Improving medication use in newly admitted home healthcare patients: a randomized controlled trial

OBJECTIVES: To test the efficacy of a medication use improvement program developed specifically for home health agencies. The program addressed four medication problems identified by an expert panel: unnecessary therapeutic duplication, cardiovascular medication problems, use of psychotropic drugs in patients with possible adverse psychomotor or adrenergic effects, and use of nonsteroidal antiinflammatory drugs (NSAIDs) in patients at high risk of peptic ulcer complications. It used a structured collaboration between a specially trained clinical pharmacist and the patients' home-care nurses to improve medication use. DESIGN: Parallel-group, randomized controlled trial. SETTING: Two of the largest home health agencies in the United States. PARTICIPANTS: Study subjects were consenting Medicare patients aged 65 and older admitted to participating agency offices from October 1996 through September 1998, with a projected home healthcare duration of at least 4 weeks and at least one study medication problem. INTERVENTION: Qualifying patients were randomized to usual care or usual care with the medication improvement program. MEASUREMENTS: Medication use was measured during an in-home interview, with container inspection at baseline and at follow-up (between 6 and 12 weeks) by interviewers unaware of treatment assignment. The trial endpoint was the proportion of patients with medication use improvement according to predefined criteria at follow-up. RESULTS: There were 259 randomized patients with completed follow-up interviews: 130 in the intervention group and 129 with usual care. Medication use improved for 50% of intervention patients and 38% of control patients, an attributable improvement of 12 patients per 100 (95% confidence interval (CI) = 0.0-24.0, P =.051). The intervention effect was greatest for therapeutic duplication, with improvement for 71% of intervention and 24% of control patients, an attributable improvement of 47 patients per 100 (95% CI = 20-74, P =.003). Use of cardiovascular medications also improved more frequently in intervention patients: 55% vs 18%, attributable improvement 37 patients per 100 (95% CI = 9-66, P =.017). There were no significant improvements for the psychotropic medication or NSAID problems. There was no evidence of adverse intervention effects: new medication problems, more agency nurse visits, or increased duration of home health care. CONCLUSIONS: A program congruent with existing personnel and practices of home health agencies improved medication use in a vulnerable population and was particularly effective in reducing therapeutic duplication.     

Benefits of telephone care over primary care for smoking cessation: a randomized trial

BACKGROUND: Brief clinician intervention and telephone counseling are both effective aids for smoking cessation. However, the potential benefit of telephone care above and beyond routine clinician intervention has not been examined previously. The objective of this study is to determine if telephone care increases smoking cessation compared with brief clinician intervention as part of routine health care. METHODS: This 2-group, prospective, randomized controlled trial enrolled 837 daily smokers from 5 Veterans Affairs medical centers in the upper Midwest. The telephone care group (n = 417) received behavioral counseling with mailing of smoking cessation medications as clinically indicated. The standard care group (n = 420) received intervention as part of routine health care. The primary outcome was self-reported 6-month duration of abstinence 12 months after enrollment. Secondary outcomes were 7-day point prevalence abstinence at 3 and 12 months, participation in counseling programs, and use of smoking cessation medications. RESULTS: Using intention-to-treat procedures, we found that the rate of 6-month abstinence at the 12-month follow-up was 13.0% in the telephone care group and 4.1% in the standard care group (odds ratio [OR], 3.50; 95% confidence interval [CI], 1.99-6.15). The rate of 7-day point prevalence abstinence at 3 months was 39.6% in the telephone care group and 10.1% in the standard care group (OR, 5.84; 95% CI, 4.02-8.50). Telephone care compared with standard care increased the rates of participation in counseling programs (97.1% vs 24.0%; OR, 96.22; 95% CI, 52.57-176.11) and use of smoking cessation medications (89.6% vs 52.3%; OR, 7.85; 95% CI, 5.34-11.53). CONCLUSION: Telephone care increases the use of behavioral and pharmacologic assistance and leads to higher smoking cessation rates compared with routine health care provider intervention.     

Case-finding for depression in primary care: a randomized trial.

