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Evaluating Improvement Strategies in Addiction Treatment

Randomized Control Trial (RCT) Evaluating Improvement Strategies in Addiction Treatment

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00934141
Acronym
NIATx 200
Enrollment
201
Registered
2009-07-08
Start date
2006-10-31
Completion date
2011-01-31
Last updated
2013-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Addiction

Keywords

Organizational change, process improvement, addiction treatment, cost effectiveness study

Brief summary

Addiction treatment is often characterized by long delays between first contact and treatment as well as high no-show and drop out rates leading to unused capacity in apparently full agencies. Patients do not get needed care and agency financial stability is threatened. The Network for Improvement of Addiction Treatment (NIATx) began as a high-intensity improvement collaborative of 39 addiction treatment agencies distributed across 25 states. NIATx substantially improved time to treatment and continuation in treatment by making improvements to organizational processes (such as first contact, intake and assessment, engagement, level of care transitions, paperwork, social support, outreach, and scheduling) in preliminary studies. While the results are very encouraging, they have, by intent, been obtained from a select group of agencies using a high-cost combination of services. A more practical diffusion model is needed to spread process improvements across the spectrum of treatment agencies. This study is a cluster-randomized trial to test the effectiveness and cost of less expensive combinations of the services that make up the NIATx collaborative (interest circles, coach calls, coach visits and learning sessions).

Detailed description

This cluster-RCT randomly assign 201 treatment agencies in 5 states to four experimental arms. The agencies were randomized to an intervention for 18 months with a 9 month sustainability period. The study aimed to: 1) Determine whether a state-based strategy can (with NIATx support) can lead mainstream treatment agencies to implement and sustain process changes that improve the study's primary outcomes: time to treatment, annual clinic admissions, and continuation in treatment; and 2) Evaluate the effectiveness and cost of the services making up NIATx. This study aims to create a practical model for improving efficiency and effectiveness of addiction treatment.

Interventions

OTHERLearning Session

Learning Sessions occur bi-annually as change teams convene to learn and gather support from each other and outside experts who offer advice on how best to adopt the innovations and learn about new directions for the collaborative (e.g., the need to create business cases for improvements). Learning Sessions and Interest Circles (see below) have similar objectives-to help agencies learn and gather support from each other and from outside experts.

OTHERInterest Circle Calls

Interest Circles are monthly teleconferences where agency change leaders discuss change-related issues and progress. Circles address how to improve timeliness, continuation, admissions, dropouts and transitions. They also address specialty topics (e.g., programs for women, adolescents). Participants discuss successes, failures, and challenges, and get advice and assignments for their improvement plans. Meeting summaries appear on the Web site. Interest Circles are inexpensive, but are they are sufficient? Should Interest Circles prove effective, they would provide a low-cost, convenient diffusion approach

OTHERCoaching

Coaching assigns an expert in process improvement to work with an agency to make, sustain, and spread process improvement efforts. Consultations focus on executive directors, change leaders and improvement teams. Coaches help agencies address key issues, but also broker relationships with other agencies, offer process improvement training, and promote the innovations to make and how to make them. Coaching takes place during site visits, monthly phone conferences, and via email.

OTHERWebsite

The NIATx Web site features resources central to improvement. The site includes: 1) a catalog of change ideas and case studies; 2) a toolbox providing just-in-time training on topics such as conducting a walk-through and key innovations; 3) on-line tools to assess organizational (or project) readiness for and ability to sustain change; 4) electronic communication services to ask questions of experts, and participate in peer discussion groups; 5) links to relevant process improvement Web sites; and 6) a secure portion for treatment agencies to report and track progress. Hence, our control group will have access to the entire website.

Sponsors

Oregon Health and Science University
CollaboratorOTHER
National Institute on Drug Abuse (NIDA)
CollaboratorNIH
University of Wisconsin, Madison
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

* at least 60 admissions/year * provide outpatient and intensive outpatient levels of care (as defined by ASAM) * provide or use detox services provided by others * have tax-exempt or government status or rely on public funding (e.g., block grants, Medicare, Medicaid, local government, private philanthropy) for at least 50% of their budget * have adopted no more than two of the planned interventions

