Expanded care planning paradigm for older adults with type 2 diabetes: Rationale, design, and protocol of the PREPARE for Your Diabetes Care randomized trial.

Expanded care planning paradigm for older adults with type 2 diabetes: Rationale, design, and protocol of the PREPARE for Your Diabetes Care randomized trial - PMC Skip to main content An official website of the United States government Here's how you know Here's how you know Search Log in Primary site navigation Search Log in Search PMC Full-Text Archive Search in PMC Journal List User Guide As a library, NLM provides access to scientific literature. Inclusion in an NLM database does not imply endorsement of, or agreement with, the contents by NLM or the National Institutes of Health. Learn more: PMC Disclaimer | PMC Copyright Notice Contemp Clin Trials . Author manuscript; available in PMC: 2026 Jun 1. Published in final edited form as: Contemp Clin Trials. 2025 Apr 11;153:107913. doi: 10.1016/j.cct.2025.107913 Expanded care planning paradigm for older adults with type 2 diabetes: Rationale, design, and protocol of the PREPARE for Your Diabetes Care randomized trial Alexandra K Lee a, b , Jose J Mejia c , Clarissa Ferguson a , Brookelle H Li a , Richard W Grant c , Rebecca L Sudore a, b, * Author information Article notes Copyright and License information a Division of Geriatrics, Department of Medicine, University of California, San Francisco, San Francisco, CA, USA b San Francisco Veterans Affairs Medical Center, San Francisco, CA, USA c Division of Research, Kaiser Permanente Northern California, Oakland, CA, USA * Corresponding author at: 490 Illinois St, Box 1265, UCSF Division of Geriatrics, San Francisco, CA 94143, USA. Rebecca.sudore@ucsf.edu (R.L. Sudore). Issue date 2025 Jun. PMC Copyright notice PMCID: PMC12148217  NIHMSID: NIHMS2083576  PMID: 40222399 The publisher's version of this article is available at Contemp Clin Trials Abstract Background: As adults with type 2 diabetes (T2D) age, they are increasingly vulnerable to treatment-related hypoglycemia and subsequent complications including falls and hospitalizations. Care planning helps patients communicate what is most important for their medical care with their family, friends, and clinicians and could help reduce treatment-related complications of T2D in older adults. Methods: We applied an expanded care planning paradigm to the specific clinical problem of type 2 diabetes management in older patients. Applying user-centered design methods, we developed an educational, web-based program called “PREPARE for Your Diabetes Care,” incorporating input and feedback from patient and provider key informants. A randomized controlled trial (RCT) of this program vs. usual care is being conducted among Kaiser Permanente Northern California members ≥75 years of age, prescribed insulin or sulfonylureas, and at high risk for hypoglycemia. The primary outcome of the RCT is clinically significant hypoglycemia episodes (self-reported 3+ symptomatic episodes of hypoglycemia, self-reported severe hypoglycemia, and/or ED or hospitalization for hypoglycemia). Secondary outcomes will include medication de-intensification, 5-item RAND Patient Satisfaction, and 5-item Perceived Efficacy in Patient - Physician Interactions. Results: This study has completed enrollment and randomized 673 participants; trial completion is expected in late 2025. Conclusions: This research will evaluate an expanded care planning intervention to reduce treatment-related hypoglycemia in older adults with T2D. If successful, this web-based expanded care planning strategy could be applied to a wide variety of geriatric conditions requiring individualization of treatment based on patients’ preferences. Trial registration numbers: NCT05263310 ; Pre-results. 1. Introduction Of the 25 million US adults aged ≥75 years [ 1 ], over 25 % have type 2 diabetes (T2D) [ 2 ]. As patients age, the potential benefits from intensive T2D management diminish while the potential harms from treatment rise. For T2D, hypoglycemia is the primary adverse consequence of diabetes treatment: it causes nearly 23,000 hospitalizations annually [ 3 ] and increases the risk of falls, cognitive decline, and cardiovascular disease [ 4 ], To mitigate hypoglycemia risk, current clinical guidelines recommend individualizing diabetes treatment intensity based on clinical status and patient preferences [ 4 ]. These treatment and management goal preferences must come from the patient . Unfortunately, many older patients report they are unprepared to identify and communicate preferences for medical care and that the care they receive does not align with their preferences and values concerning quality of life [ 5 ]. Care planning is a well-supported strategy to educate patients and build their communication skills to more effectively voice their treatment preferences [ 6 – 9 ]. The goal of care planning is to ensure that patients receive medical care that is aligned with their values and preferences [ 