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Trial record 9 of 37 for:    Developmental Disabilities | ( Map: Oregon, United States )

Partnering With Autistic Adults to Improve Healthcare

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ClinicalTrials.gov Identifier: NCT01579669
Recruitment Status : Completed
First Posted : April 18, 2012
Results First Posted : December 7, 2015
Last Update Posted : December 7, 2015
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
Syracuse University
Indiana University
Autistic Self Advocacy Network
Portland State University
Information provided by (Responsible Party):
Christina M. Nicolaidis, Oregon Health and Science University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Health Services Research
Condition Autism Spectrum Disorder
Intervention Behavioral: Use of toolkit
Enrollment 237
Recruitment Details We recruited autistic adults via fliers, postings, and announcements targeted to autism and disability-related list-serves, organizations, and forums. We invited the autistic adult's primary care providers (PCPs) to participate if the patient gave permission for us to contact their provider and provided usable contact information.
Pre-assignment Details The total number of participants enrolled includes everyone who consented to participate. Some participants clicked "yes" to the online consent, but did not participate in the initial survey. The number of participants noted as Started in the Participant Flow module includes only those that took the initial survey.
Arm/Group Title Autistic Adults Primary Care Providers
Hide Arm/Group Description Adults on the autism spectrum Participants' primary care providers
Period Title: Overall Study
Started 170 41
Completed 134 41
Not Completed 36 0
Arm/Group Title Autistic Adults Primary Care Providers Total
Hide Arm/Group Description Adults on the autism spectrum Primary care providers taking care of autistic adults participating in this study Total of all reporting groups
Overall Number of Baseline Participants 170 41 211
Hide Baseline Analysis Population Description
Baseline characteristics are presented for the autistic participants who completed the pre-intervention survey and the primary care providers who completed the PCP survey.
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 170 participants 41 participants 211 participants
36.5
(18 to 68)
36.3
(28 to 62)
36.4
(18 to 68)
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 170 participants 41 participants 211 participants
Male 75 15 90
Female 91 25 116
Other 4 0 4
Not Reported 0 1 1
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 170 participants 41 participants 211 participants
Hispanic or Latino
11
   6.5%
1
   2.4%
12
   5.7%
Not Hispanic or Latino
158
  92.9%
36
  87.8%
194
  91.9%
Unknown or Not Reported
1
   0.6%
4
   9.8%
5
   2.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 170 participants 41 participants 211 participants
American Indian or Alaska Native
2
   1.2%
0
   0.0%
2
   0.9%
Asian
2
   1.2%
3
   7.3%
5
   2.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
5
   2.9%
1
   2.4%
6
   2.8%
White
152
  89.4%
29
  70.7%
181
  85.8%
More than one race
5
   2.9%
2
   4.9%
7
   3.3%
Unknown or Not Reported
4
   2.4%
6
  14.6%
10
   4.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 170 participants 41 participants 211 participants
170 41 211
1.Primary Outcome
Title Patient Satisfaction
Hide Description Autistic participants completed an online survey about their satisfaction with the tool, including if they feel the tool is useful, how they think the tool will affect their healthcare, if and how they plan to use it with providers, and if they would recommend it to others.
Time Frame 1 month after use of toolkit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Autistic Adults
Hide Arm/Group Description:
Adults on the autism spectrum
Overall Number of Participants Analyzed 134
Measure Type: Number
Unit of Measure: percentage of participants
Percentage rating toolkit as useful 95.08
Percentage who felt toolkit was easy to use 95.96
Percentage who felt toolkit was important 96.8
Percentage who would recommend toolkit to friend 92.11
Percentage who would recommend toolkit to provider 94.87
2.Secondary Outcome
Title Provider Satisfaction
Hide Description Providers participated in a brief survey to assess satisfaction with the toolkit. Items addressed overall satisfaction and if they would or would not use the tools with other patients.
Time Frame 1-2 months after patient uses toolkit
Hide Outcome Measure Data
Hide Analysis Population Description
Participants' primary care providers. Primary care providers were included in the study to assess their impression of the toolkit, but all other outcomes (e.g. change in barriers, self-efficacy, or satisfaction with healthcare) only apply to the autistic participants, not their primary care providers.
Arm/Group Title Primary Care Providers
Hide Arm/Group Description:
Participants' primary care providers
Overall Number of Participants Analyzed 41
Measure Type: Number
Unit of Measure: percentage of PCPs
Proportion rating AHAT as moderately or very usefu 82.05
Proportion who would recommend AHAT to patients 86.49
3.Secondary Outcome
Title Patient Use of Toolkit Components
Hide Description We collected data on whether or not participants completed the Autism Healthcare Accommodations Tool (AHAT) survey and whether or not they allowed the research team to send a copy of the report to their primary care provider.
