Support Intervention For Patients Research Articles

Prehabilitative/rehabilitative exercise, nutrition, and psychological support for bladder cancer: A scoping review of randomized clinical trials.

The study of prehabilitation and rehabilitation ([p]rehabilitation) to alleviate the sequelae of bladder cancer and its treatment has generated numerous opportunities to improve the quality of life of bladder cancer survivors. The authors conducted a scoping review of randomized clinical trials (RCTs) to identify knowledge gaps in and research directions for (p)rehabilitative support for those affected by bladder cancer. The authors systematically searched six databases and synthesized key findings from RCTs conducted from January 1, 2004, through March 15, 2022, that enrolled participants with bladder cancer, survivors, or caregivers in outpatient (p)rehabilitative programs (e.g., exercise, nutrition, or psychological support). Outcomes were characterized according to eight prespecified, clinically relevant categories. The search retrieved 10,968 records, 27 of which met the inclusion criteria, and 24 described unique RCTs with 2471 enrolled participants. Of 24 interventions, 17 (71%) yielded statistically significant results for the outcome of interest. Only one RCT included a cost-effectiveness analysis, and only two characterized the efficacy of interventions for caregivers. Of 11 RCTs involving psychological support, eight yielded statistically significant results, as did nine of 11 RCTs with physical exercise interventions, three of four RCTs with educational interventions, three of four RCTs with nutritional support interventions, one of two RCTs with pharmacologic medications, and zero of one RCT with physical therapy. The most promising interventions for inclusion in multimodal, personalized (p)rehabilitation programs included exercise, stress management training, cognitive training, smoking and alcohol cessation counseling, immunonutrition, stoma education, and penile rehabilitation. Further studies of the cost effectiveness and efficacy for caregivers of such interventions are needed. PLAIN LANGUAGE SUMMARY: In a scoping review of all randomized clinical trials involving prehabilitative or rehabilitative diet, exercise, and psychological support interventions for patients with bladder cancer, survivors, and their caregivers, 17 of 24 (71%) interventions yielded statistically significant improvements in the outcome of interest. Clinicians should consider implementing such interventions for those affected by bladder cancer.

A Peer Support Intervention in Patients With Hematologic Malignancies Undergoing Hematopoietic Stem Cell Transplantation (HSCT): The STEPP Proof-of-Concept Trial

Although peer support interventions are associated with improved patient-reported outcomes in diverse cancer populations, structured peer support programs tailored to the needs of patients undergoing hematopoietic stem cell transplantation (HSCT) are lacking. This single-arm, proof-of-concept trial aimed to refine the Supporting Transplant Experiences with Peer Program (STEPP), a structured, 5-session, manualized, phone-delivered peer support intervention for patients undergoing HSCT, informed by qualitative feedback from patients. Adult patients with hematologic malignancies scheduled to undergo allogeneic or autologous HSCT were eligible to participate in the study approximately 2 wk prior to their HSCT hospitalization. Participants received the STEPP intervention, which focused on providing informational, emotional, and practical support. To refine the intervention, we conducted semi-structured qualitative exit interviews to gather feedback on the content of STEPP and to identify facilitators and barriers to engagement. Transcribed interviews were analyzed using rapid analytic methods by 2 coders. Of the 37 eligible patients, 25 enrolled in the study, 20 completed all intervention sessions and 20 completed exit interviews. Participants highlighted that discussions with peer mentors/STEPP interventionists about the transplant journey and processing information provided by the clinical team were the most valuable aspects of STEPP. Positive experiences during the first intervention session facilitated patient engagement with the program. Potential barriers to engagement included logistical challenges in connecting with interventionists while experiencing physical symptoms during inpatient hospitalization and being paired with an interventionist who had a different cancer diagnosis and/or type of transplant. Patients undergoing HSCT reported positive experiences with the structured 5-session, phone-delivered peer support intervention administered before and during the HSCT hospitalization. Patients’ descriptions of barriers and facilitators to engagement with the STEPP intervention underscore the importance of patient input and programmatic structure in peer support interventions for this population. Insights from this proof-of-concept trial will be incorporated into future trials of STEPP to improve outcomes in HSCT recipients.