Exclusion criteria

* are current NIATx members

Design outcomes

Primary

MeasureTime frameDescription
Change in Average Waiting Time From First Contact to TreatmentBaseline and 15 monthsThe average length of time in days it takes from when a patient first calls for help to the time a patient was able to meet a clinician. In this quality improvement study, changes in this measure over time are reported. Estimates of improvement show the average days of improvement per month based on a best linear unbiased predictor estimate for each site. Note: this study has three primary outcomes. The number of participants analyzed varies for each outcome. The (higher) number of clinics shown in the flow diagram results because clinics may have been analyzed on a subset of the three primary outcomes (e.g., analyzed for waiting time and continuation, but not for annual number of new patients). To be considered analyzed in the flow diagram, a clinic must have been included in at least one primary outcomes analysis.
Change in Annual Number of Patient Admissions48 months (2 year baseline period and 2 year post-intervention period)We aimed to increase clinics' treatment capacity in this quality improvement study. Capacity was measured by counting clinics' annual number of patient admissions. We monitored changes in admission counts, per clinic, in a pre-post analysis. Changes in the natural logarithm of annual admissions are presented, which approximates the average percentage change (year-to-year) in the number of new patient admissions per clinic. Note: this study has three primary outcomes. The number of participants analyzed varies for each outcome. The (higher) number of clinics shown in the flow diagram results because clinics may have been analyzed on a subset of the three primary outcomes (e.g., analyzed for waiting time and continuation, but not for annual number of new patients). To be considered analyzed in the flow diagram, a clinic must have been included in at least one primary outcomes analysis.
Change in Average Continuation Rate Through the Fourth Treatment SessionBaseline and 21 monthsThis outcome represents change in the rate at which a clinic's patients continue in treatment. Continuation rate is defined as the percentage of patients that make at least 4 visits to the clinic, on different days, before being discharged. Estimates of improvement show the average percentage points of improvement per month based on a best linear unbiased predictor estimate for each site. Note: this study has three primary outcomes. The number of participants analyzed varies for each outcome. The (higher) number of clinics shown in the flow diagram results because clinics may have been analyzed on a subset of the three primary outcomes (e.g., analyzed for waiting time and continuation, but not for annual number of new patients). To be considered analyzed in the flow diagram, a clinic must have been included in at least one primary outcomes analysis.

Secondary

MeasureTime frameDescription
Cost of GroupBaseline and 18 monthsThe goal of the economic analysis was to estimate costs of each group for governmental authorities who might organize improvement collaboratives. We collected the cost of personnel (state employees, NIATx employees, coaches and consultants), data management, buildings and facilities, lodging, travel, telephone calls and miscellaneous costs. Costs were categorized as group specific (such as hotel costs for the learning sessions group) or non-group-specific, which included state-incurred costs for outreach, data management and infrastructure, encouraging participation and administration. Cost data were collected three times during the study period and aggregated to create a total cost estimate. Figures reported below represent costs at the arm/group level (costs were not assessed at the organizational level). Measure type is Number.

Countries

United States

Participant flow

Participants by arm

ArmCount
Interest Circle Call + Website
Interest Circles are monthly teleconferences where agency change leaders discuss change-related issues and progress. Circles address how to improve timeliness, continuation, admissions, dropouts and transitions. They also address specialty topics (e.g., programs for women, adolescents). Participants discuss successes, failures, and challenges, and get advice and assignments for their improvement plans. Meeting summaries appear on the Web site. Interest Circles are inexpensive, but are they are sufficient? Should Interest Circles prove effective, they would provide a low-cost, convenient diffusion approach.
49
Coaching + Website
Coaching assigns an expert in process improvement to work with an agency to make, sustain, and spread process improvement efforts. Consultations focus on executive directors, change leaders and improvement teams. Coaches help agencies address key issues, but also broker relationships with other agencies, offer process improvement training, and promote the innovations to make and how to make them. Coaching takes place during site visits, monthly phone conferences, and via email.
50
Full: LS, Coaching, ICC, Website
Learning Session, Coaching, Interest Circle Calls, Website, see descriptions above
48
Learning Session + Website
Learning Sessions occur bi-annually as change teams convene to learn and gather support from each other and outside experts who offer advice on how best to adopt the innovations and learn about new directions for the collaborative (e.g., the need to create business cases for improvements). Learning Sessions and Interest Circles (see below) have similar objectives-to help agencies learn and gather support from each other and from outside experts.
54
Total201

