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HD: Effectiveness of Nutrition Intervention Methods (2010)

Citation:
 
Study Design:
Class:
- Click here for explanation of classification scheme.
Quality Rating:
Research Purpose:
  • To describe the reach of self-management support (SMS) strategies across three complementary dimensions: Participation among clinics, providers and patients; representativeness of patients; and patient engagement with SMS programs.
  • To explore whether engagement varied by patient literacy and language.
Inclusion Criteria:
  • Patients between dates of June 2003 and December 2004
  • Older than 17
  • ICD-9 codes consistent with type 2 diabetes
  • Spoke English, Spanish or Cantonese
  • Made greater than or equal to one primary care visit in the prior year
  • Had most recent hemoglobin A1c value (HgbA1c) greater than or equal to 8% (per database)
  • Were part of one of nine CHNSF clinics with the largest number of potentially eligible patients.
Exclusion Criteria:
  • Patients with psychotic illness or end-stage renal disease 
  • Planned extended travel or move 
  • No reliable access to phone
  • Poor fluency in study language
  • Too ill to travel to group visits
  • Visual or hearing impairment
  • Changing clinics
  • Severe mental health problems
  • Trouble with touch tone commands. 
Description of Study Protocol:

Recruitment

  • Queried patient registry for eligible patients between June 2003 and December 2004 (18 months) from the Community Health Network of San Francisco (CHNSF)
  • Created a list of potentially eligible patients at nine clinics for clinicians to review and confirm eligibility
  • Merged clinician and database eligible patients with appointment database so patients could be approached prior to their appointments by language-concordant research assistants to explore potential interest in participation and further assess for eligibility 
  • Eligible and interested patients were asked to attend study enrollment visit.

 

Design

  • This was an effectiveness study of SMS nested within a randomized trial among diverse diabetes patients in a safety net system
  • The IDEALL project was a three-arm randomized trial of two diabetes SMS interventions compared to usual care
    • Standard of care: No systematic diabetes SMS strategy
    • Automated telephone disease management (ATDM): Employs technology to provide surveillance, education and care management
      • Receive weekly, rotating automated (pre-recorded) telephone calls in their native language for nine months (39 weeks), an adjunct to standard care
      • Calls take six to 12 minutes
      • Patients selected call times and could change pre-selected call times (toll free)
      • Focus on collaborative goal-setting and action plans
      • Patients answering "out of range" on items received call back from nurse care manager to help problem-solve the issues identified in the report or any other concerns
      • There were no incentives for participation
    • Group Medical Visits (GMV): Employs a more interpersonal and collective approach with roots in adult educational theory and practice
      • Language-specific monthly 90-minute GMV for nine months
      • Six to 10 patients, co-facilitated by a language-concordant physician and health educator
      • Focus on collaborative goal-setting and action plans
      • After each session facilitators rate the level of participation of each attendee (little, some, full)
      • Bus tokens to assist with transportation and healthy snacks were provided
  • Both SMS models provide individualized assessment, skill assessment, skill enhancement, health education, follow-up and support, access to community resources and continuity of clinical care
    • Delivered in English, Spanish and Cantonese
  • IDEALL clinical staff were trained in model protocols, motivational interviewing and communication techniques for patients with limited literacy and (for GMV) in group facilitation techniques
  • Eligible and interested patients were asked to attend study enrollment visit 
  • Recruited patients attended a baseline enrollment session including:
    • Informed consent
    • Physiologic measures (HgbA1c)
    • Questionnaire
      • Literacy was assessed among English and Spanish speakers only, with the validated short form, Test of Functional Health Literacy in Adults (s-TOFHLA)
  • Blocked randomization strategy was used and stratified to ensure even distribution of languages 
    •  Randomized patients were informed of their assignment at enrollment
  • All participants were given $15 for the baseline research visit.

Blinding used (if applicable)

N/A; randomized patients were informed of their assignment at enrollment

Intervention (if applicable)

  •  Education/Care
    • Standard of care: No systematic diabetes SMS strategy
    • Automated telephone disease management (ATDM): Employs technology to provide surveillance, education and care management
    • Group Medical Visits (GMV): Employs a more interpersonal and collective approach with roots in adult educational theory and practice.

 Statistical Analysis

  • Chi-square
  • Fisher's exact test
  • Multivariate models
  • Logistic regression
  • General linear models.

 

Data Collection Summary:

Timing of Measurements

  • Automated telephone disease management (ATDM) received weekly, rotating automated (pre-recorded) telephone calls in their native language for nine months (39 weeks)
  • Calls take six to 12 minutes
  • Group Medical Visits (GMV): Language-specific monthly 90-minute GMV for nine months
    • Six to 10 patients, co-facilitated by a language-concordant physician and health educator
  • Eligible and interested patients were asked to attend study enrollment visit 
    • Recruited patients attended a baseline enrollment session including:
      • Informed consent
      • Physiologic measures (HgbA1c)
      • Questionnaire.

