Trial Outcomes & Findings for Health System Integration of Tools to Improve Primary Care for Autistic Adults (NCT NCT03234608)
NCT ID: NCT03234608
Last Updated: 2021-11-03
Results Overview
Barriers to Healthcare Checklist-Short Form: The instrument is scored as a count of the total number of barriers endorsed from a checklist of 16 items. Scores can range from 0 to 16. The score depicts the number of barriers to healthcare the participants reports. A higher number of barriers is a worse outcome. Change in barriers to healthcare is calculated by subtracting the baseline score from the 6 month score. Negative scores depict an improvement (i.e. participant is reporting fewer barriers 6 months after the intervention than they did at baseline).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
244 participants
Primary outcome timeframe
Baseline and 6 months
Results posted on
2021-11-03
Participant Flow
Participant milestones
| Measure |
AASPIRE Healthcare Toolkit
Patients will use the Academic Autism Spectrum Partnership in Research and Education (AASPIRE) Healthcare Toolkit and will share a copy of their Autism Healthcare Accommodations Tool (AHAT) Report with their primary care provider.
AASPIRE Healthcare Toolkit: The AASPIRE Healthcare Toolkit includes a variety of resources (information, worksheets, checklists, links) for patients and providers. The centerpiece of the toolkit is the Autism Healthcare Accommodations Tool, which allows a patient or their supporter to create a personalized accommodations report for the patient's provider. Intervention patients will use the toolkit and create an AHAT report. Intervention clinics will receive a copy of each patient's AHAT report, place it in the medical record, and share it with the patient's Primary Care Provider (PCP) and other staff.
|
Usual Care
Patients will receive usual care.
|
|---|---|---|
|
Overall Study
STARTED
|
127
|
117
|
|
Overall Study
COMPLETED
|
104
|
96
|
|
Overall Study
NOT COMPLETED
|
23
|
21
|
Reasons for withdrawal
| Measure |
AASPIRE Healthcare Toolkit
Patients will use the Academic Autism Spectrum Partnership in Research and Education (AASPIRE) Healthcare Toolkit and will share a copy of their Autism Healthcare Accommodations Tool (AHAT) Report with their primary care provider.
AASPIRE Healthcare Toolkit: The AASPIRE Healthcare Toolkit includes a variety of resources (information, worksheets, checklists, links) for patients and providers. The centerpiece of the toolkit is the Autism Healthcare Accommodations Tool, which allows a patient or their supporter to create a personalized accommodations report for the patient's provider. Intervention patients will use the toolkit and create an AHAT report. Intervention clinics will receive a copy of each patient's AHAT report, place it in the medical record, and share it with the patient's Primary Care Provider (PCP) and other staff.
|
Usual Care
Patients will receive usual care.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
23
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21
|
Baseline Characteristics
Participants with complete data
Baseline characteristics by cohort
| Measure |
AASPIRE Healthcare Toolkit
n=127 Participants
Patients will use the AASPIRE Healthcare Toolkit and will share a copy of their Autism Healthcare Accommodations Report with their primary care provider.
AASPIRE Healthcare Toolkit: The AASPIRE Healthcare Toolkit includes a variety of resources (information, worksheets, checklists, links) for patients and providers. The centerpiece of the toolkit is the Autism Healthcare Accommodations Tool, which allows a patient or their supporter to create a personalized accommodations report for the patient's provider. Intervention patients will use the toolkit and create an AHAT report. Intervention clinics will receive a copy of each patient's AHAT report, place it in the medical record, and share it with the patient's PCP and other staff.
|
Usual Care
n=117 Participants
Patients will receive usual care.
