Program Evaluation: Project DAWN
Project DAWN is a community-based education and naloxone distribution program. The program serves to train interested individuals on how to administer naloxone, a nasally or intramuscular-ingested drug that counters the deadly respiratory effects of opioid overdose with minimal side-effects. Two main groups of people are targeted as participants in the program: medical personnel (EMT, police, firefighters, etc.) and individuals with experiences of opioid abuse (users, friends/family of users, individuals who have witnessed overdoses, etc.). Project DAWN is an Ohio Dept. of Health initiative, and has sites in over three dozen counties. It’s pilot program took place in Scioto County in 2012, but similar programs have existed in the United States since 2001. According to the CDC, an estimated 53,032 individuals have been trained and given naloxone as a result of programs similar to Project DAWN.[i]
– Medical Professionals willing to devote time to program
– Funding for program sites, naloxone, program analysis, etc.
– Real estate space within commutable vicinity of interested individuals
– Willing participants
– Training (for both medical personnel and participants)
– Distribution of naloxone to participants
– Measurements of drug use/effectiveness (self-report surveys and information gathered from participants upon refill of naloxone doses)
– Individuals trained on how to avoid and prevent deaths due to opioid overdose, armed with relevant medication
– Increase of naloxone available to individuals in risk of overdose
Outcomes – Short term:
– Prevented deaths from opioid overdoses
Compared to relevant alternatives, Project DAWN may increase the amount of successful reversals of opioid overdoses.
– Reduced drug use by program participants
Reports of similar programs have made note of participants self-reporting reduced drug usage due to training.
Outcomes – Medium term:
– Reduced crime associated with heroin trade/use
Reduced opioid usage and knowledge of the dangers of abuse may lead to leess trade and les crime associated with the trade
Outcomes – Long term:
– Lower costs transferred to taxpayers as a result of emergency treatment for opioid abuse
Since a substantial number of Americans are publicly insured or uninsured, and since hospitals bear significant cost in treating opioid abusers experiencing an overdose, much of this cost gets passed on to taxpayers. By reducing the need to hospitalize victims of overdoses by providing them a life-saving tool, this cost passed on may be reduced.
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External factors also play into the process and effectiveness of Project DAWN. These factors include, but are not limited to, “Good Samaritan” laws, area of program execution, and willingness of participants to keep naloxone kit on their person.
Sufficient data is not available to conclude that Project DAWN reduces that amount of deaths associated with opioid overdose. It is not known whether individuals would have passed without the use of the naloxone administered, it is not known whether trained individuals followed program guidelines correctly, etc. Unfortunately, data collected has guided the question being asked into one asking if Project DAWN saves lives. A more appropriate question may focus on the methods of data collection:
How many successful administrations of naloxone were given by individuals trained and equipped by Project DAWN?
More particularly due to it being the only county to collect and release any significant amount of data, the question will focus on how many successful administrations of naloxone were given in Lorain County.
Much of the naloxone distribution program data focuses on naloxone kits and training given to laypersons. Project DAWN does this, but also puts a large emphasis on disseminating naloxone to emergency management professionals.
The first known North American naloxone distribution program began in San Francisco in 2001. The effectiveness of the program was questionable, but promising. The pilot study[ii] suffered from a small sample size (24 participants), no control group, and a seemingly non-random sample. Despite this, some of the results of the program were surprising. First off, individuals trained through the program reported using less heroin after their training than before, despite this not being an original purpose. Next, more than 20 overdoses (with victims being unconscious, unresponsive, etc.) were successfully overturned, resulting in zero deaths. An emphasis was placed during the participants’ training on alerting authorities in the cases of opioid overdose, but only two calls were placed by participants to 911 out of the 20 overdoses reported, possibly because of fear of punishment by police. While there are several very different characteristics between the naloxone distribution programs in San Francisco and Ohio, San Francisco’s program laid the foundation and helped support the case for bringing similar programs to the United States.[iii] Both the rate of overdoses overturned and the willingness of participants to involve the police when necessary should be considered.
Gaston et al. (2009) found that training increased the overall knowledge of signs of an overdose for participants in an English naloxone distribution program, and this knowledge remained for at least six months. This study also identifies a potential shortfall in naloxone distribution programs; a large portion of individuals stored their naloxone at their homes (81% in this case), meaning overdoses can only be reversed if they occur in the participants’ homes. Participants in Project DAWN may suffer from the same limitations should they choose to store their naloxone instead of carrying it with them. This study also concludes that success of naloxone programs centers around “[c]hanges in prescription laws, increasing education and communication between the police force, emergency services and opiate users and reducing the stigma”[iv] associated with opioid use. For Project DAWN, it may be worth considering the environment surrounding the program. Good Samaritan laws and prescription laws should be considered when gauging the effectiveness of Project DAWN.