Personality traits and personality problems in Korsakoff syndrome patients

ABSTRACT Personality research is of relevance because it provides insights into the psychological strengths and vulnerabilities of a person. Korsakoff’s syndrome (KS) is a severe neuropsychiatric disorder following acute thiamine deficiency, usually as a consequence of alcohol-use disorders. Research on personality traits of KS patients is currently limited. The aim of the current exploratory study was therefore to examine the personality traits and problems of KS patients. We assessed self-reported and informant-reported personality traits and problems in institutionalized KS patients (n = 30). Results indicate that the psychotic personality organization was more frequently present in KS patients compared to a psychiatric reference population, leading to increased vulnerability for the development of severe psychiatric issues. Informants observed more premorbid and current cluster B (“emotional”) and C (“anxious”) personality behavior in comparison to the general population. Also, rigid- and socially avoidant behavior in KS patients was observed to increase over the years. They also observed personality problems such as emotional-, unpredictable-, dramatic-, anxious and fearful behavior in the present and in the past. KS patients reported themselves as healthy individuals, indicating a lack of self-awareness. We recommend training programs for the medical team focussed on psycho-education and supportive interventions for patients with complex personality problems concomitant to KS.

The Academy for Patient and Informal Caregiver: self-management support interventions for patients and their informal carers

SamenvattingDe Maastricht UMC+ Academie voor Patiënt en Mantelzorger is opgericht om patiënten en mantelzorgers optimaal te ondersteunen bij het zelf voeren van de regie over hun zorg en gezondheid. Een palet aan activiteiten biedt patiënten en mantelzorgers de mogelijkheid om in toenemende mate als volwaardig partner in het zorgteam te participeren. Daarnaast beoogt de Academie voor Patiënt en Mantelzorger waarde te creëren aan de hand van de quadruple aim: toegenomen gezondheid als gevolg van het zelfstandig uitvoeren van zelfmanagementtaken op een passende en veilige manier, waarmee thuiszorgaanvragen voorkomen worden, ziekenhuisopnamen worden verkort en zorgpersoneel werkdrukverlichting ervaart en op duurzame wijze wordt ingezet.

NeuroPathways: A Novel, Population-Specific Information and Support Intervention for Patients with Newly Diagnosed Primary Malignant Brain Tumors (P3-13.003)

<h3>Objective:</h3> To develop a targeted intervention aimed at helping patients with newly diagnosed primary malignant brain tumors (PMBT) process and cope with their diagnosis and illness trajectory. <h3>Background:</h3> Patients with newly diagnosed PMBT contend not only with the physical and emotional impact of their cancer but also with the task of absorbing and assimilating an overwhelming amount of information about their diagnosis and treatment, often in the midst of significant cognitive and communicative deficits. As few resources exist to address these particular challenges, we sought to develop an intervention targeting the specific educational and supportive needs of patients with PMBT. <h3>Design/Methods:</h3> We interviewed patients with recently diagnosed PMBT (n=14) and their caregivers (n=11) to explore their cancer-related experiences and needs. Common themes included difficulties processing information, communicating with loved ones and clinicians, coping with uncertainty, and navigating life with a brain tumor. Drawing on these themes and a prior framework for information and support provision in cancer, we developed the NeuroPathways intervention for patients with newly diagnosed PMBT. With input from our multidisciplinary team, we tailored intervention content and delivery for patients with cognitive and/or communication limitations. <h3>Results:</h3> NeuroPathways consists of two components: 1) a comprehensive but accessible information guide containing details about the diagnosis, treatment modalities, practical aspects of living with a PMBT, coping strategies, and techniques for working through cognitive and communication challenges and 2) four one-on-one coaching sessions with a behavioral health clinician designed to help each patient cultivate a unique plan for learning and coping. We will evaluate feasibility and acceptability of NeuroPathways in a forthcoming pilot study and subsequent randomized controlled trial. <h3>Conclusions:</h3> NeuroPathways represents a novel approach to meeting the information and supportive care needs of patients with newly diagnosed PMBT, with potential application towards helping patients with other life-changing neurologic illnesses absorb and process information about their diagnosis. <b>Disclosure:</b> Ms. Strander has nothing to disclose. Miss Podgurski has nothing to disclose. Miss Psenka has nothing to disclose. Dr. Traeger has nothing to disclose. The institution of Jennifer Temel has received research support from Blue Note Therapeutics. Dr. Forst has received stock or an ownership interest from Eli Lilly. Dr. Forst has received research support from Conquer Cancer Foundation of the American Society of Clinical Oncology. Dr. Forst has received research support from Palliative Care Research Cooperative Group. Dr. Forst has received research support from American Cancer Society Institutional Research Grant.

