Health System Integration of Tools to Improve Primary Care for Autistic Adults

NCT03234608 | Completed Results

• 1 other identifier: 1R34MH111536-01
• Study Type: interventional
• Target: 244
• Locations: 1 country
• Sites: 3

Brief Summary

The health system is ill-equipped to meet the needs of autistic adults. The Academic Autism Spectrum Partnership in Research and Education (AASPIRE), an academic-community partnership comprised of academics, autistic adults, healthcare providers, and supporters, has used a community based participatory research (CBPR) approach to develop and test an online healthcare toolkit aimed at improving primary care services for autistic adults. It was specifically designed as a low-intensity, sustainable intervention that can realistically be used in busy primary care practices that do not have a special focus on autism or other developmental disabilities. The toolkit includes the Autism Healthcare Accommodations Tool (AHAT)--an automated tool which allows patients and/or their supporters to create a personalized accommodations report for their primary care provider (PCP)--and other targeted resources, worksheets, checklists, and information. The investigators' pilot work has demonstrated that the AHAT has strong construct validity and test-retest stability, the toolkit is highly acceptable and accessible, and it has the potential to decrease barriers to care and increase patient-provider communication. The investigators' long-term plan is to conduct a hybrid effectiveness-implementation trial, using a cluster randomized trial design, both to test the effectiveness of the AASPIRE Healthcare Toolkit in improving healthcare quality and utilization and to assess the utility of implementation strategies in diverse healthcare systems. The objective of this proposal is to use a CBPR approach to understand how to integrate the toolkit into these health systems, collect more robust efficacy data, and explore potential mechanisms of action. The investigators will do so by conducting a 6-month pilot study with patients assigned to intervention and control clinics in three diverse health systems. The investigators will meet our objectives by achieving the following specific aims: 1) to determine how to integrate use of the toolkit within diverse health systems; 2) to test the effect of the toolkit on short-term healthcare outcomes; 3) to use a mixed-methods approach to further explore the toolkit's mechanisms of action; and 4) to refine the recruitment, retention, data collection, and system integration strategies in preparation for the larger cluster-randomized trial.

Conditions

Autism Spectrum Disorder

Keywords

Healthcare services; Adults

Outcome Measures

Primary Outcomes (2)

• Change in Barriers to Healthcare

  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).

  Baseline and 6 months

• Change in Patient-Provider Communication

  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).

  Baseline and 6 months

Secondary Outcomes (3)

• Change in Healthcare Self-Efficacy

  Baseline and 6 months

• Change in Visit Preparedness

  Baseline and 6 months

• Change in Receipt of Healthcare Accommodations

  Baseline and 6 months

Other Outcomes (3)

• Healthcare Use

  6 months

• Satisfaction With Healthcare Toolkit

  6 months

• Provider Confidence and Satisfaction

  6 months

Study Arms (2)

AASPIRE Healthcare Toolkit

EXPERIMENTAL

Patients will use the AASPIRE Healthcare Toolkit and will share a copy of their Autism Healthcare Accommodations Report with their primary care provider.

Behavioral: AASPIRE Healthcare Toolkit

Usual Care

NO INTERVENTION

Patients will receive usual care.

Interventions

AASPIRE Healthcare Toolkit BEHAVIORAL

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.

AASPIRE Healthcare Toolkit

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnostic code in chart related to autism spectrum disorder or other communication disability
• Receiving care at one of participating clinics

You may not qualify if:

• Can neither participate directly (with or without support), nor has an English-speaking supporter who can answer surveys on their behalf.

Sponsors & Collaborators

• Portland State University: lead
• Oregon Health and Science University: collaborator
• Kaiser Permanente: collaborator

Study Sites (3)

Kaiser Permanente Northern California

Oakland, California, 97207, United States

Location

Legacy Health System

Portland, Oregon, 97209, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Limitations and Caveats

This study aimed to integrate the AASPIRE Healthcare Toolkit into 3 healthcare systems. The intervention relied on primary care providers receiving and using a patients' Autism Healthcare Accommodations Report (AHAT). Unfortunately, due to various implementation challenges, very few providers received the AHAT reports. As such, most participants in the intervention arm did not receive the intended intervention. Data cannot be used to assess intervention efficacy.

Results Point of Contact

• Title: Dr. Christina Nicolaidis
• Organization: Portland State University

nicol22@pdx.edu

503-725-9603

Study Officials

• Christina Nicolaidis, MD, MPH

  Portland State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: We will conduct the study in primary care clinics within three health systems. We will compare data from patients in 7 intervention clinics to patients from matched control clinics within the same systems.

Study Record Dates

• First Submitted: July 14, 2017
• First Posted: July 31, 2017
• Study Start: August 24, 2017
• Primary Completion: March 15, 2019
• Study Completion: December 15, 2019
• Last Updated: November 3, 2021
• Results First Posted: October 21, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After study completion.
• Access Criteria: Determined by NIMH Data Archive

Locations

US (3)