Diabetes MellitusPATHNCT02924207
Electronic Decision Support for Intervention in Poorly Controlled Type 2 Diabetes
A study testing PATH electronic decision support tool in people with Diabetes Mellitus, run by St Elizabeth Healthcare at 1 site in United States.
Trial summary
To determine the impact of an electronic decision support tool on physician decision making and patient outcomes for the treatment of poorly controlled diabetes mellitus. Primary endpoint will measure change in hemoglobin A1c. Secondary endpoints will examine cost of therapy and patient satisfaction with therapy. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- PATH electronic decision support tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to Dec 2018
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient under the care of a primary care physician within St. Elizabeth Physicians
- >=18 years of age
- Diagnosis of Type 2 Diabetes for at least 6 months
- Hemoglobin A1c values of >= 7.0 (drawn within the last year).
Who cannot join
- Type 1 Diabetes, Secondary Diabetes, Gestational Diabetes or LADA (presence of anti-GAD, IA-2, C-Peptide <0.5)
- Participant is currently or intended to start hemodialysis or peritoneal dialysis during the course of the study.
- Chronic or planned systemic glucocorticoid use
- Scheduled prandial insulin therapy (premix and basal okay)
- Other health threatening disease state at investigator's discretion
- Potential participant is unable to fully comprehend the risks of study participation or comply with study procedures.
- New diabetes intervention in the last 3 months (change in diabetes medication or dosage)
Trial locations and contacts
1 site in 1 country.
About this study
To determine the impact of an electronic decision support tool on physician decision making and patient outcomes for the treatment of poorly controlled diabetes mellitus. Primary endpoint will measure change in hemoglobin A1c. Secondary endpoints will examine cost of therapy and patient satisfaction with therapy. Study hypothesis is that use of the PATH decision tool will produce greater reduction overall in measurements of hemoglobin A1c in patients who participate and follow the PATH decision tool than patients who elect not to follow the PATH decision tool. PATH decision tool will provide more cost effective solutions for management of diabetic medication than current methods.
Read the detailed description
- Patients of selected St. Elizabeth Physicians Primary Care Physicians without a new intervention related to the management of the patient's diabetes in the last 3 months may be contacted via telephone by research staff.
- During the telephone call, patients will be offered the opportunity to manage their diabetic medication by following the PATH decision tool, explaining that PATH is a computer program which finds a balance between low cost and high effectiveness. If participation is elected, informed consent will be mailed with a follow up phone call from staff, or an informed consent will be signed at their upcoming primary care office visit. Some patients may be approached during their office visit, without a prior phone call. Patients who do not have an eligible hemoglobin A1c on file, but are expecting to have an eligible hemoglobin A1c value on an upcoming blood test may consent prior to the blood test. If the hemoglobin A1c comes back >=7.0, the patient will continue following protocol. If the hemoglobin A1c comes back <7.0, the patient will be categorized as a screen failure, but will remain eligible for later enrollment. If the patient becomes eligible and is later enrolled, the patient will be assigned a new study ID number.
- If a patient elects not to participate, the reason for not participating may be recorded in the screening log. As part of the standard of care, patients not selecting the study will be offered an appointment outside the study to address their poorly controlled diabetes. ii) If a patient elects to participate and a hemoglobin A1c has not been drawn in the last 3 months, one will be ordered through their insurance as part of the standard of care, to be used as the baseline hemoglobin A1c for Path calculations.
- Patients who agree to participate maybe contacted by telephone by a licensed provider (MD or ARNP) who will enter non identifiable data from the patient's chart into the PATH decision support software. Information will be gathered from the Epic EHR and the questionnaire found on Article #2. This questionnaire may be completed by the patient, or by staff during patient interview. Some patients may complete this process during their scheduled office visit.
- Study specific items will be recorded as illustrated in Article #4 ii) Time spent populating the data will be recorded, as part of the secondary analysis.
- Patient and provider will discuss options on the telephone or during the office visit, and will further customize regimen selections while discussing risks and benefits. Once a regimen is selected, the score and content of the regimen will be recorded by the provider.
- Regimen selected will be classified by "partial recommendation, full recommendation, alternate recommendation, or "no action" in relation to the options presented by the PATH program. --> final score of the course of action will be calculated and recorded.
- Definitions:
- Full recommendation: the regimen selected is the exact regimen shown in PATH, with no additions or deletions.
- Subset recommendation: the regimen selected is a subset of a regimen shown in PATH (i.e., with one or more deletions), with no additions.
- Example: PATH recommends the regimen (A, B, C, D)
- Valid subset regimens would include (A, B, C), (B, C, D), (A, B), and (A), among others.
- Superset recommendation: the regimen selected contains all of the elements of one regiment recommended by PATH, plus at least one other therapy.
- Example: PATH recommends the regimen (A, B, C)
- A valid superset recommendation would be (A, B, C, Exercise).
