A randomized controlled trial of facilitating information giving to patients with chronic medical conditions: effects on outcomes of care.

BACKGROUND: The purpose of this study was to assess the impact of an intervention to facilitate information giving to patients with chronic medical conditions on outcomes of care. METHODS: A consecutive sample of 276 eligible patients with chronic medical conditions at a family medicine clinic was randomized to control and experimental interventions. A total of 205 completed the study. Experimental group patients received copies of their medical record progress notes, and they completed question lists for physician review, while control group patients received health education sheets and completed suggestion lists for improving clinic care. Self-reported physical functioning, global health, and patient satisfaction and adherence were measured at enrollment and after the interventions. Visit lengths and patient response to medical record sharing after the interventions were also measured. RESULTS: After the intervention, experimental group patients reported 3.7% better overall physical functioning than did control patients (mean = 83.6, standard deviation [SD] = 17.6 vs mean = 79.9, SD = 25.3; P = .005 after adjusting for covariates). The experimental group was more satisfied with their physician's care (mean = 31.4, SD = 4.6 vs mean = 31.3, SD = 5.2; P = .045 after adjusting for covariates). They were also more interested in seeing their medical records than were control patients (mean = 12.0, SD = 2.8 vs mean = 11.2, SD = 2.8; P = .002 after adjusting for covariates). Experimental group patients also reported an 8.3% improvement in overall health status (postintervention mean = 3.0, SD = 1.1) compared with their pre-intervention health status (mean = 2.8, SD = 1.0; P =.001). Visit lengths for patients in the experimental group did not differ from those of the control group. CONCLUSIONS: A simple patient-centered intervention to facilitate information giving in the primary health care of patients with chronic medical conditions can improve self-reported health, physical functioning, and satisfaction with care.     

Who uses decision aids? Subgroup analyses from a randomized controlled effectiveness trial of two prostate cancer screening decision support interventions

OBJECTIVE: To examine who reported using unsolicited prostate cancer screening decision aids distributed as part of a randomized controlled trial, whether reported use varied by type of aid (video or pamphlet), and what affect reported use had on study outcomes. METHODS: A total of 1,152 men aged 50 and older from four medical facilities in the United States were randomly assigned to pamphlet, video or usual care (control). Materials were mailed 2 weeks prior to clinic appointments in general internal medicine. Outcomes were assessed by phone survey 1 week after appointments. Analyses examined the reported use of materials by study group, the association between patient characteristics and reported use, and the impact of reported use (adjusting for patient characteristics) on a 10-item knowledge index. RESULTS: Fifty-six percent of those randomized to receive the video and 50% of those randomized to receive the pamphlet reported using the materials. Reported use of the video was higher for patients who had greater than a high school education (OR 1.73), were married (OR 2.20), and reported no prior abnormal prostate cancer screening test results (OR 3.39). Reported use of the pamphlet did not vary by patient characteristics. In intent-to-treat analyses (ignoring reported use), individuals randomized to the video and pamphlet groups had significantly higher knowledge scores relative to the control group (7.44, 7.26 and 6.90 respectively). Adjusting for reported use modestly increased the estimated differences across treatment groups but did not substantially change conclusions about the relative effects of these aids on knowledge. CONCLUSIONS: Only half of men receiving unsolicited prostate cancer screening decision aids before a visit reported using the aids, and who reported using them varied by type of aid. Efforts to broadly implement decision aids may need to offer a variety of approaches, and incorporate creative strategies to enhance reaching all population subgroups.     

Assessing collaborative efforts of making care fit for each patient: A systematic review

Introduction

For too many people, their care plans are designed without fully accounting for who they are, the lives they live, what matters to them or what they aspire to achieve. We aimed to summarize instruments capable of measuring dimensions of patient–clinician collaboration to make care fit.

Methods

We systematically searched several databases (Medline, Embase, Cochrane, Scopus and Web of Science) from inception to September 2021 for studies using quantitative measures to assess, evaluate or rate the work of making care fit by any participant in real-life clinical encounters. Eligibility was assessed in duplicate. After extracting all items from relevant instruments, we coded them deductively on dimensions relevant to making care fit (as presented in a recent Making Care Fit Manifesto), and inductively on the main action described.

