Tracking and Improving Trust/Respect

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

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.

.

Study Overview

• Status: Completed
• Conditions: Impact of Feedback on Symptoms and Trust/Respect on Outcomes
• Intervention / Treatment: Other: Trust/Respect feedback

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 Type: Interventional
• Enrollment (Actual): 185
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

• N/A

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Trust/Respect feedback; Clinicians with consumers in this arm receive feedback on trust/respect in addition to symptom feedback.	Other: Trust/Respect feedback; This feedback includes information on the level of trust/respect that a consumer has for their clinician in addition to symptom feedback.
No Intervention: No Trust/Respect feedback; Clinicians with consumers in this arm do not receive feedback on trust/respect and only receive symptom feedback.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in PROMIS SF v2.0 scores	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.	Up to 12 sessions, an average of 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in BASIS-24 scores	The 24-item Behavior and Symptom Identification Scale is used to determine overall well-being. Scores range from 0 to 4. Lower scores indicate overall better well-being. This is a longitudinal assessment of change between multiple time points.	Up to 12 sessions, an average of 3 months
Change in Opinions about My Doctor/Therapist scores	Asks participants questions regarding trust/respect for their clinician. Scores range from 1 to 7, with higher scores indicating greater trust/respect. This is a longitudinal assessment of change between multiple time points.	Up to 12 sessions, an average of 3 months
Change in Satisfaction with Care scores	Evaluates satisfaction with care. Raw scores range from 1 to 7. This is a longitudinal assessment of change between multiple time points.	Up to 12 sessions, an 3 months

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: Merakey Behavioral Health

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2019
• Primary Completion (Actual): April 29, 2022
• Study Completion (Actual): April 29, 2022

Study Registration Dates

• First Submitted: March 23, 2020
• First Submitted That Met QC Criteria: May 12, 2020
• First Posted (Actual): May 18, 2020

Study Record Updates

• Last Update Posted (Actual): July 25, 2022
• Last Update Submitted That Met QC Criteria: July 22, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 830013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Requests for data can be made through the PI.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No