PURPOSE: Depression is a highly prevalent, morbid, and costly illness that is often unrecognized and inadequately treated. Because depression questionnaires have the potential to improve recognition, we evaluated the accuracy and effects on primary care of two case-finding instruments compared to usual care. SUBJECTS AND METHODS: The study was conducted at three university-affiliated and one community-based medical clinics. Consecutive patients were randomly assigned to be asked a single question about mood, to fill out the 20-item Center for Epidemiologic Studies Depression Screen, or to usual care. Within 72 hours, patients were assessed for Diagnostic and Statistical Manual of Mental Disorders Third Revised Edition (DSM-III-R) disorders by an assessor blinded to the screening results. Process of care was assessed using chart audit and administrative databases; patient and physician satisfaction was assessed using Likert scales. At 3 months, depressed patients and a random sample of nondepressed patients were re-assessed for DSM-III-R disorders and symptom counts. RESULTS: We approached 1,083 patients, of whom 969 consented to screening and were assigned to the single question (n = 330), 20-item questionnaire (n = 323), or usual care (n = 316). The interview for DSM-III-R diagnosis was completed in 863 (89%) patients; major depression, dysthymia, or minor depression was present in 13%. Both instruments were sensitive, but the 20-item questionnaire was more specific than the single question (75% vs 66%, P = 0.03). The 20-item questionnaire was less likely to be self-administered (54% vs 90%) and took significantly more time to complete (15 vs 248 seconds). Case-finding with the 20-item questionnaire or single question modestly increased depression recognition, 30/77 (39%) compared with 11/38 (29%) in usual care (P = 0.31) but did not affect treatment (45% vs 43%, P = 0.88). Effects on DSM-III-R symptoms were mixed. Recovery from depression was more likely in the case-finding than usual care groups, 32/67 (48%) versus 8/30 (27%, P = 0.03), but the mean improvement in depression symptoms did not differ significantly (1.6 vs 1.5 symptoms, P = 0.21). CONCLUSIONS: A simple question about depression has similar performance characteristics as a longer 20-item questionnaire and is more feasible because of its brevity. Case-finding leads to a modest increase in recognition rates, but does not have consistently positive effects on patient outcomes.     

Encouraging primary care physicians to help smokers quit. A randomized, controlled trial

STUDY OBJECTIVE: To increase the effect that primary care physicians have on their patients who smoke. DESIGN: Randomized, controlled trial with 112 general internists and their patients who smoke. PATIENTS: Sample of 1420 patients from a general medicine clinic of a city-county teaching hospital, who smoke at least one cigarette a day and were recruited regardless of their interest in quitting smoking. INTERVENTIONS: Physicians were randomly assigned to one of four groups: participants who received a protocol for smoking management and a lecture on the consequences and management of smoking (control); in addition, had nicotine gum freely available to patients (gum); had stickers attached to their smokers' charts (reminder); or had both gum and reminders (both). MEASUREMENTS AND MAIN RESULTS: The percentage of patients with a return visit at 6 months who quit smoking (alveolar carbon monoxide of less than nine parts per million) was 1.3% (control), 7.7% (gum), 7.0% (reminders), and 6.3% (both). At 1 year the percentages were 2.7%, 8.8%, 15.0%, and 9.6%, respectively. Subsequent pairwise comparisons showed that the three intervention groups were not significantly different, but that each was significantly different from the control group (P less than 0.05). Physicians in all three intervention groups spent significantly more time than did the physicians in the control group counseling their patients about smoking. CONCLUSIONS: The availability of nicotine gum or labeling the charts of smokers can help primary care physicians increase their success rates two- to six-fold in helping patients quit smoking. If all primary care physicians used these procedures, they could help an additional 2 million smokers quit.     

A randomized controlled trial of recovery management checkups for primary care patients: Twelve-month results

Background

Primary care settings like federally qualified health centers (FQHC) are optimal locations to identify individuals with substance use disorders (SUD) and link them to SUD treatment, yet successful linkage has proven difficult. Recovery management checkups for primary care (RMC-PC) is a promising method for increasing linkage to care, engagement in treatment, and reducing substance use.

