Evaluating a two-step approach to sexual risk reduction in a publicly-funded STI clinic: rationale, design, and baseline data from the Health Improvement Project-Rochester (HIP-R)

BackgroundSexually transmitted infection (STI) clinics provide an opportune setting for HIV prevention efforts. This randomized controlled trial evaluated a unique, two-step approach to sexual risk reduction at a publicly-funded STI clinic.MethodsDuring an initial visit, patients completed an audio-computer assisted self-interview (ACASI), were randomized to and received one of two brief interventions, obtained medical care, and completed a post-assessment. Next, two-thirds of the patients were assigned to attend an intensive sexual risk reduction workshop. At 3, 6, and 12 months, patients completed additional ACASIs and provided urine specimens to assess behavior change and incident STIs.ResultsDuring a 28-month interval, 5613 patients were screened, 2691 were eligible, and 1483 consented to participate and were randomized; the modal reason for declining was lack of time (82%). Consenting patients included 688 women and 795 men; 64% of participants were African-American. The sample was low-income, with 57% reporting an annual income of less than $15,000; most participants (62%) had a high school education or less, and 51% were unemployed. Sexual risk behavior was common, as indicated by multiple sexual partners (mean = 32.8, lifetime; mean = 2.8, past 3 months), unprotected sex (mean = 17.3 episodes, past 3 months), and prior STIs (mean = 3.3, lifetime; 23% at baseline). Bivariate analyses confirmed our prediction that HIV-related motivation and behavioral skills would be related to current sexual risk behavior. All patients received a brief intervention; patient satisfaction ratings were uniformly high for both interventions (all means ≥ 3.7 on 4-point scales). Fifty-six percent of invited patients attended the intensive workshop, and attendance did not differ as a function of brief intervention. Patient satisfaction ratings were also uniformly positive for the workshop interventions (all means ≥ 3.6). Return to follow-up assessments exceeded 70%.ConclusionsResults demonstrate that implementing an HIV preventive program in a busy, public clinic is feasible and well-accepted by patients. Ongoing evaluation will determine if the interventions reduce sexual risk behavior and lower incident STIs.     

Mindfulness-based stress reduction for HIV treatment side effects: a randomized, wait-list controlled trial

ContextAdvances in antiretroviral therapy (ART) for HIV offer life-extending benefit; however, the side effects associated with ART use negatively impact quality of life and medication adherence among people living with HIV.ObjectivesThis study tested the efficacy of Mindfulness-Based Stress Reduction (MBSR) for reducing ART symptoms and bother/distress related to ART side effects. Secondary aims were to test the impact of MBSR on medication adherence and psychological functioning.MethodsSeventy-six people living with HIV who were actively taking ART and reported distress from ART-related side effects were randomly assigned to an MBSR program or a wait-list control (WLC) standard care condition. We measured side effects, ART adherence, perceived stress, depression, positive and negative affect, and mindfulness at three time points: baseline, three-month follow-up, and six-month follow-up. Side effects and related distress were assessed separately from other symptoms.ResultsCompared with a WLC, participants in the MBSR condition experienced a reduction in the frequency of symptoms attributable to ARTs at three months post-intervention (mean difference = 0.33; 95% confidence interval [CI] = 0.01, 0.66; t(132) = 2.04, P = 0.044) and six months post-intervention (mean difference = 0.38; 95% CI = 0.05, 0.71; t(132) = 2.27, P = 0.025). MBSR participants also experienced a reduction in distress associated with those symptoms at three months post-intervention (mean difference = 0.47; 95% CI = 0.003, 0.94; t(132) = 1.99, P = 0.048) compared with the WLC condition.ConclusionMBSR is a promising approach for reducing HIV treatment-related side effects.     