|
Total
n=244 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31.32 years
STANDARD_DEVIATION 12.86 • n=127 Participants
|
29.03 years
STANDARD_DEVIATION 10.94 • n=117 Participants
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30.22 years
STANDARD_DEVIATION 12.01 • n=244 Participants
|
|
Sex/Gender, Customized
Gender · Male
|
82 Participants
n=125 Participants • Participants with complete data
|
86 Participants
n=116 Participants • Participants with complete data
|
168 Participants
n=241 Participants • Participants with complete data
|
|
Sex/Gender, Customized
Gender · Female
|
39 Participants
n=125 Participants • Participants with complete data
|
29 Participants
n=116 Participants • Participants with complete data
|
68 Participants
n=241 Participants • Participants with complete data
|
|
Sex/Gender, Customized
Gender · Other
|
4 Participants
n=125 Participants • Participants with complete data
|
1 Participants
n=116 Participants • Participants with complete data
|
5 Participants
n=241 Participants • Participants with complete data
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
80 Participants
n=124 Participants • Participants with complete data
|
67 Participants
n=115 Participants • Participants with complete data
|
147 Participants
n=239 Participants • Participants with complete data
|
|
Race/Ethnicity, Customized
Non-Hispanic Black / African-American
|
7 Participants
n=124 Participants • Participants with complete data
|
17 Participants
n=115 Participants • Participants with complete data
|
24 Participants
n=239 Participants • Participants with complete data
|
|
Race/Ethnicity, Customized
Non-Hispanic Asian / Pacific Islander
|
8 Participants
n=124 Participants • Participants with complete data
|
10 Participants
n=115 Participants • Participants with complete data
|
18 Participants
n=239 Participants • Participants with complete data
|
|
Race/Ethnicity, Customized
Non-Hispanic Multi-Racial
|
14 Participants
n=124 Participants • Participants with complete data
|
8 Participants
n=115 Participants • Participants with complete data
|
22 Participants
n=239 Participants • Participants with complete data
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
15 Participants
n=124 Participants • Participants with complete data
|
13 Participants
n=115 Participants • Participants with complete data
|
28 Participants
n=239 Participants • Participants with complete data
|
|
Region of Enrollment
United States
|
127 participants
n=127 Participants
|
117 participants
n=117 Participants
|
244 participants
n=244 Participants
|
|
Participant Residence
Place they own or rent
|
47 Participants
n=124 Participants • Participants with complete data
|
27 Participants
n=115 Participants • Participants with complete data
|
74 Participants
n=239 Participants • Participants with complete data
|
|
Participant Residence
With family
|
74 Participants
n=124 Participants • Participants with complete data
|
87 Participants
n=115 Participants • Participants with complete data
|
161 Participants
n=239 Participants • Participants with complete data
|
|
Participant Residence
Group home/Foster home
|
0 Participants
n=124 Participants • Participants with complete data
|
0 Participants
n=115 Participants • Participants with complete data
|
0 Participants
n=239 Participants • Participants with complete data
|
|
Participant Residence
Other
|
3 Participants
n=124 Participants • Participants with complete data
|
1 Participants
n=115 Participants • Participants with complete data
|
4 Participants
n=239 Participants • Participants with complete data
|
|
Participant need assistance from someone for medical care
Always or often
|
45 Participants
n=114 Participants • Participants with complete data
|
41 Participants
n=107 Participants • Participants with complete data
|
86 Participants
n=221 Participants • Participants with complete data
|
|
Participant need assistance from someone for medical care
Sometimes
|
31 Participants
n=114 Participants • Participants with complete data
|
21 Participants
n=107 Participants • Participants with complete data
|
52 Participants
n=221 Participants • Participants with complete data
|
|
Participant need assistance from someone for medical care
Rarely or never
|
38 Participants
n=114 Participants • Participants with complete data
|
45 Participants
n=107 Participants • Participants with complete data
|
83 Participants
n=221 Participants • Participants with complete data
|
|
Participant help with communication
Communicate with providers by themselves
|
57 Participants
n=123 Participants • Participants with complete data
|
47 Participants
n=115 Participants • Participants with complete data
|
104 Participants
n=238 Participants • Participants with complete data
|
|
Participant help with communication
Someone helps them some of the time
|
45 Participants
n=123 Participants • Participants with complete data
|
33 Participants
n=115 Participants • Participants with complete data
|
78 Participants
n=238 Participants • Participants with complete data
|
|
Participant help with communication