10 , 11 ]. Although often applied to end-of-life decisions, the care planning paradigm has recently been expanded to include preparation for communication and decisions across the illness trajectory [ 8 ]. This expanded care planning model aims to prepare patients to define their values and preferences and to participate more effectively with their clinicians in making complex decisions regarding the management of their chronic medical conditions. By preparing and supporting patients to participate in continually re-assessing their T2D treatment, their changing health, and their care goals, we hypothesize that this expanded care planning strategy can be a powerful tool to reduce overtreatment and associated risk for hypoglycemia in this high-risk patient population. This manuscript describes the development and implementation of a pragmatic, parallel group randomized controlled trial (RCT) to assess the efficacy of a newly developed diabetes educational tool to reduce hypoglycemic events and improve patient-primary care provider communication. This video-based, online educational tool, the PREPARE for Your Diabetes Care program, was designed using the expanded care planning paradigm to help high-risk, older adult (≥75 years) patients with T2D discuss their diabetes medication regimens with their primary care providers. We hypothesized that empowering high-risk patients to engage in values-based discussions about diabetes treatment intensity will result, when clinically appropriate, in decreases in diabetes regimen intensity leading to decreased incidence of hypoglycemia over the 12-month study period. If successful, this study will provide evidence to support strategies for safer treatment in older adults with type 2 diabetes. 2. Methods 2.1. Study overview This paper describes the study design, intervention development, recruitment process, and data collection procedures. The intervention was developed from December 2020 to November 2021. Recruitment occurred from April 2022 through May 2024, and the intervention and follow-up are ongoing through May 2025. In this paper, we use past tense for all activities through baseline and future tense for other ongoing study activities. Participants were enrolled from Kaiser Permanente Northern California (KPNC) and randomized to the intervention or usual care for the 12-month intervention period. Data are collected at baseline, 6- and 12-months post-randomization, with a $10 Target gift card provided for completion of the interview at each time point. The Institutional Review Board at KPNC approved this study protocol. This study is guided by a patient and clinical advisory board comprising older KPNC patients, primary care clinicians, and medical directors from KPNC and the University of California, San Francisco. It is also guided by a Data Safety Monitoring Board (DSMB) consisting of five experts in randomized trials, human participants research and consent, vulnerable populations, geriatrics, and biostatistics. The advisory board and the DSMB reviewed and approved all study protocols and related materials; both groups will continue to meet annually for the duration of the study. This study is registered at ClinicalTrials.gov ( NCT05263310 ). 2.2. Conceptual framework The study intervention, PREPARE for Your Diabetes Care, is an educational, web and video-based program designed to support safer long-term T2D care among older adults at high risk for treatment-related hypoglycemia. This program is based on the previously developed PREPARE tool ( prepareforyourcare.org ) and the expanded care planning paradigm that includes preparation for ongoing decisions for chronic and severe illness [ 8 , 12 ]. Our intervention design and outcome measures are derived from elements of the following 5 widely-used theoretical models: 1. Social Cognitive Theory (SCT) which identifies patients as active change agents through self-efficacy and observational learning (e.g., by observing patient-provider discussions via video vignettes) [ 13 , 14 ]; 2. Health Belief Model (HBM) which considers the individual’s perceptions of the health risk and perceived benefits of action (e.g., susceptibility to and severity of hypoglycemia, the benefits of avoiding hypoglycemia) as mediators of engagement (e.g. discussion about intensity of therapy) [ 15 ]; 3. Theory of Planned Behavior (TPB) which adds the element of perceived control to the understanding of how individuals’ beliefs and attitudes influence their intentions and behaviors [ 16 ]; 4. Stage of Changes Model (SCM) which describes a process in which patients move from pre-contemplative to contemplative to preparation to action (e.g., a process that begins before the visit) [ 17 ]; and, 5. Wagner’s Chronic Care Model (CCM) which emphasizes the importance of informed, activated patients to enable productive provider-patient interactions that improve clinical outcomes [ 18 , 19 ]. Prior research by our group [ 20 ] and others [ 21 – 26 ] has shown that modeling of behaviors (as with video vignettes of patient-provider visit interactions) can improve communication (e.g., increased question asking) and participation in decision-making. Informed by this theoretical framework, our intervention model was designed to address the following 4 modifiable mediators to affect behavior change (See Fig. 1 ): 1) Knowledge & Beliefs (by describing the importance of preparation and the balance of treatment risks and benefits in T2D); 2) Outcome expectations (by describing how preparation can decrease emotional burden for patients and create a sense of control); 3) Perceived barriers (by providing vignette examples of how to overcome typical barriers to effective communication) [ 27 ]; 4) Skills and self-efficacy (by modeling communication behavior through videos of patient-provider discussions that include examples of setting T2D treatment goals and deciding whether or not to decrease regimen intensity). Once adequate training has been provided and mediating factors have been positively affected, patients can begin to prepare, plan, and become activated to engage in expanded care planning behaviors such as asking questions and making shared decisions to re-assess current diabetes treatment and reduce the risk of hypoglycemic events through regimen de-intensification. We implemented our theory-driven intervention into the clinical setting using the Chronic Care Model, which focuses on educating and preparing patients before their primary care visits. Fig. 1. Open in a new tab Footnote: SCT, Social Cognitive Theory. HBM, Health Belief Model. TPB, Theory of Planned Behavior. SCM, Stage of Changes Model. CCM, Wagner’s Chronic Care Model. 2.3. Study setting and eligibility criteria This RCT is set within Kaiser Permanente Northern California (KPNC), a non-profit integrated health care delivery system providing care for over 4.2 million diverse members, including more than 200,000 members with T2D [ 28 ]. The distribution of member demographic and socioeconomic factors is racially and ethnically diverse and similar to that of the area population [ 29 ]. Overall, internet access by KPNC members is estimated to be 90 %, similar to average rates nationwide[ 30 ]. Furthermore, the patient population at KPNC is not unique in that most older adults with diabetes in the US are insured (99.5 % age ≥ 65) [ 31 ]; and HbAlc control at KPNC is similar to US rates (Alc < 8.0 %: 77.3 % for KPNC and 82.6 % in NHANES 2017–2020, age > 65) [ 2 ]. KPNC members were eligible for this RCT if they were 75 years of age or older with T2D, had ≥1 year of continuous KPNC membership, and were prescribed insulin and/or sulfonylureas, with last measured HbAlc ≤ 8 %. Primary care providers were provided the opportunity to exclude their patients they deemed not appropriate for the study. We excluded KPNC members who did not speak English, who screened positive for moderate-to-severe cognitive impairment using the validated Short Portable Mental Status Questionnaire (SPMSQ) followed by the Mini-Cog [ 32 – 34 ], or who self-reported to be blind. KPNC members who lacked internet access or had moderate to severe hearing impairment and were unable to communicate over the phone were also excluded. 2.4. Intervention design We used an iterative, user-centered design process to develop the PREPARE for Your Diabetes Care videos and website to specifically address T2D management for older adults. Using our team’s experience and a transdisciplinary Advisory Group convened specifically for developing PREPARE for Your Diabetes Care and composed of primary care clinicians, pharmacists, diabetes specialists, and geriatricians, we created new content and modeled video vignettes focused specifically on T2D regimen intensity reassessment. We mocked up storyboards that outlined the structure, content, and flow of the planned video vignettes and educational content. As the second step in the user-centered design process, we showed these prototypes to our Clinician Stakeholder Advisory board, which includes 9 primary care clinicians and has advised our prior projects [ 12 , 35 , 36 ], to obtain their input. We then revised and edited the content based on their feedback and suggestions. In the next step of the user-centered design process, we shared the revised prototype with KPNC’s standing Regional Pharmacy Member Advisory Council to get their expert opinions on the language we used. Finally, we conducted in-depth interviews with 7 older adults, using a semi-structured cognitive interview guide, to invite individuals to verbalize their thoughts and feelings about the content [ 37 , 38 ]. We conducted qualitative thematic content analysis and made modifications to the content and video vignettes based on their input. In particular, some patients were concerned about stopping medications, particularly insulin, which they thought they would have to be on for the rest of their life once they had started. Thus, we modified the PREPARE for Your Diabetes Care content to emphasize