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Tracking and Improving Trust/Respect

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04392336
Recruitment Status : Suspended (COVID-19)
First Posted : May 18, 2020
Last Update Posted : May 18, 2020
Sponsor:
Collaborator:
Merakey Behavioral Health
Information provided by (Responsible Party):
University of Pennsylvania

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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Condition or disease Intervention/treatment Phase
To Test Whether Feedback on Symptoms and Trust/Respect Can Improve Outcomes Other: Trust/Respect feedback Not Applicable

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 300 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: Development and Validation of a Feedback System for Tracking and Improving Trust/Respect in an Economically Disadvantaged Behavioral Health Population
Actual Study Start Date : September 27, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

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.



Primary Outcome Measures :
  1. Change in PROMIS SF v2.0 scores [ Time Frame: Each session, up to 12 sessions or around 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.

  2. Change in Satisfaction with Care scores [ Time Frame: Each session, up to 12 sessions or around 3 months ]
    Evaluates satisfaction with care. Raw scores range from 1 to 7. This is a longitudinal assessment of change between multiple time points.


Secondary Outcome Measures :
  1. Change in BASIS-24 scores [ Time Frame: Each session, up to 12 sessions or around 3 months ]
    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.

  2. Change in Opinions about My Doctor/Therapist scores [ Time Frame: Each session, up to 12 sessions or around 3 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04392336


Locations
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United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Merakey Behavioral Health
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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT04392336    
Other Study ID Numbers: 830013
First Posted: May 18, 2020    Key Record Dates
Last Update Posted: May 18, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Requests for data can be made through the PI.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No