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

Background Patients nearing the end of their lives face an array of difficult decisions. Objective This study was designed to assess the feasibility and acceptability of a decision aid (DA) designed for patients facing advanced or terminal illness. Design 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. Setting University of Colorado Hospital – December 2009 and May 2010. Participants 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. Intervention 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. Results 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. Conclusions 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.     

The multiple risk factor intervention trial (MRFIT): I. Historical perspectives

The beginnings of the Multiple Risk Factor Intervention Trial (MRFIT) for the primary prevention of coronary heart disease (CHD) are chronicled. Over the period 1960–1970, various scientific panels had urged the undertaking of primary CHD prevention trials but with limited consensus on the specific type of study needed. The Task Force on Arteriosclerosis convened by the National Heart and Lung Institute (NHLI) in 1971 recommended that a national diet-heart trial not be supported but, instead, that the NHLI undertake multiple risk factor intervention trials in individuals at high risk of CHD due to combinations of elevated serum lipids, hypertension, and cigarette smoking. Late in 1971, the NHLI invited proposals for MRFIT. Its primary purpose was to determine whether a special risk factor intervention program directed at the reduction of elevated serum cholesterol, elevated diastolic blood pressure, and cigarette smoking in men at high risk of death from CHD (but still free of clinical evidence of CHD) would result in a significant reduction in CHD mortality; nonfatal myocardial infarction or CHD mortality; cardiovascular mortality; and mortality from all causes—over a 6-year period. In 1972–1973, funds to conduct such a study among 12,000 randomized men were awarded to 22 clinical centers, a coordinating center, central laboratory, standardization laboratory, ECG centers, and a drug distribution center. The evolution of the organization of this research undertaking is described.     

The multiple risk factor intervention trial (MRFIT): V. Intervention on smoking

The development, implementation, and results of the smoking cessation program of the Multiple Risk Factor Intervention Trial (MRFIT) are presented. The MRFIT is a 6-year clinical trial designed to investigate the effects of reducing cardiovascular risk factors—elevated cholesterol, hypertension, and cigarette smoking—in a group of asymptomatic men at high risk of cardiovascular disease. The men participated in an integrated intervention program that offered both group and individual formats, a structured maintenance program for those who stopped smoking, and an extended intervention program for those unable to quit initially. Results among the original 4,103 smokers included a 47.3% quit rate 4 months after program initiation and a 45.9% quit rate after 4 years. Of those reporting no smoking at 4 months, 56% were abstinent at all visits through 48 months. Most recidivism occurred soon after initial cessation, with 17% of the men who reported quitting at 4 months reporting smoking 4 months later. The quit rates were strongly associated with the initial level of smoking, with light smokers reporting higher quit rates and lower recidivism rates at all visits through 4 years. Results exceed trial goals whether measured by self-reports or by thiocyanate levels, an objective assessment of smoking behavior. Discussion focuses on understanding the variables contributing to smoking cessation and to achieving the goals of reduction of risk of cardiovascular disease.     

An evaluation of the intervention against smoking in the multiple risk factor intervention trial

The results of the Multiple Risk Factor Intervention Trial showed no significant difference in mortality from coronary heart disease between intervention and control groups despite an apparent success of the intervention against cigarette smoking. A reanalysis of the published data indicates that the effectiveness of the smoking intervention may have been overestimated. The researchers counted those who smoked pipes or cigars at screen as nonsmokers and attempted to classify cigarette smokers who switched to pipes or cigars during the trial as successes whether or not they continued to inhale the smoke. It is unreasonable to assume a priori that inhaling pipe or cigar smoke is less dangerous than cigarette smoke. Moreover, attempting to include pipe and cigar smokers, who may have been inhaling smoke, among the successes makes biochemical validation of claims of abstinence overly lenient. When levels of serum thiocyanate are used to obtain an objective index of smoking reduction, it appears that the effect of intervention was considerably smaller than has been reported, and failed to reach design goals over the first 4 years. This could help to explain the disappointing mortality results.     