Someone does most or all of the communication
|
21 Participants
n=123 Participants • Participants with complete data
|
35 Participants
n=115 Participants • Participants with complete data
|
56 Participants
n=238 Participants • Participants with complete data
|
|
Participant overall health
Poor
|
6 Participants
n=124 Participants • Participants with complete data
|
4 Participants
n=115 Participants • Participants with complete data
|
10 Participants
n=239 Participants • Participants with complete data
|
|
Participant overall health
Fair
|
19 Participants
n=124 Participants • Participants with complete data
|
19 Participants
n=115 Participants • Participants with complete data
|
38 Participants
n=239 Participants • Participants with complete data
|
|
Participant overall health
Good
|
40 Participants
n=124 Participants • Participants with complete data
|
38 Participants
n=115 Participants • Participants with complete data
|
78 Participants
n=239 Participants • Participants with complete data
|
|
Participant overall health
Very good
|
37 Participants
n=124 Participants • Participants with complete data
|
41 Participants
n=115 Participants • Participants with complete data
|
78 Participants
n=239 Participants • Participants with complete data
|
|
Participant overall health
Excellent
|
22 Participants
n=124 Participants • Participants with complete data
|
13 Participants
n=115 Participants • Participants with complete data
|
35 Participants
n=239 Participants • Participants with complete data
|
|
Patient-Provider Communication Scale (PPCS-8)
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32.76 units on a scale
STANDARD_DEVIATION 5.71 • n=124 Participants • Participants with complete data
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33.14 units on a scale
STANDARD_DEVIATION 5.83 • n=111 Participants • Participants with complete data
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32.94 units on a scale
STANDARD_DEVIATION 5.76 • n=235 Participants • Participants with complete data
|
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The AASPIRE Visit Preparedness Scale (VPS-6)
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23.80 units on a scale
STANDARD_DEVIATION 3.76 • n=121 Participants • Participants with complete data
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23.90 units on a scale
STANDARD_DEVIATION 4.13 • n=112 Participants • Participants with complete data
|
23.85 units on a scale
STANDARD_DEVIATION 3.93 • n=233 Participants • Participants with complete data
|
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Barriers to Healthcare Checklist-Short Form
|
2.63 units on a scale
STANDARD_DEVIATION 3.08 • n=123 Participants • Participants with complete data
|
2.19 units on a scale
STANDARD_DEVIATION 2.34 • n=116 Participants • Participants with complete data
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2.42 units on a scale
STANDARD_DEVIATION 2.75 • n=239 Participants • Participants with complete data
|
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Healthcare Accommodations Scale(HAS-8)
|
28.88 units on a scale
STANDARD_DEVIATION 6.00 • n=118 Participants • Participants with complete data
|
29.84 units on a scale
STANDARD_DEVIATION 6.27 • n=107 Participants • Participants with complete data
|
29.34 units on a scale
STANDARD_DEVIATION 6.14 • n=225 Participants • Participants with complete data
|
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Individual Level Healthcare Self Efficacy Sub-scale
|
7.51 units on a scale
STANDARD_DEVIATION 1.67 • n=126 Participants • Participants with complete data
|
7.72 units on a scale
STANDARD_DEVIATION 1.52 • n=113 Participants • Participants with complete data
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7.61 units on a scale
STANDARD_DEVIATION 1.60 • n=239 Participants • Participants with complete data
|
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Relationship-Dependent Healthcare Self-Efficacy Sub-scale
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7.26 units on a scale
STANDARD_DEVIATION 1.89 • n=126 Participants • Participants with complete data
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7.49 units on a scale
STANDARD_DEVIATION 1.82 • n=113 Participants • Participants with complete data
|
7.37 units on a scale
STANDARD_DEVIATION 1.86 • n=239 Participants • Participants with complete data
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PRIMARY outcome
Timeframe: Baseline and 6 monthsPopulation: Participants with complete data
Barriers to Healthcare Checklist-Short Form: The instrument is scored as a count of the total number of barriers endorsed from a checklist of 16 items. Scores can range from 0 to 16. The score depicts the number of barriers to healthcare the participants reports. A higher number of barriers is a worse outcome. Change in barriers to healthcare is calculated by subtracting the baseline score from the 6 month score. Negative scores depict an improvement (i.e. participant is reporting fewer barriers 6 months after the intervention than they did at baseline).