reductions in dosages and changing diabetes medications, rather than outright stopping medications. The PREPARE for Your Diabetes Care program has four two-to-five-minute video modules about the interactions of treatment intensity, glycemic goals, longer-term benefits, and predicted risks for vulnerable patients with T2D. The program uses plain language (i.e., a target of the 5th-grade reading level) so that it is easy to understand, includes voice-overs of all text for the reading-impaired, and has closed-captioning for the video vignettes for the hearing impaired. The first video module orients users to the program and the importance of deprescribing. The second and third video vignettes model different patient-provider conversations on re-assessing glycemic goals and treatment intensity. The second video portrays a doctor educating the viewer on the salient issues related to diabetes goal setting, deprescribing, and treatment reassessment for older patients. The third video portrays a realistic conversation between a patient and their provider to model how the discussion can be introduced by the patient, how to recognize and avoid barriers to discussing T2D treatment goals, and what the process of reassessing and deciding to reduce treatment intensity can look like. The fourth and final video module is about the “Action Plan” handout that is available on the PREPARE for Your Diabetes Care website and can be viewed online, downloaded, or printed ( Fig. 2 ). Patient-generated action plans have been shown to help patients engage in other preventative and disease management activities in the outpatient setting as well as care planning [ 39 , 40 ]. The purpose of this handout is to prepare patients to ask their providers about safely tapering, stopping, or switching their diabetes medications. The handout contains the key points covered in the program, scripts for patients to use to bring this topic up to their providers, and questions to ask their providers regarding their treatment. The handout also helps patients answer personal values questions about their diabetes treatment and create an action plan to discuss with their providers. Fig. 2. Open in a new tab Action Plan Handout for PREPARE for Your Diabetes Care. 2.5. Recruitment To facilitate recruitment, we obtained a Health Insurance Portability and Accountability Act waiver to access KPNC electronic medical record database with patient demographics, upcoming primary care clinic appointments, as well as emergency department visits, hospitalizations, and primary care visits in the prior year. We conducted weekly administrative data pulls from the electronic health record to identify patients with upcoming primary care appointments and screen them for study eligibility. After generating a list of KPNC members meeting eligibility criteria, we emailed the primary care providers to ask permission for our study team to contact their listed patients about the study. Providers were notified that if they did not respond to our requests within 10 business days, we would assume assent to contact their patients and begin recruitment attempts 2 weeks after we requested the provider’s permission. Following provider assent, we mailed eligible patients a recruitment opt-out study letter describing the PREPARE for Your Diabetes Care RCT. This study letter provided an email and phone number to hear more about the study and/or accept or decline the invitation to participate. If eligible patients did not respond within 2 weeks of the recruitment letter mailings, they were contacted by phone. For patients interested in study participation, we conducted a telephone screening of their cognitive ability using the SPMSQ and Mini-Cog. Following a negative screen for moderate-to-severe cognitive impairment, we proceeded with enrollment and informed consent. We used our previously developed teach-to-goal protocol during the consent process to ensure that participants understand the study and related processes [ 41 , 42 ]. This consent process included clear language to minimize possibility of coercion or undue influence. This process included a clear statement that participation (or refusal to participate) has no bearing on their care at KPNC. In addition, the consent process made clear that participants can withdraw from the study at any time without any consequences to their care at KPNC. 2.6. Randomization and intervention delivery Following consent, participants were randomized to the intervention or control arm, stratified on primary care practice. While clinicians will initially be blinded to randomization status, the PREPARE for Your Diabetes Care tool is designed to encourage intervention patients to proactively communicate with their providers about treatment preferences related to their diabetes management. Thus, clinician blinding may not be maintained. However, research staff conducting baseline and follow-up outcome ascertainment and initial data analysis will remain blinded to patient randomization