ± 0.81 |
| Child PROS : Visit 3 | 3.29 ± 0.85 | 3.27 ± 0.77 |
| Child PROS : Visit 4 | 3.23 ± 0.83 | 3.41 ± 0.86 |
Student Engagement is a 4-item domain (minimum score=1, maximum score=5 on a 5 point Likert scale) of the of 30-item Child- (age 8-12) and 17-item Parent Patient Reported Outcomes Scores (PROS). The minimum total score for the Student Engagement domain is 4 and the maximum total score is 20 (total scores are not shown below). Values in the table below are reported as means at each time point and therefore fall between the minimum score of 1 and maximum score of 5. Higher scores indicate better outcomes. Parent-reported PRO and child-reported PRO measures were averaged for each domain for each time point. Student Engagement PRO scores were measured at baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4). The time range given for Visit 4 reflects the time range counted as a single value.
| Score on a scale | ADHD Portal | ADHD Portal Plus Care Manager |
|---|---|---|
| Parent PROS : Visit 1 | 2.98 ± 0.79 | 2.93 ± 0.80 |
| Parent PROS : Visit 2 | 3.18 ± 0.85 | 3.08 ± 0.80 |
| Parent PROS : Visit 3 | 3.18 ± 0.78 | 3.09 ± 0.70 |
| Parent PROS : Visit 4 | 3.24 ± 0.82 | 3.13 ± 0.80 |
| Child PROS : Visit 1 | 3.11 ± 0.82 | 3.04 ± 0.80 |
| Child PROS : Visit 2 | 3.09 ± 0.09 | 3.06 ± 0.73 |
| Child PROS : Visit 3 | 3.15 ± 0.94 | 3.01 ± 0.78 |
| Child PROS : Visit 4 | 3.08 ± 0.83 | 2.95 ± 0.79 |
Teacher Connectedness is a 9-item domain (minimum=1, maximum=5 on a 5 point Likert scale) of the of 30-item Child- (age 8-12) and 17-item Parent Patient Reported Outcomes Scores (PROS). The minimum total score for the Teacher Connectedness domain is 9 and the maximum total score is 45 (total scores not shown below). Values in the table below are reported as means at each time point and therefore fall between the minimum score of 1 and maximum score of 5. Higher scores indicate better outcomes. Parent-reported PRO and child-reported PRO measures were averaged for each domain for each time point. Teacher Connectedness PRO scores were measured at baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4). The time range given for Visit 4 reflects the time range counted as a single value.
| Score on a scale | ADHD Portal | ADHD Portal Plus Care Manager |
|---|---|---|
| Child PROS : Visit 1 | 3.81 ± 0.80 | 3.75 ± 0.76 |
| Child PROS : Visit 2 | 3.85 ± 0.76 | 3.82 ± 0.77 |
| Child PROS : Visit 3 | 3.86 ± 0.86 | 3.77 ± 0.83 |
| Child PROS : Visit 4 | 3.75 ± 0.87 | 3.72 ± 0.84 |
Peer Relationships is a 6-item domain (minimum=1, maximum=5, on a 5 point Likert scale) of the of 30-item Child- (age 8-12) and a 7-item domain (minimum=1, maximum=5 on a 5 point Likert scale) of the 17-item Parent Patient Reported Outcomes Scores (PROS). The minimum total score is 6 and the maximum total score is 30 on the Child PROs. The minimum total score for the Peer Relationships domain is 7 and the maximum total score is 35 on the Parent PROs. Total scores not shown below. Values in the table below are reported as means at each time point and therefore fall between the minimum score of 1 and maximum score of 5. Parent-reported PRO and child-reported PRO measures were averaged for each domain for each time point. Higher scores indicate better outcomes. Peer Relationships PRO scores were measured at baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4). The time range given for Visit 4 reflects the time range counted as a single value.
