BACKGROUND: Depression is common in people with coronary heart disease (CHD) and associated with worse outcome. This study explored the acceptability and feasibility of procedures for a trial and for an intervention, including its potential costs, to inform a definitive randomized controlled trial (RCT) of a nurse-led personalised care intervention for primary care CHD patients with current chest pain and probable depression.
METHODS: Multi-centre, outcome assessor-blinded, randomized parallel group study. CHD patients reporting chest pain and scoring 8 or more on the HADS were randomized to personalized care (PC) or treatment as usual (TAU) for 6 months and followed for 1 year. Primary outcome was acceptability and feasibility of procedures; secondary outcomes included mood, chest pain, functional status, well being and psychological process variables.
RESULT: 1001 people from 17 General Practice CHD registers in South London consented to be contacted; out of 126 who were potentially eligible, 81 (35% female, mean age = 65 SD11 years) were randomized. PC participants (n = 41) identified wide ranging problems to work on with nurse-case managers. Good acceptability and feasibility was indicated by low attrition (9%), high engagement and minimal nurse time used (mean/SD = 78/19 mins assessment, 125/91 mins telephone follow up). Both groups improved on all outcomes. The largest between group difference was in the proportion no longer reporting chest pain (PC 37% vs TAU 18%; mixed effects model OR 2.21 95% CI 0.69, 7.03). Some evidence was seen that self efficacy (mean scale increase of 2.5 vs 0.9) and illness perceptions (mean scale increase of 7.8 vs 2.5) had improved in PC vs TAU participants at 1 year. PC appeared to be more cost effective up to a QALY threshold of approximately £3,000.
CONCLUSIONS: Trial and intervention procedures appeared to be feasible and acceptable. PC allowed patients to work on unaddressed problems and appears cheaper than TAU.
TRIAL REGISTRATION: Controlled-Trials.com ISRCTN21615909.
INTRODUCTION: The objective of this pilot 6-month randomized controlled trial was to determine the effectiveness of an intensive, community-based, group intervention that focused on diet, physical activity, and peer support for reducing weight among urban-dwelling African Americans with comorbid type 2 diabetes and hypertension. METHODS: Sixty-one participants were randomized into an intervention or control group. The 6-month intervention consisted of 18 group sessions led by a dietitian in a community setting and weekly telephone calls from a peer supporter. The intervention featured culturally tailored nutrition education, behavioral skills training, and social support focused on changes to diet and physical activity. The control group consisted of two 3-hour group sessions of diabetes self-management education taught by a community health worker. Outcome measures were assessed at baseline and 6 months. The primary outcome was achievement of a 5% weight reduction at 6 months. A secondary outcome was achievement of a 0.5 percentage-point reduction in hemoglobin A1c (HbA1c). RESULTS: Groups did not differ in achievement of the weight-loss goal. Intervention participants lost a mean of 2.8 kg (<i>P</i> = .01); control participants did not lose a significant amount of weight. A greater proportion of intervention (50.0%) than control (21.4%) participants reduced HbA1c by 0.5 percentage points or more at 6 months (<i>P</i> = .03). CONCLUSION: The intervention was more effective than usual care (short-term diabetes education) at improving glycemic control, but not weight, in low-income African Americans with comorbid diabetes and hypertension. A community-based 6-month group class with culturally tailored education, behavioral skills training, and peer support can lead to a clinically significant reduction in HbA1c. (PsycInfo Database Record (c) 2024 APA, all rights reserved)
Objectives: To determine the effectiveness of collaborative care in reducing depression in primary care patients with diabetes or heart disease using practice nurses as case managers. Design: A two-arm open randomised cluster trial with wait-list control for 6 months. The intervention was followed over 12 months. Setting: Eleven Australian general practices, five randomly allocated to the intervention and six to the control. Participants: 400 primary care patients (206 intervention, 194 control) with depression and type 2 diabetes, coronary heart disease or both. Intervention: The practice nurse acted as a case manager identifying depression, reviewing pathology results, lifestyle risk factors and patient goals and priorities. Usual care continued in the controls. Main outcome measure: A five-point reduction in depression scores for patients with moderate-to-severe depression. Secondary outcome was improvements in physiological measures. Results: Mean depression scores after 6 months of intervention for patients with moderate-to-severe depression decreased by 5.7±1.3 compared with 4.3±1.2 in control, a significant (p=0.012) difference. (The plus-minus is the 95% confidence range.) Intervention practices demonstrated adherence to treatment guidelines and intensification of treatment for depression, where exercise increased by 19%, referrals to exercise programmes by 16%, referrals to mental health workers (MHWs) by 7% and visits to MHWs by 17%. Control-practice exercise did not change, whereas referrals to exercise programmes dropped by 5% and visits to MHWs by 3%. Only referrals to MHW increased by 12%. Intervention improvements were sustained over 12 months, with a significant (p=0.015) decrease in 10-year cardiovascular disease risk from 27.4±3.4% to 24.8±3.8%. A review of patients indicated that the study's safety protocols were followed. Conclusions: TrueBlue participants showed significantly improved depression and treatment intensification, sustained over 12 months of intervention and reduced 10-year cardiovascular disease risk. Collaborative care using practice nurses appears to be an effective primary care intervention.
