Dataset Information

SAFETEL randomised controlled feasibility trial of a safety planning intervention with follow-up telephone contact to reduce suicidal behaviour: study protocol.

ABSTRACT:

Introduction

There are no evidence-based interventions that can be administered in hospital settings following a general hospital admission after a suicide attempt.

Aim

To determine whether a safety planning intervention (SPI) with follow-up telephone support (SAFETEL) is feasible and acceptable to patients admitted to UK hospitals following a suicide attempt.

Methods and analysis

Three-phase development and feasibility study with embedded process evaluation. Phase I comprises tailoring an SPI with telephone follow-up originally designed for veterans in the USA, for use in the UK. Phase II involves piloting the intervention with patients (n=30) who have been hospitalised following a suicide attempt. Phase III is a feasibility randomised controlled trial of 120 patients who have been hospitalised following a suicide attempt with a 6-month follow-up. Phase III participants will be recruited from across four National Health Service hospitals in Scotland and randomised to receive either the SPI with telephone follow-up and treatment as usual (n=80) or treatment as usual only (n=40). The primary outcomes are feasibility outcomes and include the acceptability of the intervention to participants and intervention staff, the feasibility of delivery in this setting, recruitment, retention and intervention adherence as well as the feasibility of collecting the self-harm re-admission to hospital outcome data. Statistical analyses will include description of recruitment rates, intervention adherence/use, response rates and estimates of the primary outcome event rates, and intervention effect size (Phase III). Thematic analyses will be conducted on interview and focus group data.

Ethics and dissemination

The East of Scotland Research Ethics Service (EoSRES) approved this study in March 2017 (GN17MH101 Ref: 17/ES/0036). The study results will be disseminated via peer-reviewed publication and conference presentations. A participant summary paper will also be disseminated to patients, service providers and policy makers alongside the main publication.

Trial registration number

ISRCTN62181241.

SUBMITTER: O'Connor RC

PROVIDER: S-EPMC6377516 | biostudies-literature | 2019 Feb

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

SAFETEL randomised controlled feasibility trial of a safety planning intervention with follow-up telephone contact to reduce suicidal behaviour: study protocol.

O'Connor Rory C RC Lundy Jenna-Marie JM Stewart Corinna C Smillie Susie S McClelland Heather H Syrett Suzy S Gavigan Marcela M McConnachie Alex A Smith Michael M Smith Daniel J DJ Brown Gregory K GK Stanley Barbara B Simpson Sharon Anne SA

BMJ open 20190219 2

<h4>Introduction</h4>There are no evidence-based interventions that can be administered in hospital settings following a general hospital admission after a suicide attempt.<h4>Aim</h4>To determine whether a safety planning intervention (SPI) with follow-up telephone support (SAFETEL) is feasible and acceptable to patients admitted to UK hospitals following a suicide attempt.<h4>Methods and analysis</h4>Three-phase development and feasibility study with embedded process evaluation. Phase I compri ...[more]

PMID: 30782938

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Project description:Background/objectivesTelephone follow-up calls could optimize the transition from the emergency department (ED) to home for older patients. However, the effects on hospital return rates are not clear. We investigated whether telephone follow-up reduces unplanned hospitalizations and/or unplanned ED return visits within 30 days of ED discharge.DesignPragmatic randomized controlled trial with allocation by month; odd months intervention group, even months control group.SettingTwo ED locations of a non-academic teaching hospital in The Netherlands.ParticipantsCommunity-dwelling adults aged ≥70 years, discharged home from the ED were randomized to the intervention group (N = 4732) or control group (N = 5104).InterventionIntervention group patients: semi-scripted telephone call from an ED nurse within 24 h after discharge to identify post-discharge problems and review discharge instructions. Control group patients: scripted satisfaction survey telephone call.MeasurementsPrimary outcome: total number of unplanned hospitalizations and/or ED return visits within 30 days of ED discharge.Secondary outcomesseparate numbers of unplanned hospitalizations and ED return visits. Subgroup analysis by age, sex, living condition, and degree of crowding in the ED at discharge.ResultsOverall, 42% were males, and median age was 78 years. In the intervention group, 1516 of 4732 patients (32%) consented, and in the control group 1659 of 5104 (33%) patients. Unplanned 30-day hospitalization and/or ED return visit was found in 16% of intervention group patients and 14% of control group patients (odds ratio 1.16; 95% confidence interval: 0.96-1.42). Also, no statistically significant differences were found in secondary outcome measures. Within the subgroups, the intervention did not have beneficial effects for the intervention group.ConclusionTelephone follow-up after ED discharge in older patients did not result in reduction of unplanned hospital admissions and/or ED return visits within 30 days. These results raise the question of whether other outcomes could be improved by post-discharge ED telephone follow-up.