Baseline characteristics

CharacteristicInterest Circle Call + WebsiteCoaching + WebsiteFull: LS, Coaching, ICC, WebsiteLearning Session + WebsiteTotal
Age Continuous33.36 years
STANDARD_DEVIATION 11.81
31.89 years
STANDARD_DEVIATION 12.02
32.71 years
STANDARD_DEVIATION 11.81
32.08 years
STANDARD_DEVIATION 12.19
32.53 years
STANDARD_DEVIATION 11.96
Clinics' annual number of patient admissions per year500 Patients per year
STANDARD_DEVIATION 485
578 Patients per year
STANDARD_DEVIATION 684
488 Patients per year
STANDARD_DEVIATION 437
671 Patients per year
STANDARD_DEVIATION 1031
559.25 Patients per year
STANDARD_DEVIATION 659.25
Organizational structure
Private for-profit
0 participants0 participants0 participants3 participants3 participants
Organizational structure
Private not-for-profit
37 participants41 participants41 participants43 participants162 participants
Organizational structure
Unit of other government
7 participants6 participants1 participants3 participants17 participants
Organizational structure
Unit of state government
4 participants1 participants4 participants3 participants12 participants
Organizational structure
Unit of tribal government
1 participants2 participants2 participants2 participants7 participants
Primary setting
Community mental health clinic
7 participants13 participants5 participants10 participants35 participants
Primary setting
Corrections
3 participants0 participants1 participants1 participants5 participants
Primary setting
Family or children's service agency
3 participants2 participants1 participants2 participants8 participants
Primary setting
Free-standing alcohol or drug treatment clinic
26 participants25 participants26 participants32 participants109 participants
Primary setting
Hospital/Health Center (including primary setting)
4 participants6 participants5 participants3 participants18 participants
Primary setting
Other or unreported
5 participants2 participants7 participants4 participants18 participants
Primary setting
Social services agency
1 participants2 participants3 participants2 participants8 participants
Race/Ethnicity, Customized
American Indian or Alaska Native
0 Non-white or Hispanic participants0 Non-white or Hispanic participants0 Non-white or Hispanic participants0 Non-white or Hispanic participants0 Non-white or Hispanic participants
Race/Ethnicity, Customized
Asian
0 Non-white or Hispanic participants0 Non-white or Hispanic participants0 Non-white or Hispanic participants0 Non-white or Hispanic participants0 Non-white or Hispanic participants
Race/Ethnicity, Customized
Black or African American
0 Non-white or Hispanic participants0 Non-white or Hispanic participants0 Non-white or Hispanic participants0 Non-white or Hispanic participants0 Non-white or Hispanic participants
Race/Ethnicity, Customized
More than one race
0 Non-white or Hispanic participants0 Non-white or Hispanic participants0 Non-white or Hispanic participants0 Non-white or Hispanic participants0 Non-white or Hispanic participants
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
0 Non-white or Hispanic participants0 Non-white or Hispanic participants0 Non-white or Hispanic participants0 Non-white or Hispanic participants0 Non-white or Hispanic participants
Race/Ethnicity, Customized
Unknown or Not Reported
49 Non-white or Hispanic participants50 Non-white or Hispanic participants48 Non-white or Hispanic participants54 Non-white or Hispanic participants201 Non-white or Hispanic participants
Race/Ethnicity, Customized
White
0 Non-white or Hispanic participants0 Non-white or Hispanic participants0 Non-white or Hispanic participants0 Non-white or Hispanic participants0 Non-white or Hispanic participants
Rating of management quality3.02 Units on a scale between 1 and 5
STANDARD_DEVIATION 0.54
2.97 Units on a scale between 1 and 5
STANDARD_DEVIATION 0.64
2.99 Units on a scale between 1 and 5
STANDARD_DEVIATION 0.57
2.95 Units on a scale between 1 and 5
STANDARD_DEVIATION 0.73
2.98 Units on a scale between 1 and 5
STANDARD_DEVIATION 0.62
Region of Enrollment
United States
49 participants50 participants48 participants54 participants201 participants
Sex: Female, Male
Female
16 Participants17 Participants16 Participants17 Participants66 Participants
Sex: Female, Male
Male
33 Participants33 Participants32 Participants37 Participants135 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —— / —
other
Total, other adverse events
0 / 00 / 00 / 00 / 0
serious
Total, serious adverse events
0 / 490 / 500 / 480 / 54

Outcome results

Primary

Change in Annual Number of Patient Admissions

We aimed to increase clinics' treatment capacity in this quality improvement study. Capacity was measured by counting clinics' annual number of patient admissions. We monitored changes in admission counts, per clinic, in a pre-post analysis. Changes in the natural logarithm of annual admissions are presented, which approximates the average percentage change (year-to-year) in the number of new patient admissions per clinic. Note: this study has three primary outcomes. The number of participants analyzed varies for each outcome. The (higher) number of clinics shown in the flow diagram results because clinics may have been analyzed on a subset of the three primary outcomes (e.g., analyzed for waiting time and continuation, but not for annual number of new patients). To be considered analyzed in the flow diagram, a clinic must have been included in at least one primary outcomes analysis.

