Alcohol DrinkingReDIALNCT01326169
ReDIAL: A Telephone Brief Intervention for Injured Emergency Department Patients
A study testing Brief intervention in people with Alcohol Drinking, run by Rhode Island Hospital at 2 sites in United States.
Trial summary
The goal of this study is to reduce impaired driving, risky driving and alcohol-related negative consequences among injured emergency department (ED) patients through a telephone brief intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Drinking
- What is being tested?
- Brief intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 730 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2010to May 2014
- 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
- English or Spanish speaking
- Age greater than 17 years
- ASSIST score >=11
- Injured Emergency Department patient at time of consent
Who cannot join
- Medically unable to give consent
- Not English or Spanish speaking
- Homeless
- Cannot be contacted by telephone
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Rhode Island Hospital
Providence, Rhode Island, 02903
The Miriam Hospital
Providence, Rhode Island, 02906
About this study
The goal of this study is to reduce impaired driving, risky driving and alcohol-related negative consequences among injured emergency department (ED) patients through a telephone brief intervention. This study will allow researchers to test a novel method of brief intervention that has the potential to be convenient and efficient mechanism to deliver an intervention to an at-risk population. Eligible patients will be consented in the ED, will receive an assessment and then will be randomized into one of two conditions: 1) telephone brief intervention or 2) a comparison control group with a home safety educational program. The participant will also receive an appointment for an initial telephone call. Both conditions will be provided over three telephone sessions: the initial call (immediately following randomization) and two booster calls at 2 weeks and 6 weeks after randomization. Participants will provide information about their alcohol use, alcohol-related injuries, impaired driving, and other driving related negative consequences at 4, 8, and 12 months post-randomization.
- Conditions
- Alcohol Drinking
- Being tested
- Brief intervention, Standard care
- Keywords
- Alcohol, brief intervention, injuries
- Medical subject headings
- Alcohol Drinking, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief interventionBehavioural
Telephone-delivered counseling
Standard careBehavioural
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Standard care | Active comparator | No intervention Receives: Behavioral: Standard care |
| Counseling | Experimental | Telephone-delivered counseling Receives: Behavioral: Brief intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in number of patients with alcohol-related negative consequences from baseline to 4, 8, and 12 months post-randomization
Specifically, the effect of the intervention on alcohol-related injuries and alcohol-related psychosocial consequences from baseline at 4, 8, and 12 months post-randomization.
Measured: Change from baseline in alcohol-related negatve consequences at 4, 8, and 12 months
Secondary outcomes (1)
Evaluation of mechanisms of change model
Determine the moderators and mediators of primary outcomes.
Measured: 12 months post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2011 (estimated)
- Study startMar 2010
- Primary completionMar 2013
- Study completionMay 2014
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 Alcohol DrinkingStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 730 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael J. Mello, MD, MPH, Rhode Island Hospital
- Investigators
- Michael J Mello, MD, MPH, Principal investigator, Rhode Island Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01326169
- Sponsor's protocol ID
- 1R01AA017895
- Acronym
- ReDIAL
- Status last verified
- Sep 2014
- First submitted
- 28 Mar 2011
- Last updated
- 11 Sep 2014
- Results posted
- No
Publications
Mello MJ, Baird J, Lee C, Strezsak V, French MT, Longabaugh R. A Randomized Controlled Trial of a Telephone Intervention for Alcohol Misuse With Injured Emergency Department Patients. Ann Emerg Med. 2016 Feb;67(2):263-75. doi: 10.1016/j.annemergmed.2015.09.021. Epub 2015 Nov 14.
PubMed 26585044
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ReDIAL: A Telephone Brief Intervention for Injured Emergency Department Patients
- ClinicalTrials.gov ID
- NCT01326169
- Acronym / sponsor ID
- ReDIAL / 1R01AA017895
- Conditions
- Alcohol Drinking
- Keywords
- Alcohol, brief intervention, injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 730 participants (actual)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Mar 2013 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 30 Mar 2011 (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 goal of this study is to reduce impaired driving, risky driving and alcohol-related negative consequences among injured emergency department (ED) patients through a telephone brief intervention. This study will allow researchers to test a novel method of brief intervention that has the potential to be convenient and efficient mechanism to deliver an intervention to an at-risk population. Eligible patients will be consented in the ED, will receive an assessment and then will be randomized into one of two conditions: 1) telephone brief intervention or 2) a comparison control group with a home safety educational program. The participant will also receive an appointment for an initial telephone call. Both conditions will be provided over three telephone sessions: the initial call (immediately following randomization) and two booster calls at 2 weeks and 6 weeks after randomization. Participants will provide information about their alcohol use, alcohol-related injuries, impaired driving, and other driving related negative consequences at 4, 8, and 12 months post-randomization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care | Active comparator | Behavioral: Standard careNo intervention |
| Counseling | Experimental | Behavioral: Brief interventionTelephone-delivered counseling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- English or Spanish speaking
- Age greater than 17 years
- ASSIST score >=11
- Injured Emergency Department patient at time of consent
Key exclusion criteria (4 listed)
- Medically unable to give consent
- Not English or Spanish speaking
- Homeless
- Cannot be contacted by telephone
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 |
|---|---|---|
| Brief interventionTelephone-delivered counseling | Behavioural | Counseling |
| Standard careNo intervention | Behavioural | Standard care |
Primary outcome
Change in number of patients with alcohol-related negative consequences from baseline to 4, 8, and 12 months post-randomization
Time frame: Change from baseline in alcohol-related negatve consequences at 4, 8, and 12 months
Specifically, the effect of the intervention on alcohol-related injuries and alcohol-related psychosocial consequences from baseline at 4, 8, and 12 months post-randomization.
1 secondary outcome
Evaluation of mechanisms of change model
Time frame: 12 months post-randomization
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 11 Sep 2014.
- Derived from this study: PubMed 26585044Mello MJ, Baird J, Lee C, Strezsak V, French MT, Longabaugh R. A Randomized Controlled Trial of a Telephone Intervention for Alcohol Misuse With Injured Emergency Department Patients. Ann Emerg Med. 2016 Feb;67(2):263-75. doi: 10.1016/j.annemergmed.2015.09.021. Epub 2015 Nov 14.
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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.
Michael J Mello, MD, MPH principal investigator
Rhode Island Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief intervention in people with Alcohol Drinking, run by Rhode Island Hospital 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 4 inclusion and 4 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 11 Sep 2014. 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?
Change in number of patients with alcohol-related negative consequences from baseline to 4, 8, and 12 months post-randomization (time frame: Change from baseline in alcohol-related negatve consequences at 4, 8, and 12 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 NCT01326169, 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 11 Sep 2014.