Supporting Statement

Request for Approval under the “Generic Clearance for the Collection of Routine Customer Feedback” (OMB Control Number: 0935-0179)

Submitting Institution: Agency for Healthcare Research and Quality (AHRQ)

December 17, 2021

TITLE OF INFORMATION COLLECTION: The AHRQ Safety Program for Improving Surgical Care and Recovery (ISCR) Qualitative Evaluation

The AHRQ Improving Surgical Care and Recovery (ISCR) project is designed to help hospitals implement evidence-based practices to improve outcomes and prevent complications among patients who undergo surgery. Enhanced recovery pathways include preoperative, intraoperative, and postoperative practices that decrease complications and accelerate recovery. Several studies and meta-analyses have demonstrated successful results from the use of these pathways. In order to facilitate broader adoption of these evidence-based practices among U.S. hospitals, this AHRQ project used principles and methods from CUSP, which has been demonstrated to be an effective approach to reducing patient harms including healthcare associated infections, to enhance the recovery of surgical patients. The CUSP approach uses a combination of clinical and cultural (i.e., technical and adaptive) intervention components. The adaptive elements include promoting leadership and frontline staff engagement, improvement in safety culture, and close teamwork among surgeons, anesthesia providers, and nurses, as well as enhancing patient communication and engagement. Through this project, AHRQ helped over 200 hospitals implement surgical practices designed to reduce infections and other complications.

PURPOSE: The purpose of the qualitative evaluation is to understand hospitals’ experiences as they extended the ISCR enhanced recovery intervention from the colorectal surgical line to hip/knee replacement, hip fracture, gynecological, and emergency general surgery. In-depth, semi-structured individual interviews will be conducted with key staff from six hospitals that initiated the intervention in the colorectal line, extended it to one or more surgical lines, and are currently participating in at least one of the surgical lines. Questions include:

• What was the impetus for hospitals to participate in the ISCR intervention?

• What were the hospitals’ experiences (successes, challenges, lessons learned) in implementing the ISCR intervention in the colorectal surgical line?

• What was the impetus for extending the intervention to additional surgical lines?

• What were the hospitals’ experiences (successes, challenges, lessons learned) implementing the ISCR intervention in subsequent lines?

• What factors contributed to or challenged sustainability?

DESCRIPTION OF RESPONDENTS:

The types of respondents to participate in the study will include physicians, nurses, and other staff who have been engaged with the ISCR program in each hospital. Interviews will include surgeons, anesthesiologists, nursing staff (pre-operative, surgical, post-operative units), personnel involved in the hospital’s quality improvement (QI) program, and at least one senior leader, if possible.

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: Semi-structured individual interviews

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:___Darryl T. Gray (AHRQ Task Order Officer)

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

Personally Identifiable Information:

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

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

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

We will collect the following information for recruitment and interview scheduling purposes only. All data will be de-identified for analysis and the final report to AHRQ.

• Full name

• Address (needed for sending incentive checks)

• Telephone number

• Email address

Gifts or Payments:

Is an incentive (e.g., money or reimbursement of expenses, token of appreciation) provided to participants?

[X] Yes [ ] No

We are providing honoraria to participants. Monetary or material honoraria are usually offered to healthcare staff for participation in research as a token of appreciation. ¹

18 hospital physicians/surgeons @ $200/each = $3,600

18 hospital registered nurses @150/each = $2,700

18 hospital administrators/managers @$150/each = $2,700

TOTAL = $9,000

Survey research literature uniformly demonstrates that honoraria are an effective means of communicating the importance of the study to the respondent and of increasing participation. In a meta-analysis, Mercer, Caporaso, Cantor, and Townsend (2015)² show that, up to a point, remuneration follow a dose-response model – the greater the amount, the greater the level of respondent participation. This is also true for the honoraria offered in semi-structured in-depth interviews. Recruitment of clinical staff for research is particularly challenging.

In 2016, OMB approved a $150 remuneration for physicians, $100 remuneration for other healthcare administrators and registered nurses, and a $75 remuneration for other hospital support staff for 1-hour cognitive interviews for the AHRQ Hospital Survey on Patient Safety Culture Survey 2.0 (as approved under OMB control # 0935-0230, expiry: 01-21-2016). These amounts were paid to cognitive interview respondents to test their understanding of AHRQ Hospital Patient Safety Culture survey questions. The interviews occurred almost 5 years ago prior to the COVID-19 pandemic and the honoraria amounts used at that time are likely not enough to recruit healthcare providers and staff during the current COVID-19 pandemic.