Time Frame 1 month after use of toolkit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Autistic Adults
Hide Arm/Group Description:
Adults on the autism spectrum
Overall Number of Participants Analyzed 170
Measure Type: Number
Unit of Measure: percentage of participants
Proportion completing AHAT 96.00
Proportion who requested AHAT be sent to provider 57.74
4.Secondary Outcome
Title Change in Patient Satisfaction With Healthcare
Hide Description Patients completed an 8-item instrument assessing satisfaction with their primary healthcare experiences. The scale was previously adapted from the 2007 Health Information National Trends Survey (HINTS). In the pre-intervention survey autistic participants were asked to think about their last visit with their primary care provider. We did not assess patient-provider communication for those who were participating via a proxy as we did not feel that a proxy could adequately rate how satisfied the patient was with communication. Only autistic participants who said they had seen their PCP since using the healthcare toolkit were re-asked these items in the post-intervention survey. Responses used a 5-point Likert scale with anchors of “1 – Strongly Disagree” to “5 – Strongly Agree”. We analyzed items by summing the responses into a composite score (range 8-40; higher scores indicate higher satisfaction). Cronbach's alpha = 0.92.
Time Frame before and 1 month after use of toolkit
Hide Outcome Measure Data
Hide Analysis Population Description
Autistic adults who participated directly (not via a proxy) and who saw their provider in the 1 month between when they participated in the baseline assessment and they completed the post-intervention survey.
Arm/Group Title Autistic Adults
Hide Arm/Group Description:
Adults on the autism spectrum
Overall Number of Participants Analyzed 43
Mean (Standard Error)
Unit of Measure: units on a scale
Baseline Satisfaction 30.91  (0.978)
Post-intervention satisfaction 32.63  (1.01)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Autistic Adults
Comments Pre-post comparison
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0269
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
5.Secondary Outcome
Title Change in Patient's Perceived Barriers to Healthcare
Hide Description Autistic participants were presented with a list of 16 barriers to healthcare and asked which ones keep them from obtaining good care. We compared the total number of barriers endorsed by participants in the pre- and post-intervention surveys. The proxy version of the survey included a few modified items to differentiate between barriers faced by the autistic individuals and those faced by the supporter. Due to differences in the wording, we could not combine results from those who participated directly with those who participated by proxy. Only data from autistic adults who participated directly is shown.
Time Frame Before and 1 month after use of toolkit
Hide Outcome Measure Data
Hide Analysis Population Description
Participants completing the pre and post-test themselves (not via a supporter).
Arm/Group Title Autistic Adults
Hide Arm/Group Description:
Adults on the autism spectrum
Overall Number of Participants Analyzed 108
Mean (Standard Error)
Unit of Measure: number of barriers
Mean number of barriers at baseline 4.07  (0.25)
Mean number of barriers at follow-up 2.82  (0.19)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Autistic Adults
Comments Pre-post intervention comparison
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
6.Secondary Outcome
Title Change in Patient Healthcare Self-Efficacy
Hide Description Autistic participants completed a 21-item healthcare self-efficacy scale before and 1 month after use of the toolkit. The scale was created de novo for this study, based on our prior qualitative work. Items addressed aspects related to healthcare navigation (e.g. “How confident are you that you can make an appointment with your healthcare provider when needed?”), successful interactions with providers, (e.g. “How confident are you that you can describe your symptoms or healthcare concerns to your provider?”), and self-management (e.g. “How confident are you that you can take medications the way you are supposed to take them?”). Response options used a 4-point Likert scale with anchors of “0 - Not at all confident” to “3 - Totally confident”. We scored self-efficacy by adding responses from the 21 items, resulting in a possible range of 0 to 63, with higher scores corresponding to higher self-efficacy. Cronbach's alpha was 0.92.
Time Frame Before and 1 month after use of toolkit
Hide Outcome Measure Data
Hide Analysis Population Description
Participants completing pre- and post-intervention survey themselves (not via a supporter), who had complete data on the self-efficacy scales on both surveys.
Arm/Group Title Autistic Adults
Hide Arm/Group Description:
Adults on the autism spectrum
Overall Number of Participants Analyzed 98
Mean (Standard Error)
Unit of Measure: units on a scale
Baseline healthcare self-efficacy score 37.92  (1.21)
Follow-up healthcare self-efficacy score 39.37  (1.19)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Autistic Adults
Comments Pre-post intervention comparison
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.016
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame 1 month
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Autistic Adults Primary Care Providers
Hide Arm/Group Description Adults on the autism spectrum Primary care providers of autistic adults participating in the study.
All-Cause Mortality
Autistic Adults Primary Care Providers
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Autistic Adults Primary Care Providers
Affected / at Risk (%) Affected / at Risk (%)
Total   0/170 (0.00%)   0/41 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Autistic Adults Primary Care Providers
Affected / at Risk (%) Affected / at Risk (%)
Total   0/170 (0.00%)   0/41 (0.00%) 
This study was designed as a single-arm trial to assess feasibility and acceptability and to explore potential mechanisms of action. As such, there was no control group. PCPs are not a separate arm, but were included to assess acceptability.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Christina Nicolaidis, MD, MPH
Organization: Portland State University
Phone: 5037259603
Responsible Party: Christina M. Nicolaidis, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01579669     History of Changes
Other Study ID Numbers: R34MH092503 ( U.S. NIH Grant/Contract )
R34MH092503 ( U.S. NIH Grant/Contract )
First Submitted: April 13, 2012
First Posted: April 18, 2012
Results First Submitted: August 18, 2015
Results First Posted: December 7, 2015
Last Update Posted: December 7, 2015