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Feasibility and acceptability of a decision aid designed for people facing advanced or terminal illness: a pilot randomized trial.

ABSTRACT: Patients nearing the end of their lives face an array of difficult decisions.This study was designed to assess the feasibility and acceptability of a decision aid (DA) designed for patients facing advanced or terminal illness.We conducted a pilot randomized clinical trial of Health Dialog's Looking Ahead: choices for medical care when you're seriously ill DA (booklet and DVD) applied to patients on a hospital-based palliative care (PC) service.University of Colorado Hospital - December 2009 and May 2010.All adult, English-speaking patients or their decision makers were potentially eligible. Patients were not approached if they were in isolation, did not speak English or if any provider felt that they were not appropriate because of issues such as family conflict or actively dying.All participants received a standard PC consultation. Participants in the intervention arm also received a copy of the DA. Measurements Primary outcomes included decision conflict and knowledge. Participants in the intervention arm also completed an acceptability questionnaire and qualitative exit interviews.Of the 239 patients or decision makers, 51(21%) enrolled in the trial. The DA had no significant effect on decision conflict or knowledge. Exit interviews indicated it was acceptable and empowering, although they wished they had access to the DA earlier.While the DA was acceptable, feasibility was limited by late-life illness challenges. Future trials of this DA should be performed on patients earlier in their illness trajectory and should include additional outcome measures such as self-efficacy and confidence.

SUBMITTER: Matlock DD

PROVIDER: S-EPMC5060696 | biostudies-literature | 2014 Feb

REPOSITORIES: biostudies-literature

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Feasibility and acceptability of a decision aid designed for people facing advanced or terminal illness: a pilot randomized trial.

Matlock Dan D DD Keech Tarah A E TA McKenzie Marlene B MB Bronsert Michael R MR Nowels Carolyn T CT Kutner Jean S JS

Health expectations : an international journal of public participation in health care and health policy 20111028 1

<h4>Background</h4>Patients nearing the end of their lives face an array of difficult decisions.<h4>Objective</h4>This study was designed to assess the feasibility and acceptability of a decision aid (DA) designed for patients facing advanced or terminal illness.<h4>Design</h4>We conducted a pilot randomized clinical trial of Health Dialog's Looking Ahead: choices for medical care when you're seriously ill DA (booklet and DVD) applied to patients on a hospital-based palliative care (PC) service. ...[more]

PMID: 22032553

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Project description:BackgroundYoung adults ages 18 to 25 with first episode psychosis (FEP) have an increased risk of discontinuation antipsychotic medications and psychiatric service disengagement that lead to symptom exacerbation and deterioration. We seek to (1) examine the feasibility, usability, and potential impact of a Shared Decision Making (SDM) Antipsychotic Medication Decision Aid (DA) on decision-making, adherence to the decision made, and service engagement among young adults with FEP and (2) understand the role of additional patient-level factors on SDM.MethodsA randomized controlled trial is being conducted in a coordinated specialty care community program for FEP in an urban setting. Eligible patients are randomly assigned to receive an intervention, the Antipsychotic Medication Decision Aid, or treatment as usual. Patients receive their assigned intervention before their medication appointment with the psychiatrist and complete four interviews: before the appointment (T0), after the appointment (T1), and at 3- and 6-month follow-ups (T2 and T3). The study staff and participating psychiatrists are not blinded to the intervention. The data are de-identified to maintain blinding during the analysis process. The primary aims are feasibility of intervention delivery and research procedures and preliminary impact of the intervention on SDM-related outcomes, medication adherence, and service engagement. As a secondary aim, we will explore the contribution of personality and motivation variables, clinical relationships, cognitive functioning, and mental-health-related stigma to SDM. If the sample size permits, we plan to conduct parametric tests such as independent-samples t tests at T1 to compare differences in SDM, adherence, and engagement scales. In the case of a small sample size, we will use non-parametric tests and descriptive statistics.DiscussionThis protocol outlines the methodology for a feasibility pilot comparing the effect of a novel SDM Antipsychotic Medication encounter DA with treatment as usual on SDM, medication adherence, and service engagement in FEP care. SDM is endorsed as a framework for use in FEP and antipsychotic pharmacotherapy, but its impact on adherence and health outcomes is unclear. Understanding the potential contribution of an SDM Antipsychotic Medication DA compared with usual care in psychosis pharmacotherapy is critical. The study will help answer several key questions new to SDM research, including the contribution of personality and clinical relationships to SDM in mental health and psychosis in particular. The study will serve to gather feasibility data to inform future studies and scale-up.Trial registrationEthics approval was obtained through Temple University's institutional review board (IRB) and the City of Philadelphia's Department of Public Health IRB. The study has been retrospectively registered with ClinicalTrials.gov as NCT04373590 on 29 April 2020. https://clinicaltrials.gov/ct2/show/NCT04373590?term=NCT04373590&draw=2&rank=1.

