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Abstract

Objective:

Given limited critical care resources and an aging population, early interventions to prevent critical illness are vital. In this work, we measured post-implementation outcomes after introducing a novel electronic scoring system (Elders Risk Assessment—ERA) and a risk-factor checklist, Checklist for Early Recognition and Treatment of Acute Illness (CERTAIN), to detect older patients at high risk of critical illness in a primary care setting.

Methods:

The study was conducted at a family medicine clinic in Kasson, MN. The ADAPT-ITT framework was used to modify the CERTAIN checklist for primary care during 2 co-design workshops involving interdisciplinary clinicians, held in April 2023. The ERA score and modified CERTAIN checklist were implemented between May and July 2023 and identify and assess all patients age ≥60 years at risk of critical illness during their primary care visits. Implementation outcomes were evaluated at the end of the study via an anonymous survey and EHR data extraction.

Results:

Fourteen clinicians participated in 2 co-design workshops. A total of 19 clinicians participated in a post-pilot survey. All survey items were rated on a 5-point Likert type scale. Mean acceptability of the ERA score and checklist was rated 3.35 (SD = 0.75) and 3.09 (SD = 0.64), respectively. Appropriateness had a mean rating of 3.38 (SD = 0.82) for the ERA score and 3.19 (SD = 0.59) for the checklist. Mean feasibility was rated 3.38(SD = 0.85) and 2.92 (SD = 0.76) for the ERA score and checklist, respectively. The adoption rate was 50% (19/38) among clinicians, but the reach was low at 17% (49/289) of eligible patients.

Conclusions:

This pilot study evaluated the implementation of an intervention that introduced the ERA score and CERTAIN checklist into a primary care practice. Results indicate moderate acceptability, appropriateness, and feasibility of the ERA score, and similar ratings for the checklist, with slightly lower feasibility. While checklist adoption was moderate, reach was limited, indicating inconsistent use.

Recommendations:

We plan to use the open-ended resurvey responses to further modify the CERTAIN-FM checklist and implementation process. The ADAPT-ITT framework is a useful model for adapting the checklist to meet the primary care clinician needs.

Keywords

primary care implementation older adult family medicine checklist

Introduction

The increasing demands on critical care resources experienced during the COVID-19 pandemic and an aging population require a proactive approach to the prevention of critical illness.^1
-4 Interventions in the primary care setting that prevent outcomes such as intensive care unit (ICU) admission, death, or functional decline, are desirable.² The electronic health record (EHR) is an advantageous tool that provides opportunities for timely identification of older patients at risk of critical illness and for the development and implementation of potential preventive strategies.⁵ These opportunities derive from the comprehensive amount of standardized patient information available through the EHR, facilitating the identification and computation of variables to determine risk of an outcome, such as critical illness.

The Elders Risk Assessment (ERA) score, which is automatically generated using EHR data, has been validated to identify patients at high risk of critical illness or death. The score combines several variables such as age, gender, recent hospitalizations, and comorbidities like dementia, diabetes, or cancer.^6,7 Our group conducted a retrospective cohort study to validate use of the score in a primary care setting, with a cohort of over 12 885 patients age ≥65 years who had primary care visits at Mayo Clinic in Rochester, MN, between July 2019 and December 2021.^8,9 We determined that an ERA score threshold of 9 was optimal for prediction of critical illness, defined as ICU admission or death within 1 year of the visit, in older adults presenting to a primary care clinic. However, the ERA score has never been prospectively implemented in primary care to serve as a trigger for actions to prevent critical illness and mortality.