Feeling known and informed: Serial qualitative interviews evaluating a consultation support intervention for patients with high-grade glioma.

Interventions to support patients' engagement in shared decision making (SDM) are lacking within high-grade glioma (HGG) healthcare. Consultation Planning, Recording and Summarising (CPRS) has shown evidence of increasing patient decision self-efficacy, reducing uncertainty, and regret of decisions. This is the first study of CPRS within a HGG population and delivered over serial medical consultations. A one-arm prospective qualitative longitudinal design was used to evaluate the CPRS intervention and evaluated with participants at sequential clinic appointments depending on their care, in Edinburgh, Scotland. We report on serial semi structured interviews of 16 patients and their partners. Consultation planning before the consultation supported patients to feel known by strengthening the patient voice within the consultation. It prepared patients to actively participate in the consultation, despite the distressing nature of the content. Recording and summarising supported patients to understand their situation. The provision of a consultation record enabled accurate recall, a paced uptake of information and supported the family to feel fully informed. Ultimately, patients understood why decisions were being made rather than being part of making decisions. The CPRS intervention helped patients to understand and to feel known by increasing patient capacity for communication in the consultation, with support before, during, and after the consultation. The intervention focused on preparing patients for SDM but patients did not perceive that they had meaningful choices to make. Further research could look at the inclusion of patient decision aids to support this process.

Explaining Positive Couple Interactions after Myocardial Infarction: A Qualitative Study

Background: The quality of marital relationships can impact couples’ cardiovascular health directly and indirectly. Given that communication is essential for a happy marriage and plays an important role in health, this study aimed to explain the positive interactions of couples after myocardial infarction. Methods: The current study was conducted qualitatively with the participation of seven couples (patient and his or her spouse) in teaching hospitals affiliated with Zahedan University of Medical Sciences. Purposive sampling was used to select participants. Then, unstructured in-depth interviews were conducted after obtaining informed consent. The interviews were immediately transcribed and analyzed. MAXQDA 2020 was used to categorize the data, and the method proposed by Elo and Kingas was used for data analysis. Results: The analysis of the data revealed that myocardial infarction could affect the way couples interact through two main themes including empathetic union (acceptance of each other’s true selves, mutual understanding, adjusting expectations, increase in cooperation and joint activities) and optimizing couples’ interactions (mutual care and attention, increase in intimacy, mutual reliance). Conclusion: This study indicated that positive couple interactions affected not only marital relationships but also health status, both directly and indirectly. Therefore, the findings of this study can be used to improve nursing student education and nursing care, and would help to develop educational and supportive interventions for patients and their spouses.

Delivering an mHealth Adherence Support Intervention for Patients With HIV: Mixed Methods Process Evaluation of the Philippines Connect for Life Study.

BackgroundThe Philippines HIV epidemic is one of the fastest growing epidemics globally, and infections among men who have sex with men are increasing at an alarming rate. Connect for Life Philippines is a mobile health (mHealth) intervention that supports antiretroviral therapy (ART) adherence in this key population through individualized voice calls and SMS text messages.ObjectiveThe objective of this process evaluation is to assess the intervention reach, dose delivered and received, fidelity, and acceptability and to describe contextual factors affecting the implementation of an mHealth adherence support intervention for patients on ART in a clinic in Metro Manila, Philippines.MethodsA mixed methods process evaluation approach was used in an observational cohort study. Quantitative data sources for the process evaluation were call and SMS text message logs obtained from the mHealth platform and questionnaires collected at 12-, 24-, and 48-week study visits. Qualitative data were collected from process reports and through a series of focus group discussions conducted with a subset of participants during the intervention development phase, after an initial 8-week pilot phase, and at the end of the study.ResultsThe 462 study participants received 31,095 interactive voice calls and 8234 SMS text messages during the study. Owing to technical issues, intervention fidelity was low, with only 22.1% (102/462) of the participants receiving reminders via voice calls and others (360/462, 77.9%) receiving only SMS text messages during the intervention. After 48 weeks in the study, 63.5% (293/462) of the participants reported that they would be quite likely or very likely to recommend the program to a friend, and 53.8% (249/462) of the participants reported that they benefited quite a bit or very much from the intervention. Participants who were on ART for <6 months at the beginning of the study and those who received the daily or weekly pill reminders were more likely to report that they benefited from the intervention (P=.02 and P=.01, respectively).ConclusionsThe Connect for Life intervention had high participant satisfaction and acceptability, especially among those who received high dose of the intervention. However, poor reliability of local telecommunication networks had a large impact on the intervention’s usability, fidelity, and dose received.