Methods

Participants (n = 266) who received screening, brief intervention, and referral to treatment (SBIRT) at four FQHC sites and needed SUD treatment were randomized to receive SBIRT only or SBIRT+RMC-PC. All participants received SBIRT prior to randomization as part of usual care while those in the experimental group also received quarterly checkups. All participants completed research interviews at enrollment and 3, 6, 9, and 12 months post-enrollment. The primary outcome was whether participants received any days of SUD treatment. Key secondary outcomes were days of SUD treatment (total and by SUD level of care), days of alcohol or drug abstinence, and a reduction in days of specific substance use, all based on self-report.

Results

Relative to participants receiving SBIRT only, participants assigned to SBIRT+RMC-PC were significantly more likely to have received any SUD treatment over 12 months (adjusted odds ratio [AOR] = 3.85) and more days of SUD treatment over 12 months (Cohen's effect size d = +0.41). The SBIRT+RMC-PC group also reported significantly more days of abstinence over 12 months (d = +0.30), fewer days of alcohol use (d = −0.20) and cannabis use (d = −0.20), and lower combined substance use frequency (d = −0.25). Days of treatment were found to positively mediate the direct effect of SBIRT+RMC-PC on days of abstinence.

Conclusion

This study provides further evidence of the effectiveness of the “referral to treatment” component of SBIRT when combined with RMC for patients in primary care settings, including those with drug use problems. Moreover, results demonstrate the value of repeated checkups on longer-term treatment and substance use outcomes.     

Fall prevention in residential care: a cluster, randomized, controlled trial

OBJECTIVES: To establish the effectiveness of a fall-prevention program in reducing falls and injurious falls in older residential care residents. DESIGN: Cluster, randomized, controlled trial. SETTING: Fourteen randomly selected residential care homes in Auckland, New Zealand. PARTICIPANTS: All older residents (n=628, 95% participation rate). INTERVENTION: Residential care staff, using existing resources, implemented systematic individualized fall-risk management for all residents using a fall-risk assessment tool, high-risk logo, and strategies to address identified risks. MEASUREMENTS: Number of residents sustaining a fall, falls, and injurious-falls incidence rates. RESULTS: During 12 months of follow-up, 103 (43%) residents in the control group and 173 (56%) residents in the intervention group fell (P<.018). There was a significantly higher incidence rate of falls in intervention homes than in control homes (incident rate ratio=1.34, 95% confidence interval=1.06-1.72) during the intervention period after adjusting for dependency level (type of home), baseline fall rate, and clustering. There was no difference in the injurious fall incidence rate or incidence of serious injuries. CONCLUSION: This fall-prevention intervention did not reduce falls or injury from falls. Low-intensity intervention may be worse than usual care.     

Long-term DHEA replacement in primary adrenal insufficiency: a randomized, controlled trial

CONTEXT: Dehydroepiandrosterone (DHEA) and DHEA sulfate (DHEAS) are the major circulating adrenal steroids and substrates for peripheral sex hormone biosynthesis. In Addison's disease, glucocorticoid and mineralocorticoid deficiencies require lifelong replacement, but the associated near-total failure of DHEA synthesis is not typically corrected. OBJECTIVE AND DESIGN: In a double-blind trial, we randomized 106 subjects (44 males, 62 females) with Addison's disease to receive either 50 mg daily of micronized DHEA or placebo orally for 12 months to evaluate its longer-term effects on bone mineral density, body composition, and cognitive function together with well-being and fatigue. RESULTS: Circulating DHEAS and androstenedione rose significantly in both sexes, with testosterone increasing to low normal levels only in females. DHEA reversed ongoing loss of bone mineral density at the femoral neck (P < 0.05) but not at other sites; DHEA enhanced total body (P = 0.02) and truncal (P = 0.017) lean mass significantly with no change in fat mass. At baseline, subscales of psychological well-being in questionnaires (Short Form-36, General Health Questionnaire-30), were significantly worse in Addison's patients vs. control populations (P < 0.001), and one subscale of SF-36 improved significantly (P = 0.004) after DHEA treatment. There was no significant benefit of DHEA treatment on fatigue or cognitive or sexual function. Supraphysiological DHEAS levels were achieved in some older females who experienced mild androgenic side effects. CONCLUSION: Although further long-term studies of DHEA therapy, with dosage adjustment, are desirable, our results support some beneficial effects of prolonged DHEA treatment in Addison's disease.     