Comparison of a theory-based (AIDS Risk Reduction Model) cognitive behavioral intervention versus enhanced counseling for abused ethnic minority adolescent women on infection with sexually transmitted infection: results of a randomized controlled trial

BackgroundEthnic minority adolescent women with a history of sexual or physical abuse and sexually transmitted infections represent a vulnerable population at risk for HIV. Community-based interventions for behavior modification and subsequent risk reduction have not been effective among these women.ObjectivesTo evaluate the effects of a theory-based (AIDS Risk Reduction Model) cognitive behavioral intervention model versus enhanced counseling for abused ethnic minority adolescent women on infection with sexually transmitted infection at 6 and 12 months follow-up.DesignControlled randomized trial with longitudinal follow-up.SettingsSouthwestern United States, Metropolitan community-based clinic.ParticipantsMexican-and-African American adolescent women aged 14–18 years with a history of abuse or sexually transmitted infection seeking sexual health care.MethodsExtensive preliminary study for intervention development was conducted including individual interviews, focus groups, secondary data analysis, pre-testing and feasibility testing for modification of an evidence-based intervention prior to testing in the randomized controlled trial. Following informed consents for participation in the trial, detailed interviews concerning demographics, abuse history, sexual risk behavior, sexual health and physical exams were obtained. Randomization into either control or intervention groups was conducted. Intervention participants received workshop, support group and individual counseling sessions. Control participants received abuse and enhanced clinical counseling. Follow-up including detailed interview and physical exam was conducted at 6 and 12 months following study entry to assess for infection. Intention to treat analysis was conducted to assess intervention effects using chi-square and multiple regression models.Results409 Mexican-(n = 342) and African-(n = 67) American adolescent women with abuse and sexually transmitted infection histories were enrolled; 90% intervention group attendance; longitudinal follow-up at 6 (93%) and 12 (94%) months. Intervention (n = 199) versus control (n = 210) group participants experienced fewer infections at 0–6 (0% versus 6.6%, p = .001), 6–12 (3.6% versus 7.8%, p = .005, CI 95% lower-upper .001–.386) and 0–12 (4.8% versus 13.2%, p = .002, CI 95% lower-upper, .002–.531) month intervals.ConclusionsA cognitive behavioral intervention specifically designed for ethnic minority adolescent women with a history of abuse and sexually transmitted infection was effective for prevention of infection. These results provide evidence for development of evidence-based interventions for sexually transmitted infection/HIV. Implications include translation to community-clinic-based settings for prevention of adverse outcomes regarding sexual health of adolescent women.     

Design and rationale for Home Blood Pressure Telemonitoring and Case Management to Control Hypertension (HyperLink): a cluster randomized trial

BackgroundPatients with high blood pressure (BP) visit a physician an average of 4 times or more per year in the U.S., yet BP is controlled in fewer than half. Practical, robust and sustainable models are needed to improve BP in patients with uncontrolled hypertension.ObjectivesThe Home Blood Pressure Telemonitoring and Case Management to Control Hypertension study (HyperLink) is a cluster-randomized trial designed to determine whether an intervention that combines home BP telemonitoring with pharmacist case management improves BP control compared to usual care at 6 and 12 months in patients with uncontrolled hypertension. Secondary outcomes are maintenance of BP control at 18 months, patient satisfaction with their health care, and costs of care.MethodsHyperLink enrolled 450 hypertensive patients with uncontrolled BP from 16 primary care clinics. Eight clinics were randomized to provide usual care (UC) to their patients (n = 222) and 8 were randomized to provide the telemonitoring intervention (TI) (n = 228). TI patients received home BP telemonitors that internally store and electronically transmit BP data to a secure database. Pharmacist case managers adjust antihypertensive therapy based on the home BP data under a collaborative practice agreement with the clinics' primary care teams. The length of the intervention is 12 months, with follow-up to 18 months to determine the durability of the intervention.ConclusionsWe will test in a real primary care setting whether combining BP telemonitoring and pharmacist case management can achieve and maintain high rates of BP control compared to usual care.     