Employing a mobile health decision aid to improve decision-making for patients with advanced prostate cancer and their decision partners/proxies: the CHAMPION randomized controlled trial study design

BackgroundMetastatic prostate cancer remains a lethal malignancy that warrants novel supportive interventions for patients and their decision partners and proxies. Decision aids have been applied primarily to patients with localized disease, with minimal inclusion of patients with advanced prostate cancer and their decision partners. The use of a community patient navigator (CPN) has been shown to have a positive supportive role in health care, particularly with individuals from minority populations. Research is needed to evaluate decision support interventions tailored to the needs of advanced prostate cancer patients and their decision partners in diverse populations.MethodsGuided by Janis and Mann’s Conflict Model of Decision Making, the Cancer Health Aid to Manage Preferences and Improve Outcomes through Navigation (CHAMPION) is a randomized controlled trial to assess the feasibility and acceptability of a mobile health (mHealth), CPN-administered decision support intervention designed to facilitate communication between patients, their decision partners, and the healthcare team. Adult prostate cancer patients and their decision partners at three mid-Atlantic hospitals in the USA were randomized to receive enhanced usual care or the decision intervention. The CHAMPION intervention includes a theory-based decision-making process tutorial, immediate and health-related quality of life graphical summaries over time (using mHealth), values clarification via a balance sheet procedure with the CPN support during difficult decisions, and facilitated discussions with providers to enhance informed, shared decision-making.DiscussionThe CHAMPION intervention is designed to leverage dynamic resources, such as CPN teams, mHealth technology, and theory-based information, to support decision-making for advanced prostate cancer patients and their decision partners. This intervention is intended to engage decision partners in addition to patients and represents a novel, sustainable, and scalable way to build on individual and community strengths. Patients from minority populations, in particular, may face unique challenges during clinical communication. CHAMPION emphasizes the inclusion of decision partners and CPNs as facilitators to help address these barriers to care. Thus, the CHAMPION intervention has the potential to positively impact patient and decision partner well-being by reducing decisional conflict and decision regret related to complex, treatment-based decisions, and to reduce cancer health disparities.Trial registrationClinicalTrials.govNCT03327103. Registered on 31 October 2017—retrospectively registered. World Health Organization Trial Registration Data Set included in Supplementary Materials.

Peer Support to Enhance Social and Emotional Self-Management Following Acquired Brain Injury Rehabilitation: Design of a Pre-post Study With Process Evaluation.

Background: Specialized rehabilitation following acquired brain injury provides intensive multidisciplinary treatment to individuals with complex disabilities for optimizing recovery and supporting a safe transition to the community. Post-specialist rehabilitation, patients and caregivers have reported a need for support. We present the design of an implementation study to evaluate a new self-management support service for individuals with acquired brain injury and their caregivers.Methods: This is a pre–post intervention study with a mixed-method design. The study population comprises individuals aged ≥18 years with acquired brain injury living independently following specialized rehabilitation in the Southern part of the Netherlands. All participants receive a post-rehabilitation support service. The support service consists of several house visits by a peer support volunteer in the first weeks after specialized rehabilitation treatment. The peer support volunteers are trained according to an adapted version of the previously developed Self-Management Support (SMS) program. The SMS program is directed at improving social and emotional self-management. Patient outcomes are assessed by questionnaire pre-, directly post-, and 6 months post-intervention. The primary patient outcome measure is self-efficacy. Secondary outcomes are perceived autonomy, quality of life, and psychological well-being. A process evaluation will be performed to gain insight into barriers and facilitators for the implementation of peer-led SMS by combining both quantitative, questionnaire data and qualitative data derived from focus groups with peer supporters and patients. In a workshop with relevant stakeholders, possibilities for dissemination and sustainability will be explored.Discussion: This paper describes the design of a practice-based study on feasibility, barriers, and facilitators to the implementation of a home-based, peer-led self-management support intervention for patients with acquired brain injury. We will quantitatively and qualitatively evaluate the change in relevant patient outcomes pre- and post-intervention and the barriers and facilitators related to the implementation of the intervention. Following a positive evaluation, the final stage of the study aims to facilitate deployment and utilization of the intervention.

