Effectiveness of shared decision-making intervention in patients with lumbar degenerative diseases: A randomized controlled trial

ObjectiveTo evaluate the efficacy of shared decision-making (SDM) intervention among patients with lumbar degenerative diseases (LDDs) in terms of decision self-efficacy, control preferences, SDM process, decision satisfaction, and conflict.MethodsA total of 130 outpatients with LDDs recruited from orthopedic or rehabilitation clinics were randomly assigned to the SDM intervention (n = 67) or comparison (n = 63) groups. Patients in the intervention group received decision aids (DAs) with decision coaching and those in controlled group received standard educational materials from a health educator. The primary outcome was decision self-efficacy, and secondary outcomes were control preference, SDM process, conflict, and satisfaction.ResultsThe SDM intervention significantly improved decision self-efficacy (mean difference [MD] = 7.1, 95% confidence interval [CI]: 1.7–12.5, partial η² = 0.05) and reduced conflict (MD = −7.0, 95% CI: −12.2 to −1.9, partial η² = 0.06), especially in patients without family involvement, compared with the health education group. However, no significant between-group differences were observed in other outcomes.ConclusionSDM intervention improved SDM self-efficacy and reduced conflict in patients with LDDs.Practice ImplicationsClinicians can integrate DAs and decision coaching in SDM conversations. SDM intervention seems to engage patients in decision-making, especially those without family involvement.     

What patients want to ask their doctors: Data analysis from Question Builder,an online question prompt list tool

ObjectivesQuestion prompt lists (QPLs) are one strategy to increase patient participation in healthcare decisions but the extent to which consumers might access them in the ‘real world’ is largely unknown. This study measured usage of a passively-promoted, government-funded web-based patient-generated QPL tool, called Question Builder (Australia) (QB) hosted on healthdirect.gov.au, a consumer health information website.Methods12.5months of post-launch Google Analytics data from QB were analysed. Two existing coding frameworks (RIAS and ACEPP) were used to code QB questions thematically and 107 user-generated lists were analysed further to determine the questions chosen and prioritised.ResultsQB was accessed 8915 times, 4000 question lists were commenced and 1271 lists completed. Most lists were for general practice (GP) consultations (2444) rather than specialist consultations (1556). The most frequently chosen question was “Do I need any tests?”. Shared decision-making questions (SDM) made up 40% of questions prioritised e.g. “Do I need any treatment and what are my treatment options?”ConclusionsThere is active use of this online QPL, with strong interest in creating lists for GP consultations. Question Builder users prioritised questions which facilitate SDM.Practice ImplicationsMore research is required to assess the utilisation of QB in practice and health professionals’ views of QB.     

Supporting doctor-patient communication: Providing a question prompt list and audio recording of the consultation as communication aids to outpatients in a cancer clinic

Objective

To document the effect of a cancer specific question prompt list (QPL) on patients question asking and shared decision-making (SDM), and to evaluate the combined effect of the QPL and consultation audio recording (CAR) on patient outcomes.

Effectiveness of a web-based, individually tailored decision aid for depression or acute low back pain: a randomized controlled trial

Objective

To evaluate the effectiveness of a web-based, individually tailored decision aid (Patient Dialogue) on depression or acute low back pain for insurees of a German sickness fund.

Methods

Patient Dialogue (PD) was compared to the non-tailored Static Patient Information (SPI) in an online randomized controlled trial (RCT). The primary outcome was decisional conflict; secondary outcomes included knowledge, preparation for decision-making, preference for participation, involvement in decision-making, decision regret, and adherence.

Results

Out of 2480 randomized participants, 657 (26.5%) provided analyzable data immediately after using the system. Three months later, data from 131 (5.3%) participants could be included in the analysis. The PD group reported a significantly lower overall decisional conflict than the SPI group (38.7 vs. 45.1; p = 0.028 via multiple imputation estimator). The largest standardized effect (Cohen's d 0.56) resulted from the preparation for decision-making (PD 59.4 vs. SPI 46.8; p < 0.001).

Conclusion

PD may be an effective tool to reduce decisional conflict and prepare participants for treatment decision-making. However, the large dropout rate needs to be taken into account.

Practice implications

This study shows how a health insurance fund can support shared decision-making and how a decision aid can be evaluated in a RCT under routine care conditions.     

