Dataset Information

A Feasibility Trial of Power Up: Smartphone App to Support Patient Activation and Shared Decision Making for Mental Health in Young People.

ABSTRACT: BACKGROUND:Digital tools have the potential to support patient activation and shared decision making in the face of increasing levels of mental health problems in young people. There is a need for feasibility trials of digital interventions to determine the usage and acceptability of interventions. In addition, there is a need to determine the ability to recruit and retain research participants to plan rigorous effectiveness trials and, therefore, develop evidence-based recommendations for practice. OBJECTIVE:This study aimed to determine the feasibility of undertaking a cluster randomized controlled trial to test the effectiveness of a smartphone app, Power Up, co-designed with young people to support patient activation and shared decision making for mental health. METHODS:Overall, 270 young people were screened for participation and 52.5% (142/270) were recruited and completed baseline measures across 8 specialist child mental health services (n=62, mean age 14.66 (SD 1.99) year; 52% [32/62] female) and 2 mainstream secondary schools (n=80; mean age 16.88 [SD 0.68] years; 46% [37/80] female). Young people received Power Up in addition to management as usual or received management as usual only. Posttrial interviews were conducted with 11 young people from the intervention arms (specialist services n=6; schools n=5). RESULTS:Usage data showed that there were an estimated 50 (out of 64) users of Power Up in the intervention arms. Findings from the interviews indicated that young people found Power Up to be acceptable. Young people reported (1) their motivation for use of Power Up, (2) the impact of use, and (3) barriers to use. Out of the 142 recruited participants, 45.0% (64/142) completed follow-up measures, and the approaches to increase retention agreed by the steering group are discussed. CONCLUSIONS:The findings of this study indicate that the app is acceptable, and it is feasible to examine the effectiveness of Power Up in a prospective cluster randomized controlled trial. TRIAL REGISTRATION:ClinicalTrials.gov NCT02552797; https://clinicaltrials.gov/ct2/show/NCT02552797 (Archived by WebCite at http://www.webcitation.org/6td6MINP0).

SUBMITTER: Edbrooke-Childs J

PROVIDER: S-EPMC6682268 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature

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A Feasibility Trial of Power Up: Smartphone App to Support Patient Activation and Shared Decision Making for Mental Health in Young People.

Edbrooke-Childs Julian J Edridge Chloe C Averill Phoebe P Delane Louise L Hollis Chris C Craven Michael P MP Martin Kate K Feltham Amy A Feltham Amy A Jeremy Grace G Deighton Jessica J Wolpert Miranda M

JMIR mHealth and uHealth 20190604 6

<h4>Background</h4>Digital tools have the potential to support patient activation and shared decision making in the face of increasing levels of mental health problems in young people. There is a need for feasibility trials of digital interventions to determine the usage and acceptability of interventions. In addition, there is a need to determine the ability to recruit and retain research participants to plan rigorous effectiveness trials and, therefore, develop evidence-based recommendations f ...[more]

PMID: 31165709

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Project description:BackgroundSevere Chronic Obstructive Pulmonary Disease patients are often unprepared to make decisions about accepting intubation for respiratory failure. We developed a Web-based decision aid, InformedTogether, to facilitate severe Chronic Obstructive Pulmonary Disease patients' preparation for decision making about whether to accept invasive mechanical ventilation for respiratory failure.ObjectiveWe describe feasibility testing of the InformedTogether decision aid.MethodsMixed methods, pre- and postintervention feasibility study in outpatient pulmonary and geriatric clinics. Clinicians used InformedTogether with severe Chronic Obstructive Pulmonary Disease patients. Patient-participants completed pre- and postassessments about InformedTogether use. The outcomes measured were the following: feasibility/acceptability, communication (Combined Outcome Measure for Risk Communication [COMRADE], Medical Communication Competency Scale [MCCS], Observing Patient Involvement [OPTION] scales), and effectiveness of InformedTogether on changing patients' knowledge, Decisional Conflict Scale, and motivation.ResultsWe enrolled 11 clinicians and 38 Chronic Obstructive Pulmonary Disease patients at six sites. Feasibility/acceptability: Clinicians and patients gave positive responses to acceptability questions (mean 74.1/89 max [SD 7.24] and mean 59.63/61 [SD 4.49], respectively). Communication: 96% of clinicians stated InformedTogether improved communication (modified MCCS mean 44.54/49 [SD 2.97]; mean OPTION score 32.03/48 [SD 9.27]; mean COMRADE Satisfaction 4.31/5.0 [SD 0.58]; and COMRADE Confidence 4.18/5.0 [SD 0.56]). Preference: Eighty percent of patients discussed preferences with their surrogates by 1-month. Effectiveness: Knowledge scores increased significantly after using InformedTogether (mean difference 3.61 [SD 3. 44], P=.001) and Decisional Conflict decreased (mean difference Decisional Conflict Scale pre/post -13.76 [SD 20.39], P=.006). Motivation increased after viewing the decision aid.ConclusionsInformedTogether supports high-quality communication and shared decision making among Chronic Obstructive Pulmonary Disease patients, clinicians, and surrogates. The increased knowledge and opportunity to deliberate and discuss treatment choices after using InformedTogether should lead to improved decision making at the time of critical illness.