Transplant social worker and donor financial assistance to increase living donor kidney transplants among African Americans: The TALKS Study, a randomized comparative effectiveness trial.

Lack of donors hinders living donor kidney transplantation (LDKT) for African Americans. We studied the effectiveness of a transplant social worker intervention (TALK SWI) alone or paired with living donor financial assistance to activate African Americans' potential living kidney donors. African Americans (N=300) on the transplant waiting list were randomly assigned to usual care; TALK SWI; or TALK SWI plus Living Donor Financial Assistance. We quantified differences in live kidney donor activation (composite rate of live donor inquiries, completed new live donor evaluations, or live kidney donation) after 12months. Participants' mean age was 52years, 56% were male, and 43% had annual household income less than $40,000. Most previously pursued LDKT. Participants were highly satisfied with TALK social workers, but they rarely utilized Financial Assistance. After 12months, few (n=39, 13%) participants had a new donor activation event (35 [12%] new donor inquiries; 17 [6%] new donor evaluations; 4 [1%] LDKT). There were no group differences in donor activation events (subdistribution hazard ratio [95% CI]: 1.09 [0.51-2.30] for TALK SWI and 0.92 [0.42-2.02] for TALK SWI plus Financial Assistance compared to Usual Care, p=91). Alternative interventions to increase LDKT for African Americans on the waiting list may be needed. Trial registration: ClinicalTrials.gov (NCT02369354).

Stigma, mental illness, and COVID-19 from a frontline clinician perspective: a way to go against the grain?

A well-known insidious obstacle for patients with mental illness is stigma, linked to feelings of incomprehensibility, incurability, and dangerousness. The COVID-19 pandemic represented a relevant additional barrier for these patients, which contributed to their marginalization, quality of life reduction and diminished treatments feasibility. As part of a cross-sectional multidisciplinary project conducted in the psychiatric service of Biella, a northern Italy province, preliminary data were collected by frontline clinicians during the COVID-19 first wave regarding the vicious cycle that may have been created between stigma and psychiatric patients in COVID-19 time. Therefore, we tried to frame the observed changes not in the dual literature paradigms stigma-mental illness or stigma-social consequences in COVID-19 time, but in the mental illness-stigma-COVID-19 three-way paradigm. The protection of this vulnerable segment of population, including a rapid access to COVID-19 vaccination, needs to be recognized as a real public health priority. The role of mental health services in providing information and activating supportive interventions for patients with mental illness is also crucial. Particularly, a multidisciplinary therapeutic team including mental health providers, general practitioners, hospital physicians, and social services would be needed to ensure adequate networks and cares continuity. Actions to contrast stigma can be arduous and exhausting because they must counteract the gravitational pull of customs, prejudices, and ingrained cultural beliefs, and may therefore appear to be moving in an “unnatural” direction, like the water in Escher’s lithograph entitled “Waterfall”. Nevertheless, there is no less strenuous way to go against the grain.