Developing a question prompt list for the oncology setting: A scoping review

ObjectiveThe purpose of this study was to provide an overview of existing methods used to develop a Question Prompt List (QPL) for an oncology setting.MethodsWe conducted a search of the literature published between 1999 and 2019 in five online databases followed by a hand search, and extracted data on the methods used to develop a QPL.ResultsA total of 21 studies were included. The review shows differences in the development of older QPLs (1999–2009) and current QPLs (2010–2019). However, most QPLs were developed using interviews or focus groups with patients and an expert session to review or adapt the QPL. Health professionals, patients, and researchers were included in nearly all the studies.ConclusionTo develop a QPL, it is important to combine several information sources and at least to involve health professionals, patients, and researchers in the development process. Review or evaluation steps can improve the appropriateness and acceptance of a QPL.Practice implicationsFurther research is needed to define the type of target population for new QPLs and to develop a framework for their development.     

The influence of a question prompt list on patient-oncologist information exchange in an African-American population

ObjectivesQuestion Prompt Lists (QPL) increase patient active participation in oncology interactions, but questions remain regarding how QPLs influence patient-oncologist information exchange. We examined how a QPL influenced information exchange during oncology interactions with African-American patients.MethodsData were self-reports and video recordings from a parent study testing the effects of a QPL in the outpatient clinics of two urban cancer hospitals. In this secondary analysis, we investigated which QPL questions patients identified as ones they wanted to ask their oncologists, how frequently patients/companions used patient active participation statements to seek information related to each QPL question, whether oncologists provided QPL-related information unprompted or prompted by patients/companions, and how frequently patients’ QPL-related information needs were addressed or unaddressed.ResultsThe QPL influenced information exchange by increasing patients’ and companions’ (if present) prompting for QPL-related information from their oncologists. Patients/companions most often prompted for QPL-related information about side effects and patient experience.ConclusionThis study builds on prior research on QPL interventions by expanding the object of study to information exchange and by analyzing patients’ information needs.Practice implicationsThis research demonstrates that a QPL supports patient/companion participation in oncology consultations by making information exchange more interactive.     

Effectiveness of a group-based intervention to change medication beliefs and improve medication adherence in patients with rheumatoid arthritis: A randomized controlled trial

Objective

To assess the effect of a group-based intervention on the balance between necessity beliefs and concern beliefs about medication and on medication non-adherence in patients with rheumatoid arthritis (RA).

Methods

Non-adherent RA patients using disease-modifying anti-rheumatic drugs (DMARDs) were randomized to an intervention or control arm. The intervention consisted, amongst others, of two motivational interviewing-guided group sessions led by the same pharmacist. Control patients received brochures about their DMARDs. Questionnaires were completed up to 12 months follow-up.

Results

123 patients (mean age: 60 years, female: 69%) were randomized. No differences in necessity beliefs and concern beliefs about medication and in medication non-adherence were detected between the intervention and control arm, except at 12 months’ follow-up: participants in the intervention arm had less strong necessity beliefs about medication than participants in the control arm (b: −1.0 (95% CI: −2.0, −0.1)).

Conclusion

This trial did not demonstrate superiority of our intervention over the control arm in changing beliefs about medication or in improving medication adherence over time.

Practice implications

Absent intervention effects might have been due to, amongst others, selection bias and a suboptimal treatment integrity level. Hence, targeting beliefs about medication in clinical practice should not yet be ruled out.     

Effectiveness of individual resource-oriented joint protection education in people with rheumatoid arthritis. A randomized controlled trial

Objective

The modern joint protection (JP) concept for people with rheumatoid arthritis (RA) is an active coping strategy to improve daily tasks and role performance by changing working methods and using assistive devices. Effective group JP education includes psycho-educational interventions. The Pictorial Representation of Illness and Self Measure (PRISM) is an interactive hands-on-tool, assessing (a) the individual's perceived burden of illness and (b) relevant individual resources. Both issues are important for intrinsic motivation to take action and change behaviour. This study compared individual conventional JP education (C-JP) with PRISM-based JP education (PRISM-JP).

Methods

An assessor-blinded multicentre randomized controlled trial, including four JP education sessions over 3 weeks, with assessments at baseline and 3 months.

Results

In total 53 RA patients participated. At 3 months, the PRISM-JP (n = 26) participants did significantly better compared to the C-JP participants (n = 27) in JP behaviour (p = 0.02 and p = 0.008 when corrected for baseline values), Arthritis Self-efficacy (ASES, p = 0.015) and JP self-efficacy (JP-SES, p = 0.047). Within-group analysis also showed less hand pain (p < 0.001) in PRISM-JP group.