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A meta-analysis of naloxone distribution programs published in 2015 by Giglio et al. finds that existing “research literature suggests that bystander naloxone administration and overdose education programs are associated with increased odds of recovery and with improved knowledge of overdose recognition and management in non-clinical settings.”[v] The authors find that, among the 66 observations in the four collected studies focusing on individuals treated with naloxone from the distribution programs, “39 (59.1%) recovered after naloxone was administered by a lay participant and 22 (33.3%) recovered without the administration of naloxone. There were no deaths among the 39 instances when naloxone was administered. There were three deaths among the 27 instances when naloxone was not administered, for an 11.1% mortality rate.”[vi] Three of the four studies analyzing the effectiveness of naloxone relied on self-report surveys. The studies that analyzed the effectiveness of training programs (how to administer naloxone, how to identify overdoses, how to respond to overdoses) relied on post-tests given to participants and non-participants. There are several concerns that arise upon reading the methods of this study, though. Of the over 780 studies that are originally compiled by the authors to use in their meta-analysis, only 9 were deemed eligible and were included in their quantitative study. This is a small sample size, and the conclusions drawn from this small data set may not be generalizable to a location like Ohio. The study does identify measures that may be used to evaluate Project DAWN, though, should data be available. Namely, what is the mortality rate of individuals treated by naloxone-equipped Project DAWN participants, and how effective is training at increasing one’s ability to administer naloxone and identify/respond to overdoses.
Unprocessed data on Project DAWN is unavailable, perhaps due to the nature of the laws surrounding the dispersal of drugs classified as dangerous (naloxone). Ample results are available from data that has already been collected and processed, but data from specific observations for each set of data is unavailable. Concerning the furnishment of naloxone to either emergency personnel or laypersons for use on themselves or friends/family, the program has been designed in a way such that a comprehensive database is not available. While the Ohio Revised Code allows a physician to give naloxone to “(1) An individual who there is reason to believe is experiencing or at risk of experiencing an opioid-related overdose; or (2) A family member, friend, or other person in a position to assist an individual who there is reason to believe is at risk of experiencing an opioid-related overdose” (Section 4731.941), a physician is forced to establish his/her own specific protocol for furnishing naloxone, so long as he/she provides sufficient information in writing before he/she begins furnishment, which includes, among the 7 listed requirements, “[t]raining requirements that must be met before an individual will be authorized to furnish naloxone” and “[a]ny instructions or training that the authorized individual must provide to an individual to whom naloxone is furnished.” (Section 4731.941) The Ohio Dept. of Health specifies that no sample protocol exists[vii], meaning there is no standardized training requirement for any layperson trained by a physician to participate and be administered naloxone in Project DAWN.
Concerning training, while Ohio Administrative Code requires each prescriber or distributor of naloxone to keep records of sales and to whom sales are made (OAC 4729-9-22 (B)), there is nothing requiring the sharing of data unless requested by a “state board of pharmacy officer, agent, and/or inspector” (OAC 4729-9-22 (E)). There is no information on what is included on naloxone training since the prescriber has nearly full discretion for training both emergency personnel and laypersons, short of a requirement that the person receiving naloxone be instructed to summon emergency services in the case of an overdose.
An indication of what a typical training program would consist of may be given by information released by counties. Certain counties such as Portsmouth County outline what training should emphasize, such as “Recognizing the signs and symptoms of overdose; Distinguishing between different types of overdose; Rescue breathing and the rescue position; The importance of calling 911; Proper administration of Naloxone (intranasal)”.[viii]
I’ve decided that the best course of action is use the only available information on naloxone administration from the pilot program in Lorain County. Lorain County’s program has measured:
69 total administrations of nasal naloxone due to the pilot
63 Total known reversals
48 Police reversals
15 Fire reversals
2 Unknown Results (the status of the patient was unknown once turned over to EMS)
2 Ineffective (the cause of the symptoms was determined not likely opioid related)[ix]
My units of analysis will be Ohio Counties, and outcome variables will include total number of administrations. By considering total treatments and the success rate of each treatment, it may be easier to determine how strong of a relationship there is between naloxone administration and survival rate amongst those treated, though I cannot expect to reach a solid conclusion.
The interpretation of data in the Lorain County case is very limited, though it has strengths. If considering the design originally presented by lorain County, considering whether or not Project DAWN saves lives, weaknesses outweigh strengths. regarding strengths, first, the data was collected and self-reported my professionals in the emergency response field. Second, successful reversals are an indication that, if trying to interpret the effectiveness of naloxone and overdose training, training is effective.