Clinical medication review by a pharmacist of elderly people living in care homes--randomised controlled trial

OBJECTIVE: to measure the impact of pharmacist-conducted clinical medication review with elderly care home residents. DESIGN: randomised controlled trial of clinical medication review by a pharmacist against usual care. SETTING: sixty-five care homes for the elderly in Leeds, UK. Participants: a total of 661 residents aged 65+ years on one or more medicines. Intervention: clinical medication review by a pharmacist with patient and clinical records. Recommendations to general practitioner for approval and implementation. Control patients received usual general practitioner care. MAIN OUTCOME MEASURES: primary: number of changes in medication per participant. Secondary: number and cost of repeat medicines per participant; medication review rate; mortality, falls, hospital admissions, general practitioner consultations, Barthel index, Standardised Mini-Mental State Examination (SMMSE). RESULTS: the pharmacist reviewed 315/331 (95.2%) patients in 6 months. A total of 62/330 (18.8%) control patients were reviewed by their general practitioner. The mean number of drug changes per patient were 3.1 for intervention and 2.4 for control group (P < 0.0001). There were respectively 0.8 and 1.3 falls per patient (P < 0.0001). There was no significant difference for GP consultations per patient (means 2.9 and 2.8 in 6 months, P = 0.5), hospitalisations (means 0.2 and 0.3, P = 0.11), deaths (51/331 and 48/330, P = 0.81), Barthel score (9.8 and 9.3, P = 0.06), SMMSE score (13.9 and 13.8, P = 0.62), number and cost of drugs per patient (6.7 and 6.9, P = 0.5) (pounds sterling 42.24 and pounds sterling 42.94 per 28 days). A total of 75.6% (565/747) of pharmacist recommendations were accepted by the general practitioner; and 76.6% (433/565) of accepted recommendations were implemented. CONCLUSIONS: general practitioners do not review most care home patients' medication. A clinical pharmacist can review them and make recommendations that are usually accepted. This leads to substantial change in patients' medication regimens without change in drug costs. There is a reduction in the number of falls. There is no significant change in consultations, hospitalisation, mortality, SMMSE or Barthel scores.     

Couple-focused support to improve HIV medication adherence: a randomized controlled trial

OBJECTIVE: To assess the efficacy of a couple-based intervention to improve medication-taking behavior in a clinic population with demonstrated adherence problems. DESIGN: A randomized controlled trial (SMART Couples Study) conducted between August 2000 and January 2004. SETTING: Two HIV/AIDS outpatient clinics in New York City. PARTICIPANTS: Heterosexual and homosexual HIV-serodiscordant couples (n = 215) in which the HIV-seropositive partner had < 80% adherence at baseline. The sample was predominantly lower-income racial/ethnic minorities. INTERVENTION: Participants were randomly assigned to a four-session couple-focused adherence intervention or usual care. The intervention consisted of education about treatment and adherence, identifying adherence barriers, developing communication and problem-solving strategies, optimizing partner support, and building confidence for optimal adherence. OUTCOME MEASURES: Medication adherence at week 8 (2 weeks after the intervention) compared with baseline, assessed with a Medication Event Monitoring System cap. RESULTS: Intervention participants showed higher mean medication adherence at post-intervention when compared with controls whether adherence was defined as proportion of prescribed doses taken (76% versus 60%) or doses taken within specified time parameters (58% versus 35%). Also, participants in the intervention arm were significantly more likely to achieve high levels of adherence (> 80%, > 90%, or > 95%) when compared with controls. However, in most cases, effects diminished with time, as seen at follow-up at 3 and 6 months. CONCLUSION: The SMART Couples program significantly improved medication adherence over usual care, although the level of improved adherence, for many participants, was still suboptimal and the effect was attenuated over time.     

Psychotropic medication withdrawal and a home-based exercise program to prevent falls: a randomized, controlled trial.