Conclusion

PRISM-JP more effectively supported learning of JP methods, with meaningful occupations, resource activation and self-efficacy acting as important mediators.

Practice implications

PRISM improved patient-clinician communication and is feasible for occupational therapy.     

Family-clinician shared decision making in intensive care units: Cluster randomized trial in China

ObjectiveTo investigate if a Family-Clinician Shared Decision-Making (FCSDM) intervention benefits patients, families and intensive care units (ICUs) clinicians.MethodsSix ICUs in China were allocated to intervention or usual care. 548 patients with critical illness, 548 family members and 387 ICU clinicians were included into the study. Structured FCSDM family meetings were held in the intervention group. Scales of SSDM, HADS, QoL2 and CSACD were used to assess families’ satisfaction and distress, patients’ quality of life, and clinicians’ collaboration respectively.ResultsComparing the intervention group with the control group at post-intervention, there were significant differences in the families’ satisfaction (P = 0.0001), depression level (P = 0.005), and patients’ quality of life (P = 0.0007). The clinicians’ mean CSCAD score was more positive in the intervention group than controls (P < 0.05). There was no significant between-group differences on ICU daily medical cost, but the intervention group demonstrated shorter number of days’ stay in ICU (P = 0.0004).ConclusionThe FCSDM intervention improved families’ satisfaction and depression, shortened patients’ duration of ICU stay, and enhanced ICU clinicians’ collaboration.Practice implicationsFurther improvement and promotion of the FCSDM model are needed to provide more evidence to this field in China.     

Mammographic breast cancer screening —a randomized trial in Malmö, Sweden

A randomized trial is presented on the effect of repeated invitation to breast cancer screening with mammography on mortality from breast cancer. The invited group and the control group each consisted of approximately 21,000 women aged 45-69 yr at the start of the screening. The attendance rate was 74% at the first screening and 70% at the two subsequent screening rounds. The cancer detection rate was 7.5 per 1000 women examined in the first screening round and 2.2 and 2.0 per 1000 woman-years in the second and third screenings with an incidence of 0.9 in the intervals. The incidence in the control group was 2.7 per 1000 woman-years. The proportion of positive biopsies was 61% in the first screening round, 33% in the second, and 58% in the third. After the prevalence screening, the stage distribution was more favourable in the invited group (including non-attenders) than in the control group. In the two most recent periods of the programme, 62 out of 160 women with cancer (39%) in the invited group were in stage II-IV compared with 91 out of 159 (57%) in the control group. More than 60% of cancers detected at screening were either non-invasive or invasive with a diameter of 1 cm. The corresponding percentage in the control group was 27%. The importance of sampling bias is discussed. Although data on mortality still have to be awaited, the results so far clearly indicate a positive effect of screening.     

Exercise beliefs of breast cancer survivors before and after participation in a randomized controlled trial

The purpose of this study was to examine the exercise beliefs of breast cancer survivors before and after participation in a randomized trial. Prior to randomization, 52 breast cancer survivors completed exercise belief measures based on the theory of planned behavior. After the trial, participants assigned to the exercise group (n = 24) completed the belief measures again. Results show that there was significant variability in the expected benefits of exercise prerandomization, ranging from 40% for a reduced risk of breast cancer recurrence to 94% for an improved energy level. Moreover, attitudes toward exercise and perceptions of control were higher in the exercise group after the exercise program. The findings are discussed in terms of the veracity of the exercise beliefs held by breast cancer survivors as well as the aspects of the program that may have contributed to the positive changes in exercise beliefs.     