In addition to validating the ERA score, our multidisciplinary team has developed and demonstrated the efficacy of a robust, multi-component implementation program: Checklist for Early Recognition and Treatment of Acute Illness (CERTAIN), to improve systematic safe care delivery and patient outcomes in hospitals in diverse countries.^10
-13 The program includes a checklist for daily ICU rounding, which offers a structured approach for evaluating patients, reducing the risk of avoidable harm. The CERTAIN checklist contains items that prompt for the assessment of common sources of illness in older patients, organized by organ system. With some adaptations, the checklist may help primary care clinicians take early preventive measures during routine visits when patients have a high ERA score, leading to improved outcomes. This in turn may reduce the strain on hospital resources.¹⁴

The ERA score and CERTAIN checklist have demonstrated usefulness in other settings,¹¹ and we anticipate that using these tools may also be effective when used by primary care providers, who may be in an ideal position to suggest and follow-up on medical interventions given the long-term nature of their relationship with patients. However, because the ERA score and CERTAIN checklist have never been implemented in primary care, it is unclear how clinicians will respond to them and how successful their implementation will be. Furthermore, the CERTAIN checklist likely needs some adaptations to be applicable in primary care.

This pilot study aimed to first engage primary care clinical stakeholders in modifying the CERTAIN checklist using the Assessment, Decision, Adaptation, Production, Topical experts-integration, Training, and Testing (ADAPT-ITT) model, which provides a framework to systematically adapt interventions for different settings,¹⁵ and second, evaluate the implementation of the modified CERTAIN checklist along with the validated ERA score in the primary care setting as part of a 2-month pilot. Following the pilot, we evaluated early implementation outcomes, including acceptability, appropriateness, and feasibility by surveying clinicians. We also evaluated adoption and reach. Adoption was defined as the proportion of end-users who choose to try out the new tools, and reach refers to the proportion of eligible patients who received the intervention. These measures are helpful in assessing the potential impact and success of the intervention in clinical practice.

Methods

Study Design

This pilot prospective implementation study was part of a multi-phase project. The ERA score was previously validated in another study (IRB 22-009055) to predict critical illness, defined as death or ICU admission within 1 year of a primary care visit, in a large cohort of 12 885 community-dwelling older adults.⁸

Study Setting and Participants

Study setting

The study was conducted at Mayo Family Clinic Kasson, MN, part of the Department of Family Medicine at Mayo Clinic Rochester, from March to July 2023. Approximately 11 600 patients are empaneled at the clinic, and the clinical team includes 36 physicians (9 attendings and 27 physicians in training), 2 nurse practitioners (NP), and 26 nurses.

Participants

All clinical team members were eligible to participate in the co-design workshops and 2-month pilot and complete the post-implementation surveys.

For the implementation phase, eligible patients were those age ≥60 years, with an ERA score ≥9. We excluded patients with missing or incomplete records. Of total, 289 were eligible for inclusion.

Adapting the Checklist and Co-Design Workshops

The study team used the ADAPT-ITT framework (previously used to adapt evidence-based human immunodeficiency virus [HIV] prevention interventions) to adapt the CERTAIN checklist for use in primary care, applying current best practice guidelines for older adults.^10,15 We used a clinic-specific email distribution list to invite clinicians to participate in 2 co-design workshops, held in April 2023. During these interdisciplinary 1-hour workshops, engaging family medicine and ICU clinicians, the study team presented drafts of the modified checklist based on clinical judgment and elicited attendees’ feedback. The 14 participants (out of 36 eligible clinicians) discussed the appropriateness of each element of the checklist, modifying them and achieving consensus. Feedback was integrated to create the adapted CERTAIN Family Medicine (CERTAIN-FM) checklist. The workshops were audio-recorded, and attendee’s notes and field notes were collected during discussions.

Integrating the ERA Score and CERTAIN-FM Checklist into Practice Workflow

The clinic’s existing practice workflow included twice daily “huddles” before morning and afternoon patient visits, in which clinicians discussed patients prior to their appointment. The ERA score was available in all Mayo Clinic patients’ EHR. To integrate the ERA score into these huddles, we requested that nurses flagged patients age ≥60 years with high ERA scores (≥9) on the whiteboard. Clinicians were asked to complete a paper copy of the CERTAIN-FM checklist during their consultation with those patients. Completion of the checklist involved notating items which triggered the clinician to take an action such as asking a question, reviewing the chart, or managing the medications. The paper checklists were collected at the end of each day.

