HIV DiseaseTOWERNCT03669939
Toward Safer Opioid Prescribing for Chronic Pain in High Risk Populations
An observational study of HIV Disease and Chronic Pain, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
The overarching plan for TOWER is to develop and test an algorithmic version of the Center for Disease Control Guidelines (CDCG) tailored for a specific primary care setting, the HIV primary care clinic. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Disease, Chronic Pain
- What is being tested?
- Communication Strategy
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2018to 30 Sep 2020
- Phase
- Observational
- 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
Study population: Primary Care Providers who treat HIV patients in the Institute of Advanced Medicine Institute at Mount Sinai Health System
Who may be able to join
- Attending physician or advance practice provider in one of the Institute of Advanced Medicine (IAM) clinics
- Designated PCP for at least 5 patients to whom he/she prescribes opioids
- Willing and able to adhere to study procedures including randomization, and refraining from discussion of study procedures with other clinical staff or patients
Who cannot join
- Unwillingness to undergo randomization
- Plans to leave IAM within the study period.
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 11101
About this study
Official title: Toward Safer Opioid Prescribing for Chronic Pain in High Risk Populations: Implementing the Centers for Disease Control Guideline (CDC) Guideline in the Primary Care HIV Clinic.
The overarching plan for TOWER is to develop and test an algorithmic version of the Center for Disease Control Guidelines (CDCG) tailored for a specific primary care setting, the HIV primary care clinic. This CDCG intervention incorporates communication and implementation strategies tailored for the HIV primary care setting, and enabled with technology (an app for use by patients and EMR tools for providers).
Read the detailed description
However, according to a 2014 AHRQ report, there have been no studies evaluating the effectiveness of any prescription opioid risk mitigation strategies. Furthermore, due to ambiguity in some of the CDCG recommendations and the challenging nature of the patient-provider opioid conversation, the success of the CDCG may hinge on the manner in which it is implemented in individual care settings. Thus it is unclear what the true effect of the CDCG will be. The investigators believe that for the CDCG to have the greatest likelihood of achieving its goals of improving prescription opioid safety without causing unintended effects (e.g. exacerbation of pain, disruption of other aspects of care), its recommendations will need to be skillfully communicated. Furthermore, because of this "human element"and other sources of variability, documenting the effectiveness of the CDCG will require standardization of implementation. The overarching plan for TOWER is to develop and test an algorithmic version of the CDCG tailored for a specific primary care setting, the HIV primary care clinic. This CDCG intervention incorporates communication and implementation strategies tailored for the HIV primary care setting, and enabled with technology (an app for use by patients and EMR tools for providers). Achieving this goal has involved soliciting input from the HIV community using the method of Public Deliberation (PD) in the setting of two Citizen' s Panels, each with ~22 HIV-infected participants and lasting one day; and using the information obtained from the deliberative process to inform the development of the CDCG intervention. The investigators now plan to test the CDCG intervention for feasibility.
- Conditions
- HIV Disease, Chronic Pain
- Being tested
- Communication Strategy, Standard of Care
- Keywords
- Center for Disease Control Guidelines, Opioids for chronic pain, communication strategies
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Communication StrategyOther
Communication Strategy The intervention consists of a handbook that refers to the CDC Guidelines with tools and communication strategies that the PCP can use when assessing their patients who are on opioids. The Handbook will have a description of the Ohm-app and the information the PCP can retrieve from the dashboard in their medical record. They will also be provided a template to use when seeing the patient to use as guide and as documentation.
Standard of CareOther
The standard information about the CDC Guidelines and no other information that is available through the study.
| Study group | Role | What they receive |
|---|---|---|
| Communication strategy | Primary Care providers who see HIV patients and follow them on opiates for chronic pain to receive communication strategies developed by the study team wit the guidance from the HV community and providers Receives: Other: Communication Strategy | |
| Standard of Care | Primary Care Providers - who see HIV patients and follow them on opiates for chronic pain will receive education on the the standard information about the CDC Guidelines Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of eligible PCPs who successfully complete randomization
Feasibility of recruitment and randomization of PCPs, reflected by the proportion of eligible PCPs who successfully complete randomization (where the denominator is the total number of PCPs offered participation).
Measured: 18 months
Secondary outcomes (1)
Percentage of items in the CDCG intervention which were adhered to
Maintenance of intervention fidelity will be ascertained using the audiotaped data from the clinic visits, and will be described as the percentage of items in the CDCG intervention which were adhered to.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2018
- Study start5 Oct 2018
- Primary completion30 Sep 2020
- Study completion30 Sep 2020
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 HIV DiseaseStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- The New York Academy of Medicine
- Responsible party
- Principal investigator, Jessica Robinson-Papp, Icahn School of Medicine at Mount Sinai
- Investigators
- Jessica Robinson-Papp, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03669939
- Sponsor's protocol ID
- GCO 17-0154
- Acronym
- TOWER
- Status last verified
- Oct 2020
- First submitted
- 22 Aug 2018
- Last updated
- 9 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Clinical information that is relevant to the provider or patient
Publications
Cedillo G, George MC, Deshpande R, Benn EKT, Navis A, Nmashie A, Siddiqui A, Mueller BR, Chikamoto Y, Weiss L, Scherer M, Kamler A, Aberg JA, Vickrey BG, Bryan A, Horn B, Starkweather A, Fisher J, Robinson-Papp J. Toward Safer Opioid Prescribing in HIV care (TOWER): a mixed-methods, cluster-randomized trial. Addict Sci Clin Pract. 2022 May 16;17(1):28. doi: 10.1186/s13722-022-00311-8.