OBJECTIVE: To determine the effectiveness of an intervention to enhance self management support for patients with chronic conditions in UK primary care.
DESIGN: Pragmatic, two arm, cluster randomised controlled trial.
SETTING: General practices, serving a population in northwest England with high levels of deprivation.
PARTICIPANTS: 5599 patients with a diagnosis of diabetes (n=2546), chronic obstructive pulmonary disease (n=1634), and irritable bowel syndrome (n=1419) from 43 practices (19 intervention and 22 control practices).
INTERVENTION: Practice level training in a whole systems approach to self management support. Practices were trained to use a range of resources: a tool to assess the support needs of patients, guidebooks on self management, and a web based directory of local self management resources. Training facilitators were employed by the health management organisation.
MAIN OUTCOME MEASURES: Primary outcomes were shared decision making, self efficacy, and generic health related quality of life measured at 12 months. Secondary outcomes were general health, social or role limitations, energy and vitality, psychological wellbeing, self care activity, and enablement.
RESULTS: We randomised 44 practices and recruited 5599 patients, representing 43% of the eligible population on the practice lists. 4533 patients (81.0%) completed the six month follow-up and 4076 (72.8%) the 12 month follow-up. No statistically significant differences were found between patients attending trained practices and those attending control practices on any of the primary or secondary outcomes. All effect size estimates were well below the prespecified threshold of clinically important difference.
CONCLUSIONS: An intervention to enhance self management support in routine primary care did not add noticeable value to existing care for long term conditions. The active components required for effective self management support need to be better understood, both within primary care and in patients' everyday lives.
TRIAL REGISTRATION: Current Controlled Trials ISRCTN90940049.
CONTEXT: Patients with depression and poorly controlled diabetes mellitus, coronary heart disease (CHD), or both have higher medical complication rates and higher health care costs, suggesting that more effective care management of psychiatric and medical disease control might also reduce medical service use and enhance quality of life.
OBJECTIVE: To evaluate the cost-effectiveness of a multicondition collaborative treatment program (TEAMcare) compared with usual primary care (UC) in outpatients with depression and poorly controlled diabetes or CHD.
DESIGN: Randomized controlled trial of a systematic care management program aimed at improving depression scores and hemoglobin A(1c) (HbA(1c)), systolic blood pressure (SBP), and low-density lipoprotein cholesterol (LDL-C) levels.
SETTING: Fourteen primary care clinics of an integrated health care system.
PATIENTS: Population-based screening identified 214 adults with depressive disorder and poorly controlled diabetes or CHD.
INTERVENTION: Physician-supervised nurses collaborated with primary care physicians to provide treatment of multiple disease risk factors.
MAIN OUTCOME MEASURES: Blinded assessments evaluated depressive symptoms, SBP, and HbA(1c) at baseline and at 6, 12, 18, and 24 months. Fasting LDL-C concentration was assessed at baseline and at 12 and 24 months. Health plan accounting records were used to assess medical service costs. Quality-adjusted life-years (QALYs) were assessed using a previously developed regression model based on intervention vs UC differences in HbA(1c), LDL-C, and SBP levels over 24 months.
