NCT04392336

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. .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
185

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 27, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 23, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 18, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 29, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 29, 2022

Completed
Last Updated

July 25, 2022

Status Verified

July 1, 2022

Enrollment Period

2.6 years

First QC Date

March 23, 2020

Last Update Submit

July 22, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Change in BASIS-24 scores

    Up to 12 sessions, an average of 3 months

  • Change in Opinions about My Doctor/Therapist scores

    Up to 12 sessions, an average of 3 months

  • Change in Satisfaction with Care scores

    Up to 12 sessions, an 3 months

Study Arms (2)

Trust/Respect feedback

EXPERIMENTAL

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

Other: Trust/Respect feedback

No Trust/Respect feedback

NO INTERVENTION

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

Interventions

This feedback includes information on the level of trust/respect that a consumer has for their clinician in addition to symptom feedback.

Trust/Respect feedback

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • Connolly Gibbons MB, Duong L, Zoupou E, Kashden J, Fisher J, Crits-Christoph P. Randomized controlled trial evaluating feedback to community-based therapists based on patient reports of trust and respect. J Consult Clin Psychol. 2023 Jun;91(6):337-349. doi: 10.1037/ccp0000807. Epub 2023 Mar 2.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2020

First Posted

May 18, 2020

Study Start

September 27, 2019

Primary Completion

April 29, 2022

Study Completion

April 29, 2022

Last Updated

July 25, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will share

Requests for data can be made through the PI.

Locations