The multiple risk factor intervention trial (MRFIT).: II. The development of the protocol

The detailed development of the MRFIT protocol is discussed, beginning with the general plan outlined by the National Heart and Lung Institute in the initial solicitation of contract proposals. The protocol is designed to test the hypothesis that lowering serum cholesterol by diet, reducing high blood pressure by diet and drugs, and cessation of cigarette smoking will result in a reduced risk of (a) death from coronary heart disease (CHD), (b) combined fatal CHD and nonfatal myocardial infarction, (c) deaths from all cardiovascular disease, and (d) death from all causes, over a period of 6 years among men aged 35–57 without initial evidence of CHD. After screening 361,662 men, from 1974 to early 1976, 12,866 from the upper end of the risk spectrum of CHD on the basis of serum cholesterol, blood pressure, and smoking habits, were randomly assigned either to a program of Special Intervention (SI) directed toward altering these risk factors or to their usual source of medical care (UC). Men in the UC group have been evaluated once each year in the clinic without direct intervention on the risk factors. Men in the SI group participated in an initial intensive series of group sessions designed to assist in modification of behavior relating to the three risk factors. The SI men have since been invited to the clinic at least three times each year to maintain and increase risk factor change. Changes in the intervention protocol have resulted mainly from difficulty in achieving the expected response in serum cholesterol. These changes have included greater emphasis on control of body weight, the recommendation of more rigorous dietary specifications for those with persistently elevated levels of serum cholesterol, and advice to increase physical activity.     

The acceptability of the female and male condom: a randomized crossover trial

CONTEXT: Although studies have assessed the acceptability of male and female condoms, comparative trial data are lacking. METHODS: A sample of 108 women in stable relationships recruited from an urban, reproductive health clinic were randomly assigned to use 10 male or female condoms, followed by use of 10 of the other type. A nurse provided instruction in correct method use. Demographic information was collected in a baseline questionnaire; acceptability data were collected in follow-up and exit questionnaires and coital logs. Nonparametric and chi-square statistics were used to analyze measures of the methods' relative acceptability. Bowker's test of symmetry was adapted to test the null hypothesis of no difference in acceptability between condom types. RESULTS: Participants used 678 female and 700 male condoms. Although neither method scored high on user satisfaction measures, the 63 women completing the study protocol preferred the male condom to the female condom for ease of application or insertion, ease of removal, general fit, feel of the condom during intercourse and ease of penetration. Participants reported that their partner also favored the male condom, although women generally appeared to like this method more than their partner did. In a direct comparison between the methods at the end of the study, women generally judged male condoms superior on specified preference criteria. CONCLUSIONS: Across a range of criteria, the female condom was less acceptable than the male condom to most women and their partners. Although both types had low acceptability, they are needed and valid methods of pregnancy and disease prevention. That neither rated high on user satisfaction measures underscores the need for more barrier methods that women and men can use.     

The multiple risk factor intervention trial (MRFIT): IV. Intervention on blood lipids

The results are presented for the first 4 years of the Multiple Risk Factor Intervention Trial (MRFIT) nutrition intervention program. Study participants were at high risk (upper 10–15%) for Coronary Heart Disease (CHD). The Special Intervention (SI) group reached and sustained the goals of an eating pattern originally designed to limit cholesterol intake to less than 300 mg/day, with less than 10% of calories as saturated fat and not more than 10% as polyunsaturated fat. By the end of the first year, mean serum total cholesterol had fallen by 6.3% from the mean initial value of 254 mg/dl. The magnitude of the decrease became slightly greater in the ensuing years, reaching 7.4% by the fourth annual visit. Substantially larger decreases in mean serum cholesterol level were observed in the subgroups with the highest baseline level, greatest weight loss, in those who did not smoke, and in those who had normal blood pressure on entry. The changes in cholesterol level were accompanied by parallel changes in mean plasma LDL cholesterol, which also fell by 6.6% over the 4 years, but mean HDL cholesterol was not substantially altered. Comparison with earlier population data suggests that the overall responses to the MRFIT eating pattern were limited by the apparent fact that participants had already made self-initiated changes toward the fatcontrolled dietary pattern before they entered the study.     