Outcome measures
| Measure |
AASPIRE Healthcare Toolkit
n=102 Participants
Patients will use the AASPIRE Healthcare Toolkit and will share a copy of their Autism Healthcare Accommodations Report with their primary care provider.
AASPIRE Healthcare Toolkit: The AASPIRE Healthcare Toolkit includes a variety of resources (information, worksheets, checklists, links) for patients and providers. The centerpiece of the toolkit is the Autism Healthcare Accommodations Tool, which allows a patient or their supporter to create a personalized accommodations report for the patient's provider. Intervention patients will use the toolkit and create an AHAT report. Intervention clinics will receive a copy of each patient's AHAT report, place it in the medical record, and share it with the patient's PCP and other staff.
|
Usual Care
n=91 Participants
Patients will receive usual care.
|
|---|---|---|
|
Change in Barriers to Healthcare
|
-0.44 units on a scale
Standard Deviation 1.92
|
-0.42 units on a scale
Standard Deviation 2.07
|
PRIMARY outcome
Timeframe: Baseline and 6 monthsPopulation: Participants with complete data
AASPIRE Patient-Provider Communication Scale (PPCS-8): This scale is scored by summing responses the 8 items. Scores range from 8 to 40, with higher scores indicating higher satisfaction with patient-provider communication. Change in patient-provider communication is calculated by subtracting the score at baseline from the score at 6 months. Positive scores indicate an improved outcome (i.e. better patient-provider communication post-intervention than before).
Outcome measures
| Measure |
AASPIRE Healthcare Toolkit
n=99 Participants
Patients will use the AASPIRE Healthcare Toolkit and will share a copy of their Autism Healthcare Accommodations Report with their primary care provider.
AASPIRE Healthcare Toolkit: The AASPIRE Healthcare Toolkit includes a variety of resources (information, worksheets, checklists, links) for patients and providers. The centerpiece of the toolkit is the Autism Healthcare Accommodations Tool, which allows a patient or their supporter to create a personalized accommodations report for the patient's provider. Intervention patients will use the toolkit and create an AHAT report. Intervention clinics will receive a copy of each patient's AHAT report, place it in the medical record, and share it with the patient's PCP and other staff.
|
Usual Care
n=89 Participants
Patients will receive usual care.
|
|---|---|---|
|
Change in Patient-Provider Communication
|
-0.49 units on a scale
Standard Deviation 5.26
|
-0.48 units on a scale
Standard Deviation 4.86
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsPopulation: Participants with complete data
AASPIRE Health and Healthcare Self-Efficacy Scale (HHSES-21): This is a 21-item scale about patient confidence in navigating the healthcare system and managing health problems. There are two sub-scales. The Individual Level Self-Efficacy Sub-scale consists of items 1, 2, 3, 4, 11, 13,14, 15, 16, and 17. The Relationship Dependent Self-Efficacy Sub-scale consists of items 5, 6, 7, 8, 9, 10, 12, 18, 19, 20, and 21. Each sub-scale is scored by summing responses to the items, and then dividing the sum by the number of items. The resulting sub-scales have a possible range of 1-10, with higher scores corresponding to higher self-efficacy. Change in healthcare self-efficacy is calculated by subtracting the baseline score from the score at 6 months. A positive score indicates an improved outcome (i.e. higher self-efficacy post-intervention).
Outcome measures
| Measure |
AASPIRE Healthcare Toolkit
n=103 Participants
Patients will use the AASPIRE Healthcare Toolkit and will share a copy of their Autism Healthcare Accommodations Report with their primary care provider.