Evaluating Implementation

We conducted a pilot study implementing the combined intervention between May 11 and July 10, 2023. The family medicine physician champion promoted the pilot study via group email reminders. Our study team posted flyers and provided onsite support.

Data Collection

At the end of the study, on July 10, completed paper copies of the CERTAIN-FM checklist were reviewed. We administered an anonymous online survey available until July 31 via REDCap that asked participants about whether they had used the ERA score and/or the CERTAIN-FM checklist (see Supplemental Files).^16,17 Those who selected yes, were then administered a 12 item questionnaire to determine the Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM), of the ERA score and/or the CERTAIN-FM checklist via survey branching logic; AIM-IAM-FIM are standardized measurements used to evaluate the success of implementation efforts.¹⁸ The survey also included 6 questions to capture demographics. A space for open-ended comments was included.

Data Analysis

We calculated descriptive statistics from the REDCap survey. For the ERA score and CERTAIN-FM checklist, we calculated the mean and standard deviation (SD) of the 4 acceptability items, 4 appropriateness items, and 4 feasibility items (rated on a 1-5, Likert-type scale, with 1 = completely disagree and 5 = completely agree), using StataCorp software.¹⁹

We calculated adoption as the percentage of clinicians who completed at least 1 paper-based checklist. We extracted data from the EHR to evaluate reach as the percentage of eligible patients ≥ 60 years with ERA score ≥ 9 whose clinician completed a CERTAIN-FM checklist during the visit.

Results

Table 1 describes the steps in the checklist adaptation process following the ADAPT-ITT model.¹⁵ Figure 1 presents the final checklist, adapted for primary care. Out of 36 eligible clinicians, 14 participated in the co-design workshops.

Table 1.

Phases of Adaptation of the CERTAIN Checklist to Primary Care Practice.

Phase	What we did	Draft
Phase 1: Assessment	Discussed need for earlier identification and prevention of critical illness in older adults with critical care clinicians. Engaged with primary care clinicians to determine what support might assist them in better identifying risk and intervening to prevent critical illness in older patients presenting to their clinic. Discussed known clinical features in older adults that are predictive of critical illness in the subsequent year(s).	N/A
Phase 2: Decision	Selected the previously validated Elders Risk Assessment (ERA) score and Checklist for Early Recognition and Treatment of Acute Illness (CERTAIN)¹¹ previously used in the ICU context and chose to leverage them to identify at risk older patients presenting to primary care clinic and prompt assessment and intervention by primary care clinicians.	Original
Phase 3: Adaptation	Prior to testing the CERTAIN checklist to determine needed modifications, the research team, original creator of the CERTAIN checklist, and an experienced primary care physician champion met to make preliminary modifications to the checklist. The checklist was then presented to interdisciplinary primary care clinicians (e.g., attending physicians, nurses, residents, nurse practitioners). After receiving an overview of the checklist, staff wrote their suggestions for adapting the checklist on a paper copy of the checklist. The group then engaged in a discussion of needed adaptations and arrived at consensus on key priority adaptations.	Original
Phase 4: Production	The research team consolidated feedback received during the first workshop. This feedback was incorporated into a Family Medicine specific draft of the CERTAIN checklist (CERTAIN-FM).	Draft 1
Phase 5: Topic experts	Following incorporation of feedback and drafting of the CERTAIN-FM checklist, we met with one of the original creators of the CERTAIN checklist to discuss the revisions and adaptations. It was important to ensure that key considerations and actions were listed by organ systems (as done in the original checklist) to prompt clinicians to consider disease screening, testing, and medication management in a systematic way that does not overlook any organ systems or key preventive measures. The Family Medicine physician champion was present during discussions of adaptations to represent the needs of the family medicine practice and how this checklist would fit into their workflow and address the needs of their patient population.	Draft 1
Phase 6: Integration	The research team created a further revised version of the CERTAIN-FM checklist. This version was introduced to a second workgroup of Family Medicine clinicians, whose feedback was consolidated and discussed by the study team, resulting in a final version of the checklist.	Draft 2
Phase 7: Training	A Family Medicine physician champion introduced the ERA score and CERTAIN-FM checklist during staff meetings and via clinic-wide emails. Presentations included an explanation of what the ERA score and CERTAIN-FM checklist were, their purpose, and how they should be integrated into routine clinical care. A website was created to facilitate education and communication.	Draft 2
Phase 8: Testing	The ERA score and CERTAIN-FM checklist were introduced into the Family Medicine Clinic for a 9-week pilot. Nurses were asked to write the ERA scores ≥ 9 for patients ≥ 60 years old on a whiteboard during huddle, and physicians were encouraged to utilize a paper version of the CERTAIN-FM checklist for every patient with an elevated ERA score. They were asked to indicate items on the checklist that changed their thought process or outcome of the visit. Checklists were collected at the end of the trial period to measure reach and clinician adoption. Family Medicine clinicians were administered a survey assessing acceptability, appropriateness, and feasibility of the ERA score and CERTAIN-FM checklist.	Final