OBJECTIVE: To assess the effectiveness of psychotropic medication withdrawal and a home-based exercise program in reducing falls in older people. DESIGN: A randomized controlled trial with a two by two factorial design. SETTING: Seventeen general practices in Dunedin, New Zealand. PARTICIPANTS: Women and men aged 65 years registered with a general practitioner and currently taking psychotropic medication (n = 93). INTERVENTIONS: Two interventions: (1) gradual withdrawal of psychotropic medication versus continuing to take psychotropic medication (double blind) and (2) a home-based exercise program versus no exercise program (single blind). MEASUREMENTS: Number of falls and falls risk during 44 weeks of follow-up. Analysis was on an intent to treat basis. RESULTS: After 44 weeks, the relative hazard for falls in the medication withdrawal group compared with the group taking their original medication was .34 (95% CI, .16-.74). The risk of falling for the exercise program group compared with those not receiving the exercise program was not significantly reduced. CONCLUSIONS: Withdrawal of psychotropic medication significantly reduced the risk of falling, but permanent withdrawal is very difficult to achieve.     

Listening to music decreases need for sedative medication during colonoscopy: a randomized, controlled trial.

BACKGROUND: Music played during endoscopic procedures may alleviate anxiety and improve patient acceptance of the procedure. A prospective randomized, controlled trial was undertaken to determine whether music decreases the requirement for midazolam during colonoscopy and makes the procedure more comfortable and acceptable. METHODS: Patients undergoing elective colonoscopy between October 2003 and February 2004 were randomized to either not listen to music (Group 1; n=40) or listen to music of their choice (Group 2; n=38) during the procedure. All patients received intravenous midazolam on demand in aliquots of 2 mg each. The dose of midazolam, duration of procedure, recovery time, pain and discomfort scores and willingness to undergo a repeat procedure using the same sedation protocol were compared. RESULTS: Patients in Group 2 received significantly less midazolam than those in Group 1 (p=0.007). The pain score was similar in the two groups, whereas discomfort score was lower in Group 2 (p=0.001). Patients in the two groups were equally likely to be willing for a repeat procedure. CONCLUSION: Listening to music during colonoscopy helps reduce the dose of sedative medications and decreases discomfort experienced during the procedure.     

Home-based medication review in a high risk elderly population in primary care--the POLYMED randomised controlled trial

OBJECTIVE: To assess whether home-based medication review by a pharmacist for at-risk older patients in a primary care setting can reduce hospital admissions. DESIGN: Randomised controlled trial comparing home-based medication review with standard care. SETTING: Home-based medication review of 136 patients registered with one general practice. METHOD: Study participants were over 80 years of age, living at home, taking four or more medicines, and had at least one additional medicines-related risk factor. The intervention comprised two home visits by a community pharmacist who educated the patient/carer about their medicines, noted any pharmaceutical care issues, assessed need for an adherence aid, and subsequently met with the lead GP to agree on actions. MAIN OUTCOME MEASURE: Total non-elective hospital admissions within 6 months. Secondary outcomes included number of deaths, care home admissions and quality of life (EQ-5d). Impact on number of medicines prescribed was also assessed. RESULTS: At 6 months, no difference in hospital admissions (21 intervention versus 20 control P = 0.80), and no difference in care home admissions or deaths were detected between groups. There was a small (non-significant) decrease in quality of life in the intervention group. There was a statistically significant reduction in the mean number of medicines prescribed ( -0.87 items in favour of the intervention group, 95% confidence interval -1.66 to -0.08, P = 0.03). CONCLUSIONS: No positive impact on clinical outcomes or quality of life was demonstrated, however, this intervention did appear to reduce prescribing. This is in line with other evidence and suggests that this form of intervention may not have a clear health gain, but may lead to modest savings in terms of reduced prescribing. Future research should focus on whether such a prescribing effect would make this type of intervention cost effective.     

Plasma amino-terminal pro-brain natriuretic peptide and accuracy of heart-failure diagnosis in primary care: a randomized, controlled trial