Design and rationale of a randomized controlled trial to reduce cardiovascular disease risk for patients with bipolar disorder

BackgroundPersons with bipolar disorder (BD) experience a disproportionate burden of medical comorbidity, notably cardiovascular disease (CVD), contributing to decreased function and premature mortality. We describe the design, rationale, and baseline findings for the Self-Management Addressing Heart Risk Trial (SMAHRT), a randomized controlled effectiveness trial of an intervention (Life Goals Collaborative Care; LGCC) designed to reduce CVD risk factors and improve physical and mental health outcomes in patients with BD.MethodsPatients with BD and at least one CVD risk factor were recruited from a VA healthcare system and randomized to either LGCC or usual care (UC). LGCC participants attended four weekly, group-based self-management sessions followed by monthly individual contacts supportive of health behavior change and ongoing medical care management. In contrast, UC participants received monthly wellness newsletters. Physiological and questionnaire assessments measured changes in CVD outcomes and quality of life (QOL) over 24 months.ResultsOut of the 180 eligible patients, 134 patients were enrolled (74%) and 118 started the study protocols. At baseline (mean age = 54, 17% female, 5% African American) participants had a high burden of clinical risk with nearly 70% reporting at least three CVD risk factors including, smoking (41%) and physical inactivity (57%). Mean mental and physical HRQOL scores were 1.5 SD below SF-12 population averages.ConclusionSMAHRT participants experienced substantial CVD morbidity and risk factors, poor symptom control, and decreased QOL. LGCC is the first integrated intervention for BD designed to mitigate suboptimal health outcomes by combining behavioral medicine and care management strategies.     

Serum albumin is a useful prognostic indicator and adds important information to NT-proBNP in a Chinese cohort of heart failure

ObjectiveTo evaluate the effect of serum albumin on prognosis and the power of albumin adding information to NT-proBNP in a Chinese cohort of heart failure.Design and methods385 consecutive patients (male vs. female: 292 vs. 93; mean age: 54.89 ± 14.41 years; NYHA classes II–V) admitted for heart failure exacerbation with LVEF ≤ 45% were enrolled, and biochemical data was measured at baseline. The endpoint was defined as cardiac death or rehospitalization for aggravated heart failure. Follow-up period was 25 ± 7 months.ResultsMultivariate analysis in a Cox proportional hazard model revealed serum albumin was an independent predictor for adverse prognosis (HR 0.96,CI 0.94–0.99, P = 0.02), and the patients with higher NT-proBNP and lower albumin than median had the highest risk for cardiac events (HR 2.89, CI 1.90–4.40, P < 0.01).ConclusionSerum albumin is a significant prognosis indicator for heart failure and it adds important information to NT-proBNP.     

Nitric oxide levels in HIV-infected,untreated patients and HIV-infected patients receiving antiretroviral therapy

The role of nitric oxide (NO) in HIV infection is ambiguous; controversy exists around whether the levels of serum NO are increased or decreased in HIV-infected patients. Thus, it is necessary to reassess NO levels in HIV-infected patients. The aim of this study was to investigate the nitrite/nitrate metabolite (NOx) levels in HIV-infected untreated patients and in HIV-infected patients receiving highly active antiretroviral therapy (HAART), compared with HIV-uninfected individuals (control group). The HIV-infected patients enrolled in this study had been receiving HAART for at least 6 months (HIV-treated) or had not received HAART for at least 6 months (HIV-untreated group). New recommendations encourage initiating treatment in HIV-infected adults at a CD4 cell count of 500 cells/mm³ or less. We also investigated whether levels of NOx were associated with immunophenotypic characteristic of HIV-infected patients. Our results showed a statistically significant increase in NOx levels in the HIV-untreated group (164.0 ± 166.6 μmol/L), compared with both the control (98.9 ± 59.4 μmol/L) and HIV-treated group (71.7 ± 53.3 μmol/L). Multiple regression analysis showed that the differences in NOx level were independent of gender, liver enzyme level, lipid measurement, and hematological parameters. In addition, a lower CD4/CD8 ratio was associated with higher NOx levels in HIV-infected patients. The results further revealed that NOx levels were increased in HIV infection, and that derangement of immune system function was associated with increased NO levels. The levels of NOx were found to decline with the use of HAART, which may contribute to cardiovascular disease in HIV-infected patients.     