Efficacy of oseltamivir compared with zanamivir in COPD patients with seasonal influenza virus infection: a randomized controlled trial

Influenza viruses exacerbate chronic obstructive pulmonary disease (COPD) with considerable morbidity and mortality. Zanamivir and oseltamivir are effective in treating influenza. However, their efficacy in relieving influenza symptoms in COPD patients remains unknown, with the lack of controlled trials in this subject. Therefore, we conducted this randomized controlled trial to investigate the clinical efficacy of both interventions in this population. Patients were allocated to two groups (80 patients each): oseltamivir (OSELTA) and zanamivir (ZANA) groups. Oseltamivir (75 mg) was orally administered twice daily for 5 days, while zanamivir (10 mg) was inhaled twice daily for 5 days. Clinical parameters including body temperature, influenza symptoms (i.e., sore throat, cough, etc.), and serial blood tests were recorded on days 1, 3, and 7. We analyzed primary (changes in body temperature) and secondary outcomes (changes in non-specific symptoms) using the pre-protocol and intention-to-treat analyses. Differences between groups were assessed using t-test. Oseltamivir and zanamivir significantly reduced body temperature on the 3rd day after treatment; however, the number of patients who reported clinical improvement in influenza-like symptoms was significantly higher in the OSELTA group compared to the ZANA group on days 3 (85 vs 68.8%, P=0.015) and 7 (97.5 vs 83.8%, P=0.003). However, no significant changes in hematological (white blood cells and its subtypes) and inflammatory (C-reactive protein) parameters were noted (P>0.05). Our results suggested that oseltamivir and zanamivir are effective in reducing body temperature, while oseltamivir led to better clinical improvement regarding influenza-like symptoms in patients with COPD.     

A randomized controlled trial of estrogen treatment in men with mild cognitive impairment

This randomized, placebo-controlled, cross-over study investigated whether estrogen treatment would have a beneficial effect on tests of verbal memory in men with mild cognitive impairment (MCI). Forty-three men newly diagnosed with MCI were administered a battery of neuropsychological tests before randomly receiving 12 weeks of treatment with estrogen or placebo followed by a 12 week cross-over treatment. A significant improvement in the total score, and in two subscale scores of the Buschke Selective Reminding Test occurred following estrogen treatment compared to both pretreatment and post-placebo scores (p < 0.05). However, benefit occurred only in the men who had received estrogen for 12 weeks following 12 weeks of placebo. Although these findings tentatively suggest that treatment with estrogen may improve verbal memory in men with MCI, the fact that the improvement occurred only in the group that received estrogen following 12 weeks of placebo and the absence of improvement on every test of verbal memory administered suggests that these findings need to be replicated using a larger sample size.     

A randomized controlled trial assessing the efficacy of a self-administered psycho-educational intervention for patients with cancer

Objective: Bibliotherapy refers to psychological self-help interventions that utilize treatment books to improve psychological well-being. Research supports bibliotherapy as an efficacious intervention for a variety of mental health problems. Yet, few studies have investigated bibliotherapy in psychosocial oncology. The objective of this randomized controlled trial was to examine the efficacy of the NuCare intervention, delivered as a self-directed workbook, for enhancing empowerment, coping, and quality of life and reducing distress in patients with cancer.Methods: Eighty-nine adult patients with cancer were randomized to receive the workbook for 6 weeks or the control condition, usual care. Participants completed questionnaires at baseline, 6 weeks post-baseline, and 10 weeks post-baseline.Results: The increase of empowerment (main outcome) and quality of life and the decrease of distress in the NuCare group from pre-intervention to follow-up assessment differed significantly from the respective difference scores in the control group.Conclusions: The self-administered NuCare workbook is a potentially cost-effective, minimal intervention addressing psychosocial needs of patients with cancer.Practice implications: Evidence-based bibliotherapy can empower patients and has the promise of reducing the burden on the healthcare system while enhancing the immediacy of psychosocial support.     

Evaluation of influenza prevention in the workplace using a personally controlled health record: randomized controlled trial

Background

Personally controlled health records (PCHRs) are accessible over the Internet and allow individuals to maintain and manage a secure copy of their medical data. These records provide a new opportunity to provide customized health recommendations to individuals based on their record content. Health promotion programs using PCHRs can potentially be used in a variety of settings and target a large range of health issues.

Objectives

The aim was to assess the value of a PCHR in an employee health promotion program for improving knowledge, beliefs, and behavior around influenza prevention.

Methods

We evaluated a PCHR-based employee health promotion program using a randomized controlled trial design. Employees at Hewlett Packard work sites who reported reliable Internet access and email use at least once every 2 days were recruited for participation. PCHRs were provided to all participants for survey administration, and tailored, targeted health messages on influenza illness and prevention were delivered to participants in the intervention group. Participants in the control group received messages addressing cardiovascular health and sun protection. The main outcome measure was improvement in knowledge, beliefs, and behavior around influenza prevention. Secondary outcomes were influenza vaccine rates among household members, the impact of cardiovascular health and sun protection messages on the control group, and the usability and utility of the PCHR-based program for employees.

