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

NCT00683020 | Completed Results DMC

• 1 other identifier: R18HS017261
• Study Type: interventional
• Target: 362
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes

Keywords

Chronic Diseases; Diabetes; Vulnerable population; Urban populations; Disease Management; Health Information Technology; Safety; Health Literacy; Level of English Proficiency

Outcome Measures

Primary Outcomes (2)

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

  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.

  Baseline and 6 months

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

  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.

  Baseline and 6 months

Secondary Outcomes (10)

• 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

Study Arms (2)

ATSM Intervention

ACTIVE COMPARATOR

ATSM Intervention: Automated Telephone Self-Management Support.

Behavioral: ATSM Intervention

WAIT LIST Control

NO INTERVENTION

WAIT LIST Control: six month Wait List.

Interventions

ATSM Intervention 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.

Also known as: ATSM: Automated Telephone Self-Management Support

ATSM Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, San Francisco: lead
• San Francisco Health Plan (SFHP): collaborator
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (1)

Center for Vulnerable Populations

San Francisco, California, 94110, United States

Location

Related Publications (3)

• 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.

  PMID: 29625571 DERIVED

• 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.

  PMID: 26102298 DERIVED

• 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.

  PMID: 22280514 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Chronic Disease

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dean Schillinger, MD/Study Principal Investigator
• Organization: University of California, San Francisco

dschillinger@medsfgh.ucsf.edu

415-206-8940

Study Officials

• Dean Schillinger, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2008
• First Posted: May 23, 2008
• Study Start: April 1, 2009
• Primary Completion: November 1, 2011
• Study Completion: April 1, 2012
• Last Updated: May 15, 2013
• Results First Posted: May 15, 2013

Record last verified: 2013-05

Locations

US (1)