A collaborative approach to the recruitment and retention of minority patients with diabetes in rural community health centers

ContextRecruiting and retaining minorities from rural, community health centers is a challenge. Collaboration between the researchers and health center personnel and activities to enhance trust may improve results.PurposeTo describe recruitment and retention strategies and report results of a 12-month clinical trial of a telemedicine-based diabetes self-management intervention, conducted within a rural community health center.MethodsMulti-level, multi-staged recruitment process including collaborative planning, data extraction, medical record review, telephone screen, 2 in-person enrollment visits and randomization. Target sample was adults ≥ 35 years of age with type 2 diabetes, glycated hemoglobin (GHb) > 7% with no significant comorbidities to prevent safe participation. Follow-up visits occurred at 6 and 12 months post-randomization.FindingsOf those eligible from medical record review, 65% were African-American(AA)/other and female. Approximately 33% of those successfully contacted by telephone were randomized (n = 165), yielding a predominately AA/other (73.9%) and female (74.5%) sample. Among those eligible at the Telephone Screen, a greater percentage of Non-Hispanic Whites (NHW) refused participation than AA/other (54.2% vs 45.8%), while a greater percentage of women refused compared to men (64.4% vs 35.6%). Significant baseline differences were found by ethnicity for education, insurance, transportation and diastolic blood pressure; by gender for income, transportation, weight, and home monitoring of blood glucose. Overall 6 and 12 month retention rates were 90.9% and 82.4%, respectively, with a greater percentage of AA/Other and female participants retained.ConclusionsOur collaborative approach was successful in recruiting and retaining ethnically diverse study participants who reside in a rural underserved area of South Carolina. Differences in baseline characteristics and retention by ethnicity and gender were found. Successful translational research must allow for a collaborative approach addressing factors at the level of the community health center, key personnel, and patients in an effort to build trust for the purpose of advancing the science of translating research to practice.     

Safety-promoting behaviors of community-dwelling abused Chinese women after an advocacy intervention: a randomized controlled trial

ObjectiveTo examine the effect of an advocacy intervention on the use of safety-promoting behaviors in community-dwelling abused Chinese women as compared to a control condition of usual care.DesignThis efficacy trial used a randomized controlled, parallel group design.Participants and methodsA total of 200 Chinese women in a community setting who screened positive for intimate partner violence using the Chinese version of the Abuse Assessment Screen were randomized to receive either an advocacy intervention (intervention group, n = 100) or usual community care (control group, n = 100). The outcome measured was the change in the self-reported safety-promoting behaviors as measured by the Safety-promoting Behavior Checklist over three time-points (baseline, 3-month follow-up and 9-month follow-up). Participants and assessors were blinded to the study hypothesis. Assessors were further blinded to the group membership of the participants.ResultsThe Safety-promoting Behavior Checklist scores in the intervention group increased from the baseline on average by 5.65 (95% confidence interval [CI], 4.92–6.39) at 3-month and 6.65 (95% CI, 5.90–7.39) at 9-month follow-ups, while the scores in the control group also increased by 1.71 (95% CI, 1.06–2.37) at 3-month and 1.79 (95% CI, 1.15–2.43) at 9-month follow-ups. After adjusting for baseline differences, the between-group differences in scores were significant at 3-month and 9-month follow-ups (p = 0.04). The intervention group increased the scores by 3.61 (95% CI, 2.61–4.61, p < 0.001) more than the control group at 3-month and by 4.53 (95% CI, 3.53–5.53, p < 0.001) at 9-month follow-ups.ConclusionAn advocacy intervention is efficacious in increasing the use of safety-promoting behaviors as compared to usual community care in community-dwelling abused Chinese women.     

