Clinical trial NCT00683020: Harnessing Health IT for Self-Management Support and Medication Activation in a Medicaid Health Plan
Official title: Harnessing Health IT for Self-Management Support and Medication Activation in a Medicaid Health Plan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: Chronic Diseases
Diabetes
Vulnerable population
Urban populations
Disease Management
Health Information Technology
Safety
Health Literacy
Level of English Proficiency
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: San Francisco Health Plan (SFHP)
name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2008-05-23
Enrollment: 362
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in the Physical Component Summary of the SF-12 Health Survey
timeFrame: Baseline and 6 months
measure: Changes in the Mental Component Summary of the SF-12 Health Survey
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Number of Days Spent in Bed Due to Illness
timeFrame: 6 months
measure: Proportion of Patients Reporting Diabetes Interference of Normal Daily Activities
timeFrame: 6 months
measure: Changes in Diabetes Self-management Behaviors as Measured by Summary of Diabetes Self-Care Activities (SDSCA) Scale
timeFrame: Baseline and 6 months
measure: Changes in Self-reported Medication Adherence as Measured by Summary of Diabetes Self-Care Activities (SDSCA) Scale
timeFrame: Baseline and 6 months
measure: Changes in Diabetes Self-efficacy as Measured by Diabetes Quality Improvement Project's Patient Self-Management Scale
timeFrame: Baseline and 6 months
measure: Changes in Patient-centeredness of Care as Measured by Patient Assessment of Chronic Illness Care (PACIC) Scale
timeFrame: Baseline and 6 months
measure: Changes in Patient-centeredness of Care as Measured by Interpersonal Processes of Care (IPC) Scale
timeFrame: Baseline and 6 months
measure: Changes in Hemoglobin A1c Levels
timeFrame: Baseline and 6 months
measure: Changes in Systolic Blood Pressure (SBP)
timeFrame: Baseline and 6 months
measure: Changes in Diastolic Blood Pressure (DBP)
timeFrame: Baseline and 6 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Center for Vulnerable Populations
state: California
Study officials:
affiliation: University of California, San Francisco
name: Dean Schillinger, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.