- Alternate recommendation: Any other combination of additions and deletions from a PATH recommended regimen.
- No action: No regimen was selected.
- Manufacturer Discount coupons will be offered and mailed if applicable as part of the normal procedures of the primary care office.
- Mailed coupons will be documented in the participant's study chart.
- If Path is completed over the phone, the patient will be offered immediate "in person" follow up (traditional visit) to review the changes. As this is appropriate to the treatment of diabetes, traditional CPT billing will be used and the in-person visit will be billed to insurance as part of standard of care.
- Patient's choice to participate in a traditional office visit will be recorded in the participant's study chart.
- Follow up visit or phone call will be scheduled at 3 months (+/- 30 days) with repeat hemoglobin A1c, following the standard of care for the treatment of diabetes. The 3 months (+/- 30 days) follow up window will be calculated from the date patients are informed of their new medication regimen. During this visit, diabetes evaluation will follow the standard of care including adherence, efficacy, and adverse events. Adverse events will be categorized through the "drug intolerance" and "comorbidities" section of the PATH software. See Article #6 i) Type of follow up will be recorded ("phone follow up, live follow up, no follow up"). Reason for no follow up will also be documented.
- Conditions
- Diabetes Mellitus
- Being tested
- PATH electronic decision support tool
- Keywords
- diabetes mellitus
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PATH electronic decision support toolOther
PATH, a clinical decision support tool for Type 2 Diabetes, was developed based on patient impact of efficacy, cost, implementation difficulty, comorbidities, side effects, and evidence based pleiotropic benefit. Drug efficacy was estimated using published clinical data for agents, both in terms of placebo controlled trials and head-to-head studies. Additional information regarding interventions was added with regard to FDA package inserts as well as large post marketing studies. Cost impact of intervention was described in terms of patient's estimated copay drawn from insurance plan as well as average retail price.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Path Electronic decision support arm Receives: Other: PATH electronic decision support tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in hemoglobin A1c from baseline
change in hemoglobin A1c from baseline
Measured: 1 year
Secondary outcomes (2)
change in patient's perception of cost of diabetes medicine and side effects
At baseline and 3 month follow up visits, patients will be asked to rate affordability of their medications on a scale of 1 to 10. Subjects will also be asked to rate their satisfaction on a scale of 1 to 10.
Measured: 1 year
actual cost and change in frequency of drug side effects
The actual change in the cost of the subjects medication will be recorded and compared to the subjects perception of cost. Subjects medical records will be reviewed for reported side affects and compared to subject reported satisfaction.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2016 (estimated)
- Study startSep 2016
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- St Elizabeth Healthcare
- Sponsor type
- University, hospital or other
- Collaborators
- PATH Decision Support Software, LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02924207
- Sponsor's protocol ID
- 6/2016-018
- Acronym
- PATH
- Status last verified
- Oct 2019
- First submitted
- 29 Sep 2016
- Last updated
- 9 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electronic Decision Support for Intervention in Poorly Controlled Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT02924207
- Acronym / sponsor ID
- PATH / 6/2016-018
- Conditions
- Diabetes Mellitus
- Keywords
- diabetes mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- St Elizabeth HealthcareUniversity, hospital or other
- Collaborators
- PATH Decision Support Software, LLC
- Study start
- Sep 2016
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 5 Oct 2016 (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.
To determine the impact of an electronic decision support tool on physician decision making and patient outcomes for the treatment of poorly controlled diabetes mellitus. Primary endpoint will measure change in hemoglobin A1c. Secondary endpoints will examine cost of therapy and patient satisfaction with therapy. Study hypothesis is that use of the PATH decision tool will produce greater reduction overall in measurements of hemoglobin A1c in patients who participate and follow the PATH decision tool than patients who elect not to follow the PATH decision tool. PATH decision tool will provide more cost effective solutions for management of diabetic medication than current methods.
Detailed description
- Patients of selected St. Elizabeth Physicians Primary Care Physicians without a new intervention related to the management of the patient's diabetes in the last 3 months may be contacted via telephone by research staff.
- During the telephone call, patients will be offered the opportunity to manage their diabetic medication by following the PATH decision tool, explaining that PATH is a computer program which finds a balance between low cost and high effectiveness. If participation is elected, informed consent will be mailed with a follow up phone call from staff, or an informed consent will be signed at their upcoming primary care office visit. Some patients may be approached during their office visit, without a prior phone call. Patients who do not have an eligible hemoglobin A1c on file, but are expecting to have an eligible hemoglobin A1c value on an upcoming blood test may consent prior to the blood test. If the hemoglobin A1c comes back >=7.0, the patient will continue following protocol. If the hemoglobin A1c comes back <7.0, the patient will be categorized as a screen failure, but will remain eligible for later enrollment. If the patient becomes eligible and is later enrolled, the patient will be assigned a new study ID number.