Abbreviations: ERA Score: Elders Risk Assessment Score; CERTAIN-FM: Checklist for Early Recognition and Treatment of Acute Illness-Family Medicine.

Figure 1.

CERTAIN checklist adapted for Family Medicine (CERTAIN-FM). Final list of items was chosen by family medicine and critical care clinicians in 2 co-design workshops. The list reflects what the clinicians perceive to be items that should be addressed during primary care visits with older adults who have been identified using the ERA score as being at risk of critical illness.

Acceptability, Appropriateness, and Feasibility

The post-pilot survey measuring acceptability, appropriateness, and feasibility was completed by 19 clinicians (3 residents, 9 attending physicians, 1 NP, and 6 nurses). Five respondents (1 resident, 2 attendings, and 2 nurses) reported using neither the ERA score nor the CERTAIN-FM checklist, resulting in termination of the survey. The response rate was 100% for attending physicians, 11% for residents, 50% for NPs, and 23% for nurses. Table 2 describes the ratings obtained for the ERA Score and CERTAIN-FM checklist.

Table 2.

Mean Acceptability, Appropriateness, and Feasibility Rating of the ERA Score and Checklist by Role.

Mean acceptability, appropriateness, and feasibility rating of the ERA score by role
Clinician role	Acceptability of ERA score (SD)	Appropriateness of ERA score (SD)	Feasibility of ERA score (SD)
Resident (n = 2)	3.38 (0.53)	3.13 (0.53)	3.88 (0.18)
Attending (n = 7)	3.79 (0.62)	3.82 (0.69)	3.64 (0.86)
NP (n = 1)	2.5 (0)	2.25 (0)	3 (0)
Nurse (n = 3)	2.58(0.38)	2.92 (0.88)	2.58 (0.76)
Mean acceptability, appropriateness, and feasibility rating of the checklist by role
Clinician role	Acceptability of CERTAIN-FM checklist	Appropriateness of CERTAIN-FM checklist	Feasibility of CERTAIN-FM checklist
Resident (n = 2)	3.13 (0.18)	3.13 (SD = 0.53)	3.63 (0.18)
Attending (n = 6)^*	3.25 (0.71)	3.4 (0.52)	2.83 (0.74)
NP (n = 1)	2.25 (0)	2.25 (0)	2 (0)

Of note, one of the six Attendings responded to only one CERTAIN-FM question (Feasibility) and did not provide response to the other two items (Acceptability and Appropriateness).

Abbreviations: CERTAIN-FM, checklist for early recognition and treatment of acute illness – family medicine; ERA, elders risk assessment; NP, nurse practitioner; SD, standard deviation.