Workplace exercise intervention to prevent depression: A pilot randomized controlled trial

ObjectiveThis study evaluates whether it is feasible to deliver an exercise program to inactive employees with minimal symptoms of depression, and the size of effects on the mental and physical health of employees.MethodIn the fall of 2008, 30 white-collar employees with minimal symptoms of depression (5 ≤ PHQ-9 ≤ 9) were randomly assigned to a 10-week in-company fitness program with two supervised training sessions per week or to a control group. Demographics, depression scores, and exercise behavior were determined by questionnaire, physical health variables were measured and company records were checked to calculate sickness absence data. Participants were measured at baseline and 10 weeks after (post-test).ResultsANCOVA showed that the difference between the groups on the average change in depression from baseline to post-test approached significance. Eighty-six percent of the participants in the exercise group were below the cut-off point for experiencing minimal symptoms of depression, compared with 31% of the control participants. Most physical measures improved significantly from baseline to post-test in the exercise group compared to the control group. The difference between the groups on average change in sickness absence was not significant.ConclusionsThis intervention was feasible and shows that exercise can reduce the risk of depression in employees with sedentary jobs, an inactive lifestyle, and a high-risk of depression. A large randomized controlled trial with a long-term follow-up is needed to establish the effectiveness and cost-effectiveness of exercise in the prevention of depression in a workplace setting.     

The multiple risk factor intervention trial (MRFIT). VII. A comparison of risk factor changes between the two study groups

Risk factor changes over 4 years for MRFIT Special Intervention (SI) participants are compared with risk factor changes made by Usual Care (UC) participants. Differences between the two study groups are compared with original design assumptions. After 4 years of follow-up, serum cholesterol differences averaged 50% of what was predicted; diastolic blood pressure differences between the two study groups averaged 67% of that predicted; cigarette smoking reductions in the Special Intervention group relative to the Usual Care group have exceeded what was predicted each year based on reported histories. When serum thiocyanate is used to verify reported cessation the SI-UC difference is reduced but still averages greater than the reductions predicted in the third and fourth years of follow-up.     

Enhancing multiple domains of well-being by decreasing multiple health risk behaviors: a randomized clinical trial

Abstract Tailored behavior change programs have proven effective at decreasing health risk factors, but the impact of such programs on participant well-being has not been tested. This randomized trial evaluated the impact of tailored telephone coaching and Internet interventions on health risk behaviors and individual well-being. Exercise and stress management were the primary health risks of interest; improvements in other health risk behaviors were secondary outcomes. A sample of 3391 individuals who reported health risk in the areas of exercise and stress management were randomly assigned to 3 groups: telephonic coaching that applied Transtheoretical Model (TTM) tailoring for exercise and minimal tailoring (stage of change) for stress management; an Internet program that applied TTM tailoring for stress management and minimal tailoring for exercise; or a control group that received an assessment only. Participants were administered the Well-Being Assessment and, at baseline, had relatively low well-being scores (mean, 60.9 out of 100 across all groups). At 6 months, a significantly higher percentage of both treatment groups progressed to the Action stage for exercise, stress management, healthy diet, and total number of health risks, compared to the control group. Both treatment groups also demonstrated significantly greater improvements on overall well-being and the domains of emotional health, physical health, life evaluation, and healthy behaviors. There were no differences between the groups for 2 well-being domains: basic access to needs and work environment. These results indicate that scalable, tailored behavior change programs can effectively reduce health risk and accrue to improved well-being for participants. (Population Health Management 2012;15:276-286).     

Feasibility and acceptability of a Mediterranean-style diet intervention to reduce cardiovascular risk for low income Hispanic American women

Objective: Evidence for the cardioprotective effects of a Mediterranean-style (Med-style) diet is strong, however few Med-style dietary interventions have been developed for and tested among Hispanic Americans (HAs), especially younger HAs of reproductive age whose dietary habits may strongly influence dietary intake for all family members.

Design: We adapted a previously tested and evidence-informed lifestyle intervention to reduce CVD risk and evaluated its feasibility, acceptability, and effects on self-reported lifestyle behaviors in this study enrolling low-income HA women attending a Title X family planning clinic in eastern North Carolina. The 3-month long intervention, given to all participants, promoted a Med-style dietary pattern with a focus on increasing consumption of foods commonly consumed by HA that have high quality dietary fats (polyunsaturated and monounsaturated fats primarily from plant sources and fish) and carbohydrates (fruits, vegetables, and whole grains). The intervention also recommended increasing physical activity and was given during 2 face-to-face counseling sessions and 2 telephone counseling sessions. Major outcomes were engagement with study activities and intervention acceptability; lifestyle behavior change at 3-month follow-up is also reported.