status. Participants randomized to the control arm will receive usual care. To standardize the timing between intervention exposure and primary care visit, we scheduled patients for the baseline interview and exposure to the PREPARE for Your Diabetes Care website or the control intervention 3–10 days prior to their upcoming primary care appointment. Participants randomized to the intervention arm will review the PREPARE for Your Diabetes Care website and videos in their entirety before their next appointment with their primary care provider. After the baseline interview, a member of the study team will review all four video modules (on a video call, by phone, or in-person) to ensure the participant receives the intervention. Study coordinators will answer any questions as the participants go through the website and obtain feedback that participants have about the tool. At the end of the program, the study coordinators will ask participants to review the “Action Plan” handout (which is available to print on the website, and a ‘hard copy” will be mailed to them as well) and encourage them to discuss it with their and family and their primary care provider during the participants’ next scheduled appointment. Usage data from the website will not be collected and participants are not required to use a log-in name or password to access the website. Participants will be free to return to review segments throughout the study as needed without direct staff observation. For subsequent primary care visits, non-blinded study staff will call the participant prior to their primary care appointment to remind the participant about the study timeline and purpose of the study and encourage the use of the treatment ( PREPARE for Your Diabetes Care website and “Action Plan”). 2.7. Data collection timeline and study outcomes Clinical trial outcomes will be obtained directly from participant surveys at 6- and 12-months post-randomization administered via telephone by blinded study staff, or directly from the EHR ( Table 1 ). For participants who do not respond to telephone calls, printed surveys will be mailed directly to the participant’s residence with pre-paid return postage. All outcomes will also be assessed at the study baseline. Table 1. Outcome measures for PREPARE for your diabetes care. Primary outcome Measurement tool Timing Incidence of hypoglycemia, composite/aggregate: - 3+ symptomatic episodes of hypoglycemia in the past 4 weeks - Severe hypoglycemia in the past 6 months - Emergency Department visit or hospitalization for hypoglycemia - “How many times have you had symptoms of hypoglycemia in the past four weeks?” - “In the past 6 months, have you had low blood sugar that resulted in passing out or needing help from someone else? (For example, you were unable to treat yourself, were unconscious or were given glucagon or intravenous glucose).” - Any emergency department visit or hospital admission with primary admitting code of hypoglycemia 6- and 12-month participant surveys; EHR data pull after study completion Secondary outcomes 3 or more self-reported symptomatic hypoglycemic episodes “How many times have you had symptoms of hypoglycemia in the past four weeks?” 6- and 12-month participant surveys Self-reported severe hypoglycemia (requiring assistance from someone else in the past 6 months) “In the past 6 months, have you had low blood sugar that resulted in passing out or needing help from someone else? (For example, you were unable to treat yourself, were unconscious or were given glucagon or intravenous glucose).” 6- and 12-month participant surveys Problem areas in diabetes Problem areas in Diabetes (PAID-5) (McGuire 2010) [ 48 ] Fear of Hypoglycemia (Grabman 2017) [ 49 ] 6-and 12-month participant surveys Patient Satisfaction 5-item RAND Patient Satisfaction Questionnaire (PSQ III) 6-and 12-month participant surveys Perceived Efficacy in Patient - Physician Interactions 5-item Perceived Efficacy in Patient - Physician Interactions (PEPPI) 6-and 12-month participant surveys Medication deintensification between baseline and 6-month follow-up Any combination of: - Discontinuation of either insulin or sulfonylurea, - Reduction in dose of insulin or sulfonylurea, - Switch from a higher risk to lower risk version of insulin (e.g. from sliding scale insulin or basal-bolus insulin to twice daily basal insulin) and/or higher risk to lower risk oral medicine (e.g. switching from sulfonylureato other oral medicine less associated with hypoglycemia). EHR data pull following study completion Open in a new tab Abbreviations: EHR, electronic health record. Given that all patients eligible for this study will have an increased risk for hypoglycemia (and its severe consequences) relative to the very modest long-term benefit of tight glycemic control, our causal model is that the PREPARE for Your Diabetes Care intervention will result in a reduction of treatment intensity (if deemed clinically appropriate by the patient’s primary care provider) in a