Effectiveness of a Tailored Work-Related Support Intervention for Patients Diagnosed with Gastrointestinal Cancer: A Multicenter Randomized Controlled Trial

Purpose The aim of this research was to study the effectiveness on return to work (RTW) of an early tailored work-related support intervention in patients diagnosed with curative gastrointestinal cancer. Methods A multicenter randomized controlled trial was undertaken, in which patients were assigned randomly to the intervention or the control group (usual care). The intervention encompassed three psychosocial work-related support meetings, starting before treatment. Five self-reported questionnaires were sent over twelve months of follow-up. Primary outcome was days until RTW (fulltime or partial) and secondary outcomes included work status, quality of life, work ability, and work limitations. Descriptive analysis, Kaplan–Meier analysis, relative risk ratio and linear mixed models were applied. Results Participants (N = 88) had a mean age of 55 years; 67% were male and the most common cancer type was colon cancer (66%). Of the participants, 42 were randomized to the intervention group. The median time from sick leave until RTW was 233 days (range 187–279 days) for the control group, versus 190 days (range 139–240 days) for the intervention group (log-rank p = 0.37). The RTW rate at twelve months after baseline was 83.3% for the intervention group and 73.5% for the control group. Work limitations did statistically differ between the groups over time (p = 0.01), but quality of life and work ability did not. Conclusion Patients in the intervention group seem to take fewer days to RTW, albeit not to a statistically significant extent.Trial registration Trial NL4920 (NTR5022) (Dutch Trial Register https://www.trialregister.nl)

Using Patient-Reported Outcomes to Describe the Patient Experience on Phase I Clinical Trials.

BackgroundSymptoms are common among patients enrolled in phase I trials. We assessed the validity of Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) items in relation to previously validated assessments of quality of life and psychological distress. We used data from a randomized trial testing a palliative care support intervention for patients enrolled on phase I trials.MethodsPatients (n = 479) were accrued to the parent study prior to initiating a phase I clinical trial with data collected at baseline, 4, and 12 weeks. We determined the correlation of PRO-CTCAE with distress level, Functional Assessment of Cancer Therapy - General (FACT-G) total, and subscale domain scores.ResultsPatients were predominantly female (56.8%) and older than age 60 years, and 30.7% were from minority populations. The correlation coefficient for distress level for all PRO-CTCAE items was small to moderate (Pearson r = 0.33-0.46). Pearson correlation coefficient for FACT-G total was moderate (r = -0.45 to -0.69). Stronger associations were noted for mood items of the PRO-CTCAE only (with distress level, r = 0.55-0.6; with FACT-G, r = -0.54 to -0.6). PRO-CTCAE symptom interference scores had the strongest correlation with distress level (Pearson r = 0.46) and FACT-G total (Pearson r = -0.69). Correlations between PRO-CTCAE items and corresponding FACT-G (total and subscales) and distress levels reached statistical significance for all items (P <.001).ConclusionEvidence demonstrates validity of PRO-CTCAE in a heterogeneous US sample of patients undergoing cancer treatment on phase I trials, with small to moderate correlations with distress level for all PRO-CTCAE items and moderate correlations with quality of life as measured by FACT-G total.

Living with the cerebellar mutism syndrome: long-term challenges of the diagnosis.

After posterior fossa tumour surgery, up to 39% of children experience postoperative cerebellar mutism syndrome (CMS) characterized by mutism and other motor and cognitive impairments. There is a lack of knowledge on the patient-reported challenges and long-term needs. Consequently, no specific recommendations exist for rehabilitative and supportive interventions for patients with CMS. The aims of this study were to explore the patients' experiences related to the sequelae of CMS, to identify challenges and needs regarding support and rehabilitation in the period of growing from child to adult and to add perspectives for future developments of supportive care and rehabilitative guidelines. Ten semi-structured interviews were conducted with young adults diagnosed with CMS as children. A thematic analysis identified four themes describing challenges impacting aspects of the participants' lives. Four main themes were identified and highlight the rehabilitative need for focus on verbal and non-verbal communication skills in addition to the physical impairments. We found that brain tumour survivors with CMS can benefit from social and educational rehabilitation, straightforward and truthful information, support in structuring their everyday lives and increased public knowledge of CMS. Children with CMS face a variety of challenges affecting many aspects of their everyday lives. They should be entitled to the elements of a current rehabilitation initiative for childhood cancer to support patients' social disability and educational decline. Finally, we identified a need for an official information publication.