Results: Baseline characteristics (n?=?36) were: mean age 33 years, 35 (97%) without health insurance, 32 (89%) born in Mexico, and mean BMI 30?kg/m². Engagement was high among the 36 participants with 33 (92%) completing the intervention and follow-up measures. At follow-up, most participants thought the intervention was helpful (range: 85–100%) and acceptable (100% agreed ‘I would recommend the program to others’). The mean dietary fat quality score improved by 0.5 units (95% CI: 0.0–1.1) and the mean fruit-vegetable servings/day improved by 0.7/day (95% CI: 0.1–1.3).

Conclusion: Intervention engagement and acceptability were high and there was improvement in self-reported dietary behaviors. This type of Med-style dietary pattern intervention should be evaluated in randomized trials enrolling HAs at risk for CVD.     

Feasibility and acceptability of the multi-component P3-MumBubVax antenatal intervention to promote maternal and childhood vaccination: A pilot study

BackgroundPregnancy is a critical time for vaccine decision-making, but coverage remains suboptimal for maternal influenza (45–60%) and pertussis vaccination (65–80%) in Australia. The multi-component P3-MumBubVax intervention has been designed for Australian midwives to optimise antenatal vaccine discussions and improve maternal and childhood vaccine uptake. A pilot study was conducted to assess intervention feasibility and acceptability.MethodsP3-MumBubVax includes components at three levels: 1. Practice ('vaccine champions'; stickers to prompt and record vaccine discussions/delivery); 2. Provider (website with vaccine communication training; learning exercise; fact sheets; links to child vaccination resources); 3. Parent (SMS reminders; website; fact sheets). Midwives and pregnant women 18–22 weeks gestation were recruited at the Royal Women's Hospital, Melbourne. Post-intervention online surveys assessed intervention feasibility, implementation, acceptability and impact on vaccine uptake.ResultsTwenty-five midwives and 62 pregnant women were recruited and 19/25 midwives completed training. Surveys were returned by 18/25 midwives and 56/62 women. 14/18 midwives reported using the sticker prompts, 10/18 reported using or referring to the website, and 11/18 reported using the fact sheets. 48/56 pregnant women (86%) reported discussing influenza and 46/56 (82%) discussed pertussis vaccines with their midwives. These conversations were reported to be short (1–3 min) for 48/56 women (87%).All midwives were satisfied with the intervention and 17/18 reported feeling more confident discussing vaccines following the intervention. Women were very satisfied with SMS content (50/56; 94%) and timing (49/55; 89%), and with their vaccine discussions in general (34/56; 63%). However, 16/54 (30%) wanted more discussion about childhood vaccines. Self-reported maternal vaccine uptake was 82% (45/55) and 93% (51/55) for influenza and pertussis (baseline 2017–2018: 43% influenza, 60% pertussis) and 96% (50/52) of infants were fully vaccinated at 12 weeks.DiscussionThe P3-MumBubVax intervention is feasible and acceptable in the Australian public antenatal setting. Further evaluation is required to determine effectiveness.     

Relationship between baseline risk factors and coronary heart disease and total mortality in the multiple risk factor intervention trial

The relationship between selected baseline risk factors and subsequent coronary heart disease (CHD) death and total mortality among participants in the Multiple Risk Factor Intervention Trial (MRFIT) was studied in order to determine (a) whether the three risk factors used to identify high-risk men for the trial were associated with CHD death; (b) whether other risk factors measured at baseline, especially lipoprotein cholesterol levels, were associated with CHD and total mortality; and (c) whether there were any differences between special intervention (SI) and usual care (UC) participants in the relationship of the specific levels of risk factors to CHD or total mortality. The three main risk factors (blood cholesterol, cigarette smoking, and diastolic blood pressure) and age were significantly associated with CHD mortality; age, diastolic blood pressure, and cigarette smoking were associated with total mortality. The risk score based on the multiple logistic equation developed from the Framingham Study was also strongly associated with CHD mortality. When the joint associations of selected baseline risk factors with CHD and total mortality were considered, age, diastolic blood pressure, cigarette smoking, and low- and high-density lipoprotein cholesterol were significantly associated with CHD mortality; age, cigarette smoking, and low-density lipoprotein cholesterol were positively associated with total mortality. Systolic blood pressure significantly improved the prediction of CHD mortality for SI and UC men when it was added to a regression model that included age, diastolic blood pressure, cigarettes smoked per day, body mass index, and lipoprotein levels, but improved the prediction of total mortality only for SI men. In similar analyses, serum thiocyanate improved the prediction of both CHD and total mortality for UC men. Among SI men the improved prediction gained by considering serum thiocyanate was less pronounced and not significant for CHD death. This latter finding may be due in part to the changes made in smoking behavior by SI participants during the course of the study. The estimated regression coefficients for CHD and total mortality endpoints were not significantly different between the SI and UC groups.     