Effects of motivational interviewing intervention on self-management, psychological and glycemic outcomes in type 2 diabetes: a randomized controlled trial

BackgroundType 2 diabetes is a serious and growing problem in Taiwan where it is the fifth leading cause of death, and health care costs are 4.3 times higher than for people without diabetes.ObjectivesThe purpose of this study was to determine whether participation in a motivational interview for people with type 2 diabetes would improve their self-management, psychological and glycemic outcomes.DesignA randomized controlled trial to assess the effects of the motivational interviewing intervention.SettingsParticipants were drawn from the diabetes outpatient clinic of a large teaching hospital in South Taiwan.ParticipantsA sample of 250 type 2 diabetes people.MethodsType 2 diabetes people were randomly allocated into either the motivational interview group or the usual care group from baseline to 3 months follow-up. The intervention was based on motivational interviewing which encompassed a variety of interviewing techniques, and reflected each person's readiness stage to change. The control group was provided with usual care by nursing staff.ResultsA total of 250 type 2 diabetic participants were randomized. The retention rate in the intervention group was 83% (n = 104). The motivational interview did improve participants significantly in self-management, self-efficacy, quality of life, and HbA1c among diabetes people with appropriate baseline value (<121.24, <174.57, <107.18, and >7.62, respectively) but not in depression, anxiety and stress (F = 0.13, p = 0.72) compared to the control group at 3 months follow-up.ConclusionThe findings provided important evidence concerning the positive effect of motivational interventions in self-management, psychological and glycemic outcomes. This research provided evidence for future clinical practices in diabetes care.     

A randomized controlled trial of the efficacy and cost-effectiveness of a brief intensified cognitive behavioral therapy and/or pharmacotherapy for mood and anxiety disorders: design and methods

BackgroundAnxiety and mood disorders involve a high disease burden and are associated with high economic costs. A stepped-care approach intervention and abbreviated diagnostic method are assumed to increase effectiveness and efficiency of the mental healthcare and are expected to reduce economic costs.MethodsPresented are the rationale, design, and methods of a two-armed randomized controlled trial comparing ‘treatment as usual’ (TAU) with a brief intensified cognitive behavioral therapy (CBT) and/or pharmacotherapy. Eligible participants (N = 500) of five Dutch outpatient Mental Healthcare Centers are randomly assigned to either TAU or to the experimental condition (brief CBT and/or pharmacotherapy). Data on patients' progress and clinical effectiveness of treatment are assessed at baseline, post-treatment (3 months after baseline), and at 6 and 12 months post-treatment by Routine Outcome Monitoring (ROM). Cost analysis is performed on the obtained data.DiscussionSince few studies have investigated both the clinical and cost effectiveness of a stepped-care approach intervention and a shortened diagnostic ROM method in both anxiety and/or mood disorders within secondary mental health care, the results of this study might contribute to the improvement of (cost)-effective treatment options and diagnostic methods for these disorders.     

Cognitive behavioural therapy as an adjunct to pharmacotherapy for treatment resistant depression in primary care: the CoBalT randomised controlled trial protocol

BackgroundAntidepressants are often the first-line treatment for depression but only one third of patients respond fully to pharmacotherapy. This paper describes the protocol for a randomised controlled trial (RCT) designed to evaluate the clinical and cost effectiveness of cognitive behavioural therapy (CBT) as an adjunct to pharmacotherapy for patients with treatment resistant depression in primary care.Methods/designCoBalT is a two parallel group multi-centre pragmatic RCT. Eligible participants were those who: (i) were aged 18–75 years; (ii) were currently taking antidepressant medication (for at least 6 weeks at an adequate dose); (iii) scored ≥ 14 on the Beck Depression Inventory (BDI-II); (iv) had adhered to their medication; and (v) met ICD-10 criteria for depression (assessed using the Clinical Interview Schedule — revised version). Those who gave written informed consent were randomised to one of two treatment groups: usual care or usual care plus CBT. The primary outcome is depressive symptoms assessed using the BDI-II at 6 months post-randomisation. Secondary outcomes measured at 6 and 12 months include quality of life, antidepressant use and health care utilisation. Outcomes will be analysed on an intention-to-treat basis.DiscussionThe CoBalT trial will provide evidence on the clinical and cost effectiveness of CBT as an adjunct to antidepressant medication in the treatment of depression that has not responded to pharmacotherapy. Given the move to widen access to ‘talking therapies’, the results of this study will be timely.     

