Supporting Statement

Request for Approval under AHRQ’s Generic Clearance “Questionnaire and Data Collection Testing, Evaluation, and Research for the AHRQ” (OMB Control Number: 0935-0124)

TITLE OF INFORMATION COLLECTION: Environmental Scan for Guide to Improving Patient Safety in Primary Care Settings by Engaging Patients and Families

PURPOSE:

The purpose of this request is to conduct a series of voluntary key informant interviews as part of an environmental scan- for the Guide to Improving Patient Safety in Primary Care Settings by Engaging Patients and Families (Guide). The environmental scan is developmental work serving as the preliminary activity for a project that we will submit to OMB at a later date. We will conduct this environmental scan to analyze a wide range of research and non-research material to provide greater conceptual clarity about the field to develop the Guide. As part of this scan, we will conduct a series of interviews to help us with the following for the larger project to be submitted to OMB at a future date:

1. Identify the research question and set a purpose for the study

2. Identify relevant research and non-research materials

3. Select studies for inclusion

4. Data abstraction

5. Collate, summarize, and report the results

6. Consult with consumers and stakeholders to suggest additional references and provide insights beyond those in the literature

As part of identifying relevant research and non-research materials as indicated above, we will conduct informal interviews with members of our project team and domain experts.

DESCRIPTION OF RESPONDENTS:

We will conduct informal interviews first with our project team and second with identified domain experts in order to refine our definitions, search terms, strategy, and identify interventions and resources pertinent to guide development. We will derive input from informal conversations in the following areas:

• Conceptualizing patient safety and patient engagement in primary care;

• Identification of search terms and input on approach;

• Advice on organizations, and potential interventions;

• Key constructs to assess usability, sustainability, and generalizability of interventions;

• Recommended research (peer reviewed and grey literature) to be reviewed; And

• Recommendations for individuals to be included in interviews.

TYPE OF COLLECTION: (Check one)

[ ] Customer Comment Card/Complaint Form [ ] Customer Satisfaction Survey

[ ] Usability Testing (e.g., Website or Software [ ] Small Discussion Group

[] Focus Group [X ] Other: __Informal in-person, and phone-based semi-structured interview

CERTIFICATION:

I certify the following to be true:

1. The collection is voluntary.

2. The collection is low-burden for respondents and low-cost for the Federal Government.

3. The collection is non-controversial and does not raise issues of concern to other federal agencies.

4. The results are not intended to be disseminated to the public.

5. Information gathered will not be used for the purpose of substantially informing influential policy decisions.

6. The collection is targeted to the solicitation of opinions from respondents who have experience with the program or may have experience with the program in the future.

Name:__ Nancy Wilson

To assist review, please provide answers to the following question:

Personally Identifiable Information:

1. Is personally identifiable information (PII) collected? [ ] Yes [x] No

2. If Yes, is the information that will be collected included in records that are subject to the Privacy Act of 1974? [ ] Yes [ ] No

3. If Applicable, has a System or Records Notice been published? [ ] Yes [ ] No

Gifts or Payments:

Is an incentive (e.g., money or reimbursement of expenses, token of appreciation) provided to participants?
[ ] Yes [x] No

Category of Respondent: (the options here are Public Sector or Private Sector, or both)

Both

BURDEN HOURS

Category of Respondent	Corresponding Attachment	No. of Respondents	Participation Time	Burden
Project Team and Domain Experts (in-person)	Key informant guide (Attachment B) Interview guide for case study development (Attachment D) Interview guide for patients/Family members/Caregivers (Attachment F) Interview guide for primary care practice staff and physicians (Attachment H)	10	30 minutes	5
Project Team and Domain Experts (telephone)	Key informant guide (Attachment A) Case study development interview guide (Attachment C) Interview guide for patients/Family members/Caregivers (Attachment E) Interview guide for primary care practice staff and physicians (Attachment G)	38	60 minutes	38
Totals		48	n/a	43

FEDERAL COST: The estimated annual cost to the Federal government is __$600__________

This includes 12.5 hours at the GS-13 level to provide project management and oversight to this project. The estimate is based on an annual salary OPM Pay Schedule for Washington/DC area. This task shall occur only once. The total cost is estimated to be $600 to the Federal Government. There will be no additional cost to the Federal Government under the contract at this time. The work conducted by AHRQ’s contractor, MedStar, is already accounted.

If you are conducting a focus group, survey, or plan to employ statistical methods, please provide answers to the following questions:

The selection of your targeted respondents

1. Do you have a customer list or something similar that defines the universe of potential respondents and do you have a sampling plan for selecting from this universe? [ ] Yes [x] No

If the answer is yes, please provide a description of both below (or attach the sampling plan)? If the answer is no, please provide a description of how you plan to identify your potential group of respondents and how you will select them?

We will identify and select participants for our informal and formal interviews as follows:

Informal interviewees will include:

• Project team members

• MedStar Health’s (MSH) network of patient and family advisory committees on quality and safety (PFACQS) [Nationally recognized patient and family advocates, community representatives from each of MSH 10-hospitals and 3 PFACQS serving MSH’s more than 208 practices]

• Domain Experts defined as individuals who have high-level expertise in areas pertinent to the project, such as patient engagement, patient activation, patient safety, health literacy, and primary care practice.

We will identify these members. Those individuals who are named investigators and subject matter experts on the contract, those individuals who are identified by our project team as being thought leaders in the field, through scan of the peer reviewed and grey literature on the topic and through consultation with the contracting officer.

Formal interviewees will include:

• Patients, patient advocacy and consumer organizations

• Primary care providers (physicians, nurses, nurse practitioners, physician assistants)

• Primary care practice staff

• Researchers

• Practice domain experts

We will identify the appropriate domain experts by review of the published and grey literature, consultation with our technical expert panel members and project team, consultation with the contracting officer.

We will conduct informal email consultations (15 minutes) with:

• Patients, family members & lay caregivers

• Primary care providers

• Primary care practice staff

• Practice administrators

• Researchers

• Pharmacists/other affiliated healthcare providers

• Safety & quality improvement professionals

We will identify these by named investigators on the project, subject matter experts on the contract and on the technical expert panel, those individuals who are identified by our project team as being thought leaders in the field, through scan of the peer reviewed and grey literature on the topic and through consultation with the contracting officer.

Administration of the Instrument

1. How will you collect the information? (Check all that apply)

[ ] Web-based or other forms of Social Media

[x ] Telephone

[ x ] In-person

[ ] Mail

[ X ] Other, Explain Email contact to elicit feedback about research questions and areas of focus for the literature search

2. Will interviewers or facilitators be used? [ x] Yes [ ] No

Please make sure that all instruments, instructions, and scripts are submitted with the request.

Attachment A: Key Informant Interview Guide- Telephone

Attachment B: Key Informant Interview Guide- In-person

Attachment C: Interview Guide for Case Study Development- Telephone

Attachment D: Interview Guide for Case Study Development- In-person

Attachment E: Interview Guide for Patients/Family Members/Caregivers- Telephone

Attachment F: Interview Guide for Patients/Family Members/Caregivers- In-person

Attachment G: Interview Guide for Primary Care Practice Staff and Physicians- Telephone

Attachment H: Interview Guide for Primary Care Practice Staff and Physicians- In-person