Results

We included 189 papers, mostly from North America (N = 83, 44%) and in the context of primary care (N = 54, 29%). Half of the papers (N = 88, 47%) were published in the last 5 years. We found 1243 relevant items to assess efforts of making care fit, included within 151 instruments. Most items related to the dimensions ‘Patient-clinician collaboration: content’ (N = 396, 32%) and ‘Patient-clinician collaboration: manner’ (N = 382, 31%) and the least related to ‘Ongoing and iterative process’ (N = 22, 2%) and in ‘Minimally disruptive of patient lives’ (N = 29, 2%). The items referred to 27 specific actions. Most items referred to ‘Informing’ (N = 308, 25%) and ‘Exploring’ (N = 93, 8%), the fewest items referred to ‘Following up’, ‘Comforting’ and ‘Praising’ (each N = 3, 0.2%).

Discussion

Measures of the work that patients and clinicians do together to make care fit focus heavily on the content of their collaborations, particularly on exchanging information. Other dimensions and actions previously identified as crucial to making care fit are assessed infrequently or not at all. The breadth of extant measures of making care fit and the lack of appropriate measures of this key construct limit both the assessment and the successful implementation of efforts to improve patient care.

Patient Contribution

Patients and caregivers from the ‘Making care fit Collaborative’ were involved in drafting the dimensions relevant to patient–clinician collaboration.     

Decision aids to prepare patients for shared decision making: Two randomized controlled experiments on the impact of awareness of preference‐sensitivity and personal motives

ObjectiveTo participate in shared decision making (SDM), patients need to understand their options and develop trust in their own decision‐making abilities. Two experiments investigated the potential of decision aids (DAs) in preparing patients for SDM by raising awareness of preference‐sensitivity (Study 1) and showing possible personal motives for decision making (Study 2) in addition to providing information about the treatment options.MethodsParticipants (Study 1: N = 117; Study 2: N = 217) were put into two scenarios (Study 1: cruciate ligament rupture; Study 2: contraception), watched a consultation video and were randomized into one of three groups where they received additional information in the form of (a) narrative patient testimonials; (b) non‐narrative decision strategies; and (c) an unrelated text (control group).ResultsParticipants who viewed the patient testimonials or decision strategies felt better prepared for a decision (Study 1: P < .001, ηP2 = 0.43; Study 2: P < .001, ηP2 = 0.57) and evaluated the decision‐making process more positively (Study 2: P < .001, ηP2 = 0.13) than participants in the control condition. Decision certainty (Study 1: P < .001, ηP2 = 0.05) and satisfaction (Study 1: P < .001, ηP2 = 0.11; Study 2: P = .003, d = 0.29) were higher across all conditions after watching the consultation video, and certainty and satisfaction were lower in the control condition (Study 2: P < .001, ηP2 = 0.05).DiscussionDecision aids that explain preference‐sensitivity and personal motives can be beneficial for improving people''s feelings of being prepared and their perception of the decision‐making process. To reach decision certainty and satisfaction, being well informed of one''s options is particularly relevant. We discuss the implications of our findings for future research and the design of DAs.     

Absolute cardiovascular disease risk and shared decision making in primary care: a randomized controlled trial