Project description:BACKGROUND:Persistent smoking after a cancer diagnosis predicts worse treatment outcomes and mortality, but access to effective smoking cessation interventions is limited. Smartphone apps can address this problem by providing a highly accessible, low-cost smoking cessation intervention designed for patients with a recent cancer diagnosis. OBJECTIVE:This study aimed to summarize our development process and report the trial design, feasibility, participant acceptability, preliminary effectiveness, and impact on processes of change (eg, cancer stigma) of the first-known smoking cessation smartphone app targeted for cancer patients. METHODS:We used an agile, user-centered design framework to develop a fully automated smartphone app called Quit2Heal that provided skills training and stories from cancer survivors focusing on coping with internalized shame, cancer stigma, depression, and anxiety as core triggers of smoking. Quit2Heal was compared with the National Cancer Institute's QuitGuide, a widely used stop smoking app for the general population, in a pilot double-blinded randomized trial with a 2-month follow-up period. Participants were 59 adult smokers diagnosed with cancer within the past 12 months and recruited through 2 cancer center care networks and social media over a 12-month period. The most common types of cancer diagnosed were lung (21/59, 36%) and breast (10/59, 17%) cancers. The 2-month follow-up survey retention rate was 92% (54/59) and did not differ by study arm (P=.15). RESULTS:Compared with QuitGuide participants, Quit2Heal participants were more satisfied with their assigned app (90% [19/21] for Quit2Heal vs 65% [17/26] for QuitGuide; P=.047) and were more likely to report that the app assigned to them was made for someone like them (86% [18/21] for Quit2Heal vs 62% [16/26] for QuitGuide; P=.04). Quit2Heal participants opened their app a greater number of times during the 2-month trial period, although this difference was not statistically significant (mean 10.0, SD 14.40 for Quit2Heal vs mean 6.1, SD 5.3 for QuitGuide; P=.33). Self-reported 30-day point prevalence quit rates at the 2-month follow-up were 20% (5/25) for Quit2Heal versus 7% (2/29) for QuitGuide (odds ratio 5.16, 95% CI 0.71-37.29; P=.10). Quit2Heal participants also showed greater improvement in internalized shame, cancer stigma, depression, and anxiety, although these were not statistically significant (all P>.05). CONCLUSIONS:In a pilot randomized trial with a high short-term retention rate, Quit2Heal showed promising acceptability and effectiveness for helping cancer patients stop smoking. Testing in a full-scale randomized controlled trial with a longer follow-up period and a larger sample size is required to test the effectiveness, mediators, and moderators of this promising digital cessation intervention. TRIAL REGISTRATION:ClinicalTrials.gov NCT03600038; https://clinicaltrials.gov/ct2/show/NCT03600038.