Time frame: 48 months (2 year baseline period and 2 year post-intervention period)

ArmMeasureValue (MEAN)Dispersion
Interest Circle Call + WebsiteChange in Annual Number of Patient Admissions-3.6 Percent change (approx.)95% Confidence Interval 0.04
Coaching + WebsiteChange in Annual Number of Patient Admissions19.5 Percent change (approx.)95% Confidence Interval 0.089
Full: LS, Coaching, ICC, WebsiteChange in Annual Number of Patient Admissions0.0 Percent change (approx.)95% Confidence Interval 0.065
Learning Session + WebsiteChange in Annual Number of Patient Admissions8.9 Percent change (approx.)95% Confidence Interval 0.041
Primary

Change in Average Continuation Rate Through the Fourth Treatment Session

This outcome represents change in the rate at which a clinic's patients continue in treatment. Continuation rate is defined as the percentage of patients that make at least 4 visits to the clinic, on different days, before being discharged. Estimates of improvement show the average percentage points of improvement per month based on a best linear unbiased predictor estimate for each site. Note: this study has three primary outcomes. The number of participants analyzed varies for each outcome. The (higher) number of clinics shown in the flow diagram results because clinics may have been analyzed on a subset of the three primary outcomes (e.g., analyzed for waiting time and continuation, but not for annual number of new patients). To be considered analyzed in the flow diagram, a clinic must have been included in at least one primary outcomes analysis.

Time frame: Baseline and 21 months

ArmMeasureValue (MEAN)Dispersion
Interest Circle Call + WebsiteChange in Average Continuation Rate Through the Fourth Treatment Session-.019 Change in continuation rateStandard Error 0.021
Coaching + WebsiteChange in Average Continuation Rate Through the Fourth Treatment Session-.02 Change in continuation rateStandard Error 0.016
Full: LS, Coaching, ICC, WebsiteChange in Average Continuation Rate Through the Fourth Treatment Session-.004 Change in continuation rateStandard Error 0.017
Learning Session + WebsiteChange in Average Continuation Rate Through the Fourth Treatment Session.013 Change in continuation rateStandard Error 0.018
Primary

Change in Average Waiting Time From First Contact to Treatment

The average length of time in days it takes from when a patient first calls for help to the time a patient was able to meet a clinician. In this quality improvement study, changes in this measure over time are reported. Estimates of improvement show the average days of improvement per month based on a best linear unbiased predictor estimate for each site. Note: this study has three primary outcomes. The number of participants analyzed varies for each outcome. The (higher) number of clinics shown in the flow diagram results because clinics may have been analyzed on a subset of the three primary outcomes (e.g., analyzed for waiting time and continuation, but not for annual number of new patients). To be considered analyzed in the flow diagram, a clinic must have been included in at least one primary outcomes analysis.

Time frame: Baseline and 15 months

ArmMeasureValue (MEAN)Dispersion
Interest Circle Call + WebsiteChange in Average Waiting Time From First Contact to Treatment.253 Change in daysStandard Error 1.514
Coaching + WebsiteChange in Average Waiting Time From First Contact to Treatment4.610 Change in daysStandard Error 1.414
Full: LS, Coaching, ICC, WebsiteChange in Average Waiting Time From First Contact to Treatment4.723 Change in daysStandard Error 1.421
Learning Session + WebsiteChange in Average Waiting Time From First Contact to Treatment3.520 Change in daysStandard Error 1.407
Secondary

Cost of Group

The goal of the economic analysis was to estimate costs of each group for governmental authorities who might organize improvement collaboratives. We collected the cost of personnel (state employees, NIATx employees, coaches and consultants), data management, buildings and facilities, lodging, travel, telephone calls and miscellaneous costs. Costs were categorized as group specific (such as hotel costs for the learning sessions group) or non-group-specific, which included state-incurred costs for outreach, data management and infrastructure, encouraging participation and administration. Cost data were collected three times during the study period and aggregated to create a total cost estimate. Figures reported below represent costs at the arm/group level (costs were not assessed at the organizational level). Measure type is Number.

Time frame: Baseline and 18 months

ArmMeasureValue (NUMBER)
Interest Circle Call + WebsiteCost of Group59790 USD ($)
Coaching + WebsiteCost of Group135244 USD ($)
Full: LS, Coaching, ICC, WebsiteCost of Group380652 USD ($)
Learning Session + WebsiteCost of Group229229 USD ($)

Source: ClinicalTrials.gov · Data processed: Mar 29, 2026