Project description:BackgroundPrevious research demonstrates that less than 50% of military veterans experiencing mental health difficulties seek formal support. Veterans often struggle to identify problems as mental health difficulties. In addition, they may fail to recognize the need for support before reaching a crisis point and face difficulties navigating care pathways to access support.ObjectiveA feasibility trial was conducted to assess a novel digital smartphone app (Mental Health Toolkit for Veterans Project [MeT4VeT]) for UK Armed Forces (UKAF) veterans experiencing mental health difficulties. The trial aimed to explore the feasibility and acceptability of trial procedures for a later randomized controlled trial (RCT) and to assess the acceptability of the MeT4VeT app.MethodsParticipants were recruited at UK military medical centers, by advertising on social media, and through veteran third-sector organizations between February and November 2021, and assessed for eligibility (male, owned a smartphone, served at least 2 years in the UKAF, left the UKAF within the last 2 years, not undertaking formal mental health treatment). Eligible participants were assigned, on a 1:1 ratio, to either the intervention group (full app) or a control group (noninteractive app with signposting information). Three key objectives were determined a priori to assess the practicality of running an RCT including an assessment of recruitment and retention, evaluation of the technical app delivery and measurement processes, and acceptability and usability of the intervention.ResultsIn total, 791 individuals completed the participant information sheet, of which 261 (33%) were ineligible, 377 (48%) declined or were unable to be contacted for consent, and 103 (13%) did not download the app or complete the baseline measures. Of this, 50 participants completed baseline measures and were randomly assigned to the intervention group (n=24) or the control group (n=26). The trial was effective at enabling both the technical delivery of the intervention and collection of outcome measures, with improvements in mental health demonstrated for the intervention group from baseline to the 3-month follow-up. Recruitment and retention challenges were highlighted with only 50 out of the 530 eligible participants enrolled in the trial. The acceptability and usability of the MeT4VeT app were generally supported, and it was reported to be a useful, accessible way for veterans to monitor and manage their mental health.ConclusionsThe results highlighted that further work is needed to refine recruitment processes and maintain engagement with the app. Following this, an RCT can be considered to robustly assess the ability of the app to positively affect mental health outcomes indicated within this trial.Trial registrationClinicalTrials.gov NCT05993676; https://clinicaltrials.gov/ct2/show/NCT05993676.

Project description:BackgroundShared decision-making (SDM) is a process aimed at facilitating patient-centered care by ensuring that the patient and provider are actively involved in treatment decisions. In mental health care, SDM has been advocated as a means for the patient to gain or regain control and responsibility over their life and recovery process. To support the process of patient-centered care and SDM, digital tools may have advantages in terms of accessibility, structure, and reminders.ObjectiveIn this randomized controlled trial, we aimed to investigate the effect of a digital tool to support patient activation and SDM.MethodsThe trial was designed as a randomized, assessor-blinded, 2-armed, parallel-group multicenter trial investigating the use of a digital SDM intervention for 6 months compared with treatment as usual. Participants with a diagnosis of schizophrenia, schizotypal or delusional disorder were recruited from 9 outpatient treatment sites in the Capital Region of Denmark. The primary outcome was the self-reported level of activation at the postintervention time point. The secondary outcomes included self-efficacy, hope, working alliance, satisfaction, preparedness for treatment consultation, symptom severity, and level of functioning. Explorative outcomes on the effect of the intervention at the midintervention time point along with objective data on the use of the digital tool were collected.ResultsIn total, 194 participants were included. The intention-to-treat analysis revealed a statistically significant effect favoring the intervention group on patient activation (mean difference 4.39, 95% CI 0.99-7.79; Cohen d=0.33; P=.01), confidence in communicating with one's provider (mean difference 1.85, 95% CI 0.01-3.69; Cohen d=0.24; P=.05), and feeling prepared for decision-making (mean difference 5.12, 95% CI 0.16-10.08; Cohen d=0.27; P=.04). We found no effect of the digital SDM tool on treatment satisfaction, hope, self-efficacy, working alliance, severity of symptoms, level of functioning, use of antipsychotic medicine, and number or length of psychiatric hospital admissions.ConclusionsThis trial showed a significant effect of a digital SDM tool on the subjective level of patient activation, confidence in communicating with one's provider, and feeling prepared for decision-making at the postintervention time point. The effect size was smaller than the 0.42 effect size that we had anticipated and sampled for. The trial contributes to the evidence on how digital tools may support patient-centered care and SDM in mental health care.Trial registrationClinicalTrials.gov NCT03554655; https://clinicaltrials.gov/ct2/show/NCT03554655.International registered report identifier (irrid)RR2-doi: 10.1186/s12888-019-2143-2.

