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Clinical Trials/NCT04392336
NCT04392336CompletedNot Applicable

Development and Validation of a Feedback System for Tracking and Improving Trust/Respect in an Economically Disadvantaged Behavioral Health Population

University of Pennsylvania1 site in 1 country185 target enrollmentStarted: September 27, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
185
Locations
1
Primary Endpoint
Change in PROMIS SF v2.0 scores

Study Overview

Brief Summary

This study will examine the efficacy of a feedback system for providers that tracks patient trust/respect on an ongoing basis and to test the hypothesis that receiving feedback on trust/respect will lead to improvements in patient satisfaction, functioning, symptoms, and trust/respect.

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Detailed Description

This is a randomized effectiveness trial in which real-world providers will be given feedback on patient trust/respect. Approximately 40 clinicians, and up to 180 consumers will be enlisted participate in the randomized effectiveness trial. All enrolled patients will complete the BASIS-24, the Satisfaction with Care scale, and the Satisfaction with Social Roles and Activities Scale on handheld tablets or desktop computers at baseline. Patients will be randomized to one of two conditions. Patients in the first condition will attend therapy with clinicians who have received a standard automated outcome report, plus a report that contains information on the patient's trust/respect with suggestions for interventions if low/declining trust/respect is apparent. Patients in the second condition will attend therapy and complete the same measures as patients in the first condition, but their therapists will only receive a standard automated outcome report, without any patient information on trust/respect. At the time of the first therapy appointment and for all remaining therapy appointments, patients will complete four total measures: the new measure of trust/respect, the BASIS-24, the Satisfaction with Care scale, and the Satisfaction with Social Roles and Activities scale.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Ability to read at least at the 4th grade level
  • •18 years of age and older
  • •Willingness to participate in research.

Exclusion Criteria

  • Not provided

Arms & Interventions

Trust/Respect feedback

Experimental

Clinicians with consumers in this arm receive feedback on trust/respect in addition to symptom feedback.

Intervention: Trust/Respect feedback (Other)

No Trust/Respect feedback

No Intervention

Clinicians with consumers in this arm do not receive feedback on trust/respect and only receive symptom feedback.

Outcomes

Primary Outcomes

Change in PROMIS SF v2.0 scores

Time Frame: Up to 12 sessions, an average of 3 months

Evaluates satisfaction with social roles and activities. Raw scores range from 4 to 20. This is a longitudinal assessment of change between multiple time points.

Secondary Outcomes

  • Change in Opinions about My Doctor/Therapist scores(Up to 12 sessions, an average of 3 months)
  • Change in BASIS-24 scores(Up to 12 sessions, an average of 3 months)
  • Change in Satisfaction with Care scores(Up to 12 sessions, an 3 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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