There are considerable threats to internal validity, though. Observations of successful reversals is by nature accurate if an individual survived, but there is no way to tell if naloxone administered by emergency personnel is the reason for the survival. Due to the high rate of survival from opioid overdose without emergency treatment, it may be possible the naloxone had negligible effects or solely increased the speed of an inevitable recovery. It may also be possible that the alternative to naloxone treatment (which in the case of many Ohio counties would be IV treatment and hospital observation) would have been as or more effective. It may also be the case that there is a systematic bias in the observations of individuals in the Lorain County pilot. Since all individuals treated by emergency personnel were in a situation in which they or someone caring for their personal health were willing to call emergency services, it may be case those same people have an already higher likelihood to survive an overdose than the general overdose victim in Ohio (perhaps other safety measures were prepared, more caution is taken in the consumption of drugs, etc.).
Regarding external validity, strengths may include the possibility that similar training will have been undergone by emergency personnel in all Ohio counties, possibly resulting in a more similar treatment of naloxone to individuals overdosing. Also, counties with similar characteristics regarding the type of opioids most commonly abused (prescription drugs, heroin, fentanyl, etc.) may experience similar responses to the treatment that Project DAWN gave to Lorain County overdose victims.
Weaknesses of this design are numerous. Not only are there a host of variables that aren’t accounted for in the experiment conducted by Lorain (response time in relation to overdose incident, number of vials of naloxone present at each scene, etc.), but the sample size and variables collected about the pre- and post-treatment of Project DAWN overdose treatment is minimal.
Unfortunately, due to lack of other resources and data, a conclusion as to whether Project DAWN is effective to saving lives is out of the question. There is limited “pre-“ data on Lorain, and available data is made more difficult to interpret against “post-“data due to Project DAWN’s limited treatment on emergency personnel in the county. An outcome question such as “How many successful administrations of naloxone were given by individuals trained and equipped by Project DAWN?” is more appropriate. Even this question, though, is limited due to the inability to decipher whether naloxone administrations were successful or whether recovery of victims was to occur whether or no they were treated with naloxone.
Data analysis for the proposed question “How many successful administrations of naloxone were given by individuals trained and equipped by Project DAWN?” is very straightforward. Lorain County has released a report detailing administrations of naloxone by program participants. Program participants, by law, have been given necessary (though not uniform” training. The main point of contention surrounds how “successful” is determined in the question. If interpreted as the number of individuals who have survived after being treated by naloxone, the answer is at least 63. Should “successful” be interpreted as the number of reversals and survivals as a direct result of naloxone administration by Project DAWN individuals, the number may change.
Naloxone distribution programs have been plagued by limited data collection during execution since their American inception in 2001. Project DAWN is no exception. Though the original pilot took place in 2012, data collection efforts have been almost non-existent outside of Lorain County. As the data section outlines, this is likely due to the codes surrounding drug dissemination and privacy laws regarding collection of information surrounding overdoses and medical actions taken. The success of Project DAWN, still in its early stages, is unknown and certainly not statistically significant. The limited data currently available suggests that reversals by “first responders” such as firefighters and police officers may prevent deaths, assuming those officers continue to be well-equipped to respond to such incidents over time.
[i] Project DAWN (Deaths Avoided with Naloxone). Ohio Department of Health. http://www.odh.ohio.gov/health/vipp/drug/ProjectDAWN.aspx.
[ii] Seal et al. Naloxone Distribution and Cardiopulmonary Resuscitation Training for Injection Drug Users to Prevent Heroin Overdose Death: A Pilot Intervention Study. Journal of Urban Health (2005) Vol. 82, Issue 2.
[iii] Seal et al. Naloxone Distribution
[iv] Gaston et al. Can we prevent drug related deaths by training opioid users to recognize and manage overdoses?. Harm Reduction Journal (2009) 6:26
[v] Giglio et al. Effectiveness of bystander naloxone administration
and overdose education programs: a meta-analysis. Injury Epidemiology (2015) 2:10
[vi] Giglio et al. Effectiveness of bystander.
[vii] Guidance Document – Personally Furnishing Naloxone Pursuant to a Protocol. http://www.odh.ohio.gov/-/media/ODH/ASSETS/Files/health/injury-prevention/Project-Dawn-Toolkit/1-Personally-Furnishing-Naloxone-Pursuant-to-a-Protocol.pdf?la=en
[viii] Project D.A.W.N. (Deaths Avoided With Naloxone) Overdose Reversal Project. http://www.healthy.ohio.gov/vipp/drug/~/media/11A4765509B74405BF6CE39954AF0AF6.ashx
[ix] Project DAWN Lorain County Pilot Year End Report. http://www.lorainadas.org/wp-content/uploads/SB-57-Project-DAWN-Lorain-Pilot-Year-End-Report-distributed.pdf
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