PubMed 35578356
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Toward Safer Opioid Prescribing for Chronic Pain in High Risk Populations: Implementing the Centers for Disease Control Guideline (CDC) Guideline in the Primary Care HIV Clinic.
- ClinicalTrials.gov ID
- NCT03669939
- Acronym / sponsor ID
- TOWER / GCO 17-0154
- Conditions
- HIV Disease, Chronic Pain
- Keywords
- Center for Disease Control Guidelines, Opioids for chronic pain, communication strategies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- The New York Academy of Medicine
- Study start
- 5 Oct 2018 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 13 Sep 2018 (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.
The overarching plan for TOWER is to develop and test an algorithmic version of the Center for Disease Control Guidelines (CDCG) tailored for a specific primary care setting, the HIV primary care clinic. This CDCG intervention incorporates communication and implementation strategies tailored for the HIV primary care setting, and enabled with technology (an app for use by patients and EMR tools for providers).
Detailed description
However, according to a 2014 AHRQ report, there have been no studies evaluating the effectiveness of any prescription opioid risk mitigation strategies. Furthermore, due to ambiguity in some of the CDCG recommendations and the challenging nature of the patient-provider opioid conversation, the success of the CDCG may hinge on the manner in which it is implemented in individual care settings. Thus it is unclear what the true effect of the CDCG will be. The investigators believe that for the CDCG to have the greatest likelihood of achieving its goals of improving prescription opioid safety without causing unintended effects (e.g. exacerbation of pain, disruption of other aspects of care), its recommendations will need to be skillfully communicated. Furthermore, because of this "human element"and other sources of variability, documenting the effectiveness of the CDCG will require standardization of implementation. The overarching plan for TOWER is to develop and test an algorithmic version of the CDCG tailored for a specific primary care setting, the HIV primary care clinic. This CDCG intervention incorporates communication and implementation strategies tailored for the HIV primary care setting, and enabled with technology (an app for use by patients and EMR tools for providers). Achieving this goal has involved soliciting input from the HIV community using the method of Public Deliberation (PD) in the setting of two Citizen' s Panels, each with ~22 HIV-infected participants and lasting one day; and using the information obtained from the deliberative process to inform the development of the CDCG intervention. The investigators now plan to test the CDCG intervention for feasibility.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Communication strategy | – | Other: Communication StrategyPrimary Care providers who see HIV patients and follow them on opiates for chronic pain to receive communication strategies developed by the study team wit the guidance from the HV community and providers |
| Standard of Care | – | Other: Standard of CarePrimary Care Providers - who see HIV patients and follow them on opiates for chronic pain will receive education on the the standard information about the CDC Guidelines |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary Care Providers who treat HIV patients in the Institute of Advanced Medicine Institute at Mount Sinai Health System
Key inclusion criteria (3 listed)
- Attending physician or advance practice provider in one of the Institute of Advanced Medicine (IAM) clinics
- Designated PCP for at least 5 patients to whom he/she prescribes opioids
- Willing and able to adhere to study procedures including randomization, and refraining from discussion of study procedures with other clinical staff or patients
Key exclusion criteria (2 listed)
- Unwillingness to undergo randomization
- Plans to leave IAM within the study period.
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 |
|---|---|---|
| Communication StrategyCommunication Strategy The intervention consists of a handbook that refers to the CDC Guidelines with tools and communication strategies that the PCP can use when assessing their patients who are on opioids. The Handbook will have a description of the Ohm-app and the information the PCP can retrieve from the dashboard in their medical record. They will also be provided a template to use when seeing the patient to use as guide and as documentation. | Other | Communication strategy |
| Standard of CareThe standard information about the CDC Guidelines and no other information that is available through the study. | Other | Standard of Care |
Primary outcome
Proportion of eligible PCPs who successfully complete randomization
Time frame: 18 months
Feasibility of recruitment and randomization of PCPs, reflected by the proportion of eligible PCPs who successfully complete randomization (where the denominator is the total number of PCPs offered participation).
1 secondary outcome
Percentage of items in the CDCG intervention which were adhered to
Time frame: 18 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 9 Oct 2020.
- Derived from this study: PubMed 35578356Cedillo G, George MC, Deshpande R, Benn EKT, Navis A, Nmashie A, Siddiqui A, Mueller BR, Chikamoto Y, Weiss L, Scherer M, Kamler A, Aberg JA, Vickrey BG, Bryan A, Horn B, Starkweather A, Fisher J, Robinson-Papp J. Toward Safer Opioid Prescribing in HIV care (TOWER): a mixed-methods, cluster-randomized trial. Addict Sci Clin Pract. 2022 May 16;17(1):28. doi: 10.1186/s13722-022-00311-8.
- Individual participant dataSharing planned: Yes. Clinical information that is relevant to the provider or patient
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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.
Jessica Robinson-Papp, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Disease and Chronic Pain, run by Icahn School of Medicine at Mount Sinai 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 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 9 Oct 2020. 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?
Proportion of eligible PCPs who successfully complete randomization (time frame: 18 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 NCT03669939, 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 9 Oct 2020.