Impact of Feedback on Symptoms and Trust/Respect on OutcomesNCT04392336
Tracking and Improving Trust/Respect
A study testing Trust/Respect feedback in people with Impact of Feedback on Symptoms and Trust/Respect on Outcomes, run by University of Pennsylvania at 1 site in United States.
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. . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Impact of Feedback on Symptoms and Trust/Respect on Outcomes
- What is being tested?
- Trust/Respect feedback
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 185 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Sep 2019to 29 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to read at least at the 4th grade level
- 18 years of age and older
- Willingness to participate in research.
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: 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.
.
Read the 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.
- Being tested
- Trust/Respect feedback
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trust/Respect feedbackOther
This feedback includes information on the level of trust/respect that a consumer has for their clinician in addition to symptom feedback.
| Study group | Role | What they receive |
|---|---|---|
| Trust/Respect feedback | Experimental | Clinicians with consumers in this arm receive feedback on trust/respect in addition to symptom feedback. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 12 sessions, an average of 3 months
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Up to 12 sessions, an 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2020
- Study start27 Sep 2019
- Primary completion29 Apr 2022
- Study completion29 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Impact of Feedback on Symptoms and Trust/Respect on OutcomesStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Merakey Behavioral Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04392336
- Sponsor's protocol ID
- 830013
- Status last verified
- Jul 2022
- First submitted
- 23 Mar 2020
- Last updated
- 25 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Requests for data can be made through the PI.
Publications
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.
PubMed 36862463
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Feedback System for Tracking and Improving Trust/Respect in an Economically Disadvantaged Behavioral Health Population
- ClinicalTrials.gov ID
- NCT04392336
- Acronym / sponsor ID
- 830013
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Merakey Behavioral Health
- Study start
- 27 Sep 2019 (actual)
- Primary completion
- 29 Apr 2022 (actual)
- Study completion
- 29 Apr 2022 (actual)
- First posted
- 18 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trust/Respect feedback | Experimental | Other: Trust/Respect feedbackClinicians with consumers in this arm receive feedback on trust/respect in addition to symptom 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ability to read at least at the 4th grade level
- 18 years of age and older
- Willingness to participate in research.
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trust/Respect feedbackThis feedback includes information on the level of trust/respect that a consumer has for their clinician in addition to symptom feedback. | Other | Trust/Respect feedback |
Primary outcome
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.
3 secondary outcomes
Change in BASIS-24 scores
Time frame: Up to 12 sessions, an average of 3 months
Change in Opinions about My Doctor/Therapist scores
Time frame: Up to 12 sessions, an average of 3 months
Change in Satisfaction with Care scores
Time frame: Up to 12 sessions, an 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2022.
- Derived from this study: PubMed 36862463Connolly 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.
- Individual participant dataSharing planned: Yes. Requests for data can be made through the PI.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trust/Respect feedback in people with Impact of Feedback on Symptoms and Trust/Respect on Outcomes, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PROMIS SF v2.0 scores (time frame: Up to 12 sessions, an average of 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04392336, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2022.