Virtual group-based walking intervention for persons with schizophrenia: A pilot randomized controlled trial

Persons with schizophrenia have reduced cardiorespiratory fitness (CRF), a predictor of all-cause mortality. Exercise is effective for improving CRF; however, motivational challenges affecting those with schizophrenia impact exercise engagement and maintenance. Virtual Physical Activity Can Enhance Life (Virtual PACE-Life), a multicomponent walking intervention guided by self-determination theory (SDT), was developed to target CRF in this population while addressing motivational difficulties. Virtual PACE-Life includes live video-delivered group walking sessions, Fitbit activity tracking, recommendations for home-based walking sessions, goal setting, and if-then plans. The present study was a 16-week pilot randomized controlled trial that evaluated the impact of Virtual PACE-Life against Fitbit Alone in a sample of 37 participants with schizophrenia on intermediate targets (competence, autonomy, and relatedness satisfaction, autonomous motivation), proximal outcomes (Fitbit-measured steps/day and minutes spent walking), and the primary outcome (CRF using the 6-min walk test). Blinded research staff completed assessments at baseline, midpoint, posttest, and one-month follow-up. Analysis of covariance and hierarchical linear regression analyses were used to evaluate group differences at each timepoint controlling for baseline. Attendance at Virtual PACE-Life groups was 58% and Fitbit adherence was above 70% in both conditions. Intent-to-treat results indicated greater competence and autonomy satisfaction for Virtual PACE-Life but not in relatedness satisfaction or autonomous motivation. There were no group differences in proximal or primary outcomes during the intervention period. Completer analyses showed improvements in steps/day and autonomous motivation favoring Virtual PACE-Life. Future research is needed to maximize the exercise and CRF benefits of virtual group-based exercise for persons with schizophrenia.     

The multiple risk factor intervention trial in the U.S. a summary of results at four years in special intervention and usual care men

Four-year results of the Multiple Risk Factor Intervention Trial indicate that an integrated approach to lifestyle modification of multiple risk factors is feasible and achieves significant lowering of risk factors compared with a group referred to usual medical care. The greatest changes and differences were in cigarette smoking. The hypertension treatment result met design predictions in the Special Intervention (SI) group. However, at 4 years the difference between groups was less than predicted, primarily due to unanticipated effectiveness of treatment of elevated pressures in the Usual Care (UC) group, reflecting recent secular changes in hypertension detection and control in the U.S. Similarly, the serum cholesterol net fall in the SI compared to UC group was 59% of goal, in part because of an unanticipated reduction in the UC group. The risk factor differences between groups were considerable, even though in some areas short of initial design expectations. The most serious consequence of a less than anticipated difference in risk characteristics between groups is an effective loss of power to detect significant differences in major disease endpoints. A further major benefit from the study has been the demonstration of the ability to have diverse scientific disciplines work effectively together in the long-term preventive management of healthy but high-risk men.     

Designing a pilot sequential multiple assignment randomized trial for developing an adaptive treatment strategy

There is growing interest in how best to adapt and readapt treatments to individuals to maximize clinical benefit. In response, adaptive treatment strategies (ATS), which operationalize adaptive, sequential clinical decision making, have been developed. From a patient's perspective an ATS is a sequence of treatments, each individualized to the patient's evolving health status. From a clinician's perspective, an ATS is a sequence of decision rules that input the patient's current health status and output the next recommended treatment. Sequential multiple assignment randomized trials (SMART) have been developed to address the sequencing questions that arise in the development of ATSs, but SMARTs are relatively new in clinical research. This article provides an introduction to ATSs and SMART designs. This article also discusses the design of SMART pilot studies to address feasibility concerns, and to prepare investigators for a full-scale SMART. We consider an example SMART for the development of an ATS in the treatment of pediatric generalized anxiety disorders. Using the example SMART, we identify and discuss design issues unique to SMARTs that are best addressed in an external pilot study prior to the full-scale SMART. We also address the question of how many participants are needed in a SMART pilot study. A properly executed pilot study can be used to effectively address concerns about acceptability and feasibility in preparation for (that is, prior to) executing a full-scale SMART.