ERA Score

14 respondents reported using the ERA score (2 residents, 7 attendings, 1 NP, and 4 nurses). Thirteen responses demonstrated acceptability of the ERA score with a mean rating of 3.35 (0.75), appropriateness a mean rating of 3.38 (0.82), and feasibility a mean rating of 3.38 (0.85).

CERTAIN-FM Checklist

Nine respondents reported using the CERTAIN-FM checklist (2 residents, 6 attendings, and 1 NP) and rated feasibility a mean of 2.92 (0.76). Using data provided by 8 participants for acceptability and appropriateness, we found acceptability of the CERTAIN-FM checklist was rated a mean of 3.09 (0.64) and appropriateness a mean of 3.19 (0.59).

Adoption and Reach of the CERTAIN-FM Checklist

Of the 38 clinicians who worked in the clinic, 19 completed a checklist, indicating an adoption rate of 50%. A total of 289 patients ≥ 60 years with ERA score ≥ 9 were seen in clinic during the study period and eligible for checklist completion. Of these, checklists were completed for 49 patients, revealing the intervention reached 17% of eligible patients.

Discussion

This pilot study is the first to implement the validated ERA score for predicting critical illness in older adults with the CERTAIN-FM checklist in a primary care clinic. We involved family medicine clinicians in adapting the ICU CERTAIN checklist, to create the CERTAIN-FM version for use in primary care. Implementation outcomes measured at the pilot’s conclusion suggested moderate acceptability, appropriateness, and feasibility of the ERA score and moderate acceptability and appropriateness of the CERTAIN-FM checklist (mean ratings of 3) corresponding to “neither agree nor disagree”). Feasibility of the CERTAIN-FM checklist was rated slightly lower with a mean rating below 3. Checklist adoption was moderate, but reach was low.

These results suggest opportunities for refining implementation of the ERA score and CERTAIN-FM checklist. Open-ended responses provided in the post-pilot survey suggested that asking nurses to identify and write the ERA score on the whiteboard for huddle discussions increased burden. Future efforts may consider automated approaches to prompt clinicians with the score. Open-ended responses also suggested opportunities for streamlining the items on the CERTAIN-FM checklist to reduce clinical burden.²⁰ This feedback echoes responses from qualitative studies examining perceptions about checklist use by home help staff.²¹ Sharing data about critical illness outcomes, once available in 1 year, may bolster support by justifying the added effort of checklist completion.

The prevalence of critical illness continues to rise with increased longevity.²² This increased demand on ICU resources and demonstrates the value of preventing critical illness, considering that a large proportion of ICU-associated hospitalizations may be preventable with community-based interventions.²³ Furthermore, the primary care setting could be the ideal environment for prevention of critical illness, given the opportunity to periodically assess each patient in a comprehensive way and the unique long term patient-provider relationship.

Checklist implementation in primary care for specific diseases and symptoms such as kidney disease and asthma have been shown to be effective.^24
-26 Checklists have been developed for addressing the needs of older adults during acute admissions.²⁷ However, this pilot study using a score and checklist to address broader concerns about critical illness with an organ-based approach in primary care is a promising prevention strategy.

Strengths and Limitations

We used a robust approach to modify the CERTAIN checklist and involved experienced team members who had adapted checklists in other contexts.^15,28 Adapting an already established evidence-based ICU checklist reduces the time and costs associated with creating a new intervention, while maintaining the relationship between critical and primary care. We also utilized the frequently used implementation measures of acceptability, appropriateness, and feasibility to estimate implementation success. However, response rates to the post-implementation survey varied by role, from 100% of attending physicians to 11% of residents. It is possible that due to the relative inexperience and time constraints, resident learners did not respond. Due to this variation in completion and small number of staff in certain roles, we could not assess differences in perceptions of acceptability, appropriateness, and feasibility by role and experience.

