Dataset Information

Implementing the DEcision-Aid for Lupus (IDEAL): study protocol of a multi-site implementation trial with observational, case study design : Implementing the DEcision-Aid for Lupus.

ABSTRACT:

Objective

To provide the details of the study protocol for an observational, case study design, implementation trial.

Methods

Implementing the DEcision-Aid for Lupus (IDEAL) study will put into practice a shared decision-making (SDM) strategy, using an individualized, culturally appropriate computerized decision-aid (DA) for lupus patients in 15 geographically diverse clinics in the USA. The overarching frameworks that guide this implementation study are the Consolidated Framework for Implementation Research (CFIR) and Powell's typology of implementation strategies. All 15 clinics will receive standardized capacity-building activities for lupus DA implementation in the clinic, including education, training, technical assistance, re-training, and incorporation of a clinic champion in the core team of each site. In addition, clinics will also choose among clinic-targeted activities to integrate the DA into existing work processes and/or patient-targeted activities to raise awareness and educate patients about the DA. These activities will be chosen to stimulate participant recruitment and retention activities that support the implementation of the DA at their clinic. In study aim 1, using surveys and semi-structured interviews with clinic personnel in 15 lupus clinics, we will assess stakeholder needs and identify clinic and contextual characteristics that inform the implementation strategy component selection and influence implementation effectiveness. Study aim 2 is to implement and assess the effectiveness of the IDEAL (standardized and tailored) strategy in 15 lupus clinics by examining the changes in our primary outcome of penetration, i.e., the proportion of all eligible patients in the clinic that receive the lupus DA, and secondary outcomes include DA appropriateness, acceptability, success, permanence, and feasibility. Study aim 3 is to identify ways to sustain and disseminate our lupus DA via semi-structured debriefing interviews with key clinic personnel and patients.

Discussion

The study will enroll at least 500 patient participants with lupus across all 15 sites and assess the effectiveness in implementing the DA in various clinic settings across the USA.

Trial registration

ClinicalTrials.gov, NCT03735238 . Protocol version number: 15, date 6/8/2020.

SUBMITTER: Singh JA

PROVIDER: S-EPMC7951119 | biostudies-literature | 2021 Mar

REPOSITORIES: biostudies-literature

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Publications

Implementing the DEcision-Aid for Lupus (IDEAL): study protocol of a multi-site implementation trial with observational, case study design : Implementing the DEcision-Aid for Lupus.

Singh Jasvinder A JA Hearld Larry R LR Hall Allyson G AG Beasley T Mark TM

Implementation science communications 20210311 1

<h4>Objective</h4>To provide the details of the study protocol for an observational, case study design, implementation trial.<h4>Methods</h4>Implementing the DEcision-Aid for Lupus (IDEAL) study will put into practice a shared decision-making (SDM) strategy, using an individualized, culturally appropriate computerized decision-aid (DA) for lupus patients in 15 geographically diverse clinics in the USA. The overarching frameworks that guide this implementation study are the Consolidated Framework ...[more]

PMID: 33706813

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Project description:BackgroundThe American Urological Association White Paper on Implementation of Shared Decision Making (SDM) into Urological Practice suggested SDM represents the state of the art in counseling for patients who are faced with difficult or uncertain medical decisions. The Michigan Urological Surgery Improvement Collaborative (MUSIC) implemented a decision aid, Personal Patient Profile-Prostate (P3P), in 2018 to help newly diagnosed prostate cancer patients make shared decisions with their clinicians. We conducted a qualitative study to assess statewide implementation of P3P throughout MUSIC.MethodsWe recruited urologists and staff from 17 MUSIC practices (8 implementation and 9 comparator practices) to understand how practices engaged patients on treatment discussions and to assess facilitators and barriers to implementing P3P. Interview guides were developed based on the Tailored Interventions for Chronic Disease (TICD) Framework. Interviews were transcribed for analysis and coded independently by two investigators in NVivo, PRO 12. Additionally, quantitative program data were integrated into thematic analyses.ResultsWe interviewed 15 urologists and 11 staff from 16 practices. Thematic analysis of interview transcripts indicated three key themes including the following: (i) P3P is compatible as a SDM tool as over 80% of implementation urologists asked patients to complete the P3P questionnaire routinely and used P3P reports during treatment discussions; (ii) patient receptivity was demonstrated by 370 (50%) of newly diagnosed patients (n = 737) from 8 practices enrolled in P3P with 78% completion rate, which accounts for 39% of all newly diagnosed patients in these practices; and (iii) urologists' attitudes towards SDM varied. Over a third of urologists stated they did not rely on a decision aid. Comparator practices indicated habit, inertia, or concerns about clinic flow as reasons for not adopting P3P and some were unconvinced a decision aid is needed in their practice.ConclusionUrologists and staff affiliated with MUSIC implementation sites indicated that P3P focuses the treatment discussion on items that are important to patients. Experiences of implementation practices indicate that once initiated, there were no negative effects on clinic flow and urologists indicated P3P saves time during patient counseling, as patients were better prepared for focused discussions. Lack of awareness, personal habits, and inertia are reasons for not implementing P3P among the comparator practices.