OBJECTIVES: The purpose of this study was to determine the effect of amino-terminal pro-brain natriuretic peptide (N-BNP) on the diagnostic accuracy of heart failure (HF) in primary care. BACKGROUND: The accurate diagnosis of patients with suspected HF presenting in primary care is difficult. Amino-terminal pro-brain natriuretic peptide is present in high levels in cardiac dysfunction and may improve the diagnostic accuracy of HF in primary care. METHODS: The Natriuretic Peptides in the Community Study was a prospective, randomized controlled trial of the effect of N-BNP on the accuracy of HF diagnosis. Patients presenting to their general practitioner (GP) with symptoms of dyspnea and/or peripheral edema were included. The GPs formulated an initial diagnosis based on clinical assessment. All patients underwent a full cardiologic assessment that included echocardiography and N-BNP. Each patient was randomized to the BNP group (GP received the N-BNP result) or the control group (GP did not receive the N-BNP result). Patients were then reviewed by their GP, and their diagnosis was reviewed. The primary end point was the accuracy of the GPs' diagnoses compared with the panel standard. RESULTS: A total of 305 patients were included; mean age was 72 years, 65% were female. Seventy-seven patients met the panel criteria for HF. The diagnostic accuracy improved 21% in the BNP group and 8% in the control group (p = 0.002). The main impact of N-BNP measurement on diagnostic accuracy was the GPs' correctly ruling out HF. The number needed to diagnose by N-BNP measurement was seven patients. CONCLUSION: This study demonstrates that N-BNP measurement significantly improves the diagnostic accuracy of HF by GPs over and above customary clinical review.     

Primary care for patients infected with human immunodeficiency virus: a randomized controlled trial

OBJECTIVE: To measure the impact of a teaching intervention and to compare process and outcomes of care for HIV-infected patients randomly assigned to a general medicine clinic (GMC) or an infectious disease clinic (IDC) for primary care. DESIGN: Prospective, randomized, controlled trial. SETTING: University hospital in Durham, NC. PATIENTS: Two hundred fourteen consecutive HIV-infected patients presenting for primary care. INTERVENTION: Physicians at the GMC received HIV-related training and evidence-based practice guidelines. MEASUREMENTS: Utilization of services, health-related quality of life, preventive and screening measures, and antiretroviral use for one year. RESULTS: At baseline GMC patients were more likely to be African American (85% vs 71%; P =.03) and had lower baseline CD4+ cell counts than IDC patients (262 +/- 269 vs 329 +/- 275; P =.05). A similar and high proportion of patients in both groups received appropriate preventive care services including Pneumocystis carinii pneumonia (PCP) prophylaxis, pneumococcal vaccination, and antiretroviral therapy. Screening for TB was more frequent in GMC (89% vs 68%; P =.001). In the year following randomization, GMC patients made more visits to the emergency department than IDC patients (1.6 +/- 3.0 vs 0.7 +/- 1.5; P =.05). Hospital use was higher for GMC patients with average length of stay 7.8 +/- 6.3 days compared to 5.7 +/- 3.8 days for IDC patients (P =.01). In analyses, which adjust for potential baseline imbalances, these differences remained. CONCLUSIONS: Targeted education in GMC achieved similar provision of primary care for GMC patients, yet use of health care services was higher for this group. The delivery of adequate primary care is necessary but not sufficient to produce changes in health care utilization.     

Effect of telephone counseling on physical activity for low-active older people in primary care: a randomized, controlled trial

OBJECTIVES: To assess the long-term effectiveness of a telephone counseling intervention on physical activity and health-related quality of life in low-active older adults recruited through their primary care physician. DESIGN: Randomized, controlled trial. SETTING: Three primary care practices from different socioeconomic regions of Auckland, New Zealand. PARTICIPANTS: One hundred and eighty-six low-active adults (aged 65) recruited from their primary care physicians' patient databases. INTERVENTION: Eight telephone counseling sessions over 12 weeks based on increasing physical activity. Control patients received usual care. MEASUREMENTS: Change in physical activity (as measured using the Auckland Heart Study Physical Activity Questionnaire) and quality of life (as measured using the Short Form-36 Health Survey (SF-36)) over a 12-month period. RESULTS: Moderate leisure physical activity increased by 86.8 min/wk more in the intervention group than in the control group (P=.007). More participants in the intervention group reached 2.5 hours of moderate or vigorous leisure physical activity per week after 12 months (42% vs 23%, odds ratio=2.9, 95% confidence interval=1.33-6.32, P=.007). No differences on SF-36 measures were observed between the groups at 12 months. CONCLUSION: Telephone-based physical activity counseling is effective at increasing physical activity over 12 months in previously low-active older adults.