Additionally, our findings may not be generalizable to different practice workflows. For instance, existing twice daily huddles were used to implement discussion of patient ERA scores and prompt CERTAIN-FM checklist use. Practices with different workflows may need to consider an alternative implementation strategy. Given the simplicity of the intervention, we believe this could be adapted to diverse settings. Mayo Clinic has several similarly sized primary care and family medicine clinics in which this intervention could be implemented. Given the widespread adoption of EHRs it is likely that the ERA score can be calculated in other healthcare systems.

We calculated adoption and reach by collecting paper checklists signed by clinicians. However, we are unable to determine precisely how the checklist was used by clinicians and whether it prompted a change in clinical management. Consequently, future efforts may consider more thorough instructions for completing the checklist and assess fidelity as an outcome. Furthermore, checklists may have been utilized but not returned and therefore undercounted.

This innovative adaptation and implementation of an evidence-based intervention in primary care was a novel first attempt at improving outcomes in older adults who may be at risk for critical illness. However, implementation outcomes revealed the need to refine the fit of this intervention for primary care and test its fit in diverse primary care practices. Nonetheless, this pilot study provided encouraging data, particularly the moderate rate of adoption of the CERTAIN-FM checklist.

Conclussion

This pilot study combined the ERA score and an adapted version of the CERTAIN checklist in primary care and assessed implementation outcomes. Results indicate moderate acceptability, appropriateness, and feasibility of the ERA score, and similar ratings for the checklist, albeit slightly lower feasibility. While checklist adoption was moderate, reach was limited, indicating inconsistent tool usage. Survey results suggest ways to modify the CERTAIN-FM checklist and implementation. The ADAPT-ITT framework proved useful in tailoring the checklist to primary care provider needs.

Recommendations

Approximately 50% of clinicians used the checklist at least once, suggesting willingness to explore such interventions. Improving the checklist and its implementation may address usage inconsistencies. Open-ended responses provide a foundation for further refinements. Future efforts should include precise instructions for checklist completion and assess fidelity as an outcome. Involving end-users in the design process is crucial, offering insights into needs, challenges, and strategies to improve usability and acceptance.

Supplemental Material

sj-pdf-1-jpc-10.1177_21501319241231238 – Supplemental material for Early Prevention of Critical Illness in Older Adults: Adaptation and Pilot Testing of an Electronic Risk Score and Checklist

Supplemental material, sj-pdf-1-jpc-10.1177_21501319241231238 for Early Prevention of Critical Illness in Older Adults: Adaptation and Pilot Testing of an Electronic Risk Score and Checklist by Christopher L. Boswell, Sarah A. Minteer, Svetlana Herasevich, Juan P. Garcia-Mendez, Yue Dong, Ognjen Gajic and Amelia K. Barwise in Journal of Primary Care & Community Health

Supplemental Material

sj-pdf-2-jpc-10.1177_21501319241231238 – Supplemental material for Early Prevention of Critical Illness in Older Adults: Adaptation and Pilot Testing of an Electronic Risk Score and Checklist

Supplemental material, sj-pdf-2-jpc-10.1177_21501319241231238 for Early Prevention of Critical Illness in Older Adults: Adaptation and Pilot Testing of an Electronic Risk Score and Checklist by Christopher L. Boswell, Sarah A. Minteer, Svetlana Herasevich, Juan P. Garcia-Mendez, Yue Dong, Ognjen Gajic and Amelia K. Barwise in Journal of Primary Care & Community Health

Footnotes

Acknowledgements

We want to thank the participant clinicians who attended the checklist co-design workshop as well as those who used the ERA-score and CERTAIN-FM checklist and responded the post-implementation survey.

Declaration of Conflicting Interests

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding

The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This work was supported by an Innovation in Aging award funded by the Kogod Center for Aging at Mayo Clinic and the National Center for Advancing Translational Sciences Grant [UL1TR002377]. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the NIH.

ORCID iDs

Christopher L. Boswell

Juan P. Garcia-Mendez

Supplemental Material

Supplemental material for this article is available online.

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Supplementary Material

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