Patient Partnership Tools to Support Medication Safety in Community-Dwelling Older Adults: Protocol for a Nonrandomized Stepped Wedge Clinical Trial

doi:10.2196/57878

. 2024 Apr 29:13:e57878.

doi: 10.2196/57878.

Patient Partnership Tools to Support Medication Safety in Community-Dwelling Older Adults: Protocol for a Nonrandomized Stepped Wedge Clinical Trial

Yan Xiao^{1

2}, Kimberley G Fulda³, Richard A Young⁴, Z Noah Hendrix¹, Kathryn M Daniel¹, Kay Yut Chen⁵, Yuan Zhou², Jennifer L Roye¹, Ludmila Kosmari¹, Joshua Wilson⁶, Anna M Espinoza³, Kathleen M Sutcliffe^{7

8

9

10}, Samantha I Pitts⁸, Alicia I Arbaje^{8

9}, Michelle A Chui¹¹, Somer Blair¹², Dawn Sloan⁴, Masheika Jackson⁴, Ayse P Gurses^{8

9

13}

Affiliations

¹ College of Nursing and Health Innovation, University of Texas at Arlington, Arlington, TX, United States.
² College of Engineering, University of Texas at Arlington, Arlington, TX, United States.
³ Department of Family Medicine and Osteopathic Manipulative Medicine and North Texas Primary Care Practice-Based Research Network (NorTex), University of North Texas Health Science Center, Fort Worth, TX, United States.
⁴ Family Medicine Residency Program, John Peter Smith Health Network, Fort Worth, TX, United States.
⁵ College of Business, University of Texas at Arlington, Arlington, TX, United States.
⁶ College of Liberal Arts, University of Texas at Arlington, Arlington, TX, United States.
⁷ Carey Business School, Johns Hopkins University, Baltimore, MD, United States.
⁸ School of Medicine, Johns Hopkins University, Baltimore, MD, United States.
⁹ Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, United States.
¹⁰ School of Nursing, Johns Hopkins University, Baltimore, MD, United States.
¹¹ School of Pharmacy, University of Wisconsin-Madison, Madison, WI, United States.
¹² Office of Clinical Research, John Peter Smith Health Network, Fort Worth, TX, United States.
¹³ Whiting School of Engineering, Johns Hopkins University, Baltimore, MD, United States.

PMID: 38684080
PMCID: PMC11091807
DOI: 10.2196/57878

Patient Partnership Tools to Support Medication Safety in Community-Dwelling Older Adults: Protocol for a Nonrandomized Stepped Wedge Clinical Trial

Yan Xiao et al. JMIR Res Protoc. 2024.

. 2024 Apr 29:13:e57878.

doi: 10.2196/57878.

Authors

Affiliations

¹ College of Nursing and Health Innovation, University of Texas at Arlington, Arlington, TX, United States.
² College of Engineering, University of Texas at Arlington, Arlington, TX, United States.
³ Department of Family Medicine and Osteopathic Manipulative Medicine and North Texas Primary Care Practice-Based Research Network (NorTex), University of North Texas Health Science Center, Fort Worth, TX, United States.
⁴ Family Medicine Residency Program, John Peter Smith Health Network, Fort Worth, TX, United States.
⁵ College of Business, University of Texas at Arlington, Arlington, TX, United States.
⁶ College of Liberal Arts, University of Texas at Arlington, Arlington, TX, United States.
⁷ Carey Business School, Johns Hopkins University, Baltimore, MD, United States.
⁸ School of Medicine, Johns Hopkins University, Baltimore, MD, United States.
⁹ Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, United States.
¹⁰ School of Nursing, Johns Hopkins University, Baltimore, MD, United States.
¹¹ School of Pharmacy, University of Wisconsin-Madison, Madison, WI, United States.
¹² Office of Clinical Research, John Peter Smith Health Network, Fort Worth, TX, United States.
¹³ Whiting School of Engineering, Johns Hopkins University, Baltimore, MD, United States.

PMID: 38684080
PMCID: PMC11091807
DOI: 10.2196/57878

Abstract

Background: Preventable harms from medications are significant threats to patient safety in community settings, especially among ambulatory older adults on multiple prescription medications. Patients may partner with primary care professionals by taking on active roles in decisions, learning the basics of medication self-management, and working with community resources.

Objective: This study aims to assess the impact of a set of patient partnership tools that redesign primary care encounters to encourage and empower patients to make more effective use of those encounters to improve medication safety.