Dependent Variables

Assessment of reach:

  • Measurement of reach of interventions 
    • Participation among clinics, clinicians and patients
      • First determined the number eligible patients at the nine participating clinics, then created a list of potentially eligible patients deemed eligible by clinicians, next calculated the proportion of patients approached by research assistants that enrolled, refused or were ineligible at interview
    • Representatives
      • Patients who enrolled by comparing characteristics (age, sex, language, race/ethnicity, insurance or HgbA1c) vs. three sub-groups
        • Non-enrolled database-eligible patients from the study clinics
        • Clinician and database-eligible patients who were ineligible based on self-report
        • Eligible patients who refused
    • Engagement with interventions (SMS programs)
      • Among patients randomized to ATDM of GMV across a number of steps
        • Proportion of individuals who engaged in an SMS interaction (greater than or equal to ATDM call or attending greater than or equal to one GMV)
        • Proportion of SMS sessions attended among users
        • Proportion of these individuals who created greater than or equal to one action plan
        • Mean number of action plans created and achieved based on self-report.

Independent Variables

  • Language
  • Literacy.

 

Control Variables

 

Description of Actual Data Sample:

Initial N

  • Database 2,261 patients
    • Database 1,307 (86%) patients eligible
    • 499 patients approached (38%).

Attrition (final N)

  • IDEALL Project 339 (68%) patients; 59% female
    • 70 refused (14%)
    • 90 were found ineligible (18%)
      • 4% planned extended travel or move
      • 4% no reliable access to phone
      • 3% poor fluency in study language
      • 2% too ill to travel to group visits
      • 2% visual or hearing impairment
      • 1% changing clinics
      • Less than 1% severe mental health problems
      • Less than 1% trouble with touch tone commands 
      • 1% other.

Age

Greater than or equal to 17 years

Ethnicity

  • Asian
  • African American
  • Hispanic/Latino
  • White.

Other relevant demographics

Anthropometrics (e.g., were groups same or different on important measures)

Location

San Francisco, California

 

Summary of Results:

Participation

  • Six of nine CHNSF clinics cared for the majority of patients with diabetes, these were approached for potential participation; four (67%) agreed
    • The two who did not, could not conform to the study design
  • Nearly all clinicians (97%) from the four clinics completed eligibility forms and agreed to expose patients to one or more SMS program
    • 84% had greater than or equal to one enrolled patient
  •  58% of CHNSF database-eligible patients attended the four participating clinics
    • Clinician review resulted in an exclusion of 222 of 1,612 patients (14%)   
    • 339 (68%) patients; 59% female were approached
      • 70 refused (14%)
      • 90 were found ineligible (18%).

Representativeness

  • Enrolled patients appeared to be representative of non-enrolled database-eligible from the four clinics with respect to age, sex and HbgA1c
    • More likely to be Spanish-speaking, Hispanic or African American
    • More likely to be uninsured or have Medi-Cal
  • Enrolled patients differed from approached patients in age (55.4 vs. 61.9; p=<0.01), sex and insurance (uninsured 50.2% vs. 38.9%; Medicare 21.5% vs. 36.7%; p<0.001)
  • Enrolled patients were more likely to be uninsured or have Medi-Cal than patients who refused (n=70; p<0.001).

Engagement with interventions 

  • In ATDM (n=112), engagement levels were high, 93.8% of individuals responding to greater than or equal to one ADTM call, with no significant differences by language and literacy
    • Among patients with greater than or equal to nurse call-back, the proportion that generated greater than or equal to one action plan was high (88.0%), with similar levels across language and literacy
  • The ADTM composite engagement product was 22.2, with higher products among those with limited English proficiency and those with limited literacy in both English and Spanish
  • In GVM (n=112), engagement levels were modest, with language and literacy related patterns
    • 69.6% of individuals attended greater than or equal to one GVM, higher rates among Cantonese (92.3%, p=0.02) and Spanish speakers (75%, p=0.02)
    • Among patients who attended greater than or equal to one GVM, the proportion that generated greater than or equal to one action plan was high (88.5%), with similar levels across language and literacy
  • The GVM composite engagement product for GVM was 4.8 with lower products for both those with limited English proficiency and those with limited literacy in both English and Spanish.

 

Other Findings

 

Author Conclusion:
  • Socioeconomically vulnerable, and ethnically and linguistically diverse patients in the public sector safety net delivery system appear interested in receiving diabetes SMS as adjuncts to care
  • ATDM not only reached a greater proportion of the target population than the GMV, but also yielded higher rates of engagement for those with limited literacy and limited English proficiency.
Funding Source:
Government: The California Endowment, San Francisco Dept of Public Health, California Health Care Foundation, NIH
Other: The Commonwealth Fund
Reviewer Comments:
  • Recent study (2008)
  • Small sub-group sample sizes.
Quality Criteria Checklist: Primary Research
Relevance Questions
  1. Would implementing the studied intervention or procedure (if found successful) result in improved outcomes for the patients/clients/population group? (Not Applicable for some epidemiological studies) Yes
  2. Did the authors study an outcome (dependent variable) or topic that the patients/clients/population group would care about? Yes
  3. Is the focus of the intervention or procedure (independent variable) or topic of study a common issue of concern to dieteticspractice? Yes
  4. Is the intervention or procedure feasible? (NA for some epidemiological studies) Yes
 