Project description:BACKGROUND:We previously developed a pamphlet decision aid (DA) on mammography screening for women ≥ 75 years. However, implementing DAs in primary care may be challenging and may require support from non-physician healthcare team members. OBJECTIVE:To learn from primary care administrators, nurses, and staff their thoughts on how best to implement a mammography DA for women ≥ 75 years in practice. DESIGN:Qualitative study entailing in-person individual interviews using a semi-structured interview guide. PARTICIPANTS:Thirty-two non-physician healthcare team members (69.6% of those approached) participated from 8 different primary care practices (community and academic) in the Boston area or in Chapel Hill, NC. APPROACH:Participants were asked to provide feedback on the DA, their thoughts on ways to make the DA available to older women, and factors that would make it easier and/or harder to implement. KEY RESULTS:Participants felt the DA was clear, balanced, and understandable, but felt that it needed to be shorter for women with low health literacy. Most participants felt that as long as use of the DA was approved and supported by clinicians that women ≥ 75 years should receive the DA before a visit from staff (usually medical assistants) so that patients could ask their clinicians questions during the visit. Facilitators of DA use included its perceived helpfulness with decision-making, its format, and that existing systems (panel management, electronic medical record alerts) could be accessed to get the DA to patients especially at Medicare Annual Wellness visits. Participants perceived a need for training, albeit minimal, to provide the DA to patients. Barriers of DA use included competing demands on clinician and staff time. CONCLUSIONS:Participants felt that as long as use of the mammography DA for women ≥ 75 years was supported by clinicians, it would be feasible to implement with minimal refinements to existing healthcare system processes.

Project description:Systemic Lupus erythematosus (SLE), also commonly referred to as lupus, is a rare, but sometimes, fatal disease, that primarily affects young women. Lupus nephritis, a common manifestation of lupus, is more common and more devastating in patients of minority race/ethnicity. Patients have negative views of immunosuppressive drugs for lupus nephritis due to a concern about side effects and under-appreciation of its benefit. We designed a study to assess the effectiveness of individualized, computerized patient decision-aid for immunosuppressive drugs for lupus nephritis compared to a standard pamphlet for patient decision-making.Adult women with lupus nephritis, with a current lupus nephritis flare or at risk of a future lupus nephritis flare will be randomized to individualized, computerized patient decision-aid for immunosuppressive drugs vs. standard pamphlet with information about lupus and its treatment including immunosuppressive drugs and outcomes. Patients will complete outcome assessments immediately after the intervention has been administered. Patients will be followed at 3-months with a brief survey, either in person or on the phone, and at 6-months with medical record review for exploratory outcomes. Co-primary outcomes are decisional conflict and informed choice regarding immunosuppressive drugs (combines values, knowledge and choice). Secondary outcomes include: (1) assessment of patient-physician communication by assessing audio-taped physician-patient communication after intervention administration; (2) concordance between patient's desired and actual role in immunosuppressive drugs decision-making using the control preference scale (CPS); and (3) patient perception of physician interaction using the interpersonal process of care- short form (IPC-SF).This is one of the first studies to evaluate the effectiveness of an educational intervention targeting minorities with lupus nephritis. This patient-centered lupus nephritis decision-aid will be available in the public domain in English and Spanish.ClinicalTrials.gov Identifier: NCT02319525 ; registered on November 5, 2014.