Methods: The study is a nonrandomized, cross-sectional stepped wedge cluster-controlled trial with 1 private family medicine clinic and 2 public safety-net primary care clinics each composing their own cluster. There are 2 intervention sequences with 1 cluster per sequence and 1 control sequence with 1 cluster. Cross-sectional surveys will be taken immediately at the conclusion of visits to the clinics during 6 time periods of 6 weeks each, with a transition period of no data collection during intervention implementation. The number of visits to be surveyed will vary by period and cluster. We plan to recruit patients and professionals for surveys during 405 visits. In the experimental periods, visits will be conducted with two partnership tools and associated clinic process changes: (1) a 1-page visit preparation guide given to relevant patients by clinic staff before seeing the provider, with the intention to improve communication and shared decision-making, and (2) a library of short educational videos that clinic staff encourage patients to watch on medication safety. In the control periods, visits will be conducted with usual care. The primary outcome will be patients' self-efficacy in medication use. The secondary outcomes are medication-related issues such as duplicate therapies identified by primary care providers and assessment of collaborative work during visits.

Results: The study was funded in September 2019. Data collection started in April 2023 and ended in December 2023. Data was collected for 405 primary care encounters during that period. As of February 15, 2024, initial descriptive statistics were calculated. Full data analysis is expected to be completed and published in the summer of 2024.

Conclusions: This study will assess the impact of patient partnership tools and associated process changes in primary care on medication use self-efficacy and medication-related issues. The study is powered to identify types of patients who may benefit most from patient engagement tools in primary care visits.

Trial registration: ClinicalTrials.gov NCT05880368; https://clinicaltrials.gov/study/NCT05880368.

International registered report identifier (irrid): DERR1-10.2196/57878.

Keywords: ambulatory; care; communication; community dwelling; data collection; decision; decision making; effective; elderly; engagement; engagement tool; human factors; medication; medication safety; medications; older adults; patient engagement; patient safety; primary care; protocol; safety; self-efficacy; self-management; support; tool; tools.

©Yan Xiao, Kimberley G Fulda, Richard A Young, Z Noah Hendrix, Kathryn M Daniel, Kay Yut Chen, Yuan Zhou, Jennifer L Roye, Ludmila Kosmari, Joshua Wilson, Anna M Espinoza, Kathleen M Sutcliffe, Samantha I Pitts, Alicia I Arbaje, Michelle A Chui, Somer Blair, Dawn Sloan, Masheika Jackson, Ayse P Gurses. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 29.04.2024.

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Conflict of interest statement

Conflicts of Interest: KYC has a potential research conflict of interest due to a financial interest with companies Hewlett-Packard Enterprise, Boostr and DecisionNext. A management plan has been created to preserve objectivity in research in accordance with UTA policy. The authors have no further interests to declare.

References

1. Kuriakose R, Aggarwal A, Sohi RK, Goel R, Rashmi NC, Gambhir RS. Patient safety in primary and outpatient health care. J Family Med Prim Care. 2020;9(1):7–11. doi: 10.4103/jfmpc.jfmpc_837_19. http://www.jfmpc.com/article.asp?issn=2249-4863;year=2020;volume=9;issue... JFMPC-9-7 - DOI - PMC - PubMed
1. Goulding R, Birtwell K, Hann M, Peters S, van Marwijk H, Bower P. Safer Patients Empowered to Engage and Communicate about Health (SPEECH) in primary care: a feasibility study and process evaluation of an intervention for older people with multiple long-term conditions (multimorbidity) BMC Prim Care. 2024;25(1):12. doi: 10.1186/s12875-023-02221-3. https://europepmc.org/abstract/MED/38178010 10.1186/s12875-023-02221-3 - DOI - PMC - PubMed
1. Budnitz DS, Shehab N, Lovegrove MC, Geller AI, Lind JN, Pollock DA. US emergency department visits attributed to medication harms, 2017-2019. JAMA. 2021;326(13):1299–1309. doi: 10.1001/jama.2021.13844. https://europepmc.org/abstract/MED/34609453 2784662 - DOI - PMC - PubMed
1. Medication without harm: WHO's third global patient safety challenge. World Health Organization. 2017. [2024-04-03]. https://www.who.int/initiatives/medication-without-harm .
1. Harris Y, Hu DJ, Lee C, Mistry M, York A, Johnson TK. Advancing medication safety: establishing a national action plan for adverse drug event prevention. Jt Comm J Qual Patient Saf. 2015;41(8):351–360. doi: 10.1016/s1553-7250(15)41046-3.S1553-7250(15)41046-3 - DOI - PubMed