Project description:BackgroundTargeted naloxone distribution to potential lay responders increases the timeliness of overdose response and reduces mortality. Little is known, however, about the patterns of decision-making among overdose lay responders. This study explored heuristic decision-making among laypersons equipped with an emergency response smartphone app.MethodsUnityPhilly, a smartphone app that connects lay responders equipped with naloxone to overdose victims, was piloted in Philadelphia from March 2019 to February 2020. Participants used the app to signal overdose alerts to peer app users and emergency medical services, or respond to alerts by arriving at overdose emergency sites. This study utilised in-depth interviews, background information, and app use data from a sample of 18 participants with varying histories of opioid use and levels of app use activity.ResultsThe sample included 8 people who used opioids non-medically in the past 30 days and 10 people reporting no opioid misuse. Three prevailing, not mutually exclusive, heuristics were identified. The heuristic of unconditional signalling ("Always signal for help or backup") was used by 7 people who valued external assistance and used the app as a replacement for a 911 call; this group had the highest number of signalled alerts and on-scene appearances. Nine people, who expressed confidence in their ability to address an overdose themselves, followed a heuristic of conditional signalling ("Rescue, but only signal if necessary"); these participants had the highest frequency of prior naloxone administrations. Eleven participants used the heuristic of conditional responding ("Assess if I can make a difference"), addressing an alert if they carried naloxone, were nearby, or received a signal before dark hours.ConclusionThe deployment of specific heuristics was influenced by prior naloxone use and situational factors. Success of overdose prevention interventions assisted by digital technologies may depend on the involvement of people with diverse overdose rescue backgrounds.

Project description:BACKGROUND:Shared decision making (SDM) is recognized as a person-centered approach to improving health care quality and outcomes. Few digital interventions to improve SDM have been tested in child and adolescent mental health (CAMH) settings. One such intervention is Power Up, a mobile phone app for young people (YP), which has shown some evidence of promise that YP who received Power Up reported greater levels of SDM. However, even though parents play a critical role in CAMH care and treatment, they often feel excluded from services. OBJECTIVE:This protocol is for a pilot trial to determine the feasibility of a large-scale randomized trial to develop and evaluate a Web app called Power Up for Parents (PUfP) to support parents and promote involvement in CAMH decisions. METHODS:A 2-stage process, consisting of the development stage and pilot-testing stage of the initial PUfP prototype, will be conducted. At the development stage, a qualitative study with parents and clinicians will be conducted. The interviews will aim to capture the experience of making CAMH decisions, preferences for involvement in SDM, and determine situations within which PUfP can be useful. At the pilot-testing stage, up to 90 parents and their clinicians will be invited to participate in the testing of the prototype. Parents will be randomly allocated to receive the intervention or be part of the control group. This study design will allow us to assess the acceptability and usefulness of PUfP in addition to examining the feasibility of a prospective randomized trial. Clinicians' perceptions of the prototype and how it has influenced parents' involvement in SDM will also be examined. RESULTS:Recruitment began in January 2019 and is scheduled to last for 10 months. Interviews and baseline data collection are currently in progress. To date, 11 CAMH sites have been recruited to take part in the study. It is anticipated that data collection will be completed by October 2019. CONCLUSIONS:The lack of parents' involvement in CAMH care and treatment can lead to higher rates of dropout from care and lower adherence to therapeutic interventions. There are significant benefits to be gained globally if digital SDM interventions are adopted by parents and shown to be successful in CAMH settings. TRIAL REGISTRATION:ISRCTN Registry ISRCTN39238984; http://www.isrctn.com/ISRCTN39238984. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/14571.