- If a patient elects not to participate, the reason for not participating may be recorded in the screening log. As part of the standard of care, patients not selecting the study will be offered an appointment outside the study to address their poorly controlled diabetes. ii) If a patient elects to participate and a hemoglobin A1c has not been drawn in the last 3 months, one will be ordered through their insurance as part of the standard of care, to be used as the baseline hemoglobin A1c for Path calculations.
- Patients who agree to participate maybe contacted by telephone by a licensed provider (MD or ARNP) who will enter non identifiable data from the patient's chart into the PATH decision support software. Information will be gathered from the Epic EHR and the questionnaire found on Article #2. This questionnaire may be completed by the patient, or by staff during patient interview. Some patients may complete this process during their scheduled office visit.
- Study specific items will be recorded as illustrated in Article #4 ii) Time spent populating the data will be recorded, as part of the secondary analysis.
- Patient and provider will discuss options on the telephone or during the office visit, and will further customize regimen selections while discussing risks and benefits. Once a regimen is selected, the score and content of the regimen will be recorded by the provider.
- Regimen selected will be classified by "partial recommendation, full recommendation, alternate recommendation, or "no action" in relation to the options presented by the PATH program. --> final score of the course of action will be calculated and recorded.
- Definitions:
- Full recommendation: the regimen selected is the exact regimen shown in PATH, with no additions or deletions.
- Subset recommendation: the regimen selected is a subset of a regimen shown in PATH (i.e., with one or more deletions), with no additions.
- Example: PATH recommends the regimen (A, B, C, D)
- Valid subset regimens would include (A, B, C), (B, C, D), (A, B), and (A), among others.
- Superset recommendation: the regimen selected contains all of the elements of one regiment recommended by PATH, plus at least one other therapy.
- Example: PATH recommends the regimen (A, B, C)
- A valid superset recommendation would be (A, B, C, Exercise).
- Alternate recommendation: Any other combination of additions and deletions from a PATH recommended regimen.
- No action: No regimen was selected.
- Manufacturer Discount coupons will be offered and mailed if applicable as part of the normal procedures of the primary care office.
- Mailed coupons will be documented in the participant's study chart.
- If Path is completed over the phone, the patient will be offered immediate "in person" follow up (traditional visit) to review the changes. As this is appropriate to the treatment of diabetes, traditional CPT billing will be used and the in-person visit will be billed to insurance as part of standard of care.
- Patient's choice to participate in a traditional office visit will be recorded in the participant's study chart.
- Follow up visit or phone call will be scheduled at 3 months (+/- 30 days) with repeat hemoglobin A1c, following the standard of care for the treatment of diabetes. The 3 months (+/- 30 days) follow up window will be calculated from the date patients are informed of their new medication regimen. During this visit, diabetes evaluation will follow the standard of care including adherence, efficacy, and adverse events. Adverse events will be categorized through the "drug intolerance" and "comorbidities" section of the PATH software. See Article #6 i) Type of follow up will be recorded ("phone follow up, live follow up, no follow up"). Reason for no follow up will also be documented.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: PATH electronic decision support toolPath Electronic decision support arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient under the care of a primary care physician within St. Elizabeth Physicians
- >=18 years of age
- Diagnosis of Type 2 Diabetes for at least 6 months
- Hemoglobin A1c values of >= 7.0 (drawn within the last year).
Key exclusion criteria (7 listed)
- Type 1 Diabetes, Secondary Diabetes, Gestational Diabetes or LADA (presence of anti-GAD, IA-2, C-Peptide <0.5)
- Participant is currently or intended to start hemodialysis or peritoneal dialysis during the course of the study.
- Chronic or planned systemic glucocorticoid use
- Scheduled prandial insulin therapy (premix and basal okay)
- Other health threatening disease state at investigator's discretion
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 |
|---|---|---|
| PATH electronic decision support toolPATH, a clinical decision support tool for Type 2 Diabetes, was developed based on patient impact of efficacy, cost, implementation difficulty, comorbidities, side effects, and evidence based pleiotropic benefit. Drug efficacy was estimated using published clinical data for agents, both in terms of placebo controlled trials and head-to-head studies. Additional information regarding interventions was added with regard to FDA package inserts as well as large post marketing studies. Cost impact of intervention was described in terms of patient's estimated copay drawn from insurance plan as well as average retail price. | Other | Intervention |
Primary outcome
change in hemoglobin A1c from baseline
Time frame: 1 year
change in hemoglobin A1c from baseline
2 secondary outcomes
change in patient's perception of cost of diabetes medicine and side effects
Time frame: 1 year
actual cost and change in frequency of drug side effects
Time frame: 1 year
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 2019.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PATH electronic decision support tool in people with Diabetes Mellitus, run by St Elizabeth Healthcare 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 4 inclusion and 7 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 2019. 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?
change in hemoglobin A1c from baseline (time frame: 1 year). 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 9 Oct 2019.