PURPOSE We wanted to determine the effect of promoting the effective communication of absolute cardiovascular disease (CVD) risk and shared decision making through disseminating a simple decision aid for use in family practice consultations.METHODS The study was based on a pragmatic, cluster randomized controlled trial (phase III) with continuing medical education (CME) groups of family physicians as the unit of randomization. In the intervention arm, 44 physicians (7 CME groups) consecutively recruited 550 patients in whom cholesterol levels were measured. Forty-seven physicians in the control arm (7 CME groups) similarly included 582 patients. Four hundred sixty patients (83.6%) of the intervention arm and 466 patients (80.1%) of the control arm were seen at follow-up. Physicians attended 2 interactive CME sessions and received a booklet, a paper-based risk calculator, and individual summary sheets for each patient. Control physicians attended 1 CME-session on an alternative topic. Main outcome measures were patient satisfaction and participation after the index consultation, change in CVD risk status, and decisional regret at 6 months’ follow-up.RESULTS Intervention patients were significantly more satisfied with process and result (Patient Participation Scale, difference 0.80, P<.001). Decisional regret was significantly lower at follow-up (difference 3.39, P = .02). CVD risk decreased in both groups without a significant difference between study arms.CONCLUSION A simple transactional decision aid based on calculating absolute individual CVD risk and promoting shared decision making in CVD prevention can be disseminated through CME groups and may lead to higher patient satisfaction and involvement and less decisional regret, without negatively affecting global CVD risk.     

The effect of a home-based walking program on risk factors for coronary heart disease in hypercholesterolaemic men. A randomized controlled trial

BACKGROUND: Hypercholesterolaemia and physical inactivity significantly contribute towards risk of coronary heart disease. Increased physical activity may be an effective way to improve lipid profiles in hypercholesterolaemic individuals. The aim of this study was to investigate whether a home-based physical activity program meeting current guidelines improved the lipid profile of hypercholesterolaemic men. METHODS: Sixty-seven hypercholesterolaemic men (55.1 (4.9) years), from Bristol England, recruited between 2002-2004, were randomized to either 12 weeks of brisk walking sufficient to expend at least 300 kcal each walk or control condition. Fasting lipids including total cholesterol (TC), high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C), triglycerides (TG), glucose, insulin, blood pressure and anthropometric characteristics were measured at baseline and follow-up. Compliance was monitored using accelerometers and activity logs. RESULTS: After controlling for baseline differences, TC/HDL-C was significantly lower in the intervention group at follow-up (-0.28, 95% CI: -0.52, -0.03, p=0.03). An increase in HDL-C (0.07 mmol/l: -0.01, 0.12, p=0.07) and reduction in TG (-0.30 mmol/l: -0.64, 0.03, p=0.07) in intervention participants were of borderline statistical significance. Weight significantly decreased in intervention participants (-1.40 kg: -2.43, -0.38, p<0.01). No other significant between group effects were found. Compliance to the walking program was 97.6%. CONCLUSIONS: Twelve weeks of moderate intensity walking was sufficient to improve TC/HDL-C in hypercholesterolaemic men, primarily through improvement in HDL-C.     

Effects of writing down the request for help: A randomized controlled trial

Background: Studies investigating interventions, aimed at improving patient satisfaction by exploring the patient's request for help, show conflicting results.

Objectives: To investigate whether writing down the request for help on a request card, prior to the consultation improves patient satisfaction.

Methods: This study was a single-blind randomized controlled trial, in which the patients were blinded to the intervention. Patients were recruited in two rural practices (five GPs) and one urban practice (four GPs) in The Netherlands. Consecutive patients with a new request for help were asked to participate. All patients received general information about patient satisfaction. After randomization, patients in the intervention group were asked to fill in a card with their request(s) for help; the general practitioners started the consultations with these questions. We used the ‘Professional Care’ subscale of the Consultation Satisfaction Questionnaire (CSQ) to examine the effect of the intervention on patient satisfaction. Secondary outcomes were patient satisfaction measured with the patient's VAS score, the GP's VAS score on satisfaction, consultation time, the other subscales of the CSQ, and the number of consultations during follow-up.

Results: There was no difference in patient satisfaction (CSQ, VAS) between both groups. We also did not find any differences between the other subscales of the CSQ.

Conclusion: A beneficial effect of the use of a ‘request card’ by the patient on patient satisfaction of the consultation could not be demonstrated.     