Project description:BackgroundEnhanced communication with health care providers (HCPs) can improve symptom management and health-related quality of life (HRQoL) for patients with chronic health conditions. Access to appropriate communication venues is needed to improve communication, however. As such, digital communication interventions mediated by patient portals carry the potential to support patient-provider communication and interaction and through this, also facilitate shared decision-making (SDM). The InvolveMe intervention was designed to provide patients with the opportunity to communicate symptoms and informational needs prior to consultation via digital assessment, including prioritizing what is most important to discuss with their HCPs, as well as to interact with HCPs through secure messages between outpatient visits.ObjectiveThe aim of this study was to assess the feasibility of the InvolveMe intervention by investigating acceptability, demand (ie, system use), and limited efficacy.MethodsThe study was designed as a single-arm, pre-post feasibility study combining quantitative and qualitative methods for data collection. Patients from an endocrine outpatient clinic were invited to use the InvolveMe intervention for 3 months, and HCPs administering InvolveMe were invited to participate in a focus group. Guided by descriptions of how to design feasibility studies by Bowen et al, feasibility was tested by exploring (1) acceptability, using data collected during recruitment from patient participants and nonparticipants (ie, declined to participate or did not meet study requirements), HCP experiences with recruitment, and the System Usability Scale (SUS); (2) demand via exploration of system use through extraction of system log data and HCP experiences with system use; and (3) limited efficacy testing, via exploration of potential effects from the Short-Form Health Survey (RAND 36), Hospital Anxiety and Depression Scale, and Health Literacy Questionnaire.ResultsPatient participants (N=23) were a median 54 (range 26-78) years old and primarily male (14/23, 61%). Nonparticipants (N=16) were a median 73 (range 55-80) years old and primarily male (12/16, 75%). The average SUS score was 72.2, indicating good system usability. Assessments were completed by 8 participants from home prior to outpatient visits. The assessments entailed various bodily symptoms and needs for information. Participants sent 17 secure messages related to patient administrative matters, symptoms, and challenges. Focus group participants (N=4) were all female and registered nurses. Data were analyzed in 2 predefined themes: Acceptability and Demand. Acceptability included the subthemes intervention attractiveness and intervention suitability. Demand included the subthemes elements of SDM and intervention challenges and opportunities. All patient participants completed outcome measures at baseline, and 19 (19/23, 83%) completed outcome measures at 3 months. These preliminary efficacy findings were mixed and inconclusive.ConclusionsThe study design provided findings from both patient and HCP perspectives and supported feasibility of the InvolveMe intervention. The investigation of acceptability and demand supported the potential for remote SDM mediated by patient portals using assessments and secure messages.Trial registrationClinicalTrials.gov NCT NCT04218721; https://www.clinicaltrials.gov/ct2/show/NCT04218721.

Project description:BackgroundThere is a critical need to improve support for families making difficult shared decisions about patient care with clinicians in the neuroscience ICU (neuro-ICU). The aim of this study is to identify patient- and family-related factors associated with dissatisfaction with shared decision-making support among families of neuro-critically ill patients.MethodsWe conducted a retrospective observational cohort study using survey data that had been collected from a consecutive sample of family members of patients in the neuro-ICU (one family member per patient) at two US academic centers. Satisfaction with shared decision-making support on ICU discharge had been measured among family members using one specific Likert scale item on the Family Satisfaction in the ICU 24 survey, a validated survey instrument for families of patients in the ICU. We dichotomized top-box responses for this particular item as an outcome variable and identified available patient- and family-related covariates associated with dissatisfaction (i.e., less than complete satisfaction) via univariate and multivariate analyses.ResultsAmong 355 surveys, 180 (49.5%) of the surveys indicated dissatisfaction with support during decision-making. In a multivariate model, no preexisting characteristics of families or patients ascertainable on ICU admission were predictive of dissatisfaction. However, among family factors determined during the ICU course, experiencing three or fewer formal family meetings (odds ratio 1.93 [confidence interval 1.13-3.31]; p = 0.01) was significantly predictive of dissatisfaction with decisional support in this cohort with an average patient length of stay of 8.6 days (SD 8.4). There was also a trend toward a family's decision to keep a patient as full code, without treatment limitations, being predictive of dissatisfaction (odds ratio 1.80 [confidence interval 0.93-3.51]; p = 0.08).ConclusionsFamily dissatisfaction with neuro-ICU shared decision-making support is not necessarily predicted by any preexisting family or patient variables but appears to correlate with participating in fewer formal family meetings during ICU admission. Future studies to improve family satisfaction with neurocritical care decision-making support should have broad inclusion criteria for participants and should consider promoting frequency of family meetings as a core strategy.

Dataset Information

A Feasibility Trial of Power Up: Smartphone App to Support Patient Activation and Shared Decision Making for Mental Health in Young People.

Publications

A Feasibility Trial of Power Up: Smartphone App to Support Patient Activation and Shared Decision Making for Mental Health in Young People.

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