Harnessing Health IT for Self-Management Support and Medication Activation in a Medicaid Health Plan

NCT ID: NCT00683020

Last Updated: 2013-05-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

362 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2012-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To measure the effects of a Medical health plan-directed automated telephone self-management support system (ATSM) on patient outcomes among ethnically diverse health plan enrollees with diabetes.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

We will be conducting an evaluation of a quality improvement initiative that the San Francisco Health Plan (SFHP), a large Medicaid managed care plan in SF, is conducting for approximately 500 SFHP enrollees with diabetes who are attending 4 Community Health Network Clinics in San Francisco (CHNSF) over a two year period. The intervention that SFHP is implementing is Automated Telephone Support Management (ATSM), a health IT innovation used as adjunct to care management. The partnership with University of California, San Francisco-San Francisco General Hospital (UCSF-SFGH) researchers is based on previous work we have done in the CHNSF regarding using ATSM among diabetes patients to improve self-management activities and other health outcomes,but in the current demonstration project and evaluation, the recruitment of participants and implementation of the intervention will be done by the SFHP; UCSF will only conduct an evaluation. The Governing Board at the SFHP decided to adopt the ATSM model for its growing number of diabetes patients, to dedicate nursing staff to respond to ATSM data and engage with enrollees and their providers, to underwrite the costs of ATSM implementation, to randomly assign their patients to one of two types of ATSM (one that involves medication review/intensification vs. one that only delivers behavioral support), and to contact eligible SFHP members for ATSM and also to briefly describe the evaluation study to be carried out by UCSF. We, as UCSF researchers, will evaluate the impact of the interventions on patient outcomes. There will be limited contact with patients by the UCSF research team. UCSF research staff will only contact patients after SFHP has determined that their patients are interested in being contacted about the evaluation; and there will be no collection of personal health information by UCSF evaluators. UCSF research staff will conduct a telephone survey after verbal consent procedures, at baseline and 6 months (and for patients wait-listed, again at 12 months), for patients participating in the ATSM intervention. The SFHP will maintain an identification (ID) link between patients who are in the intervention and who are conducted about the evaluation, but they will not have patient-linked survey data, nor will UCSF have linked health-related data from the SFHP regarding patient outcomes, although de-identified data will be included in the UCSF evaluation. UCSF will conduct the quantitative data analyses of de-identified data provided to us by the SFHP at set times over the study period to examine the impact of the interventions on clinical outcomes. The evaluation will focus on the effects of ATSM on both patient-centered outcomes and on clinical outcomes through this "real-world" effectiveness study. The fact that recruitment and implementation will be carried out by SFHP, that SFHP will maintain the link to patients in the evaluation but will not have the survey data linked to individuals, and that only SFHP will have control over the personal health information of patients, has important implications for generalizability.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ATSM Intervention

ATSM Intervention: Automated Telephone Self-Management Support.

Group Type ACTIVE_COMPARATOR

ATSM Intervention

Intervention Type BEHAVIORAL

The ATSM system is designed to promote the efficiency of a care manager by having her focus outreach phone calls to patients who, by virtue of their responses to the ATSM system, report a need for further support. The purpose of these call-backs is to have the care manager directly engage patients in setting goals and developing an action plan to improve their overall health. The care manager is trained to perform motivational interviewing, assess and overcome barriers to health communication.

For some patients, the ATSM system as described above is augmented by additional phone communications from care manager to patient, triggered by health IT derived from 2 additional data sources: SFHP pharmacy claims data and CHNSF diabetes registry. The latter combines clinical data (labs and blood pressure). Based on clinical criteria, the ATSM system will alert care manager to make additional calls to patients.

WAIT LIST Control

WAIT LIST Control: six month Wait List.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ATSM Intervention

The ATSM system is designed to promote the efficiency of a care manager by having her focus outreach phone calls to patients who, by virtue of their responses to the ATSM system, report a need for further support. The purpose of these call-backs is to have the care manager directly engage patients in setting goals and developing an action plan to improve their overall health. The care manager is trained to perform motivational interviewing, assess and overcome barriers to health communication.

For some patients, the ATSM system as described above is augmented by additional phone communications from care manager to patient, triggered by health IT derived from 2 additional data sources: SFHP pharmacy claims data and CHNSF diabetes registry. The latter combines clinical data (labs and blood pressure). Based on clinical criteria, the ATSM system will alert care manager to make additional calls to patients.

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

ATSM: Automated Telephone Self-Management Support

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Diabetes diagnosis
* Attend one of 4 CHNSF clinics
* Ages 18 or above
* Speak English, Spanish or Cantonese
* Have a touch tone phone
* Have had one or more clinic visits in the preceding 24 months
* Will be in the SF Bay Area for the following six months

Exclusion Criteria

* Pregnant
* Unable to provide verbal consent
* Leaving the region in the next 12 months
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

San Francisco Health Plan (SFHP)

UNKNOWN

Sponsor Role collaborator

Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Dean Schillinger, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Center for Vulnerable Populations

San Francisco, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Ratanawongsa N, Quan J, Handley MA, Sarkar U, Schillinger D. Language-concordant automated telephone queries to assess medication adherence in a diverse population: a cross-sectional analysis of convergent validity with pharmacy claims. BMC Health Serv Res. 2018 Apr 6;18(1):254. doi: 10.1186/s12913-018-3071-4.

Reference Type DERIVED
PMID: 29625571 (View on PubMed)

Quan J, Lee AK, Handley MA, Ratanawongsa N, Sarkar U, Tseng S, Schillinger D. Automated Telephone Self-Management Support for Diabetes in a Low-Income Health Plan: A Health Care Utilization and Cost Analysis. Popul Health Manag. 2015 Dec;18(6):412-20. doi: 10.1089/pop.2014.0154. Epub 2015 Jun 23.

Reference Type DERIVED
PMID: 26102298 (View on PubMed)

Ratanawongsa N, Handley MA, Quan J, Sarkar U, Pfeifer K, Soria C, Schillinger D. Quasi-experimental trial of diabetes Self-Management Automated and Real-Time Telephonic Support (SMARTSteps) in a Medicaid managed care plan: study protocol. BMC Health Serv Res. 2012 Jan 26;12:22. doi: 10.1186/1472-6963-12-22.

Reference Type DERIVED
PMID: 22280514 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R18HS017261

Identifier Type: AHRQ

Identifier Source: org_study_id

View Link

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The Medication Experience Study
NCT01702883 COMPLETED NA
Telenhealth and Adherence to Stains
NCT05872919 COMPLETED NA