Substance Use DisordersNCT00798044
Patient Feedback Effectiveness Study
A study testing Other: quality improvement feedback system and Patient Feedback in people with Substance Use Disorders, run by University of Pennsylvania at 2 sites in United States.
Trial summary
The purpose of the study is to determine if a semi-automated quality improvement system that provides addiction counselors with feedback on their average treatment satisfaction and therapeutic alliance (as rated by patients currently in treatment) is superior to no feedback in 32 community-based outpatient addiction… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Use Disorders
- What is being tested?
- Other: quality improvement feedback system and Patient Feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2006to Apr 2009
- 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
- program: adult, outpatient, non-methadone maintenance substance abuse treatment programs
- clinician: must be leading at least one weekly group with minimum of 5 patients
- must be working at least 20% time at facility
Who cannot join
- clinics with fewer than 5 clinicians who conduct weekly group counseling
- clinics in which fewer than 50% of clinicians agree to participate
Trial locations and contacts
2 sites in 1 country.
United States2 sites
New York University School of Medicine
New York, New York, 10010
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
The purpose of the study is to determine if a semi-automated quality improvement system that provides addiction counselors with feedback on their average treatment satisfaction and therapeutic alliance (as rated by patients currently in treatment) is superior to no feedback in 32 community-based outpatient addiction treatment clinics.
Read the detailed description
Quality improvement (Ql) methods are a cornerstone of business and healthcare management throughout the United States yet there have been few studies of Ql interventions in addiction treatment settings. The proposed study tests the effectiveness of one Ql system - Patient Feedback (PF) - at increasing outpatient group therapy attendance and self-reported abstinence. The feasibility and acceptability of PF was established in a six-site study conducted within the National Drug Abuse Treatment Clinical Trials Network. In the proposed study, 32 community-based outpatient treatment programs with approximately 250 clinicians will be randomly assigned to PF, or usual clinic practices. In the PF condition, every week fro 12 weeks clinic patients are invited to complete a 12-item, self-administered survey in which they rate therapeutic alliance and treatment satisfaction, and report past week substance use. These anonymous surveys are faxed by clinic staff to a University of Pennsylvania data center where a custom software application converts the surveys into feedback reports and posts them to a password protected website. Clinicians can access their caseload feedback reports and aggregated reports for the whole clinic; supervisors can only access the aggregated clinic reports. On a monthly basis staff meet as a team to review the feedback reports and develop Ql plans intended to yield improvements in select Ql indicators. The PF website and the monthly PF e-newsletter provide social recognition, clinical resources, and a virtual community for participating clinicians. After 12 weeks, participants in both conditions complete follow-up measures and then both groups are given open access to PF for 12 additional months. During "sustainability phase" staff usage of the PF website is monitored. Alternate versions of the PF Survey are introduced during the sustainability study, including one that monitors HIV risk behavior. The rapid processing of surveys enables near real time feedback to clinic staff. Organizations may share their feedback reports with funding sources, regulatory agencies, policy makers, and other stakeholders. This centralized, semi-automated feedback system eases fulfillment of accreditation requirements and as such, reduces the cost of clinic operations.
- Conditions
- Substance Use Disorders
- Being tested
- Other: quality improvement feedback system, Patient Feedback
- Keywords
- quality improvement, feedback, substance use disorders
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other: quality improvement feedback systemBehavioural
Surveys patients regarding treatment experiences.
Patient FeedbackBehavioural
Weekly feedback reports provided to counselors
| Study group | Role | What they receive |
|---|---|---|
| Feedback to counselors | Experimental | substance abuse counselors received feedback reports on their average performance and on the average performance of the clinic as a whole. Feedback reports contained information on average alliance, treatment satisfaction, and drug/alcohol use. Receives: Behavioral: Other: quality improvement feedback system; Behavioral: Patient Feedback |
| Treatment as Usual | No intervention | No feedback reports were provided in this arm. |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinician average weekly caseload patient-rated therapeutic alliance
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2008 (estimated)
- Study startNov 2006
- Primary completionNov 2008
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use DisordersStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Paul Crits-Christoph, University of Pennsylvania
- Investigators
- Paul Crits-Christoph, Ph.D., Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00798044
- Sponsor's protocol ID
- R01DA020799
- Other IDs
- R01DA020799
- Status last verified
- Jan 2012
- First submitted
- 24 Nov 2008
- Last updated
- 20 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Feedback Effectiveness Study
- ClinicalTrials.gov ID
- NCT00798044
- Acronym / sponsor ID
- R01DA020799
- Conditions
- Substance Use Disorders
- Keywords
- quality improvement, feedback, substance use disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Nov 2006
- Primary completion
- Nov 2008 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 25 Nov 2008 (estimated)
- 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.