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[1] Kuriakose R, Aggarwal A, Sohi RK, Goel R, Rashmi NC, Gambhir RS. Patient safety in primary and outpatient health care. J Family Med Prim Care. 2020;9(1):7–11. doi: 10.4103/jfmpc.jfmpc_837_19. http://www.jfmpc.com/article.asp?issn=2249-4863;year=2020;volume=9;issue... JFMPC-9-7 - DOI - PMC - PubMed

[2] Kuriakose R, Aggarwal A, Sohi RK, Goel R, Rashmi NC, Gambhir RS. Patient safety in primary and outpatient health care. J Family Med Prim Care. 2020;9(1):7–11. doi: 10.4103/jfmpc.jfmpc_837_19. http://www.jfmpc.com/article.asp?issn=2249-4863;year=2020;volume=9;issue... JFMPC-9-7 - DOI - PMC - PubMed

[3] Goulding R, Birtwell K, Hann M, Peters S, van Marwijk H, Bower P. Safer Patients Empowered to Engage and Communicate about Health (SPEECH) in primary care: a feasibility study and process evaluation of an intervention for older people with multiple long-term conditions (multimorbidity) BMC Prim Care. 2024;25(1):12. doi: 10.1186/s12875-023-02221-3. https://europepmc.org/abstract/MED/38178010 10.1186/s12875-023-02221-3 - DOI - PMC - PubMed

[4] Goulding R, Birtwell K, Hann M, Peters S, van Marwijk H, Bower P. Safer Patients Empowered to Engage and Communicate about Health (SPEECH) in primary care: a feasibility study and process evaluation of an intervention for older people with multiple long-term conditions (multimorbidity) BMC Prim Care. 2024;25(1):12. doi: 10.1186/s12875-023-02221-3. https://europepmc.org/abstract/MED/38178010 10.1186/s12875-023-02221-3 - DOI - PMC - PubMed

[5] Budnitz DS, Shehab N, Lovegrove MC, Geller AI, Lind JN, Pollock DA. US emergency department visits attributed to medication harms, 2017-2019. JAMA. 2021;326(13):1299–1309. doi: 10.1001/jama.2021.13844. https://europepmc.org/abstract/MED/34609453 2784662 - DOI - PMC - PubMed

[6] Budnitz DS, Shehab N, Lovegrove MC, Geller AI, Lind JN, Pollock DA. US emergency department visits attributed to medication harms, 2017-2019. JAMA. 2021;326(13):1299–1309. doi: 10.1001/jama.2021.13844. https://europepmc.org/abstract/MED/34609453 2784662 - DOI - PMC - PubMed

[7] Medication without harm: WHO's third global patient safety challenge. World Health Organization. 2017. [2024-04-03]. https://www.who.int/initiatives/medication-without-harm .

[8] Medication without harm: WHO's third global patient safety challenge. World Health Organization. 2017. [2024-04-03]. https://www.who.int/initiatives/medication-without-harm .

[9] Harris Y, Hu DJ, Lee C, Mistry M, York A, Johnson TK. Advancing medication safety: establishing a national action plan for adverse drug event prevention. Jt Comm J Qual Patient Saf. 2015;41(8):351–360. doi: 10.1016/s1553-7250(15)41046-3.S1553-7250(15)41046-3 - DOI - PubMed

[10] Harris Y, Hu DJ, Lee C, Mistry M, York A, Johnson TK. Advancing medication safety: establishing a national action plan for adverse drug event prevention. Jt Comm J Qual Patient Saf. 2015;41(8):351–360. doi: 10.1016/s1553-7250(15)41046-3.S1553-7250(15)41046-3 - DOI - PubMed

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Patient Partnership Tools to Support Medication Safety in Community-Dwelling Older Adults: Protocol for a Nonrandomized Stepped Wedge Clinical Trial

Affiliations

Patient Partnership Tools to Support Medication Safety in Community-Dwelling Older Adults: Protocol for a Nonrandomized Stepped Wedge Clinical Trial

Authors

Affiliations

Abstract

Conflict of interest statement

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References

Publication types

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Associated data

Grants and funding

LinkOut - more resources

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Miscellaneous