Antibody response to influenza immunization in coronary artery disease patients: A controlled trial

Safety of and humoral immune response to the anti-influenza vaccine in coronary artery disease (CAD) patients were evaluated. The trivalent vaccine was administered to 137 eligible CAD patients and 67 age- and sex-matched healthy individuals. Antibody (Ab) titers were measured before and 1 month after vaccination. CAD and HC groups were not significantly different in serologic response and magnitude of change in antibody titers against each of the vaccine antigens. In multivariate analyses, regular exercise and using multivitamin supplements were independently associated with better antibody response among CAD patients. There were no major cardiac or general adverse effects. Influenza vaccine was found safe in CAD patients and antibody responses were similar to HCs.     

The combined effects of participatory styles of elderly patients and their physicians on satisfaction

OBJECTIVES: To test whether concordance or discordance of patient participation between patients and physicians is associated with higher satisfaction, and to examine the effects of patients' and physicians' participatory styles on patients' satisfaction with their physicians. DATA: Data collected in the Texas Tech 5000 Survey of elderly patients in West Texas were used. Patient satisfaction with their physicians was measured by a single item from the Consumer Assessment of Health Plans (CAHPS), representing patients' ratings of their physicians. Patient participation was measured by an index derived from a three-item instrument and physicians' participatory decision-making (PDM) style was measured by a three-item instrument developed by the Medical Outcomes Study. METHODS: An ordered logit multivariate regression was used to investigate the effects of patients' and physicians' participatory styles on satisfaction with physicians. The interaction between patients' participation and physicians' participatory styles was also included to examine the dependency of the two variables. RESULTS: Controlling for confounding factors, a higher PDM score was associated with a higher rating of patient satisfaction with physicians. A higher patient participation score was related to a lower physician satisfaction rating. The combined effect of patients' and physicians' participation styles indicated that for a low patient participation score, a high PDM score was not needed to produce high satisfaction. The greater the discordance in this direction, the higher the satisfaction. However, with a high patient participation score, only an extremely high PDM score would produce relatively high satisfaction. CONCLUSIONS: The current study supports the discordance hypothesis. Participatory physicians and patient-physician communications concerning patient participation can promote higher satisfaction.     

Effects of secondary prevention clinics on health status in patients with coronary heart disease: 4 year follow-up of a randomized trial in primary care

BACKGROUND: The long-term effects of disease management programmes for coronary heart disease on health status are unknown. In a randomized trial of nurse-led secondary prevention clinics, we found significantly improved health status at 1 year. Participants were followed-up again at 4 years to determine if improvements had been sustained. OBJECTIVE: Our aim was to evaluate the effects on health of nurse-led clinics for the secondary prevention of coronary heart disease in primary care. METHODS: A total of 1343 patients with coronary heart disease were randomized to nurse-led secondary prevention clinics or usual care, with follow-up at 1 and 4 years by review of medical case notes and national data sets, and postal questionnaires. The study involved a stratified, random sample of 19 general practices in north-east Scotland. Health status was measured by the SF-36 questionnaire, chest pain by the angina TyPE specification and anxiety and depression by the hospital anxiety and depression scale. RESULTS: At 1 year, there were significant improvements in five of eight SF-36 domains (all functioning scales, pain and general health) in patients randomized to clinics. Role limitations attributed to physical problems improved the most [adjusted difference 8.52, 95% confidence interval (CI) 4.16-12.9]. At 4 years, the intervention group scored higher than control in all domains, but differences were no longer significant. At 1 year, fewer patients in the intervention group reported worsening chest pain (odds ratio 0.59, 95% C1 0.37-0.94). At 4 years, there were no significant differences between the proportion of intervention or control group patients who reported chest pain in the last week or who reported worsening chest pain. No significant effects were observed on anxiety or depression at 1 or 4 years. CONCLUSION: We have demonstrated previously a significantly greater survival in attendees at nurse-led secondary prevention clinics. Despite this, improvements in health status achieved in the first year of the study were reduced at 4 years. The case for nurse-led clinics remains strong, but further research is required on ways to optimize current health status.     

Development and evaluation of a decision aid for patients with stage IV non‐small cell lung cancer

Although guidelines for treating stage IV non‐small cell lung cancer suggest that the patient’s values should be considered in decision‐making, there are no practical tools available to assist them with their decision‐making.

