Partnering With Autistic Adults to Improve Healthcare

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT01579669
First received: April 13, 2012
Last updated: October 30, 2015
Last verified: October 2015
Results First Received: August 18, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Health Services Research
Condition: Autism Spectrum Disorder
Intervention: Behavioral: Use of toolkit

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
Autistic Adults Adults on the autism spectrum
Primary Care Providers Participants' primary care providers

Participant Flow:   Overall Study
    Autistic Adults     Primary Care Providers  
STARTED     170     41  
COMPLETED     134     41  
NOT COMPLETED     36     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Baseline characteristics are presented for the autistic participants who completed the pre-intervention survey and the primary care providers who completed the PCP survey.

Reporting Groups
  Description
Autistic Adults Adults on the autism spectrum
Primary Care Providers Primary care providers taking care of autistic adults participating in this study
Total Total of all reporting groups

Baseline Measures
    Autistic Adults     Primary Care Providers     Total  
Number of Participants  
[units: participants]
  170     41     211  
Age  
[units: years]
Mean (Full Range)
  36.5   (18 to 68)     36.3   (28 to 62)     36.4   (18 to 68)  
Gender, Customized  
[units: participants]
     
Male     75     15     90  
Female     91     25     116  
Other     4     0     4  
Not Reported     0     1     1  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     11     1     12  
Not Hispanic or Latino     158     36     194  
Unknown or Not Reported     1     4     5  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     2     0     2  
Asian     2     3     5  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     5     1     6  
White     152     29     181  
More than one race     5     2     7  
Unknown or Not Reported     4     6     10  
Region of Enrollment  
[units: participants]
     
United States     170     41     211  



  Outcome Measures
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1.  Primary:   Patient Satisfaction   [ Time Frame: 1 month after use of toolkit ]

2.  Secondary:   Provider Satisfaction   [ Time Frame: 1-2 months after patient uses toolkit ]

3.  Secondary:   Patient Use of Toolkit Components   [ Time Frame: 1 month after use of toolkit ]

4.  Secondary:   Change in Patient Satisfaction With Healthcare   [ Time Frame: before and 1 month after use of toolkit ]

5.  Secondary:   Change in Patient's Perceived Barriers to Healthcare   [ Time Frame: Before and 1 month after use of toolkit ]

6.  Secondary:   Change in Patient Healthcare Self-Efficacy   [ Time Frame: Before and 1 month after use of toolkit ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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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
e-mail: nicol22@pdx.edu



Responsible Party: Christina M. Nicolaidis, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01579669     History of Changes
Other Study ID Numbers: R34MH092503 ( US NIH Grant/Contract Award Number )
Study First Received: April 13, 2012
Results First Received: August 18, 2015
Last Updated: October 30, 2015
Health Authority: United States: Institutional Review Board
United States: Federal Government