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
  Purpose
The goal of this proposal is to develop and evaluate patient-centered care tools for autistic adults and their primary care providers (PCPs).

Condition Intervention
Autism Spectrum Disorder
Behavioral: Use of toolkit

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Partnering With Autistic Adults to Develop Tools to Improve Primary Healthcare

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Patient Satisfaction [ Time Frame: 1 month after use of toolkit ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Provider Satisfaction [ Time Frame: 1-2 months after patient uses toolkit ] [ Designated as safety issue: No ]
    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.

  • Patient Use of Toolkit Components [ Time Frame: 1 month after use of toolkit ] [ Designated as safety issue: No ]
    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.

  • Change in Patient Satisfaction With Healthcare [ Time Frame: before and 1 month after use of toolkit ] [ Designated as safety issue: No ]
    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.

  • Change in Patient's Perceived Barriers to Healthcare [ Time Frame: Before and 1 month after use of toolkit ] [ Designated as safety issue: No ]
    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.

  • Change in Patient Healthcare Self-Efficacy [ Time Frame: Before and 1 month after use of toolkit ] [ Designated as safety issue: No ]
    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.


Enrollment: 237
Study Start Date: September 2013
Study Completion Date: August 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Use of Toolkit
All participants will have access to the toolkit
Behavioral: Use of toolkit
Patient participants will be given access to the toolkit and will create a customized report for their provider. Team will send report to providers and ask them to schedule appointment with patient to discuss.

Detailed Description:
The goal of this study is to develop and evaluate patient-centered care tools for autistic adults and their primary care providers (PCPs). One tool will allow autistic adults and/or their supporters to provide individualized information to PCPs about how being on the spectrum affects their healthcare and possible strategies to facilitate quality care. Another tool will capitalize on the power of patient narrative to educate PCPs about autism. These tools and other resources will be housed on an interactive website for autistic adults, supporters, and PCPs. The research team will evaluate the feasibility and acceptability of using the new web-based patient-centered care tools with autistic adults and their primary care providers. This study will provide data for a future trial testing the effectiveness of these tools in improving the health of autistic adults by increasing patient-centered care and patient activation.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Medical diagnosis of autism spectrum disorder (including autistic disorder, Asperger's disorder, Childhood Disintegrative Disorder, and pervasive developmental disorder NOS)
  • Understands written or spoken English or has a support person available who understands written or spoken English
  • Has a primary care provider

Exclusion Criteria:

  • Is not a resident of the United States
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01579669

Locations
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
National Institute of Mental Health (NIMH)
Syracuse University
Indiana University
Autistic Self Advocacy Network
Portland State University
Investigators
Principal Investigator: Christina Nicolaidis, MD, MPH Oregon Health and Science University
  More Information

Additional Information:
Responsible Party: Christina M. Nicolaidis, Associate Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01579669     History of Changes
Other Study ID Numbers: R34MH092503 
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

Keywords provided by Oregon Health and Science University:
Autism Spectrum Disorder
Primary Care Services
Patient-Provider Communication
Adults

Additional relevant MeSH terms:
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Mental Disorders
Neurodevelopmental Disorders

ClinicalTrials.gov processed this record on May 25, 2016