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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04392336
Other study ID # 830013
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 27, 2019
Est. completion date April 29, 2022

Study information

Verified date July 2022
Source University of Pennsylvania
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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. .


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.


Recruitment information / eligibility

Status Completed
Enrollment 185
Est. completion date April 29, 2022
Est. primary completion date April 29, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms

  • Impact of Feedback on Symptoms and Trust/Respect on Outcomes

Intervention

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.

Locations

Country Name City State
United States University of Pennsylvania Philadelphia Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
University of Pennsylvania Merakey Behavioral Health

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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