AASPIRE Healthcare Toolkit: The AASPIRE Healthcare Toolkit includes a variety of resources (information, worksheets, checklists, links) for patients and providers. The centerpiece of the toolkit is the Autism Healthcare Accommodations Tool, which allows a patient or their supporter to create a personalized accommodations report for the patient's provider. Intervention patients will use the toolkit and create an AHAT report. Intervention clinics will receive a copy of each patient's AHAT report, place it in the medical record, and share it with the patient's PCP and other staff.
|
Usual Care
n=92 Participants
Patients will receive usual care.
|
|---|---|---|
|
Change in Healthcare Self-Efficacy
Individual Level Self-Efficacy Sub-scale
|
0.11 units on a scale
Standard Deviation 1.10
|
0.06 units on a scale
Standard Deviation 1.06
|
|
Change in Healthcare Self-Efficacy
Relationship Dependent Self-Efficacy Sub-scale
|
0.19 units on a scale
Standard Deviation 1.30
|
0.08 units on a scale
Standard Deviation 1.45
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsPopulation: Participants with complete data
AASPIRE Visit Preparedness Scale (VPS-6): The scale is scored by summing responses to the 6 items. It has a range of 6-30, with higher scores indicating higher visit preparedness. This scale measures how well-prepared patient felt for their most recent visit. Change in visit preparedness is calculated by subtracting the baseline score from the score at 6 months. Positive scores indicate an improved outcome (i.e. higher visit preparedness post-intervention).
Outcome measures
| Measure |
AASPIRE Healthcare Toolkit
n=98 Participants
Patients will use the AASPIRE Healthcare Toolkit and will share a copy of their Autism Healthcare Accommodations Report with their primary care provider.
AASPIRE Healthcare Toolkit: The AASPIRE Healthcare Toolkit includes a variety of resources (information, worksheets, checklists, links) for patients and providers. The centerpiece of the toolkit is the Autism Healthcare Accommodations Tool, which allows a patient or their supporter to create a personalized accommodations report for the patient's provider. Intervention patients will use the toolkit and create an AHAT report. Intervention clinics will receive a copy of each patient's AHAT report, place it in the medical record, and share it with the patient's PCP and other staff.
|
Usual Care
n=91 Participants
Patients will receive usual care.
|
|---|---|---|
|
Change in Visit Preparedness
|
-0.04 units on a scale
Standard Deviation 3.17
|
0.05 units on a scale
Standard Deviation 3.21
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsPopulation: Participants with complete data
AASPIRE Healthcare Accommodations Scale (HAS-8): The scale is scored by summing responses from the eight items. The resulting scale can range from 8 to 40, with higher scores indicating higher receipt of necessary accommodations. Patient report, using 8-item scale, of how well clinic providers and staff make necessary accommodations. Change in receipt of healthcare accommodations is calculated by subtracting the baseline score from the score at 6 months. A positive change in score indicates an improved outcome (i.e. greater receipt of necessary accommodations after the intervention).
Outcome measures
| Measure |
AASPIRE Healthcare Toolkit
n=94 Participants
Patients will use the AASPIRE Healthcare Toolkit and will share a copy of their Autism Healthcare Accommodations Report with their primary care provider.
AASPIRE Healthcare Toolkit: The AASPIRE Healthcare Toolkit includes a variety of resources (information, worksheets, checklists, links) for patients and providers. The centerpiece of the toolkit is the Autism Healthcare Accommodations Tool, which allows a patient or their supporter to create a personalized accommodations report for the patient's provider. Intervention patients will use the toolkit and create an AHAT report. Intervention clinics will receive a copy of each patient's AHAT report, place it in the medical record, and share it with the patient's PCP and other staff.
|
Usual Care
n=87 Participants
Patients will receive usual care.
|
|---|---|---|
|
Change in Receipt of Healthcare Accommodations
|
0.80 units on a scale
Standard Deviation 5.10
|
-0.07 units on a scale
Standard Deviation 4.38
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsPatient self-report of use of preventive, outpatient, and emergency services; unmet healthcare needs
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsOpen- and closed-ended survey and interview questions about patient satisfaction with healthcare toolkit (intervention only)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsSurvey items on primary care provider's confidence in caring for autistic patients and satisfaction with toolkit
Outcome measures
Outcome data not reported
Adverse Events
AASPIRE Healthcare Toolkit
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place