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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).

ABSTRACT: BACKGROUND:Pain 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. METHODS:In 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. RESULTS:Recruitment 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). CONCLUSIONS:The 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 REGISTRATION:ClinicalTrials.gov Identifier: NCT02891785 Date of registration: September 8, 2016.

SUBMITTER: Raphaelis S

PROVIDER: S-EPMC7296932 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature

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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).

Raphaelis Silvia S Frommlet Florian F Mayer Hanna H Koller Antje A

BMC cancer 20200616 1

<h4>Background</h4>Pain 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.<h4>Methods</h4>In this cluster randomized study with a stepped we ...[more]

PMID: 32546177

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Project description:BackgroundRecipients of an organ transplantation face a number of challenges and often need to change their health behaviour. Good self-management skills are essential for optimal clinical outcomes. However, few interventions are available to support post-transplant self-management. To fill this gap, we developed a self-management support intervention offered by nurse practitioners. The primary aim of the study is to implement and test the effectiveness of the ZENN intervention in promoting self-management skills among heart, kidney liver and lung transplant recipients in comparison to standard care. The secondary aim is to assess the self-management support skills of nurse practitioners who will deliver the intervention.MethodsThis multi-centre stepped-wedge randomized controlled trial will take place from September 2020 until May 2023. All departments will commence with inclusion of patients in the control period. Each department will be randomly assigned to a start date (step in the wedge) to commence the experimental period. Patients in the control period will receive standard care and will be asked to complete questionnaires at baseline (T0), 6 months (T1) and 12 months (T2), to assess self-management, self-regulation, quality of life and adherence. During the experimental period, patients will receive standard care plus the ZENN intervention and receive the same set of questionnaires as participants in the control period. Nurse practitioners will complete a baseline and follow-up questionnaire to assess differences in self-management support skills. Video recordings of outpatient clinic consultations during the control and experimental periods will determine the differences in nurses' needs-thwarting and needs-supporting skills between the control and experimental period.DiscussionThe ZENN intervention could be a useful approach to support patients' self-management skills after organ transplantation and thus promote clinical outcomes as well as avoid adverse events.Trial registrationDutch Trial Register NL8469 . Registered on March 19, 2020.

Project description:BackgroundUp to 75% of residents from residential aged care facilities (RACF) are transferred to emergency departments (ED) annually to access assessment and care for unplanned or acute health events. Emergency department presentations of RACF residents can be both expensive and risky, and many are unnecessary and preventable. Processes or triage systems to assess residents with a health event, prior to transfer, may reduce unnecessary ED transfer. The Aged Care Emergency (ACE) service is a nurse-led ED outreach service that provides telephone support to RACF nurses regarding residents' health events. This service is available Monday to Friday, 8am to 4 pm (ED ACE hours). The primary objective of this study was to assess whether the augmentation of the phone-based ED ACE service with the addition of a visual telehealth consultation (VTC) would reduce RACF rate of ED presentations compared to usual care. The secondary objectives were to 1) monitor presentations to ED within 48 h post VTC to detect any adverse events and 2) measure RACF staff perceptions of VTC useability and acceptability.MethodsThis implementation study used a stepped wedge cluster randomised controlled trial design. Study settings were four public hospital EDs and 16 RACFs in two Local Health Districts. Each ED was linked to 4 RACFs with approximately 350 RACF beds, totalling 1435 beds across 16 participating RACFs. Facilities were randomised into eight clusters with each cluster comprising one ED and two RACFs.ResultsA negative binomial regression demonstrated a 29% post-implementation reduction in the rate of ED presentations (per 100 RACF beds), within ED ACE hours (IRR [95% CI]: 0.71 [0.46, 1. 09]; p = 0.122). A 29% reduction, whilst not statistically significant, is still clinically important and impactful for residents and EDs. A post-hoc logistic regression demonstrated a statistically significant 69% reduction in the probability that an episode of care resulted in an ED presentation within ED ACE hours post-implementation compared to pre-implementation (OR [95% CI]: 0.31 [0.11, 0.87]; p = 0.025).ConclusionFindings have shown the positive impact of augmenting ACE with a VTC. Any reduction of resident presentations to a busy ED is beneficial to healthcare overall, but more so to the individual older person who can recover safely and comfortably in their own RACF.Trial registrationAustralian New Zealand Clinical Trials Registry (ID ACTR N12619001692123) (02/12/2019) https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378629andisReview=true.