A self-management support intervention for patients with atrial fibrillation: a randomized controlled pilot trial

BackgroundAtrial fibrillation (AF) is the most common arrhythmia worldwide. Despite effective treatment, it is characterized by frequent recurrences. Optimal therapeutic management of AF requires active participation and self-management from patients. Two major components of self-management are self-monitoring and sign-and-symptom management. Pulse self-palpation (PSP) is a method of self-monitoring; however, not all AF patients are capable of successfully performing PSP. Due to a lack of interventions on this topic, a nurse-led intervention for patients with AF (PSPAF intervention) was developed to foster self-monitoring and to enhance self-management through PSP. The purpose of this pilot study was to test the acceptability, feasibility, and potential effects of this intervention on the capability of patients’ PSP and sign-and-symptom management. Moreover, we aimed at gathering data on the feasibility of applied research methods to aid in the design of future studies.MethodsThe pilot trial involved 20 adult patients with AF, randomized to an intervention or usual care group. At baseline and during a home visit 3–5 weeks later, we collected data using questionnaires, checklists, field notes, a mobile ECG device, and a diary. Acceptability and feasibility measures were validated through predefined cut-off points. Effect size estimates were expressed as relative risks (RR) and the number needed to treat (NNT).ResultsThe PSPAF intervention seemed feasible, but only partly acceptable. There were limitations in terms of potential effectiveness, suitability, addressing participants’ willingness to implement its content in daily life, and adherence. Estimations of effect sizes suggest a large effect of the intervention on patients’ PSP capability (RR = 6.0; 95% CI = [0.83, 43.3]; NNT = 2.4), but almost no effect on sign-and-symptom management (RR = 1.5; 95% CI = [0.7, 3.1]; NNT = 4.0). The feasibility of applied research methods showed minor limitations on recruitment and participant burden.ConclusionsDespite some limitations, the intervention seemed to be applicable and promising. Taking into account the suggestions and amendments we have made, we recommend conducting a full-scale trial to examine the efficacy of the PSPAF intervention.Trial registrationThis pilot study was registered in the German Clinical Trials Register at September 4, 2017 (Main ID: DRKS00012808).

Implementation of a nurse-led self-management support intervention for patients with cancer-related pain: a cluster randomized phase-IV study with a stepped wedge design (EvANtiPain)

BackgroundPain self-management support interventions were effective in controlled clinical trials and meta analyses. However, implementation of these complex interventions may not translate into identical effects. This paper evaluates the implementation of ANtiPain, a cancer pain self-management support intervention in routine clinical practice according to the Reach Efficacy-Adoption Implementation Maintenance framework.MethodsIn this cluster randomized study with a stepped wedge design, N = 153 adult patients with cancer-related pain were recruited from 01/17 to 05/18 on 17 wards of 3 hospitals in Vienna, Austria. ANtiPain entailed a face-to-face in-hospital session by a trained nurse to prepare discharge according to key strategies, information on pain self-management, and skills building. After discharge, cancer-pain self-management was coached via phone calls. Patient-level data were collected at recruitment, and 2, 4 and 8 weeks after discharge via postal or online questionnaire. Primary outcome was pain interference with daily activities. Secondary outcomes included pain intensity, self-efficacy, and patient satisfaction. Organizational-level data (e.g., on implementation procedures) were collected by study or intervention nurses. The mixed model to analyze patient-level data included a random intercept and a random slope for individual and a random intercept for ward.ResultsRecruitment was slower than expected and unevenly distributed over wards and hospitals. The face-to-face session was clinically feasible (mean duration = 33 min) as well as the mean amount (n = 2) and duration of phone calls (mean = 17 min). Only 16 (46%) of 35 trained nurses performed the intervention on nine wards. To deal with the loss of power, analyses were adapted. Overall effects on pain interference were not significant. However, effects were significant in sub analyses of the nine wards that recruited patients in the intervention period (p = .009). Regarding secondary outcomes, the group-by-time effect was significant for self-efficacy (p = .033), and patient satisfaction with information on pain-self-management (p = .002) and in-hospital pain management (p = .018).ConclusionsThe implementation of ANtiPain improved meaningful patient outcomes on wards that applied the intervention routinely. Our analyses showed that the implementation benefited from being embedded in larger scale projects to improve cancer pain management and that the selection of wards with a high percentage of oncology patients may be crucial.Trial registrationClinicalTrials.gov Identifier: NCT02891785 Date of registration: September 8, 2016.

Decision Support for Implantable Cardioverter-Defibrillator Replacement: A Pilot Feasibility Randomized Controlled Trial.