Project description:BackgroundMany patient decision aids (PDAs) are developed in academic settings by academic researchers. Academic settings are different from public health clinics where the focus is on clinical work. Thus, research on implementation in public health settings will provide insights to effective implementation of PDA in real-world settings. This study explores perceived factors influencing implementation of an insulin PDA in five public health clinics.MethodsThis study adopted a comparative case study design with a qualitative focus to identify similarities and differences of the potential barriers and facilitators to implementing the insulin PDA across different sites. Focus groups and individual interviews were conducted with 28 healthcare providers and 15 patients from five public health clinics under the Ministry of Health in Malaysia. The interviews were transcribed verbatim and analysed using the thematic approach.ResultsFive themes emerged which were: 1) time constraint; 2) PDA costs; 3) tailoring PDA use to patient profile; 4) patient decisional role; and 5) leadership and staff motivation. Based on the interviews and drawing on observations and interview reflection notes, time constraint emerged as the common prominent factor that cut across all the clinics, however, tailoring PDA use to patient profile; patient decisional role; leadership and staff motivation varied due to the distinct challenges faced by specific clinics. Among clinics from semi-urban areas with more patients from limited education and lower socio-economic status, patients' ability to comprehend the insulin PDA and their tendency to rely on their doctors and family to make health decisions were felt to be a prominent barrier to the insulin PDA implementation. Staff motivation appeared to be stronger in most of the clinics where specific time was allocated to diabetes team to attend to diabetes patients and this was felt could be a potential facilitator, however, a lack of leadership might affect the insulin PDA implementation even though a diabetes team is present.ConclusionsThis study found time constraint as a major potential barrier for PDA implementation and effective implementation of the insulin PDA across different public health clinics would depend on leadership and staff motivation and, the need to tailor PDA use to patient profile. To ensure successful implementation, implementers should avoid a 'one size fits all' approach when implementing health innovations.

Project description:BackgroundTreatment decision-making regarding immunosuppressive therapy is challenging for individuals with lupus. We assessed the effectiveness of a decision aid for immunosuppressive therapy in lupus nephritis.Methods and findingsIn a United States multicenter, open-label, randomized controlled trial (RCT), adult women with lupus nephritis, mostly from racial/ethnic minority backgrounds with low socioeconomic status (SES), seen in in- or outpatient settings, were randomized to an individualized, culturally tailored, computerized decision aid versus American College of Rheumatology (ACR) lupus pamphlet (1:1 ratio), using computer-generated randomization. We hypothesized that the co-primary outcomes of decisional conflict and informed choice regarding immunosuppressive medications would improve more in the decision aid group. Of 301 randomized women, 298 were analyzed; 47% were African-American, 26% Hispanic, and 15% white. Mean age (standard deviation [SD]) was 37 (12) years, 57% had annual income of <$40,000, and 36% had a high school education or less. Compared with the provision of the ACR lupus pamphlet (n = 147), participants randomized to the decision aid (n = 151) had (1) a clinically meaningful and statistically significant reduction in decisional conflict, 21.8 (standard error [SE], 2.5) versus 12.7 (SE, 2.0; p = 0.005) and (2) no difference in informed choice in the main analysis, 41% versus 31% (p = 0.08), but clinically meaningful and statistically significant difference in sensitivity analysis (net values for immunosuppressives positive [in favor] versus negative [against]), 50% versus 35% (p = 0.006). Unresolved decisional conflict was lower in the decision aid versus pamphlet groups, 22% versus 44% (p < 0.001). Significantly more patients in the decision aid versus pamphlet group rated information to be excellent for understanding lupus nephritis (49% versus 33%), risk factors (43% versus 27%), medication options (50% versus 33%; p ≤ 0.003 for all); and the ease of use of materials was higher in the decision aid versus pamphlet groups (51% versus 38%; p = 0.006). Key study limitations were the exclusion of men, short follow-up, and the lack of clinical outcomes, including medication adherence.ConclusionsAn individualized decision aid was more effective than usual care in reducing decisional conflict for choice of immunosuppressive medications in women with lupus nephritis.Trial registrationClinicaltrials.gov, NCT02319525.

Dataset Information

Implementing the DEcision-Aid for Lupus (IDEAL): study protocol of a multi-site implementation trial with observational, case study design : Implementing the DEcision-Aid for Lupus.

Objective

Methods

Discussion

Trial registration

Publications

Implementing the DEcision-Aid for Lupus (IDEAL): study protocol of a multi-site implementation trial with observational, case study design : Implementing the DEcision-Aid for Lupus.

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