The purpose of the study is to determine if a semi-automated quality improvement system that provides addiction counselors with feedback on their average treatment satisfaction and therapeutic alliance (as rated by patients currently in treatment) is superior to no feedback in 32 community-based outpatient addiction treatment clinics.
Detailed description
Quality improvement (Ql) methods are a cornerstone of business and healthcare management throughout the United States yet there have been few studies of Ql interventions in addiction treatment settings. The proposed study tests the effectiveness of one Ql system - Patient Feedback (PF) - at increasing outpatient group therapy attendance and self-reported abstinence. The feasibility and acceptability of PF was established in a six-site study conducted within the National Drug Abuse Treatment Clinical Trials Network. In the proposed study, 32 community-based outpatient treatment programs with approximately 250 clinicians will be randomly assigned to PF, or usual clinic practices. In the PF condition, every week fro 12 weeks clinic patients are invited to complete a 12-item, self-administered survey in which they rate therapeutic alliance and treatment satisfaction, and report past week substance use. These anonymous surveys are faxed by clinic staff to a University of Pennsylvania data center where a custom software application converts the surveys into feedback reports and posts them to a password protected website. Clinicians can access their caseload feedback reports and aggregated reports for the whole clinic; supervisors can only access the aggregated clinic reports. On a monthly basis staff meet as a team to review the feedback reports and develop Ql plans intended to yield improvements in select Ql indicators. The PF website and the monthly PF e-newsletter provide social recognition, clinical resources, and a virtual community for participating clinicians. After 12 weeks, participants in both conditions complete follow-up measures and then both groups are given open access to PF for 12 additional months. During "sustainability phase" staff usage of the PF website is monitored. Alternate versions of the PF Survey are introduced during the sustainability study, including one that monitors HIV risk behavior. The rapid processing of surveys enables near real time feedback to clinic staff. Organizations may share their feedback reports with funding sources, regulatory agencies, policy makers, and other stakeholders. This centralized, semi-automated feedback system eases fulfillment of accreditation requirements and as such, reduces the cost of clinic operations.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Feedback to counselors | Experimental | Behavioral: Other: quality improvement feedback system, Behavioral: Patient Feedbacksubstance abuse counselors received feedback reports on their average performance and on the average performance of the clinic as a whole. Feedback reports contained information on average alliance, treatment satisfaction, and drug/alcohol use. |
| Treatment as Usual | No intervention | –No feedback reports were provided in this arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- program: adult, outpatient, non-methadone maintenance substance abuse treatment programs
- clinician: must be leading at least one weekly group with minimum of 5 patients
- must be working at least 20% time at facility
Key exclusion criteria (2 listed)
- clinics with fewer than 5 clinicians who conduct weekly group counseling
- clinics in which fewer than 50% of clinicians agree to participate
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 |
|---|---|---|
| Other: quality improvement feedback systemSurveys patients regarding treatment experiences. | Behavioural | Feedback to counselors |
| Patient FeedbackWeekly feedback reports provided to counselors | Behavioural | Feedback to counselors |
Primary outcome
clinician average weekly caseload patient-rated therapeutic alliance
Time frame: 12 weeks
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 20 Jan 2012.
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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.
Paul Crits-Christoph, Ph.D. principal investigator
University of Pennsylvania
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Other: quality improvement feedback system and Patient Feedback in people with Substance Use Disorders, run by University of Pennsylvania at 2 sites 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 2 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 20 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
clinician average weekly caseload patient-rated therapeutic alliance (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jan 2012.