More recently, in 2020, OMB approved $300 honoraria m for physicians and $225 honoraria for pharmacists, physician assistants, nurse practitioners, and nurse midwives for 75-minute online focus groups for an FDA project entitled, “Pregnancy and Lactation Labeling Rule End-User Testing to Improve Health Communications and Prescribing Decisions in Pregnant Women” (as approved under OMB control # 0910-0497).

To successfully recruit 54 healthcare providers and administrators during the current COVID-19 pandemic for 1-hour in-depth, semi-structured interviews, we propose $200 honoraria for hospital physicians/surgeons, and $150 honoraria for registered nurses and for hospital administrators/managers. These amounts are higher than what was approved in 2016 for 1-hour cognitive interviews for the AHRQ Hospital Survey on Patient Safety Culture 2.0 but lower than the amounts approved in 2020 for FDA focus groups. However, the amounts currently proposed for these interviews are also lower than the average amounts typically paid by research recruitment vendors for these healthcare positions. Vendors have indicated that they typically pay $300 for physicians (e.g., Sermo Inc.) and $200 for healthcare administrators and nurses (Opinions, LTD) since these are very difficult positions to recruit for research participation unless honoraria amounts are sufficient. We note that honoraria such as those we plan to offer often serve as a recognition of the respondents’ niche professional expertise and the value of their time.

We note that this project is on a tight one-year timeline that cannot be extended. Therefore, we consider it vitally important that the honoraria be high enough to ensure adequate participation when initially offered.

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

Private Sector

BURDEN HOURS

Category of Respondent	No. of Respondents	Participation Time (hours)	Burden (hours)
Physicians Surgeons, Except Ophthalmologists (Code 29-1248)	18	1	18
Nurses Registered Nurses (Code 29-1141)	18	1	18
Hospital administrators/senior leaders Medical and Health Services Managers (Code 11-9111)	18	1	18
Total			54

FEDERAL COST: The estimated annual cost to the Federal government is $38,544.80

Estimated total and annualized cost of Federal employee involvement in this one-year project-

Cost Component: Salaries	Total Cost (% effort)	Annualized Cost
Primary oversight provided by AHRQ GS-15 Task Order Officer	$16,334.50 (10 %)	$16,334.50
Review and support provided by AHRQ GS-15	$16,334.50 (10 %)	$16,334.50
Administrative support provided by AHRQ GS-13 Program Manager	$5,875.80 (5 %)	$5,875.80
Total		$38,544.80

Exhibit A describes the estimated annualized cost burden to hospitals.

Exhibit A. Estimated annualized cost burden on hospitals¹

Staff Position	Number of Hours & Hourly Wage	Cost Burden
Surgeons, Except Ophthalmologists (Code 29-1248)	18 ($105.43/hr)	$1,897.74
Registered Nurses (Code 29-1141)	18 ($39.27/hr)	$ 706.86
Medical and Health Services Managers (Code 11-9111)	18 ($61.22/hr)	$1,101.96
Total		$3,706.56

¹ Estimated hourly wages for the staff positions and codes were obtained from the National Industry-Specific Occupational Employment and Wage Estimates, May 2020, from the Bureau of Labor Statistics (available at http://www.bls.gov/oes/current/naics4_621100.htm [for general medical and surgical hospitals, NAICS 622100]).

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? [X ] Yes [ ] No

2. 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?

A convenience sample of six hospitals will be needed for the qualitative study. The six hospitals will be selected from ISCR hospitals that initiated the intervention in the colorectal line, extended it to one or more surgical lines, and are currently participating in at least one of the surgical lines. ISCR program staff will communicate with several hospitals meeting these criteria in order to identify six that are willing to participate in the qualitative study. A point-of-contact at each interested hospital will then be asked to identify potential individual surgeons, RNs, hospital administrators and managers within the hospital who would be willing to participate in individual qualitative interviews. The names and any identifying information from the hospitals and individuals that participate will be kept confidential and will not be disclosed in any reports or summaries of findings from the qualitative interviews. No formal quantitative statistical analysis is planned.

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

[ ] In-person

[ ] Mail

[X] Other, Explain – Zoom.gov

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

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

See Appendix A: Interview Protocol

1 Mohan, D., Rosengart, M.R., Fischhoff, B. et al. (2017). Using incentives to recruit physicians into behavioral trials: lessons learned from four studies. BMC Res Notes 10 (776). https://doi.org/10.1186/s13104-017-3101-z

2 Mercer A., Caporaso, A., Cantor, D., and Townsend, R. (2015). How much gets you how much? Monetary incentives and response rates in household surveys. Public Opinion Quarterly, 79(1), 105-129.

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