Project description:BackgroundHIV self-testing (HIVST) is an innovative HIV testing approach that effectively reaches those who do not otherwise test, including key populations (KPs). Despite potential benefits, HIVST is not currently implemented in Pakistan. The high risk of HIV among transgender (TGs) persons is among the highest risk group for HIV in Pakistan, yet knowledge of HIV status remains low in this key population group. We conducted a pilot project to assess the acceptability and feasibility of distributing HIVST to TGs in Larkana.MethodsEligible participants were 18 years or above and self-identified as transgender ("hijra"). One oral fluid HIVST kit per person was distributed free of cost in the community by trained transgender peer outreach workers (ORW). Participants could request a demonstration of the HIVST procedure before performing self-testing which was provided by the trained ORW. Demographic characteristics of participants were collected. The ORW followed up with phone calls two days later to record if HIVST kits were used, the results, and whether assistance was required.ResultsBetween November 2020 and February 2021, 150 HIVST kits were distributed to eligible TGs. The average age of participants was 25.5 years (standard deviation: 7.0). Over a third (52, 34.7%) had no formal education, while (16, 10.6%) had attended at least five years of schooling. Over one-third (58, 38.6%) of participants were first-time testers. One hundred and thirty-nine (92.7%) participants reported their results within two days. For the remaining 11 participants, ORWs had to contact them. All participants reported using HIVST kits within three days. A majority (141, 94%) used the kit in their homes, and the remaining nine (6%) used it at the community-based organization's office. Overall, a small proportion (11, 7.3%) of participants requested a demonstration of the test procedure before performing HIVST. Four (2.7%) participants who had performed unsupervised self-tests reported reactive HIVST results; all were linked to treatment within five working days once their HIV result was confirmed. The majority (136, 90.6%) of participants felt that self-testing was easy to perform independently, and 143 (95%) reported that they would recommend HIVST to their peers.ConclusionHIVST is acceptable among TGs and identified by first-time testers as undiagnosed infections. Peer-led distribution appears to be a feasible approach for implementation in this setting. HIVST should be considered for routine implementation and scale up to reduce testing gaps among Pakistan's key population, particularly TGs.

Project description:ObjectivesPilot feasibility randomised controlled trial (RCT) for the singing groups for people with aphasia (SPA) intervention to assess: (1) the acceptability and feasibility of participant recruitment, randomisation and allocation concealment; (2) retention rates; (3) variance of continuous outcome measures; (4) outcome measure completion and participant burden; (5) fidelity of intervention delivery; (6) SPA intervention costs; (7) acceptability and feasibility of trial and intervention to participants and others involved.DesignA two-group, assessor-blinded, randomised controlled external pilot trial with parallel mixed methods process evaluation and economic evaluation.SettingThree community-based cohorts in the South-West of England.ParticipantsEligible participants with post-stroke aphasia were randomised 1:1 to SPA or control.InterventionThe manualised SPA intervention was delivered over 10 weekly singing group sessions, led by a music facilitator and assisted by an individual with post-stroke aphasia. The intervention was developed using the Information-Motivation-Behavioural skills model of behaviour change and targeted psychosocial outcomes. Control and intervention participants all received an aphasia information resource pack.Outcome measuresCollected at baseline, 3 and 6 months post-randomisation, candidate primary outcomes were measured (well-being, quality of life and social participation) as well as additional clinical outcomes. Feasibility, acceptability and process outcomes included recruitment and retention rates, and measurement burden; and trial experiences were explored in qualitative interviews.ResultsOf 87 individuals screened, 42 participants were recruited and 41 randomised (SPA=20, control=21); 36 participants (SPA=17, control=19) completed 3-month follow-up, 34 (SPA=18, control=16) completed 6-month follow-up. Recruitment and retention (83%) were acceptable for a definitive RCT, and participants did not find the study requirements burdensome. High fidelity of the intervention delivery was shown by high attendance rates and facilitator adherence to the manual, and participants found SPA acceptable. Sample size estimates for a definitive RCT and primary/secondary outcomes were identified.ConclusionsThe SPA pilot RCT fulfilled its objectives, and demonstrated that a definitive RCT of the intervention would be both feasible and acceptable.Trial registration numberNCT03076736.

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Feasibility and acceptability of a decision aid designed for people facing advanced or terminal illness: a pilot randomized trial.

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Feasibility and acceptability of a decision aid designed for people facing advanced or terminal illness: a pilot randomized trial.

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