Usefulness of a run-in period to reduce drop-outs in a randomized controlled trial of a behavioral intervention

ObjectivesWe evaluated the usefulness of a simple run-in period to reduce drop-outs in a behavioral intervention to improve blood pressure (BP). In a pilot study where a run-in period was not used, we had a 25% drop-out rate.MethodsA prospective evaluation was performed in the context of a blinded 3-arm randomized trial. Participants are eligible if they have uncontrolled BP on 2 consecutive visits. Potential participants are approached during a routine visit, informed, consented and enrolled. After a 1-month run-in period during which all participants receive a phone call to: i) verify phone availability, ii) get basic information on treatment, and iii) confirm the baseline visit, participants return for a baseline visit. They are then randomized to one of the three treatment arms: usual care, non-tailored counseling, or tailored counseling. Participants make return visits at 3, 6 and 12 months.ResultsOf the 1275 potential participants who received detailed study information, 301 consented to participate, of whom 226 were enrolled. During the run-in period, 73 withdrew consent and 153 participants were randomized; 7 subsequently dropped out. There were no differences (p > .1) between the 73 cancelled and the 153 randomized patients. There were fewer drop-outs than in the pilot study (5% vs. 25%, p < .0001).ConclusionsThe run-in period reduces the number of drop-outs after randomization and improves statistical power. In order to retain external validity, it is important to compare participants who remain in the study and those that cancel, and incorporate that in generalizing from the study.     

Quality of life 2 years after coronary revascularization

ObjectiveTo determine the impact of coronary revascularization surgery on patients’ quality of life and to identify the presence of lifestyles representing a risk for coronary heart disease.MethodWe performed a longitudinal prospective study of 150 consecutive patients who underwent coronary surgery over a 6-month period. Perceived quality of life was evaluated before the intervention, at 6 months (n = 132) and 2 years later (n = 119). As measurement instruments, the MOS Health Survey (SF-36), the Nottingham Health Profile (NHP) and a questionnaire to identify lifestyles were used.ResultsMost of the patients (95.8%) were men and were aged more than 50 years old (80.7%). Before surgery, significant physical limitations were present in 39.5%, comorbidity in 79%, prior infarction in 8.7% and three-vessel disease in 68%. The mean length of hospital stay was ≤ days in 88.2% of the patients. The health benefits were greater at 6 months after the intervention than at 2 years, with better perceived quality of life in all dimensions of the instruments used to assess quality of life (p< 0.001). Comorbidity, the number of risk factors and postoperative complications showed no influence on quality of life 6 months after surgery. Two years after the intervention, 33.6% of the patients resumed their professional activity and most adopted healthier lifestyles.ConclusionsCoronary revascularization substantially improves patients’ quality of life, providing health benefits 2 years after the intervention.     