Decision support can help patients facing implantable cardioverter-defibrillator (ICD) replacement understand their options and reach an informed decision reflective of their preferences. The aim of this study was to evaluate the feasibility of a decision support intervention for patients faced with the decision to replace their ICD. A pilot feasibility randomized trial was conducted. Patients approaching ICD battery depletion were randomized to decision support intervention or usual care. Feasibility outcomes included recruitment rates, intervention use, and completeness of data; secondary outcomes were knowledge, values-choice concordance, decisional conflict, involvement in decision making, and choice. A total of 30 patients were randomized to intervention (n = 15) or usual care (n = 15). The intervention was used as intended, with 2% missing data. Patients in the intervention arm had better knowledge (77.4% vs 51.1%; P = .002). By 12 months, 8 of 13 (61.5%) in the intervention arm and 10 of 14 (71.4%) in the usual care arm accepted ICD replacement; 1 per arm declined (7.7% vs 7.1%, respectively). It was feasible to deliver the intervention, collect data, despite slow recruitment. The decision support intervention has the potential to improve ICD replacement decision quality.

A multicenter trial of a shared DECision Support Intervention for Patients offered implantable Cardioverter-DEfibrillators: DECIDE-ICD rationale, design, Medicare changes, and pilot data

Shared decision making (SDM) facilitates delivery of medical therapies that are in alignment with patients' goals and values. Medicare national coverage decision for several interventions now includes SDM mandates, but few have been evaluated in nationwide studies. Based upon a detailed needs assessment with diverse stakeholders, we developed pamphlet and video patient decision aids (PtDAs) for implantable cardioverter/defibrillator (ICD) implantation, ICD replacement, and cardiac resynchronization therapy with defibrillation to help patients contemplate, forecast, and deliberate their options. These PtDAs are the foundation of the Multicenter Trial of a Shared Decision Support Intervention for Patients Offered Implantable Cardioverter-Defibrillators (DECIDE-ICD), a multicenter, randomized trial sponsored by the National Heart, Lung, and Blood Institute aimed at understanding the effectiveness and implementation of an SDM support intervention for patients considering ICDs. Finalization of a Medicare coverage decision mandating the inclusion of SDM for new ICD implantation occurred shortly after trial initiation, raising novel practical and statistical considerations for evaluating study end points. METHODS/DESIGN: A stepped-wedge randomized controlled trial was designed, guided by the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) planning and evaluation framework using an effectiveness-implementation hybrid type II design. Six electrophysiology programs from across the United States will participate. The primary effectiveness outcome is decision quality (defined by knowledge and values-treatment concordance). Patients with heart failure who are clinically eligible for an ICD are eligible for the study. Target enrollment is 900 participants. DISCUSSION: Study findings will provide a foundation for implementing decision support interventions, including PtDAs, with patients who have chronic progressive illness and are facing decisions involving invasive, preference-sensitive therapy options.

A nurse-led self-management support intervention for patients and informal caregivers facing incurable cancer: A feasibility study from the perspective of nurses.

Investigation of the feasibility of recruitment through nurses of patients with incurable cancer, and the feasibility (adoption, usage) and nurses' evaluation of a nurse-led self-management support intervention, integrated in continuity home visits and based on the 5 A's Behavior Change Model. Questionnaire, registrations, evaluation forms, and interviews. Recruitment was complicated; many patients were ineligible for participation, nurses appeared protective of their patients (gatekeeping), and recruitment during the first continuity home visit appeared to be a barrier as a lot of other issues had to be discussed. The adoption rate was 81%, meaning that 18 out of 22 nurses recruited were willing to use the intervention. The usage rate at the nurse level was 56%, meaning that 10 nurses applied the intervention in full (having applied all five A's) in at least one patient. Nurses used the intervention in full in 21 out of the 36 patients included, implying a usage rate at the patient level of 58%. Nurses' mean general satisfaction score for the intervention was 7.57 (range 0-10). Nurse were especially positive about the 5 A's model, and considered the continuity home visits to be an appropriate setting for the intervention. Timing of recruitment and gatekeeping complicated recruitment of patients through nurses. Although nurses were positive about the intervention, nurses often did not fully apply the intervention. To improve its usage, it is suggested that nurses should first be trained in using the 5 A's model.