Project description:BackgroundPeople with dementia are susceptible to adverse drug reactions (ADRs). However, they are not always closely monitored for potential problems relating to their medicines: structured nurse-led ADR Profiles have the potential to address this care gap. We aimed to assess the number and nature of clinical problems identified and addressed and changes in prescribing following introduction of nurse-led medicines' monitoring.DesignPragmatic cohort stepped-wedge cluster Randomised Controlled Trial (RCT) of structured nurse-led medicines' monitoring versus usual care.SettingFive UK private sector care homes.Participants41 service users, taking at least one antipsychotic, antidepressant or anti-epileptic medicine.InterventionNurses completed the West Wales ADR (WWADR) Profile for Mental Health Medicines with each participant according to trial step.OutcomesProblems addressed and changes in medicines prescribed.Data collection and analysisInformation was collected from participants' notes before randomisation and after each of five monthly trial steps. The impact of the Profile on problems found, actions taken and reduction in mental health medicines was explored in multivariate analyses, accounting for data collection step and site.ResultsFive of 10 sites and 43 of 49 service users approached participated. Profile administration increased the number of problems addressed from a mean of 6.02 [SD 2.92] to 9.86 [4.48], effect size 3.84, 95% CI 2.57-4.11, P <0.001. For example, pain was more likely to be treated (adjusted Odds Ratio [aOR] 3.84, 1.78-8.30), and more patients attended dentists and opticians (aOR 52.76 [11.80-235.90] and 5.12 [1.45-18.03] respectively). Profile use was associated with reduction in mental health medicines (aOR 4.45, 1.15-17.22).ConclusionThe WWADR Profile for Mental Health Medicines can improve the quality and safety of care, and warrants further investigation as a strategy to mitigate the known adverse effects of prescribed medicines.Trial registrationISRCTN 48133332.

Project description:BackgroundThe Sustainable Development Goals (SDGs) highlight the importance of investments in early childhood care and education (ECCE) and youth development. Given Pakistan's large young population, and gender and urban-rural inequalities in access to education, training, and employment, such investments offer opportunities. LEAPS is a youth-led ECCE program that trains female youth, 18-24 years, as Community Youth Leaders (CYLs) to deliver high-quality ECCE for children, 3.5-5.5 years, in rural Sindh, Pakistan.MethodsWe use a stepped wedge cluster-randomized trial to evaluate implementation of LEAPS. Ninety-nine clusters will be randomized to receive the intervention in one of three 7-month steps (33 clusters/step). The primary outcome is children's school readiness (indexed by the total score on the International Development and Early Learning Assessment (IDELA)). Secondary child outcomes are children's IDELA domain scores and executive functions. Data are collected in cross-sectional surveys of 1089 children (11 children/cluster from 99 clusters) aged 4.5-5.5 years at four timepoints (baseline and at the end of each step). Additionally, we will enroll three non-randomized youth participant open cohorts, one per step (33 CYLs: 66 comparison youth per cohort; 99:198 in total). Youth cohorts will be assessed at enrollment and every 7 months thereafter to measure secondary outcomes of youth personal and professional development, depressive symptoms, and executive functions. A non-randomized school cohort of 330 LEAPS students (10 students/cluster from 33 clusters) will also be enrolled and assessed during Step 1 after intervention rollout and at endline. The quality of the learning environment will be assessed in each LEAPS ECCE center and in a comparison center at two timepoints midway following rollout and at endline. A concurrent mixed-methods implementation evaluation will assess program fidelity and quality, and the extent to which a technical support strategy is successful in strengthening systems for program expansion. A cost evaluation will assess cost per beneficiary. Data collection for implementation and cost evaluations will occur in Step 3.DiscussionYouth-led models for ECCE offer a promising approach to support young children and youth. This study will contribute to the evidence as a means to promote sustainable human development across multiple SDG targets.Trial registrationClinicalTrials.gov NCT03764436 . Registered on December 5, 2018.

Project description:BackgroundUnplanned nursing home (NH) transfers are burdensome for residents and costly for health systems. Innovative nurse-led models of care focusing on improving in-house geriatric expertise are needed to decrease unplanned transfers. The aim was to test the clinical effectiveness of a comprehensive, contextually adapted geriatric nurse-led model of care (INTERCARE) in reducing unplanned transfers from NHs to hospitals.MethodsA multicenter nonrandomized stepped-wedge design within a hybrid type-2 effectiveness-implementation study was implemented in 11 NHs in German-speaking Switzerland. The first NH enrolled in June 2018 and the last in November 2019. The study lasted 18 months, with a baseline period of 3 months for each NH. Inclusion criteria were 60 or more long-term care beds and 0.8 or more hospitalizations per 1'000 resident care days. Nine hundred and forty two long-term NH residents were included between June 2018 and January 2020 with informed consent. Short-term residents were excluded. The primary outcome was unplanned hospitalizations. A fully anonymized dataset of overall transfers of all NH residents served as validation. Analysis was performed with segmented mixed regression modeling.ResultsThree hundred and three unplanned and 64 planned hospitalizations occurred. During the baseline period, unplanned transfers increased over time (β1 = 0.52), after which the trend significantly changed by a similar but opposite amount (β2 = -0.52; p = 0.0001), resulting in a flattening of the average transfer rate throughout the postimplementation period (β1 + β2 ≈ 0). Controlling for age, gender, and cognitive performance did not affect these trends. The validation set showed a similar flattening trend.ConclusionA complex intervention with six evidence-based components demonstrated effectiveness in significantly reducing unplanned transfers of NH residents to hospitals. INTERCARE's success was driven by registered nurses in expanded roles and the use of tools for clinical decision-making.