Objective

To develop and evaluate a decision aid that incorporates patient values.

Design and sample

(1) Before/after evaluation with patients referred to a regional cancer centre. (2) Mailed survey of thoracic surgeons and respirologists in Ontario.

Intervention

An audio‐tape guided individuals to review a booklet describing stage IV non‐small cell lung cancer, its impact and possible coping strategies, treatment options, benefits and risks, and examples of the decision‐making of others. Patients then used a worksheet to consider and communicate personal issues involved in the choice, including: personal values using a ‘weigh‐scale’; questions; preferred role in decision‐making; and predisposition.

Measures

(1) Patient questionnaires eliciting knowledge, the decision, decisional conflict and acceptability of the decision aid. (2) Physician questionnaires eliciting attitudes toward the decision aid.

Results

(1) Twenty of 30 patients used the aid in decision‐making. Users thought that the aid was acceptable and significantly improved their knowledge about options and outcomes (P < 0.001), and reduced their decisional conflict (P < 0.001). (2) The majority of the 29 physicians who reviewed the decision aid found it acceptable, were comfortable providing it to patients and said that they were likely to use it.

Conclusion

The decision aid is a useful and acceptable adjunct to personal counselling.

     

Impact of patient information booklet on treatment decision – a randomized trial among women with heavy menstruation

Objective  Does a patient information booklet influence treatment for menorrhagia? Design  Randomized trial and a pre‐trial prospective cohort study. Setting  Gynaecology outpatient clinics in 14 Finnish hospitals. Participants  A total of 363 (randomized trial) plus 206 (cohort study) patients with menorrhagia. Intervention  An information booklet about menorrhagia and treatment options, mailed before the first visit to the outpatient clinic. Main outcome measures  Distribution of treatment modalities, knowledge about treatment options, satisfaction with communication with personnel and anxiety. Results  Treatment decision within 3 months was made more often in the intervention group than in the control group (96% and 89% respectively, P = 0.02). Oral medication was more frequently chosen, and newly introduced treatments (minor surgery, hormonal intrauterine system) were less frequently used in the intervention group (at 3‐month follow‐up 21% and 29%, respectively). The differences persisted at the 12‐month follow‐up. In the pre‐trial group, new treatment methods were less frequently chosen and used than in the control group. Additional information did not increase the number of surgical procedures used, improve knowledge, or influence satisfaction or anxiety. Conclusion  Additional information led to an increase in specific treatment decisions and changed the distribution of used treatments without increasing the number of surgical procedures. The study suggests that well‐informed women adopting an active role may counteract physicians’ emphasis on newly introduced treatments.     

Six and 12 months' effects of individual joint protection education in people with rheumatoid arthritis: A randomized controlled trial

Abstract

Backgiround: Joint protection (JP) education for people with rheumatoid arthritis (RA) is effective when applying psycho-educational teaching strategies. The Pictorial Representation of Illness and Self Measure (PRISM) was used to identify relevant JP education goals and life aspects, both supporting motivation and behaviour change. The objective of this study was to compare the effects of individual JP education, PRISM-based (PRISM-JP) vs. conventional (C-JP), in people with rheumatoid arthritis (RA). Methods: An assessor-blinded randomized controlled trial was conducted in four rheumatology centres. Patients were randomized to PRISM-JP or C-JP, consisting of five JP education sessions over three months. Primary outcome was JP behaviour at six and 12 months. Results: A total of 53 RA patients participated. The PRISM-JP group (n = 26) demonstrated significantly more JP behaviour at six months (effect size ES = 0.32; p = 0.02) and 12 months (ES = 0.28; p = 0.04) than the C-JP (n = 27). Within-group analysis showed that the JP intervention was successful at six and 12 months in both groups (p < 0.001). At 12 months the PRISM-JP group had better JP self-efficacy (p = 0.02) and grip strength (p = 0.04) compared with baseline. Conclusion: PRISM-JP was more effective than C-JP in terms of long-term JP behaviour at six and 12 months.