greater proportion of intervention patients compared to control patients. This reduction in insulin and/or sulfonylurea exposure, in turn, will reduce episodes of clinically-significant hypoglycemia. The primary outcome for this clinical trial is an aggregate of any of the following clinically-significant hypoglycemia: 1) three or more symptomatic hypoglycemia episodes (in the past 4 weeks, assessed at 6- and 12-months post-randomization), 2) severe hypoglycemia requiring assistance (in the past 6 months, assessed at 6- and 12-months post-randomization), and 3) an emergency department visit or hospitalization with primary diagnosis code of hypoglycemia [ 43 ] (assessed using EHR data for the 12-month period following randomization date). Although emergency department and hospital admissions for hypoglycemia presumably reflect the most severe incidences of treatment-associated hypoglycemia, evidence suggests that relying solely on admissions misses over 90 % of severe hypoglycemic episodes [ 44 ]. We, therefore, included the following validated survey item [ 28 ] as part of the composite hypoglycemia outcome: “ In the past 6 months, have you had low blood sugar that resulted in passing out or needing help from someone else? (For example, you were unable to treat yourself, were unconscious, or were given glucagon or intravenous glucose). ” This survey item has been previously used as a sensitive and specific assessment of clinically-significant hypoglycemia with an annual incidence of 29.6 % among patients treated with insulin (mean age 58 years) [ 45 ]. Additionally, symptomatic hypoglycemia in the past four weeks has been previously shown to have a negative impact on quality of life and diabetes-related distress and thus is clinically significant [ 46 ]. Secondary outcomes are also listed in Table 1 . Secondary outcomes included validated surveys that address the domains of patient-provider interactions (Perceived Efficacy in Patient-Physician Interactions [ 47 ]), patient satisfaction (5-item RAND Patient Satisfaction Questionnaire (PSQ III)), and diabetes care (Problem Areas in Diabetes [ 48 ], Fear of Hypoglycemia [ 49 ]). Medication de-intensification is also a secondary outcome and will be assessed using EHR data as meeting any of the following criteria: discontinuation of either insulin or sulfonylurea, reduction in dose of insulin or sulfonylurea, or switch from a higher risk to lower risk version of insulin (e.g. from sliding scale insulin or basal-bolus insulin to twice daily basal insulin). 2.8. Blinding Research staff will be blinded to patient randomization status during all phases of the trial, from conducting baseline and follow-up outcome ascertainment to initial data analysis. Clinicians will also be blinded to randomization status, but the PREPARE for Your Diabetes Care tool is designed to encourage patients in the intervention arm to proactively communicate with their providers about treatment preferences related to their diabetes management. Thus, clinician blinding may not be maintained. 2.9. Statistical analysis As per clinical trial guidelines [ 50 ], all primary analyses will be intention-to-treat. For the primary outcome of self-reported hypoglycemic events, our analysis will be a test for differences by treatment arm in the proportion of patients experiencing clinically-significant hypoglycemic events based on 6- and 12-month survey ascertainment. We will estimate the proportion of patients with clinically-significant hypoglycemia in each arm, reporting the point estimates and corresponding 95 % confidence intervals. We will test for a difference in die proportions by treatment arm using a chi-square test and report the p -value for the test. We will adjust for baseline hypoglycemic events and any variables that differ between study arms and will assess for any clustering effects by primary care clinician. For secondary patient-reported survey items, we will use published scoring methods both to calculate summary scores and to create binary outcomes based on accepted standard thresholds. For binary outcomes, we will estimate the proportion of patients who exceed the survey score threshold in each arm, reporting the point estimates and corresponding 95 % confidence intervals. We will test for a difference in the proportions by treatment arm using a chi-square test and report the p -value for the test. For continuous outcomes, we will report means and standard deviations, and we will test for a difference in the means by treatment arm using a t-test and report the p-value for the test. Planned sensitivity analyses will include examining: 1) the potential influence of missing data using multiple imputation, 2) “on-treatment” effects based on intervention dose (e.g. number of times intervention patient accessed the PREPARE for Your Diabetes Care website), and 3) a random effects model to explore any correlation of patients within PCP cluster or facility, although from prior studies we expect a very low intra-class correlation. 