Project description:Hand osteoarthritis (OA) is one of the most prevalent musculoskeletal diseases in an adult population and may have a large influence on an individual's functioning, health-related quality of life and participation in society. Several studies have demonstrated that exercises may reduce pain and improve functioning in people with knee OA, with a similar effect suggested for hip OA. For hand OA, available research is very limited and shows conflicting results, and high-quality randomised controlled trials are warranted.This paper outlines the protocol for a randomised controlled trial that aims to determine the effect of an exercise intervention on self-reported hand activity performance in people with hand OA.Participants with physician-confirmed hand OA according to the ACR clinical criteria are being recruited from two Norwegian OA cohorts: the population-based "Musculoskeletal pain in Ullensaker Study" (MUST) OA cohort, and the hospital-based Oslo Hand OA cohort. Participants are randomised into an intervention- or control group. The control group receives "usual care", whereas the intervention group receives a 12-week exercise intervention. The intervention group attends four group sessions and is instructed to perform the exercise program three times a week at home. Adherence will be captured using self-report. During the eight weeks with no group sessions, the intervention group receives a weekly telephone call. The assessments and group sessions are being conducted locally in Ullensaker Municipality and at Diakonhjemmet Hospital, Oslo. Outcomes are collected at baseline, and at 3 and 6 months. The primary outcome measure is self-reported hand activity performance at 3 months post-randomisation, as measured by the Functional Index for Hand Osteoarthritis (FIHOA); and a patient-generated measure of disability, the Patient-Specific Functional Scale (PSFS). Secondary outcome measures are self-reported OA symptoms (e.g. pain, stiffness and fatigue), the Patient Global Assessment of disease activity, measured hand function (e.g. grip strength, thumb web space and hand dexterity) and health-related quality of life. Cost-utility and cost-effectiveness analyses will be conducted.This study will contribute to the knowledge on both the effect and resource use of an exercise programme with telephone follow-up on self-reported hand activity performance among people with hand OA.The trial is registered at ClinicalTrials.gov with registration number: NCT01245842.

Project description:Importance:Suicidal behavior is a major public health problem in the United States. The suicide rate has steadily increased over the past 2 decades; middle-aged men and military veterans are at particularly high risk. There is a dearth of empirically supported brief intervention strategies to address this problem in health care settings generally and particularly in emergency departments (EDs), where many suicidal patients present for care. Objective:To determine whether the Safety Planning Intervention (SPI), administered in EDs with follow-up contact for suicidal patients, was associated with reduced suicidal behavior and improved outpatient treatment engagement in the 6 months following discharge, an established high-risk period. Design, Setting, and Participants:Cohort comparison design with 6-month follow-up at 9 EDs (5 intervention sites and 4 control sites) in Veterans Health Administration hospital EDs. Patients were eligible for the study if they were 18 years or older, had an ED visit for a suicide-related concern, had inpatient hospitalization not clinically indicated, and were able to read English. Data were collected between 2010 and 2015; data were analyzed between 2016 and 2018. Interventions:The intervention combines SPI and telephone follow-up. The SPI was defined as a brief clinical intervention that combined evidence-based strategies to reduce suicidal behavior through a prioritized list of coping skills and strategies. In telephone follow-up, patients were contacted at least 2 times to monitor suicide risk, review and revise the SPI, and support treatment engagement. Main Outcomes and Measures:Suicidal behavior and behavioral health outpatient services extracted from medical records for 6 months following ED discharge. Results:Of the 1640 total patients, 1186 were in the intervention group and 454 were in the comparison group. Patients in the intervention group had a mean (SD) age of 47.15 (14.89) years and 88.5% were men (n?=?1050); patients in the comparison group had a mean (SD) age of 49.38 (14.47) years and 88.1% were men (n?=?400). Patients in the SPI+ condition were less likely to engage in suicidal behavior (n?=?36 of 1186; 3.03%) than those receiving usual care (n?=?24 of 454; 5.29%) during the 6-month follow-up period. The SPI+ was associated with 45% fewer suicidal behaviors, approximately halving the odds of suicidal behavior over 6 months (odds ratio, 0.56; 95% CI, 0.33-0.95, P?=?.03). Intervention patients had more than double the odds of attending at least 1 outpatient mental health visit (odds ratio, 2.06; 95% CI, 1.57-2.71; P?<?.001). Conclusions and Relevance:This large-scale cohort comparison study found that SPI+ was associated with a reduction in suicidal behavior and increased treatment engagement among suicidal patients following ED discharge and may be a valuable clinical tool in health care settings.

