Targeted Adherence Intervention to Reach Glycemic Control With Insulin Therapy for Patients With Diabetes (TARGIT-DM)
Targeted Adherence Intervention to Reach Glycemic Control With Insulin Therapy for Patients With Diabetes (TARGIT-DM)
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
In an era of rapidly growing healthcare costs, due to in large part to the increasing burden and complexity of chronic disease management, targeting outreach to patients who are most likely to benefit from them and tailoring interventions to individual patient needs, represent important opportunities to maximize healthcare value. The Targeted Adherence intervention to Reach Glycemic control with Insulin Therapy for patients with Diabetes (TARGIT-DM) trial is a pragmatic, intention-to-treat, randomized-controlled study that will evaluate the impact of three equivalently-priced strategies to improve insulin persistence and glycosylated hemoglobin [HbA1c] control among patients with diabetes on insulin.
The interventions in each of the three study arms will consist of educational mailings and telephonic pharmacist outreach. The pharmacists will assess and address potential barriers to insulin adherence and optimal glycemic control. The three study arms will employ differ both in regards to which patients are targeted and the intensity of the engagement strategy used. The low intensity intervention in arm 1 will be deployed to all subjects randomized to that arm. The moderate and high intensity interventions will be delivered to focused populations within arms 2 and 3, respectively, as defined by poor disease control and/or predicted risk of non-adherence. The interventions provided in the moderate and high intensity arms will also include feedback to the patient's provider, as needed, and potential enrollment in a text messaging program. Patients in these two arms who are not targeted will receive usual care.
The study population for this trial will consist of members enrolled in commercial insurance provided by Horizon Blue Cross Blue Shield of New Jersey. Insurance claims data will be used to apply the inclusion and exclusion criteria. Eligible patients will be randomized into one of three arms, stratified by baseline availability of HbA1c and a valid telephone number.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
New Jersey
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Newark, New Jersey, Forente stater, 07105-2200
- Horizon Blue Cross Blue Shield of New Jersey
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Commercially-insured individuals receiving medical and pharmacy health insurance benefits from Horizon Blue Cross Blue Shield of New Jersey
- At least 3 months of continuous enrollment prior to randomization
- At least 1 prescription for basal insulin, 6 months prior to randomization
- Type 2 diabetes diagnosis
Exclusion Criteria:
- Patients with Medicaid or Medicare as primary insurance
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: Low intensity
All participants randomized to this arm will receive quarterly educational mailings and limited telephonic outreach delivered by a pharmacist focused on insulin adherence and glycemic control.
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Low intensity telepharmacy outreach
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Eksperimentell: Moderate intensity
Participants will receive all intervention components as in the low-intensity arm but will receive more frequent pharmacist follow-up and the option of enrolling in a text-messaging program.
The pharmacist will also provide limited follow-up with the participant's provider.
Only 60% of participants randomized will be targeted to receive the intervention based on adherence risk score.
|
Moderate intensity telepharmacy outreach
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Eksperimentell: High intensity
Participants will receive all intervention components as in the moderate-intensity arm but will receive more frequent pharmacist follow-up.
The pharmacist will also provide more follow-up with the participant's provider and/or pharmacist.
Only 40% of participants randomized will be targeted to receive the intervention based on adherence risk score and baseline disease control.
|
High intensity telepharmacy outreach
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Insulin Persistence
Tidsramme: From 1 month (30 days) after randomization through 12 months (365 days) after randomization
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Percentage of participants who were non-persistent if they did not refill insulin before a set threshold of time over the entire follow-up period
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From 1 month (30 days) after randomization through 12 months (365 days) after randomization
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Glycated Hemoglobin Level (HbA1c)
Tidsramme: From 1 month (30 days) after randomization through 12 months (365 days) after randomization
|
The percent change in HbA1c level between the latest baseline value to the latest follow up value, among those with at least 1 baseline HbA1c available.
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From 1 month (30 days) after randomization through 12 months (365 days) after randomization
|
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Health Care Spending
Tidsramme: From 1 month (30 days) after randomization through 12 months (365 days) after randomization
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Health care spending includes prescription medications, nondrug medical services, and the combination of these two factors over the entire follow-up period
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From 1 month (30 days) after randomization through 12 months (365 days) after randomization
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Number of Physician Office Visits
Tidsramme: From 1 month (30 days) after randomization through 12 months (365 days) after randomization
|
Number of all-cause physician office visits over the entire follow-up period
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From 1 month (30 days) after randomization through 12 months (365 days) after randomization
|
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Number of Emergency Room Visits
Tidsramme: From 1 month (30 days) after randomization through 12 months (365 days) after randomization
|
Number of all-cause emergency room visits over the entire follow-up period
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From 1 month (30 days) after randomization through 12 months (365 days) after randomization
|
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Number of Hospitalizations
Tidsramme: From 1 month (30 days) after randomization through 12 months (365 days) after randomization
|
Number of All-cause hospitalizations over the entire follow-up period
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From 1 month (30 days) after randomization through 12 months (365 days) after randomization
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Lauffenburger JC, Lewey J, Jan S, Makanji S, Ferro CA, Krumme AA, Lee J, Ghazinouri R, Haff N, Choudhry NK. Effectiveness of Targeted Insulin-Adherence Interventions for Glycemic Control Using Predictive Analytics Among Patients With Type 2 Diabetes: A Randomized Clinical Trial. JAMA Netw Open. 2019 Mar 1;2(3):e190657. doi: 10.1001/jamanetworkopen.2019.0657. Erratum In: JAMA Netw Open. 2019 Jul 3;2(7):e198448.
- Lewey J, Wei W, Lauffenburger JC, Makanji S, Chant A, DiGeronimo J, Nanchanatt G, Jan S, Choudhry NK. Targeted Adherence Intervention to Reach Glycemic Control with Insulin Therapy for patients with Diabetes (TARGIT-Diabetes): rationale and design of a pragmatic randomised clinical trial. BMJ Open. 2017 Oct 30;7(10):e016551. doi: 10.1136/bmjopen-2017-016551.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2016P000648
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