POC-R Questionnaire_Justification B_v3_1162013

TO CONDUCT THE POINT-OF-CARE RESEARCH QUESTIONNAIRE
OMB FORM 2900-XXXX
VA Form 10-10069

B. COLLECTIONS OF INFORMATION EMPLOYING STATISTICAL METHODS

1. Provide a numerical estimate of the potential respondent universe and describe any sampling or other respondent selection method to be used. Data on the number of entities (e.g., households or persons) in the universe and the corresponding sample are to be provided in tabular format for the universe as a whole and for each strata. Indicate expected response rates. If this has been conducted previously include actual response rates achieved.

The sample size will be based on a two-factor sampling frame, blocking on two factors: age and utilization. For the utilization factor, patients will be divided into high and low utilizers. Blocking will ensure that we are the most efficient in sample size estimates. All participants have had to be seen in the VA in the last three years. High utilizers are defined as those with one or more hospitalizations within the last three years and at least two visits per year. Low utilizers will be the remaining group of patients with a minimum of two visits per year in the last three years. Random selection will be within those two utilization groups.

The second factor is age. Blocking will be on three age groups: ≤ aged 55, aged 56 – 80, and ≥ aged 81. We are randomly sampling from all veterans from a national database (VINCI). We are measuring their age in order to do internal comparisons across age groups. We believe that age makes a difference in attitudes toward research, but that question is exploratory. It is relatively standard in survey research to explore the moderating effects of certain demographic variables, such as geography, age and gender. It is our goal and the goal of the funding agency to include only those who use the VA sufficiently to have some experience with the institution. We did a data pull of visits per veteran and 65% of those veterans who have been to the VA at least once in the last 3 years have at least 3 visits in the last 2 years. We feel completely justified in that cutoff as we want to include those individuals who know the VA and since 2 visits per year is the recommended time frame for primary care, we saw this cutoff as a minimum figure. Of course, the mean the number of visits was much higher.

The number of patients we will attempt to contact is limited to 1,000 with the hope of getting a response from 500-600. Survey response rates vary and the true response rate is unknown. A 50% response rate for surveys is a good estimate. The National VA Westat survey achieved 66.7%, but the effective coverage rate was 38.8%. As you can see, estimating response rates is a very difficult. We actually do not know what it will be. Here are some websites that discuss the issue. To learn more about the topic, the work done by Don Dillman is explained in his book, Tailored Design Method.

http://www.practicalsurveys.com/respondents/typicalresponserates.php

http://www.va.gov/SURVIVORS/docs/NVSSurveyFinalWeightedReport.pdf

2. Describe the procedures for the collection of information, including:

1. Statistical methodology for stratification and sample selection

The approved IRB protocol is provided as a supplemental document. The relevant procedures are highlighted in yellow.

2. Estimation procedure

Most analysis will simply be descriptive, although we will regression modeling to estimate the impact of age and utilization as well as factor analysis to confirm the internal structure of the survey.

The constructs were adapted from Theory of Planned Behavior and our prior focus groups. The Theory of Planned Behavior manual is attached. The recommended and well-accepted procedure is to use qualitative work to identify the exact content regarding beliefs and attitudes and compose items based on the general constructs of: Normative Beliefs (what others think of us doing the action), behavioral beliefs (attitudes towards the expected outcomes) and control beliefs (self-efficacy and/or general control beliefs). We focused on expected outcomes as derived from the focus groups and direct attitudes only. We were going to conduct a factor analyses, but because of a now small sample size, the data analysis will be descriptive only with some correlations within subgroups.

3. Unusual problems requiring specialized sampling procedures

We will be blocking (or sampling within groups) for age and high versus low utilizers.

4. Any use of less frequent than annual data collection to reduce burden

To meet minimum public burden, Point-of-Care Research Questionnaire data collection will only be conducted one time.

3. Describe methods to maximize response rate and to deal with issues of non-response. The accuracy and reliability of information collected must be shown to be adequate for intended uses. For collections based on sampling, a special justification must be provided for any collection that will not yield “reliable” data that can be generalized to the universe studied.

The following procedures will be followed to deal with issues of non-response for questionnaires that are mailed:

1. A letter describing the study and inviting veterans to complete the questionnaire online via a Web link will be mailed.

2. If no response, two weeks later a postcard reminder will be mailed. The postcard will include the Web link to complete the questionnaire online.

3. If not response, two weeks later another letter will be sent re-inviting veterans to complete the questionnaire online via the Web link. In case veterans prefer not to answer the questionnaire via the Web link, a paper questionnaire with an enclosed self-addressed envelope will be mailed with this letter.

4. If no response, two weeks later a fourth reminder will be sent out on colored paper inviting the veterans to complete the questionnaire, as well as the questionnaire and a self-addressed stamped envelope.

5. If not response one week after the fourth reminder, veterans will be called asking them to complete the survey either online via the Web link or on paper. If the veteran chooses to complete a paper questionnaire and no longer has it, another questionnaire will be mailed.

4. Describe any tests of procedures or methods to be undertaken. Testing is encouraged as an effective means of refining collections to minimize burden and improve utility. Tests must be approved if they call for answers to identical questions of 10 or more individuals.

We have done pilot testing with less than 9 patients in Salt Lake City.

5. Provide the name and telephone number of individuals consulted on statistical aspects of the design and the name of the agency unit, contractor(s), grantee(s), or other person(s) who will actually collect and/or analyze the information for the agency.

Individuals consulted on statistical design are all employees of the Salt Lake City VA Salt Lake Informatics, Decision Enhancement, and Surveillance Center.

Charlene Weir, PhD (801)582-1565, ext. 5114
Jorie Butler, PhD (801)582-1565, ext. ____
Brian Sauer, PhD (801)582-1565, ext. ____

The names of our Boston collaborators are listed below. In addition, the names of the individuals in the original approved funding budget are listed. Others listed on the budget worked on the Focus Groups only.

Boston Maverick Group

Louise Fiore, MD, Executive Director MAVERIC, POCR Principal Investigator

Ryan Ferguson, Program Manager, MAVERIC

John Hermos, MD, Regulatory Advisor, MAVERIC

Pat Woods, Study Nurse/Project Manager

VA Research Representative

Theresa Gleason, Senior Program Manager, VA CSR&D

Local Staff and Researchers

Charlene Weir, PhD, RN, Principal Investigator

Jorie Butler, PhD, Co-Investigator

Brian Sauer, PhD, Co-Investigator

Robyn Barrus, MS, Project Manager

Deborah Hoffman, Research Assistant

Lacey Lewis, Research Assistant

Sophia Lu, PhD, Data Analyst

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