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Clinical Trials/NCT00683020
NCT00683020
Completed
Not Applicable

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

University of California, San Francisco1 site in 1 country362 target enrollmentApril 2009
ConditionsDiabetes

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes
Sponsor
University of California, San Francisco
Enrollment
362
Locations
1
Primary Endpoint
Changes in the Physical Component Summary of the SF-12 Health Survey
Status
Completed
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2009
End Date
April 2012
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

  • Unable to provide verbal consent
  • Leaving the region in the next 12 months

Outcomes

Primary Outcomes

Changes in the Physical Component Summary of the SF-12 Health Survey

Time Frame: Baseline and 6 months

The SF-12 Health Survey (SF-12) is a 12-item short-form survey used to measure health status and monitor health outcomes. The survey asks about various health aspects, including physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health (psychological distress and psychological well-being). Two summary measures are derived: the Physical and the Mental Health Component Summary. For each component summary, survey items were weighted and summed to create a summary score between 0 and 100 with higher score indicating better functioning and outcome. Change is calculated as 6-month score minus baseline score.

Changes in the Mental Component Summary of the SF-12 Health Survey

Time Frame: Baseline and 6 months

The SF-12 Health Survey (SF-12) is a 12-item short-form survey used to measure health status and monitor health outcomes. The survey asks about various health aspects, including physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health (psychological distress and psychological well-being). Two summary measures are derived: the Physical and the Mental Health Component Summary. For each component summary, survey items were weighted and summed to create a summary score between 0 and 100 with higher score indicating better functioning and outcome. Change is calculated as 6-month score minus baseline score.

Secondary Outcomes

  • Number of Days Spent in Bed Due to Illness(6 months)
  • Proportion of Patients Reporting Diabetes Interference of Normal Daily Activities(6 months)
  • Changes in Diabetes Self-management Behaviors as Measured by Summary of Diabetes Self-Care Activities (SDSCA) Scale(Baseline and 6 months)
  • Changes in Self-reported Medication Adherence as Measured by Summary of Diabetes Self-Care Activities (SDSCA) Scale(Baseline and 6 months)
  • Changes in Diabetes Self-efficacy as Measured by Diabetes Quality Improvement Project's Patient Self-Management Scale(Baseline and 6 months)
  • Changes in Patient-centeredness of Care as Measured by Patient Assessment of Chronic Illness Care (PACIC) Scale(Baseline and 6 months)
  • Changes in Patient-centeredness of Care as Measured by Interpersonal Processes of Care (IPC) Scale(Baseline and 6 months)
  • Changes in Hemoglobin A1c Levels(Baseline and 6 months)
  • Changes in Systolic Blood Pressure (SBP)(Baseline and 6 months)
  • Changes in Diastolic Blood Pressure (DBP)(Baseline and 6 months)

Study Sites (1)

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