Small Changes and Lasting Effects (SCALE) Trial: The Formation of a Weight Loss Behavioral Intervention Using EVOLVE

BackgroundObesity is a major health problem that disproportionately affects Black and Hispanic adults. This paper presents the rationale and innovative design of a small change eating and physical activity intervention (SC) combined with a positive affect and self-affirmation (PA/SA) intervention versus the SC intervention alone for weight loss.MethodsUsing a mixed methods translational model (EVOLVE), we designed and tested a SC approach intervention in overweight and/ or obese African American and Hispanic adults. In Phase I, we explored participant’s values and beliefs about the small change approach. In Phase II, we tested and refined the intervention and then, in Phase III we conducted a RCT. Participants were randomized to the SC approach with PA/SA intervention vs. a SC approach alone for 12 months. The primary outcome was clinically significant weight loss at 12 months.ResultsOver 4.5 years a total of 574 participants (67 in Phase I, 102 in Phase II and 405 in Phase III) were enrolled. Phase I findings were used to create a workbook based on real life experiences about weight loss and to refine the small change eating strategies. Phase II results shaped the recruitment and retention strategy for the RCT, as well as the final intervention. The RCT results are currently under analysis.ConclusionThe present study seeks to determine if a SC approach combined with a PA/SA intervention will result in greater weight loss at 12 months in Black and Hispanic adults compared to a SC approach alone.     

Design and methods of “diaBEAT-it!”: A hybrid preference/randomized control trial design using the RE-AIM framework

BackgroundDiabetes prevention is a public health priority that is dependent upon the reach, effectiveness, and cost of intervention strategies. However, understanding each of these outcomes within the context of randomized controlled trials is problematic.PurposeTo describe the methods and design of a hybrid preference/randomized control trial using the RE-AIM framework.MethodsThe trial, which was developed using the RE-AIM framework, will contrast the effects of 3 interventions: (1) a standard care, small group, diabetes prevention education class (SG), (2) the small group intervention plus 12 months of interactive voice response telephone follow-up (SG–IVR), and (3) a DVD version of the small group intervention with the same IVR follow-up (DVD–IVR). Each intervention includes personal action planning with a focus on key elements of the lifestyle intervention from the Diabetes Prevention Program (DPP). Adult patients at risk for diabetes will be randomly assigned to either choice or RCT. Those assigned to choice (n = 240) will have the opportunity to choose between SG–IVR and DVD–IVR. Those assigned to RCT group (n = 360) will be randomly assigned to SG, SG–IVR, or DVD–IRV. Assessment of primary (weight loss, reach, & cost) and secondary (physical activity, & dietary intake) outcomes will occur at baseline, 6, 12, and 18 months.ConclusionThis will be the first diabetes prevention trial that will allow the research team to determine the relationships between reach, effectiveness, and cost of different interventions.     

Evaluation of a primary care musculoskeletal clinical assessment service: a preliminary study

ObjectivesTo evaluate the clinical effectiveness of a primary care musculoskeletal clinical assessment service (MCAS). The MCAS is a triage and treatment service for the management of patients with musculoskeletal conditions.DesignProspective observational cohort study.ParticipantsConsecutive patients with musculoskeletal disorders referred to the MCAS from primary care over a 6-month period.InterventionsPatients were managed within the service in accordance with usual MCAS management/treatment pathways.Main outcome measuresPreviously validated self-administered questionnaires were selected as outcome measures in order to facilitate the use of postal responses. These comprised two generic health status questionnaires (Short Form 36, EuroQol EQ-5D), a pain assessment using a visual analogue scale and two measures of patient satisfaction (Perceived Improvement Evaluation, Deyo and Diehl satisfaction questionnaire). Outcome measures were taken at baseline, and 3 and 12 months after recruitment.ResultsIn total, 217 patients were recruited into the study. Significant improvement was demonstrated with EuroQol at 3 and 12 months (P = 0.043 and 0.035, respectively) and the pain visual analogue scale at 3 and 12 months (P = 0.001 and 0.002, respectively). No significant differences were demonstrated with Short Form 36 (P = 0.73 and 0.87). The mean patient-perceived improvement was 33% at 3 months and 46% at 12 months. Results showed high levels of patient satisfaction, with 72% of patients indicating total satisfaction with all aspects of the MCAS.ConclusionsNationally, models similar to the MCAS have been developed to help improve care for patients and achieve the 18-week access target. This preliminary study shows the possible benefits of adopting this model of care, and identifies the need for further research.