2.10. Sample size calculations After accounting for attrition (conservatively estimated at 10 % at 12 months, with prior KPNC experience closer to 5 %), with 600 patients (300 per treatment group) we will have 80 % power to detect a 10.5 % absolute difference in the proportion of clinically-significant hypoglycemic events by study arm, assuming 35 % of patients in the control group will experience a clinically-significant hypoglycemic event. 3. Results 3.1. Enrollment The study has completed enrollment; of 4348 patients assessed for eligibility, 1807 were eligible for enrollment and 673 were enrolled and randomized. Reasons for ineligibility and non-enrollment are shown in the CONSORT diagram in Fig. 3 . Major reasons for ineligibility were cognitive impairment (n = 251), no longer on insulin or sulfonylureas (n = 114), lack of computer/internet access (n = 52), and not English proficient (n = 41). Major reasons given by eligible patients for not participating included health concerns (n = 186), time constraints (n = 89), and not interested (n = 771). Overall, despite the advanced age of our eligible cohort and the requirements for accessing the intervention via the internet, we had an 37.2 % successful enrollment rate, which compares favorably with other geriatric behavioral RCTs [ 51 ]. Fig. 3. Open in a new tab Flow chart of enrollment and randomization. 4. Discussion This study is the first to test the hypothesis that the expanded care planning paradigm (values elicitation and skill building for communication and decision making) can lead to reduced hypoglycemia among older adult patients with T2D. Type 2 diabetes is an ideal application of the expanded care planning paradigm because the lack of evidence-based approaches to diabetes medication de-intensification requires that tailored treatment approaches to diabetes management must include the elicitation and inclusion of patient preferences, which may change as their clinical context changes and as they age. The PREPARE for Your Diabetes Care intervention has several strengths. First, the intervention features patients as agents of change, based on behavioral theory. It also provides a user-friendly, patient-facing tool to prepare older adults with T2D for deprescribing conversations, thereby facilitating more efficient decision making during clinical encounters. This approach does not require additional care team trainings or changes to workflow, but rather empowers the patient using evidenced-based approaches [ 6 , 52 , 53 ] to ask about their diabetes medications. Second, the intervention was designed to avoid common barriers to large-scale implementation, such as sustainability and fitting within clinical workflows [ 54 , 55 ]. Given the time and financial constraints in primary care, PREPARE for Your Diabetes Care is designed to be used by diverse patients prior to the clinical encounter and, therefore, will be resource efficient. In summary, this patient-facing intervention implements an easy-to-use tool that was adapted from PREPARE ( prepareforyourcare.org ) and co-created with patients and providers within the primary care setting where most older patients with T2D receive care. This strategy represents an innovative and potentially widely applicable method to help older adults and their providers improve prescribing safety in T2D by preparing patients to make informed decisions based on their goals and preferences. If successful, this intervention could be scaled and applied in a wide variety of healthcare settings and chronic conditions where better alignment of treatment goals with older patients’ values can improve care. Funding PREPARE for Your Diabetes Care is funded by the National Institute on Aging, National Institutes of Health (R01AG068133). Dr. Lee is supported by the National Institute on Aging (K01AG073532). Dr. Sudore is funded in part by the National Institute on Aging (K24AG054415). Dr. Grant is funded in part by the National Institute of Diabetes and Digestive and Kidney Diseases (R01DK134446). Footnotes CRediT authorship contribution statement Alexandra K. Lee : Writing – review & editing, Writing – original draft, Visualization. Jose J. Mejia : Writing – review & editing, Visualization, Project administration, Investigation, Data curation. Clarissa Ferguson : Formal analysis. Brookelle H. Li : Writing – review & editing, Project administration, Investigation, Data curation. Richard W. Grant : Formal analysis. Rebecca L. Sudore : Writing – review & editing, Supervision, Resources, Project administration, Funding acquisition, Conceptualization. Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. Data availability Data will be shared appropriately at the conclusion of the trial. References [1]. Roberts AW, Ogunwole SU, Blakeslee L, Rabe MA, The Population 65 Years and Older in the United States, 2016. [ Google Scholar ] [2]. CDC National Diabetes Statistics Report, Diabetes (July 23, 2024). 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