Project description:BACKGROUND:Regular outpatient follow-up programmes are usually offered to patients following treatment for gynaecological and other cancers. Despite the substantial resources involved in providing these programmes, there is evidence that routine follow-up programmes do not affect survival or the likelihood of detecting recurrence and may not meet patient needs. Alternative follow-up modalities may offer the same outcomes at lower cost. We examined the costs of using telephone-based routine follow-up of women treated for endometrial cancer undertaken by specialist gynaecology oncology nurses in comparison to routine hospital-based follow-up. METHODS:The ENDCAT trial randomised 259 women at five centres in the north west of England with a known diagnosis of Stage I endometrial cancer who had completed primary treatment on a 1:1 basis to receive either standard hospital outpatient follow-up or a telephone follow-up intervention administered by specialist nurses. A cost-consequence analysis was undertaken in which we compared costs to the health system and to individuals with the trial's co-primary outcomes of psychological morbidity and participant satisfaction with information received. RESULTS:Psychological morbidity, psychosocial needs, patient satisfaction and quality of life did not differ between arms. Patients randomised to telephone follow-up underwent more and longer consultations. There was no difference in total health service mean per patient costs at 6 months (mean difference £8, 95% percentile confidence interval: -?£147 to £141) or 12 months (mean difference: -?£77, 95% percentile confidence interval: -?£334 to £154). Estimated return journey costs per patient for hospital consultations were £11.47. Productivity costs were approximately twice as high under hospital follow-up. CONCLUSION:Telephone follow-up was estimated to be cost-neutral for the NHS and may free up clinic time for other patients. There was some evidence that telephone follow-up may be more efficient for patients and wider society, and is not associated with additional psychological morbidity, lower patient satisfaction or reduced quality of life. TRIAL REGISTRATION:ISRCTN: 75220876, prospectively registered 28 October 2011.

Project description:Loss to follow-up (LTFU) in clinical trials is an important source of bias that can affect statistical power and generalisability of findings. The aim of this paper is to assess factors associated with LTFU in the MObile Technology for Improved Family Planning (MOTIF) trial in Cambodia and compare how the result might have varied using different analytical methods.Follow-up in the MOTIF trial was 86% at 4 months and 66% at 12 months. For the primary analysis, we undertook a complete case analysis, similar to the approach used in similar trials of interventions delivered by mobile phone to increase contraception use. We conducted an exploratory analysis and found that factors associated with LTFU were young age, lower socio-economic status, not planning to use post-abortion contraception, availability of phone credit and not providing additional contact numbers. We then undertook two analyses to estimate the effect of the intervention on the primary outcome at 4 and 12 months for comparison with the complete case analysis. First, we undertook multiple imputation, and second we conducted an analysis treating all participants' LTFU as non-users of contraception.Using multiple imputation, we found that the risk ratio was slightly increased at 4 months and slightly decreased at 12 months compared with the complete case analysis. When counting all participants' LTFU as non-users of contraception, we observed that, compared with the complete case analysis, the risk ratio was slightly decreased at 4 months and slightly increased at 12 months. Despite the changes in the risk ratio, use of the different analytical methods did not result in an effect using the complete case analysis becoming statistically significant or vice versa.Future studies assessing contraception use might anticipate increased attrition amongst younger participants, those of lower socio-economic status or those who do not provide additional contact details. Attrition could be reduced by collecting as many contact details as possible, by providing incentives and possibly by enhanced counselling to groups at higher risk of LTFU on recruitment. Multiple imputation should be considered in addition to complete case analysis if LTFU not missing at random is expected or observed.ClinicalTrials.gov, NCT01823861 . Registered on 30 March 2013.

Project description:BackgroundOffice work generally consists of high amounts of sedentary behaviour (SB) which has been associated with negative health consequences. We developed the "WorktivIty" mobile app to help office workers reduce their SB through self-monitoring and feedback on sedentary time, prompts to break sedentary time, and educational facts. The aim of this paper is to report the feasibility of delivering the Worktivity intervention to desk-based office workers in the workplace setting and describe methodological considerations for a future trial.MethodsWe conducted a three-arm feasibility cluster randomised controlled pilot study over an 8-week period with full time-desk based employees. Clustered randomisation was to one of three groups: Worktivity mobile app (MA; n = 20), Worktivity mobile app plus SSWD (MA+SSWD; n = 20), or Control (C; n = 16). Feasibility was assessed using measures of recruitment and retention, intervention engagement, intervention delivery, completion rates and usable data, adverse events, and acceptability.ResultsRecruitment of companies to participate in this study was challenging (8% of those contacted), but retention of individual participants within the recruited groups was high (81% C, 90% MA + SSWD, 95% MA). Office workers' engagement with the app was moderate (on average 59%). Intervention delivery was partially compromised due to diminishing user engagement and technical issues related to educational fact delivery. Sufficient amounts of useable data were collected, however either missing or unusable data were observed with activPAL™, with data loss increasing at each follow up time point. No serious adverse events were identified during the study. The majority of participants agreed that the intervention could be implemented within the workplace setting (65% MA; 72% MA + SSWD) but overall satisfaction with the intervention was modest (58% MA; 39% MA + SSWD).ConclusionsThe findings suggest that, in principle, it is feasible to implement a mobile app-based intervention in the workplace setting however the Worktivity intervention requires further technical refinements before moving to effectiveness trials. Challenges relating to the initial recruitment of workplaces and maintaining user engagement with the mHealth intervention over time need to be addressed prior to future large-scale implementation. Further research is needed to identify how best to overcome these challenges.

Dataset Information

SAFETEL randomised controlled feasibility trial of a safety planning intervention with follow-up telephone contact to reduce suicidal behaviour: study protocol.

Introduction

Aim

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

SAFETEL randomised controlled feasibility trial of a safety planning intervention with follow-up telephone contact to reduce suicidal behaviour: study protocol.

Similar Datasets

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