RESULTS: Over 24 months, compared with UC controls, intervention patients had a mean of 114 (95% CI, 79 to 149) additional depression-free days and an estimated 0.335 (95% CI, -0.18 to 0.85) additional QALYs. Intervention patients also had lower mean outpatient health costs of $594 per patient (95% CI, -$3241 to $2053) relative to UC patients.
CONCLUSIONS: For adults with depression and poorly controlled diabetes, CHD, or both, a systematic intervention program aimed at improving depression scores and HbA(1c), SBP, and LDL-C levels seemed to be a high-value program that for no or modest additional cost markedly improved QALYs.
TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00468676
BACKGROUND: Home telehealth programs often focus on a single disease, yet many patients who need monitoring have multiple conditions. This study evaluated secondary outcomes from a clinical trial evaluating the efficacy of home telehealth to improve outcomes of patients with co-morbid diabetes and hypertension.
SUBJECTS AND METHODS: A single-center randomized controlled clinical trial compared two remote monitoring intensity levels (low and high) and usual care in patients with type 2 diabetes and hypertension being treated in primary care. Secondary outcomes assessed were knowledge (diabetes, hypertension, medications), self-efficacy, adherence (diabetes, medications), and patient perceptions of the intervention mode.
RESULTS: Knowledge scores improved in the high-intensity intervention group participants, but upon further analysis, we found the intervention effect was not mediated by gain in knowledge. No significant differences were found across the groups in self-efficacy, adherence, or patient perceptions of the intervention mode.
CONCLUSIONS: Home telehealth can enhance detection of key clinical symptoms that occur between regular physician visits. While our intervention improved glycemic and blood pressure control, the mechanism of the effect for this improvement was not clear.
OBJECTIVE: This study tested the efficacy of a patient engagement intervention for older adults with multiple chronic illnesses. METHODS: Seventy-nine participants were randomly assigned to receive the intervention (Intervention Group), contacts on a different topic (Safety Group), or Usual Care. The Intervention and Safety Groups attended a 2-h workshop and participated in phone calls; one before and one after a naturally-occurring medical encounter. The Intervention Group discussed patient engagement concepts from publicly distributed content. The Safety Group discussed general safety (e.g., fire safety, identity theft). Self-report measures were gathered by telephone interview at Baseline and 6-months following Baseline. RESULTS: We did not find expected improvements in patient activation and health-related quality of life. However, the Intervention Group was the only group to show a statistically significant improvement in self-efficacy for self-management. CONCLUSION: The intervention shows promise for improving quality of life and/or health, but requires refinement to reach persons not already engaged in their healthcare and to strengthen its effects. PRACTICE IMPLICATIONS: Patient-directed skills training interventions may be a successful way to support clinicians' and others' efforts to encourage older patients to be actively involved in their care.
Objective: Guided Care (GC) is a model of proactive, evidence-based comprehensive healthcare provided by physician-nurse teams for people with several chronic health conditions. Our objective was to evaluate the preliminary effects of GC on health service utilization and costs. Study Design: Cluster-randomized controlled trial of GC involving 14 primary care teams (49 physicians) and 904 of their chronically ill patients age 65 years or older. Methods: Using insurance claims, we compared the health services used by patients who received GC with the health services used by patients who received usual care during the first 8 months of the study. Results: After adjustment for baseline characteristics, GC patients experienced, on average, 24% fewer hospital days (95% confidence interval [CI]: 49% fewer, 13% more), 37% fewer skilled nursing facility days (95% CI: 65% fewer, 5% more), 15% fewer emergency department visits (95% CI: 38% fewer, 18% more), and 29% fewer home healthcare episodes (95% CI: 53% fewer, 8% more), as well as 9% more specialist visits (95% CI: 8% fewer, 29% more). Based on current Medicare payment rates and GC costs, these differences in utilization represent an annual net savings of $75,000 (95% CI: -$244,000, $150,900) per nurse, or $1364 per patient. Conclusions: Initial introduction of GC into primary care practices may be associated with less use of expensive health services and a net savings in healthcare costs among older patients with several chronic health conditions. Final results from the remaining 2 years of this ongoing study will be published in 2011.