Validity Questions
1. Was the research question clearly stated? Yes
  1.1. Was (were) the specific intervention(s) or procedure(s) [independent variable(s)] identified? Yes
  1.2. Was (were) the outcome(s) [dependent variable(s)] clearly indicated? Yes
  1.3. Were the target population and setting specified? Yes
2. Was the selection of study subjects/patients free from bias? Yes
  2.1. Were inclusion/exclusion criteria specified (e.g., risk, point in disease progression, diagnostic or prognosis criteria), and with sufficient detail and without omitting criteria critical to the study? Yes
  2.2. Were criteria applied equally to all study groups? Yes
  2.3. Were health, demographics, and other characteristics of subjects described? Yes
  2.4. Were the subjects/patients a representative sample of the relevant population? Yes
3. Were study groups comparable? Yes
  3.1. Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT) Yes
  3.2. Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline? Yes
  3.3. Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.) N/A
  3.4. If cohort study or cross-sectional study, were groups comparable on important confounding factors and/or were preexisting differences accounted for by using appropriate adjustments in statistical analysis? N/A
  3.5. If case control study, were potential confounding factors comparable for cases and controls? (If case series or trial with subjects serving as own control, this criterion is not applicable.) Yes
  3.6. If diagnostic test, was there an independent blind comparison with an appropriate reference standard (e.g., "gold standard")? N/A
4. Was method of handling withdrawals described? Yes
  4.1. Were follow-up methods described and the same for all groups? Yes
  4.2. Was the number, characteristics of withdrawals (i.e., dropouts, lost to follow up, attrition rate) and/or response rate (cross-sectional studies) described for each group? (Follow up goal for a strong study is 80%.) Yes
  4.3. Were all enrolled subjects/patients (in the original sample) accounted for? Yes
  4.4. Were reasons for withdrawals similar across groups? Yes
  4.5. If diagnostic test, was decision to perform reference test not dependent on results of test under study? N/A
5. Was blinding used to prevent introduction of bias? No
  5.1. In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate? No
  5.2. Were data collectors blinded for outcomes assessment? (If outcome is measured using an objective test, such as a lab value, this criterion is assumed to be met.) No
  5.3. In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded? N/A
  5.4. In case control study, was case definition explicit and case ascertainment not influenced by exposure status? Yes
  5.5. In diagnostic study, were test results blinded to patient history and other test results? N/A
6. Were intervention/therapeutic regimens/exposure factor or procedure and any comparison(s) described in detail? Were interveningfactors described? Yes
  6.1. In RCT or other intervention trial, were protocols described for all regimens studied? Yes
  6.2. In observational study, were interventions, study settings, and clinicians/provider described? N/A
  6.3. Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect? Yes
  6.4. Was the amount of exposure and, if relevant, subject/patient compliance measured? Yes
  6.5. Were co-interventions (e.g., ancillary treatments, other therapies) described? Yes
  6.6. Were extra or unplanned treatments described? N/A
  6.7. Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups? Yes
  6.8. In diagnostic study, were details of test administration and replication sufficient? N/A
7. Were outcomes clearly defined and the measurements valid and reliable? Yes
  7.1. Were primary and secondary endpoints described and relevant to the question? Yes
  7.2. Were nutrition measures appropriate to question and outcomes of concern? Yes
  7.3. Was the period of follow-up long enough for important outcome(s) to occur? Yes
  7.4. Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures? Yes
  7.5. Was the measurement of effect at an appropriate level of precision? Yes
  7.6. Were other factors accounted for (measured) that could affect outcomes? Yes
  7.7. Were the measurements conducted consistently across groups? Yes
8. Was the statistical analysis appropriate for the study design and type of outcome indicators? Yes
  8.1. Were statistical analyses adequately described and the results reported appropriately? Yes
  8.2. Were correct statistical tests used and assumptions of test not violated? Yes
  8.3. Were statistics reported with levels of significance and/or confidence intervals? Yes
  8.4. Was "intent to treat" analysis of outcomes done (and as appropriate, was there an analysis of outcomes for those maximally exposed or a dose-response analysis)? N/A
  8.5. Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)? Yes
  8.6. Was clinical significance as well as statistical significance reported? Yes
  8.7. If negative findings, was a power calculation reported to address type 2 error? N/A
9. Are conclusions supported by results with biases and limitations taken into consideration? Yes
  9.1. Is there a discussion of findings? Yes
  9.2. Are biases and study limitations identified and discussed? Yes
10. Is bias due to study's funding or sponsorship unlikely? Yes
  10.1. Were sources of funding and investigators' affiliations described? Yes
  10.2. Was the study free from apparent conflict of interest? Yes