Results

The intervention did not have a statistically significant effect on the influenza knowledge elements we assessed but did impact certain beliefs surrounding influenza. Participants in the intervention group were more likely to believe that the influenza vaccine was effective (OR = 5.6; 95% CI = 1.7-18.5), that there were actions they could take to prevent the flu (OR = 3.2; 95% CI = 1.1-9.2), and that the influenza vaccine was unlikely to cause a severe reaction (OR = 4.4; 95% CI = 1.3-15.3). Immunization rates did not differ between the intervention and control groups. However, participants in the intervention group were more likely to stay home during an infectious respiratory illness compared with participants in the control group (39% [16/41] vs 14% [5/35], respectively; P = .02). The program also succeeded in improving recognition of the signs of heart attack and stroke among participants in the control group. Overall, 78% of participants rated the PCHR as “extremely/very” easy to use, and 73% responded that they would be “extremely/very” likely to participate again in a PCHR-based health promotion system such as this one.

Conclusions

With a small sample size, this study identified a modest impact of a PCHR-based employee health program on influenza prevention and control. Employees found the PCHR acceptable and easy to use, suggesting that it should be explored as a common medium for health promotion in the workplace.

Trial Registration

ClinicalTrials.gov {"type":"clinical-trial","attrs":{"text":"NCT00142077","term_id":"NCT00142077"}}NCT00142077     

Fostering informed decisions: A randomized controlled trial assessing the impact of a decision aid among men registered to undergo mass screening for prostate cancer

Objective

Screening asymptomatic men for prostate cancer is controversial and informed decision making is recommended. Within two prostate cancer screening programs, we evaluated the impact of a print-based decision aid (DA) on decision-making outcomes.

Methods

Men (N = 543) were 54.9 (SD = 8.1) years old and 61% were African-American. The 2(booklet type: DA vs. usual care (UC)) × 2(delivery mode: Home vs. Clinic) randomized controlled trial assessed decisional and screening outcomes at baseline, 2-months, and 13-months.

Results

Intention-to-treat linear regression analyses using generalized estimating equations revealed that DA participants reported improved knowledge relative to UC (B = .41, p < .05). For decisional conflict, per-protocol analyses revealed a group by time interaction (B = −.69, p < .05), indicating that DA participants were less likely to report decisional conflict at 2-months compared to UC participants (OR = .49, 95% CI: .26–.91, p < .05).

Conclusion

This is the first randomized trial to evaluate a DA in the context of free mass screening, a challenging setting in which to make an informed decision. The DA was highly utilized by participants, improved knowledge and reduced decisional conflict.

Practice implications

These results are valuable in understanding ways to improve the decisions of men who seek screening and can be easily implemented within many settings.     

Comparison of two approaches in achieving smoking abstinence among patients in an outpatient clinic: A Phase 2 randomized controlled trial

Objectives

To compare the effectiveness of quitting immediately and cutting down to quit in promoting smoking abstinence among smokers in an outpatient clinic.

Effect of a decision aid with patient narratives in reducing decisional conflict in choice for surgery among early-stage breast cancer patients: A three-arm randomized controlled trial

ObjectiveWe aimed to evaluate the effect of a decision aid (DA) with patient narratives on decisional conflict in surgery choice for Japanese women with early-stage breast cancer.MethodsTwo hundred ten women with early-stage breast cancer were randomly assigned to an intervention or control group. Groups 1 and 2 received standard information and a DA, with or without patient narratives, and Group 3 received standard information (control) before surgery choice. At baseline, post-intervention (Time 2), and 1 month after surgery (Time 3), we evaluated decisional conflict as the primary outcome using a decisional conflict scale (DCS). Sidak corrections for multiple comparisons in analysis of covariate were used to compare Time 2 and Time 3 DCS mean scores between each pair of groups.ResultsAt Time 3, decisional conflict was significantly reduced for Group 1 vs control (P = 0.021, Cohen’s d  = 0.26) and Group 2 vs control (P = 0.008, Cohen’s d = 0.40).ConclusionThe DAs with and without patient narratives are equivalently effective at reducing postoperative decisional conflict in Japanese women with early-stage breast cancer.Practice implicationsThe DAs with and without patient narratives can be used in clinical practice for women with early-stage breast cancer.