| Score on a scale | ADHD Portal | ADHD Portal Plus Care Manager |
|---|---|---|
| Parent PROS : Visit 1 | 3.56 ± 0.82 | 3.54 ± 0.74 |
| Parent PROS : Visit 2 | 3.63 ± 0.75 | 3.56 ± 0.75 |
| Parent PROS : Visit 3 | 3.61 ± 0.79 | 3.63 ± 0.74 |
| Parent PROS : Visit 4 | 3.72 ± 0.80 | 3.66 ± 0.72 |
| Child PROS : Visit 1 | 4.03 ± 0.74 | 4.07 ± 0.71 |
| Child PROS : Visit 2 | 3.79 ± 0.75 | 3.93 ± 0.84 |
| Child PROS : Visit 3 | 3.84 ± 0.74 | 3.99 ± 0.72 |
| Child PROS : Visit 4 | 3.91 ± 0.83 | 3.94 ± 0.79 |
Family Relationships is a 6-item domain (minimum=1, maximum=5 on a 5 point Likert scale) of the 30-item Child- (age 8-12) Patient Reported Outcomes Measures of relationships with other family members over the past 4 weeks. The minimum total score for the Family Relationships domain is 6 and the maximum total score is 30 (total scores not shown below). Values in the table below are reported as means at each time point and therefore fall between the minimum score of 1 and maximum score of 5. Child-reported PRO measures were averaged for each domain for each time point. Higher scores indicate better outcomes. Family Relationships PRO scores were measured at baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4). The time range given for Visit 4 reflects the time range counted as a single value.
| Score on a scale | ADHD Portal | ADHD Portal Plus Care Manager |
|---|---|---|
| Child PROS : Visit 1 | 3.81 ± 0.77 | 3.82 ± 0.68 |
| Child PROS : Visit 2 | 3.83 ± 0.69 | 3.80 ± 0.65 |
| Child PROS : Visit 3 | 3.96 ± 0.67 | 3.72 ± 0.72 |
| Child PROS : Visit 4 | 3.81 ± 0.77 | 3.79 ± 076 |
The Engagement Measure is a 28-item parent self-report measure comprised of four domains: Access (5-items, total score range 5-25), Patient Family Centered Care or PFCC (6-items, total score range 6-30), Communication (3-items, total score range 3-15), and Understanding (5-items, total score range 5-25). Total scores are not reported below. Scores for each individual item and therefore the mean for each domain (means reported in the table below) ranged from 1-5 with higher scores indicating greater engagement. The time range given for Visit 4 reflects the time range counted as a single value.
| Score on a scale | ADHD Portal | ADHD Portal Plus Care Manager |
|---|---|---|
| Access | 3.43 ± 0.7 | 3.52 ± 0.6 |
| PFCC | 3.45 ± 0.7 | 3.44 ± 0.7 |
| Communication | 2.50 ± 1.1 | 2.64 ± 1.0 |
| Understanding | 2.89 ± 0.8 | 3.02 ± 0.8 |
Collected over 9-12 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ADHD Portal | 0/149 (0%) | 0/149 (0%) | 0/149 (0%) |
| ADHD Portal Plus Care Manager | 0/154 (0%) | 0/154 (0%) | 0/154 (0%) |
| Age, Categorical(Participants) | ADHD Portal | ADHD Portal Plus Care Manager | Total |
|---|---|---|---|
| <=18 years | 149 | 154 | 303 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | ADHD Portal | ADHD Portal Plus Care Manager | Total |
|---|---|---|---|
| Female | 47 | 47 | 94 |
| Male | 102 | 106 | 208 |
| Race/Ethnicity, Customized(Participants) | ADHD Portal | ADHD Portal Plus Care Manager | Total |
|---|---|---|---|
| Race/Ethnicity — White | 58 | 62 | 120 |
| Race/Ethnicity — Black/African American | 69 | 70 | 139 |
| Race/Ethnicity — Hispanic | 7 | 8 | 15 |
| Race/Ethnicity — Other | 15 | 13 | 28 |
| Region of Enrollment(participants) | ADHD Portal | ADHD Portal Plus Care Manager | Total |
|---|---|---|---|
| United States | 149 | 154 | 303 |
| Baseline Vanderbilt Parent Rating Scale Scores(Vanderbilt Parent Rating Scale Score) | ADHD Portal | ADHD Portal Plus Care Manager | Total |
|---|---|---|---|
| Mean | 32.6 ± 11.8 | 31.3 ± 10.8 | 31.9 ± 11.3 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — A complete, cleaned, and de-identified dataset will be made available to the Patient-Centered Outcomes Research Institute (PCORI) and other investigators after all analyses have been conducted and within nine months of the end of the final year of funding. To obtain this data set, other investigators may contact the study PI who will provide a data sharing agreement. The data sharing agreement will permit the data set to be shared once an Institutional Review Board (IRB) protocol has been approved at the investigators' home institution and the investigators have signed a pledge to not attempt to identify individual study subjects. The data set will be made available electronically or via a secure file transfer protocol (FTP) site.
Supporting information: Study protocol
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