Project description:BackgroundWhile effective lay-health worker models for mental health care have been demonstrated through efficacy trials, there is limited evidence of the effectiveness of these models implemented in rural LMIC settings.AimTo evaluate the impact of a volunteer community-led intervention on reduction in depression and anxiety symptoms and improvement in functioning, and social participation among people living in rural Gujarat, India.MethodsStepped-wedge cluster randomized controlled trial was used to assess the effectiveness of delivery of psychosocial intervention across 645 villages in Mehsana district of Gujarat, India between April 2017 and August 2019. The primary outcome was an improvement in depression and/or anxiety symptoms assessed using GHQ-12 at 3-month follow-up. Secondary outcomes were improvement in (a) depression and anxiety (Patient Health Questionnaire, (PHQ-9), Generalized Anxiety Disorder (GAD-7) & Self-Reporting Questionnaire-20 (SRQ-20); b) quality of life (EQ- 5D); c) functioning (WHO-DAS-12), and social participation (Social Participation Scale SPS). Generalized linear mixed-effects models were used to assess the independent effect of the intervention.ResultsOut of a total of 1191 trial participants (608- intervention & 583-control), 1014 (85%) completed 3-month follow-up. In an adjusted analysis, participants in the intervention condition showed significant recovery from symptoms of depression or anxiety (OR 2.2; 95% CI 1.2 to 4.6; p<0.05) at the end of 3-months, with effects sustained at 8-month follow-up (OR 3.0; 95% CI 1.6 to 5.9). Intervention participants had improved scores on the PHQ-9 (Adjusted mean difference (AMD) -1.8; 95%CI -3.0 to -0.6), and SRQ-20 (AMD -1.7; 95%CI -2.7 to -0.6), at 3-months and PHQ-9, GAD-7, SRQ-20, EQ-5D and WHO-DAS at 8 months follow-up.ConclusionFindings suggest that Atmiyata had a significant effect on recovery from symptoms of depression and anxiety with sustained effects at 8-month follow-up.Trial registrationTrial registration details. The trial was registered prospectively with the "Clinical Trial Registry in India" (registry number: CTRI/2017/03/008139).

Project description:ObjectiveTo evaluate the impact of Teach-Back on communication quality in a national telephone-based telehealth service, for callers varying in health literacy.DesignCross-sectional stepped wedge cluster randomised trial with continuous recruitment, short (fixed) exposure and blinded outcome assessors. Nurses were stratified by hours worked and randomised into training groups using a computer generated sequence.SettingAn Australian national pregnancy and parenting telephone helpline.InterventionComplex intervention involving a single 2-hour group Teach-Back training session, combined with ongoing nurse self-reflection on their communication following each call and each shift.ParticipantsParticipants were 637 callers to the telephone helpline aged 18-75 (87% female), of whom 127 (13%) had inadequate health literacy (measured with the Single Item Literacy Screener); and 15 maternal and child health nurses with 15 years' experience on average.MeasuresPrimary outcome was a modified subscale of the Health Literacy Questionnaire, 'having sufficient information to manage health'. Secondary caller outcomes included caller confidence, perceived actionability of information and nurse effort to listen and understand. Nurse outcomes were perceptions of their communication effectiveness.ResultsOver a 7 week period, 376 surveyed callers received usual care and 261 Teach-Back. Ratings on the primary outcome increased over time (OR 1.17, CI 1.01 to 1.32, p = 0.03) but no independent Teach-Back effect was observed. A consistent pattern suggests that, compared with usual care, Teach-Back helps callers with inadequate health literacy feel listened to (OR 2.3, CI 0.98 to 5.42, p = 0.06), confident to act (OR 2.44, CI 1.00 to 5.98, p = 0.06), and know what steps to take (OR 2.68, CI 1.00 to 7.17, p = 0.06). Nurse perceptions of both their own communication effectiveness (OR = 2.31; CI 1.38 to 3.86, p<0.0001), and caller understanding (OR = 2.56; CI 1.52 to 4.30, p<0.001) both increased with Teach-Back. No harms were reported.ConclusionsTeach-Back appears to benefit telephone health service users with inadequate health literacy, but the extent of this is unclear due to smaller numbers of lower literacy participants. Improving caller ratings over time are likely due to increasing nurse communication competence.

Dataset Information

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).

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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).

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